Oracle Empirica Signal User Guide and Online Help

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Ali
Oracle Health Sciences Empirica

Signal
User Guide and Online Help
Release 9.1.x
F31971-07
Oracle Health Sciences Empirica Signal User Guide and Online Help, Release 9.1.x
F31971-07
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Contents
Preface
Documentation accessibility xvii
Related resources xvii
Access to Oracle Support xvii
Additional copyright information xvii
1 Start here
Log in to Oracle Empirica Signal 1-1
Prerequisites and usage notes 1-2
View release notes and other documents 1-6
About the Oracle Empirica Signal application 1-6
Signal detection methods 1-8
Common tasks and tools 1-15
Set your user preferences 1-17
Change your password 1-25
Print a table 1-25
Use Help 1-26
Send feedback 1-27
Exit Oracle Empirica Signal 1-27
FAQs 1-28
What is a project? 1-28
Data mining FAQs 1-29
About tables 1-37
Specify a SQL WHERE clause 1-40
How do I select hierarchy terms? 1-43
How do I select values from a list? 1-48
Specify hierarchy versions for timestamped data 1-50
Use hierarchy tables 1-52
What is an alias? 1-53
How can a saved list keep me from having to select values individually? 1-53
Typing values in text boxes 1-54
iii
2 Review signal information
Overview of Signal Review 2-1
Signal Review configurations: interactive vs. scripted 2-1
Configured alerts: tracked vs. informational 2-2
Start with the Signal Review pages 2-3
Keyboard shortcuts for the Products and Product-Event Combinations tables 2-4
View aggregate information for a selected group or product 2-5
Step 1: Choose a published configuration 2-5
Choose a published configuration 2-5
Why you might have multiple configurations 2-5
Step 2: Select a product or group of products to investigate 2-6
Start with the Signal Review Products page 2-6
Panels on the Products page 2-8
Choose a grouping from the Products By drop-down 2-8
Filter the Products table to the selected group 2-10
Focus on a single product from the Products table 2-11
Enter a note about a product 2-11
View notes about a product 2-12
View event comments 2-12
Change the name of a monitored product 2-13
Use sector maps 2-14
Step 3: Investigate product-event combinations for a product 2-18
Panels of the Product-Event Combinations page 2-19
Investigate product-event combinations for a product 2-22
View product-event combinations for a card or tab 2-24
Perform a periodic review 2-25
Use Row Selection mode 2-26
Save a modified product-event table as a new view 2-26
Add a tab to the Product-Event Combinations panel 2-28
Product-event combination statistics 2-28
Focus on a product-event combination 2-30
Add a private comment 2-30
Add a private comment to multiple combinations 2-31
Assign a reviewer to a product-event combination 2-32
View the signal history 2-32
View signals for similar product-event combinations 2-33
View product-event interactions 2-34
Suppress a product-event combination 2-36
Limit the product-event combinations to a specific alert type 2-37
View age group breakdown in a bar graph 2-37
iv
View gender breakdown for a product-event combination 2-38
Step 4: Submit the review 2-38
Submit a review for a product-event combination 2-38
Submit a review for multiple combinations 2-40
3 Use Oracle Empirica Topics

Overview of topic management 3-2
About topics, actions, and the calendar 3-4
Display the Topic Management page 3-4
Sections of the Topic Management page 3-5
Download the Topics or Actions table 3-7
Sections of the Topics tab 3-8
Sections of the Actions tab 3-10
Sections of the Calendar tab 3-13
Keyboard shortcuts for the Topics and Actions tables 3-14
Select a topic workflow configuration 3-15
Choose which items to view on the Topics, Actions, and Calendar tabs 3-16
Define the set of topics to work with 3-16
Graph the distribution of topics and actions by a specific field 3-17
Filter the Topics and Actions tables 3-18
Manage the columns on the Topics and Actions tables 3-19
Work with topics 3-21
View topics 3-22
Filter the Topics table 3-24
View a topic 3-25
Quickly access topic information 3-26
Open a topic from the Recent Topics list 3-26
View Topic and Edit Topic pages 3-27
Edit the general information about a topic 3-31
Associate a topic with a product-event combination 3-33
Make a topic visible to a work team 3-34
Add or view comments for a topic 3-35
Link topics 3-36
Remove a link 3-36
Add a topic 3-37
Reopen a topic 3-39
Delete a topic 3-39
View the history of a topic 3-40
Viewing topic reports 3-40
About topic reports 3-40
v
Generate a predefined topic report in Oracle Business Intelligence 3-41
Predefined Oracle Business Intelligence topic reports 3-42
Create a topic PDF or ZIP file 3-46
You can document changes to the current contents of a topic 3-47
Select attachments to include information about a topic in a PDF or ZIP file 3-47
Select content attributes for a topic PDF or ZIP file 3-48
About the Topic History section of a topic exported to PDF 3-50
Work with actions 3-50
Work with actions 3-51
View all actions 3-52
View a topic from the Actions table 3-53
View actions for a topic 3-53
View Action and Edit Action pages 3-54
Edit the general information about an action 3-57
Add or view comments for an action 3-58
Add an action 3-59
Delete an action 3-60
View the history of an action 3-61
Reopen an action 3-61
Work with the calendar 3-61
View actions on the calendar 3-62
Pick a date from the Calendar view 3-62
Work with attachments 3-63
About attachments 3-63
Save Oracle Empirica Signal objects as attachments 3-63
Oracle Empirica Signal objects types 3-64
Select a topic to save an Oracle Empirica Signal attachment to 3-65
Save to Topic dialog box 3-66
Save Oracle Empirica Signal tables and graphs as attachments 3-67
View tabular data as an attachment 3-69
Add other types of attachments 3-70
Add an attachment to a topic or action 3-70
Work with attachments 3-71
Edit attachment information 3-71
Add or view comments for an attachment 3-72
View source details for an attachment 3-72
Add an attachment count column to the Topics or Actions table 3-73
4 Initiate and monitor data mining runs

What is a data mining run? 4-1
vi
View data mining runs 4-2
Data Mining Runs page 4-3
Create a Data Mining Run 4-3
Step 1: Select the run type and data configuration 4-3
Step 2: (For timestamped data only) Select the as-of date 4-5
Step 3: Select the variables 4-5
Step 4 for MGPS runs: Specify data mining parameters 4-7
Step 4 for logistic regression runs: Select the events and specify drugs 4-12
Step 5: Define data mining run options 4-14
Step 6: Name the data mining run 4-15
Step 7: Submit the data mining run 4-15
Reference 4-18
About MGPS runs 4-19
MGPS computations 4-20
MGPS independence model 4-22
Information Component computations 4-23
RGPS computations 4-24
Use the PRR calculator 4-25
PRR computations 4-27
Select a case series for PRR computation 4-30
ROR computations 4-31
About logistic regression runs 4-33
Logistic regression computations 4-34
Guidelines for specifying drugs for logistic regression 4-41
Drug and event hierarchies 4-42
Timestamped data 4-43
Specify an As Of date 4-44
Stratification variables 4-44
Dimensions and patterns 4-45
View interactions 4-48
Manage custom terms 4-48
What are custom terms? 4-48
Define custom terms 4-49
Define subsets for an MGPS run 4-51
Select a subset variable 4-51
Define subset values 4-51
Define subset labels 4-53
Subset variables 4-54
View source data 4-56
What is source data? 4-56
View a data source table 4-58
vii
Source database tables 4-59
Set viewing options for a data source table 4-62
Filter a data source table 4-63
Manage data mining runs 4-64
Rename a data mining run 4-64
View details of a data mining run 4-64
Arrange the columns on the Data Mining Runs page 4-68
View jobs for a data mining run 4-69
View job details for a data mining run 4-71
Define a database restriction 4-72
Refine a query to create a database restriction or custom term 4-73
Cancel or delete a data mining run 4-74
Re-run a data mining run 4-76
Data configuration and object compatibility 4-78
Publish a data mining run 4-79
Logistic regression log files 4-80
5 Retrieve and review data mining results

About data mining run results 5-1
Load the run and select variables 5-1
Look up drug names 5-3
View results tables 5-4
View a data mining results table 5-4
Data mining results for MGPS runs 5-5
Data mining results for logistic regression runs 5-14
Find and select a data mining run 5-18
Precision of displayed values in data mining results 5-20
Create a case series from a results table 5-21
View results graphs 5-22
View a data mining graph 5-22
Work with results graphs 5-23
Set graph cutpoints and palette choices 5-24
Graphs for 2D results 5-25
View a bar graph 5-27
Bar graphs 5-29
View a confidence interval graph 5-30
Confidence interval graphs 5-32
View a discrete map graph 5-33
Discrete map graphs 5-35
viii
View a cumulative map graph 5-36
Cumulative map graphs 5-38
View a sector map 5-39
Sector maps 5-42
View a hierarchy graph 5-45
Hierarchy graphs 5-47
View an overlap graph 5-48
Overlap graphs 5-50
View a nested confidence interval graph 5-51
Nested confidence interval graphs 5-53
Drill down through data 5-54
Add a drilldown map table 5-54
Drilldown options 5-57
View a list of cases from the Data Mining Results page 5-57
View case details 5-58
Case ID links 5-60
Create a case series from drill-down information 5-60
6 Query the safety database

View existing queries 6-1
Queries and the query library 6-2
Create, edit, and run a query 6-3
Step 1: Create and edit a query 6-3
Step 2 (Optional): Specify query logic 6-5
Step 3: Preview the query 6-6
Step 4: Save the query 6-6
Step 5: Run a query 6-7
Step 6: Work with the cases retrieved by the query 6-8
Manage your queries 6-8
Create a query from an existing query 6-9
Specify query values 6-9
Use logical and set operators 6-10
View query logic 6-17
Rename a query 6-17
7 Create and manage case series

About case series 7-1
ix
Case Series page 7-2
Create and manage case series 7-5
Create a query-based case series 7-5
Create an empty case series 7-7
Transfer cases to a case series 7-7
Manually add cases to a case series 7-8
Save a case series 7-9
Publish a case series 7-9
Work with case series 7-10
View existing case series 7-10
View cases in a case series 7-11
Rename a case series 7-12
Copy a case series 7-13
Combine case series 7-14
Case series background processing 7-15
What is background processing for case series? 7-15
How does the background processing job queue for case series work? 7-15
Background processing job status for case series 7-16
Cancel a background processing job for a case series 7-16
8 Manage report definitions and output

About reports 8-1
Report structure 8-2
View existing report definitions 8-2
Built-in reports 8-3
Create report definitions 8-11
Create a report definition 8-12
Step 1: Select a case series for a report 8-13
Step 2: Name a report definition 8-14
Step 3: Add rows and columns to a report definition 8-15
Step 4: Specify a data source in a report 8-17
Step 5: Specify content details 8-18
Step 6: Preview a report 8-23
Step 7: Run a report and work with report data 8-23
Step 8: Save a report output 8-25
Work with report definitions 8-26
Select entries using a match string 8-26
Edit a report definition 8-28
Copy a report definition 8-29
Rename a report definition 8-30
x
Publish a built-in or interactive report definition 8-30
Use XML to create a report definition 8-31
Specify report attributes/descriptors 8-32
Edit report attributes 8-32
Allow report drilldown 8-33
Specify report restrictions 8-33
Edit report descriptors 8-34
Specify variable breakdowns 8-36
Define breakdown details 8-36
Define breakdown by distinct values 8-39
Define breakdown by individual values 8-41
Edit individual value labels 8-44
Define breakdown by grouped values 8-45
Cutpoints 8-46
Define breakdown by cutpoints 8-47
View column statistics 8-48
Define breakdown by query values 8-49
Report background processing 8-50
About background processing for reports 8-50
About background processing job queues for reports 8-50
About background processing job status for reports 8-51
View background processing job status for reports 8-51
Cancel a background processing job for a report 8-51
Create and run interactive reports 8-52
About interactive reports 8-52
Interactive Reports page 8-53
Create or edit an interactive report definition 8-54
Run an interactive report 8-56
Create a report definition file 8-57
Run a report using a report definition file 8-57
Query-based interactive reports 8-59
Define a query for an interactive report definition 8-59
Create a query-based report output 8-60
Summary of all cases interactive reports 8-61
About all cases summary reports 8-61
Create an all cases summary report output 8-63
Manage interactive reports 8-64
View an interactive report definition 8-64
Delete an interactive report definition 8-64
Work with report outputs 8-65
View existing report outputs 8-65
xi
Rename a report output 8-67
Work with a report output 8-67
Work with report graphs 8-69
Work with report graphs 8-69
Report graph types 8-70
Graph display options 8-71
Aggregate bar graphs 8-71
About aggregate bar graphs 8-71
View an aggregate bar graph 8-72
Detail bar graphs 8-73
About detail bar graphs 8-73
View a detail bar graph 8-76
Box plot graphs 8-77
About box plots 8-77
View a box plot 8-79
Scatter plot graphs 8-80
About scatter plots 8-80
View a scatter plot 8-82
9 Set up and use drug profiles

About drug profiles and layouts 9-1
Drug Profile page 9-1
Select drugs for a drug profile 9-2
Select a drug profile layout 9-3
Add a chart to a drug profile layout 9-4
Print or copy charts (Drug Profile page) 9-5
Link to an outside URL 9-6
Define the Links menu 9-6
Manage drug profile layouts 9-7
Manage existing drug profile layouts 9-7
Create a new drug profile layout 9-8
Save a drug profile layout 9-10
Order charts in a drug profile layout 9-11
Rename a drug profile layout 9-11
Publish a drug profile layout 9-12
Chart types and options 9-12
Work with chart options 9-12
Sector map graph (Drug Profile page) 9-13
Bar graph (Drug Profile page) 9-16
Confidence interval graph (Drug Profile page) 9-17
xii
Nested confidence interval graph (Drug Profile page) 9-18
Cumulative map graph (Drug Profile page) 9-19
Reports (Drug Profile page) 9-21
10 Settings and administration

Specify settings 10-1
Manage users, login groups, and work teams 10-2
Ways to administer users 10-2
How user permissions work 10-3
What superusers can do 10-8
Manage users 10-8
View existing users 10-9
Add or edit a user in a self-hosted environment 10-10
Add or edit a user in an Oracle-hosted environment 10-13
Assign roles to a user 10-16
Assign permissions to a user 10-16
Change user passwords 10-17
Rename a user 10-17
About user names 10-18
Purge users 10-19
Change the authentication method for a user 10-20
Delete a user 10-20
Manage user profiles 10-21
View user profiles 10-21
Add or edit a user profile 10-22
Assign roles to a user profile 10-23
Assign permissions to a user profile 10-23
Assign preferences to a user profile 10-24
Apply a user profile 10-24
Manage user roles 10-25
Predefined user roles 10-25
View existing user roles 10-27
Create a user role 10-27
Edit a user role 10-27
Delete a user role 10-28
Manage login groups 10-28
View existing login groups 10-28
Create a login group 10-29
Edit a login group 10-30
Delete a login group 10-31
xiii
Manage work teams 10-31
About work teams 10-31
Work team permissions 10-32
View existing work teams 10-35
Add or edit a work team 10-37
Assign permissions to work team members 10-38
Use single sign-on 10-38
About single sign-on 10-38
Configure single sign-on in a self-hosted environment 10-39
Manage LDAP users 10-40
Configure Oracle Empirica Signal for use with LDAP in a self-hosted
environment 10-40
LDAP properties 10-42
Import LDAP users 10-44
Change a user to LDAP authentication 10-45
Refresh LDAP users 10-45
System configurations 10-46
Select a data configuration 10-46
Manage configurations 10-48
About data configurations 10-48
View existing data configurations 10-49
Data configuration example 10-50
Add a data configuration 10-51
Modify a data configuration 10-63
Manage subscription data releases 10-77
Manage subscription data releases 10-77
Import a subscription data release 10-79
Manage aliases 10-80
Manage aliases 10-80
Add or edit an alias 10-82
Manage drug profile configurations 10-82
About drug profile configurations 10-82
Set up the Drug Profiles feature 10-83
View existing drug profile configurations 10-87
Add or edit a drug profile configuration 10-87
Save a drug profile configuration 10-89
View a drug profile configuration 10-90
Rename a drug profile configuration 10-92
Manage signal configurations 10-92
Manage signal configuration reference data 10-93
Edit a signal configuration 10-93
xiv
Manage Signal Configurations page 10-96
Configure alerts 10-98
Set up for interactive signal management and review 10-102
Manage interactive signal configuration refreshes 10-109
Manage signal comment types 10-115
Assign reviewers 10-118
Arrange or download tables 10-121
Manage events and custom terms 10-127
Manage signal views 10-132
Manage reviewer-user mapping 10-136
Map reviewers to users 10-136
Manage topic workflow configurations 10-136
Topic workflow configuration design 10-137
Definitions in the sample topic workflow configuration 10-138
Set up Oracle Empirica Topics 10-141
Manage Topic Workflow Configurations page 10-142
Add a topic workflow configuration 10-143
Work with topic workflow configurations 10-146
Manage fields 10-154
Manage topic states 10-177
Manage action states 10-182
Manage topic templates 10-186
Manage email notification rules 10-197
Transform data 10-202
About data transformations 10-203
Map text values 10-204
Custom terms and mapped text values 10-207
Define variable cutpoints 10-207
Convert dates 10-210
Exclude synthetic values 10-211
Administer the system 10-212
Set site options 10-212
Send a message to all users 10-217
Manually restart the listener process 10-218
Manage run storage 10-218
Manage data mining run storage 10-218
Export data mining run data 10-219
Import data mining run data 10-219
Mark a data mining run as archived 10-220
Move a data mining run with a Move script 10-220
Create a run definition file 10-221
xv
Change user default data mining runs 10-221
Monitor the system 10-221
View currently logged in users 10-222
View the user activity audit trail 10-222
About auditing 10-223
View the server status 10-225
View free disk space 10-225
View the batch report queue 10-225
Truncate a report batch run 10-226
Set up saved lists 10-226
About saved lists 10-226
Saved Lists page 10-226
Create or edit a saved list 10-228
Add saved lists in bulk 10-229
View or print a saved list 10-229
Set permissions for a saved list 10-230
xvi
Preface
This preface contains the following sections:
• Documentation accessibility
• Related resources
• Access to Oracle Support
• Additional copyright information
Documentation accessibility
For information about Oracle's commitment to accessibility, visit the
Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?
ctx=acc&id=docacc.
Related resources
All documentation and other supporting materials are available on the Oracle Help
Center.
Access to Oracle Support

Oracle customers that have purchased support have access to electronic support
through Support Cloud.
Contact our Oracle Customer Support Services team by logging requests in one of the
following locations:
• English interface of Oracle Health Sciences Customer Support Portal (https://
hsgbu.custhelp.com/)
• Japanese interface of Oracle Health Sciences Customer Support Portal (https://
hsgbu-jp.custhelp.com/)
You can also call our 24x7 help desk. For information, visit http://
www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html or visit
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.
Additional copyright information

This documentation may include references to materials, offerings, or products that
were previously offered by Phase Forward Inc. Certain materials, offerings, services,
or products may no longer be offered or provided. Oracle and its affiliates cannot be
held responsible for any such references should they appear in the text provided.
xvii
1
Start here
• Log in to Oracle Empirica Signal
• Prerequisites and usage notes
• View release notes and other documents
• About the Oracle Empirica Signal application
• Signal detection methods
• Common tasks and tools
• Set your user preferences
• Change your password
• Print a table
• Use Help
• Send feedback
• Exit Oracle Empirica Signal
• FAQs
Log in to Oracle Empirica Signal

You log in to Oracle Empirica Signal with the username and password that your site
administrator provided. If your site administrator has enabled single sign-on, you can
log in to the application using your single sign-on username and password. When you
log in, the application authenticates your username using a case-insensitive match.
For example, jkelley and JKelley both resolve to the jkelley username.
Note:
If you are using Internet Explorer, prior to logging in to the Oracle Empirica
Signal application, configure your Internet Explorer browser for printing color
and downloading, as described in Prerequisites and usage notes
To log in initially:
1. Open the Google® Chrome, Microsoft® Edge, or Microsoft® Internet Explorer
browser.
2. Navigate to the URL provided by your site administrator.
3. Log in using your Oracle Empirica Signal username or single sign-on username.
1-1
Chapter 1
Prerequisites and usage notes
To log in using your Oracle Empirica Signal username:

1. In the Username field, enter the username provided by your site administrator.
The username field is not case sensitive. You can enter your username in
uppercase, lowercase, or mixed case.
2. In the Password field, enter your user password. The password field is case
sensitive. You must enter your password using the same case (upper, lower, or
mixed) that was used when the password was defined. Oracle recommends that
you then change your password immediately.
If a message appears stating that your password is due to expire, click Click
here to change your password. If you do not change your password, the warning
message appears each time you log in, until your password expires and you are
forced to change it.
3. Click Log In or press Enter.
The page you set to display initially when you log in to the Oracle Empirica Signal
application in user preferences appears.
Note:
Do not open more than one Oracle Empirica Signal session at the same
time.
To log in using your single sign-on username:

• If you are currently logged in via single sign-on, no login page appears. You can
access Oracle Empirica Signal without re-entering your username and password.
• If you are not currently logged in via single sign-on, the Single Sign-on Login page
appears. Enter your single sign-on username and password, and then click Log
In.

The Oracle Empirica Signal application requires Google® Chrome, Microsoft® Edge, or
Microsoft® Internet Explorer (IE), version 11.
Configure Google Chrome
Clear the cache in Chrome

1. Open the Chrome browser.
2. From the Customize and control Google Chrome menu ( ) on the far right of
the browser header, select More tools, then Clear browsing data.
3. On the Basic tab, select Cached images and files, then click Clear data.
4. To close the Chrome browser, click the Customize and control Google Chrome
menu ( ) and select Exit.
Allow pop-ups within Oracle Empirica Signal

1. Open the Chrome browser.
1-2
Chapter 1
2. From the Chrome menu on the right of the browser header, select Settings.
3. In the left pane, under Privacy and security, select the Site Settings link.
4. Under Content, select the Pop-ups and redirects link.
5. Select Add and enter the Oracle Empirica Signal URL.
6. Select Add and enter [*.]oracle.com.
Note:
If Chrome blocks a pop-up window, it displays an icon to the right of the URL
address area ( ). If this happens, you can also allow pop-ups for Oracle
Empirica Signal by:
1. Clicking the icon ( ).

2. Selecting the radio button option to Always allow pop-ups
and redirects from [your Oracle Empirica Signal site] and
[*.]oracle.com.
Configure Microsoft Edge
Clear the cache in Edge

1. Open the Edge browser.
2. From the Settings and more menu ( ) on the far right of the browser header,
select Settings.
3. From the left pane of the Settings tab, select Privacy, search, and services.
4. From the Clear browsing data section, click Choose what to clear.
5. Select Cached cached images and files, then click Clear Now.
6. Close the Settings tab.
Turn off the pop-up blocker

1. Open the Microsoft Edge browser.
2. From the Settings and more menu ( ) on the far right of the browser header,
select Settings.
3. In the left pane, select Cookies and site permissions.
4. In the right pane, under All permissions, select Pop-ups and redirects.
5. In the Allow section, select Add and enter the Oracle Empirica Signal URL, then
click Add.
6. Select Add and enter [*.]oracle.com, then click Add.
7. Close the Settings tab.
1-3
Chapter 1
Configure Internet Explorer
Clear the cache in Internet Explorer

1. Open the Internet Explorer browser.
2. From the Tools menu, select Internet options.
3. On the General tab, in the Browsing history section, click Delete.
4. On the Delete Browsing History dialog box, select the Temporary Internet files
and website files checkbox.
5. Click Delete.
6. Click OK to close the Internet options dialog box.
Allow pop-up windows only for Oracle Empirica Signal

2. From the Tools menu, select Pop-up Blocker, and then select Pop-up Blocker
Settings.
3. Add the Oracle Empirica Signal URL and *.oracle.com to the list of allowed
sites.
Alternatively, turn off the pop-up blocker for all pop-ups

2. From the Tools menu, select Pop-up Blocker, and then select Turn Off Pop-up
Blocker to toggle it off.
Specify print background colors

1. From the IE File menu, select Page Setup.
2. Check the Print Background Colors and Images checkbox. This setting allows
Oracle Empirica Signal to print the color key along with a graph and the shading
for table column headers and grid lines.
Specify required Internet Explorer browser settings
1. Click the IE gear icon ( ):

2. Turn off Compatibility View.
3. Set the following Internet options:
• Set the cache information to check every time you visit the web page.
Under the General tab, under Browsing history, click Settings to open the
Website Data Settings dialog box.
• To avoid a warning message when using the Copy to Clipboard feature, add
the Oracle Empirica Signal URL to the browser’s Trusted sites. Under the
Security tab, select Trusted sites, click the Sites button, and add the Oracle
Empirica Signal URL.
• Enable Allow script-initiated windows without size or position
constraints. Under the Security tab, select Trusted sites, select Custom
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level to open the Security Settings dialog box. The setting is in the
Miscellaneous section.
• To allow Oracle Empirica Signal to download data, make sure the Do
not save encrypted pages to disk checkbox is unchecked. Under the
Advanced tab, in the Security section. Due to a limitation in IE, when you
download data you may not be able to use the Open button in the File
Download dialog box. If you encounter problems opening a file, use the Save
option and then open the saved file. Or, you can clear Internet Explorer's
cache.
Settings that apply to all browsers
The browser's Back button

Because the appearance of many pages presented by the Oracle Empirica Signal
application relies on choices made on previous pages, Oracle recommends that you
do not use the browser's Back button. Choices made on other pages may not be
captured appropriately. To make navigation between pages easier, while providing
accurate information on each page, Back links appear on many application pages.
It is preferable to use these Back links, and the left navigation pane, to navigate to
another page.
Multiple sessions
Do not run more than one session of the application using multiple browser sessions
or several tabs in the same browser.
Adobe ® Acrobat ® Reader

For certain features in Oracle Empirica Signal, you can download to a PDF (Portable
Document Format) file. To do so, you must install Adobe Acrobat Reader on your
computer. Adobe Acrobat Reader is freely distributed software for viewing and printing
PDF files, and is available at www.adobe.com.
You also need Adobe Acrobat Reader to view any PDF files that may be provided as
links in this help system.
A PDF file that you create for a topic might include links to open ZIP files that
are attached to the topic. Security features in Adobe Acrobat Reader might prevent
you from opening a ZIP file from within the PDF file. See the Adobe website for
instructions on modifying this behavior.
If you are using Adobe Acrobat Reader 6.x, you might need to set link options
correctly to view certain types of attachments from within a topic PDF file.
ZIP file utility

If you create ZIP archive files when downloading data, you must have a ZIP file
compression and extraction utility, such as WinZip, installed on your computer. WinZip
is available at www.winzip.com. You must also associate the file extension .zip with
the ZIP file utility.
Microsoft Excel
If you plan to download data to Microsoft Excel®, make sure that Excel is installed on
your computer.
SAS System Viewer

To view files that you create by downloading data to SAS Version 5 transport
files (.xpt files), you need the SAS® System Viewer. The SAS® System Viewer
is freely distributed software for viewing and printing .xpt files, and is available at
www.sas.com.
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View release notes and other documents
Base SAS
To use files that you create by downloading data to SAS data step definition files
(.sas files), you need Base SAS®. Base SAS® is a third-party application that you can
purchase at www.sas.com.
Built-in reports
To run the built-in reports delivered with the Oracle Empirica Signal application,
you must set up a data stub, as described in AERS(1q03: S) Configuration
Installation Instructions (located in the Data_Stub folder on the
installation CD).
View release notes and other documents

The latest product documentation is available from the Oracle Help Center.
To view release notes and other documents maintained on your server, in the left
navigation pane, select Settings ( ), then click About.
The relevant links are at the bottom of the page.
About the Oracle Empirica Signal application

Oracle Empirica Signal offers an analysis environment for exploring post-marketing
safety data. The product supports pharmacovigilance and risk management activities
at pharmaceutical companies and regulatory agencies.
Oracle Empirica Signal generates statistical scores for combinations of products and
events in a product safety database, and detects signals (unexpected associations of
products and events).
1. Set up the database(s)

The source data may be public data, such as the data in the FDA Adverse Event
Reporting System (AERS); Vaccine Adverse Event Reporting System (VAERS); WHO
Vigibase ADR (Adverse Drug Reaction) databases; PMDA Japanese Adverse Drug
Event Report (JADER) database; or your organization's proprietary product-safety
database. Oracle offers data subscriptions for AERS (beginning with extract 2012Q4,
FDA refers to the data as FAERS), VAERS and VigiBase data. Argus Mart data can
also be used with Oracle Empirica Signal. OCS provides support for incorporating
proprietary data sets.
If you have the Manage Configurations user permission and onboarding for the client
machine is complete, you can import the database from within Oracle Empirica Signal
and configure the Manage Subscription Data Releases feature.
2. Define data configurations

Once an Oracle safety database is set up, you define data configurations in Oracle
Empirica Signal to specify the source data available for data mining and how it can be
used. For example, if the source data includes both trade names and generic names
for products, the data configuration can specify that data mining be performed using
generic names only.
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About the Oracle Empirica Signal application
3. Perform data mining runs

Once you have created data configurations, you can perform data mining runs. A data
mining run extracts data from the source and applies a statistical algorithm to generate
signal scores. Oracle Empirica Signal offers different algorithms as options for data
mining runs:
• Multi-item Gamma Poisson Shrinker (MGPS)—For MGPS data mining runs,
you can indicate a variety of parameters, such as the number of ways in which
products and events are combined. For example, a run can generate scores for
combinations of up to five values, enabling the study of product interactions and
medical syndromes. You can specify a database restriction to specify cases to
include in a run.
• Regression-adjusted Gamma Poisson Shrinker (RGPS)—If R and RGPS are
installed, you can include computations of RGPS in a two-dimensional MGPS data
mining run that does not include subsets.
• Information component (IC)—You can include Information Component as an
additional option to an MGPS run.
• Proportional Reporting Ratios (RRR)—You can include computations of
PRR and ROR in an MGPS run. PRR computation relates to product-event
combinations only, in two-dimensional data mining runs. In two-dimensional
data mining runs, the application computes the ROR only for product-event
combinations.
• Logistic Regression (LR)—These data mining runs model how the probability
of an event appearing in an adverse event report depends on multiple predictors
(both demographic factors and the presence/absence of various products), which
can be important for obtaining unbiased results in the presence of polytherapy.
4. View the data mining run results

Once a run is completed and published for use by other Oracle Empirica Signal users,
you can view the resulting signal scores in tabular or graphical format. You can select
criteria to choose results for review and sort the results as needed. You can also
choose a variety of options for displaying the table or graph. If a hierarchy is available,
representing different levels for product or event terms, you can specify terms at any
of these hierarchical levels before reviewing results. For example, you can view the
scores for combinations of a particular product and any event in a particular MedDRA
System Organ Class (SOC), the highest level in the MedDRA event hierarchy.
If appropriate site options and permissions are set up, you can drill down from run
results to view the list of cases involved. For example, the combination of ProductA
and EventB has a high signal score and there are 12 cases with that product-event
combination. You can drill down to view a list of those 12 cases, and then drill down to
detailed information about any of those cases.
You can also print tables or graphs of results and download them for use in
applications such as Microsoft Excel (.xls, .csv) or Microsoft Word (.rtf).
5. (Optional) Monitor potential safety signals

Signal review is an optional feature in the Oracle Empirica Signal and Topics
application to view disproportionality analysis statistics for successive updates of
safety data, allowing monitoring of alerts and evaluating of changes in safety signals
over time.
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Signal detection methods
6. Query data and define and run reports

You can query the source data based on criteria that you specify. You can save the
query results as a case series, which is a list of cases of interest.
In addition to reports that are delivered with Oracle Empirica Signal, you can construct
your own reports by specifying which variables to include as columns and which
variables determine report rows. There are two types of reports:
• Regular reports, which are non-interactive and are run against cases in a case
series.
• Interactive reports, which are based on a specified query for which you can supply
values when running the report.
Note:
A special type of interactive report is the All Cases Summary report, which is
used for drug profiles.
7. View drug profiles

From the Drug Profile page, you can view drug profiles, which are presentations of
statistical and other information about one or more selected drugs. Depending on how
the drug profile feature is set up, you can view existing charts or create your own. Drug
profiles are made up of charts, which can be either of the following:
• A graph based on the results of a data mining run.
• A graph or table based on a report output.
A drug profile layout is a saved collection of charts, as well as their placement and
display options.
8. (Optional) Track signals with topics

By selecting Topic Management, an optional feature, from the left navigation pane, you
can use the Oracle Empirica Topics feature to organize and track tables, graphs, and
documents related to particular subject matter. For example, issues identified through
various means, such as automated signal detection, literature review, regulatory
requests, and so on, can be saved as attachments to a topic.
You can set up topics to follow workflow through different states, such as Initial,
Reviewed, and Closed. You can also assign topics to users and make them visible to
work teams.
Note:
This information was excerpted from the WebVDME Newsletter, Volume
2, Issue 2 (Autumn 2005). WebVDME is the previous name of the Oracle
Empirica Signal application.
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What benefits can signal detection methods bring to the pharmacovigilance effort, and
what are the costs? How can different methods be compared and assessed? What
do data mining statistics do? The information in this article is intended to help non-
statisticians understand similarities and differences between the statistical algorithms
that are used for safety data mining. It can also help reframe these concerns into
new questions that can make your evaluation and implementation of signal detection
methods more effective.
What do data mining statistics do?

Data mining is the process of applying statistical algorithms to a database, resulting
in the generation of statistical values or scores. As part of a pharmacovigilance effort,
these scores can alert safety evaluators to potential safety issues, including actual
safety signals.
At Oracle, we believe that data mining statistics yield information that safety evaluators
can use to help prioritize investigations. Whether a pharmacovigilance group uses
data mining or not does not change the need for experienced medical professionals
to perform careful evaluations to determine causal relationships between drugs and
adverse events.
What data mining statistics do is indicate the strength of the association between a
drug of interest and an event in the reporting database: the higher the score, the
stronger the statistical association.
Statistical association vs. causal relationship

While a strong association (high score) may indicate a causal relationship between
the drug and the event, it could also be the result of some other circumstance:
some examples include an AE that is an indication for the drug (known as “reverse
causality”), or a product-event combination that has been subject to media attention
and that has a higher reporting rate than would otherwise occur as a result (often
called “publicity effects”). A strong association can also indicate a causal relationship
that is already known and labeled.
So, while a high score may serve as an alert to a previously undetected problem,
medical knowledge is crucial to the interpretation of data mining results.
Prioritizing with rankings or thresholds

When used with a large database, such as the public FDA AERS data, data mining
statistics help users sort through several million potential combinations of drugs and
events. Even a hypothetical pharmacovigilance department with an unlimited staff and
budget, that could investigate every possible product-event relationship for causality,
could use data mining statistics to help them determine which reviews to undertake
first.
Using ranking
A straightforward way to prioritize investigations using statistical scores would be to
start with the highest score generated and work down through the list to the lowest
score. Outside of our hypothetical big-bucks department, practical considerations
mean that the number of investigations must be limited: a prioritization approach that
ranks scores might result in investigations into the top 10, 250, or 10,000 scores,
whatever number is feasible for a group’s resources.
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Choosing a threshold
Another way to limit the number of investigations is to choose one score as a
threshold. Any score that exceeds this predetermined threshold alerts reviewers to
a potential signal for investigation. Unlike the cutoff for ranking, the number of scores
above the threshold will fluctuate over time. But, like ranking, departments can select
a threshold score that makes the best use of their resources while helping prioritize
investigations.
Other factors to consider

Regardless of whether ranking or a threshold is used for the scores, some reports are
likely to be prioritized ahead of any others: a safety evaluator wouldn’t have to wait
for a high data mining score to flag just one new report of Torsade de pointes, QT
prolongation, Stevens-Johnson syndrome, or a similar sentinel event as a high priority
for investigation. Serious events in general are likely to need investigation earlier than
less serious events. To meet this need for different prioritization levels, a low threshold
could be set for sentinel events, a slightly higher one for other serious events, and a
third threshold for all other events.
Problems in nonscientific public safety databases, including the biases that result from
under reporting, over reporting, and publicity effects, have been widely discussed.
When working with signal scores generated from these databases, a higher threshold
(or set of thresholds) might be used than when working with a smaller, more controlled
and complete company database.
For departments that use ranking as the prioritization method, the relative reliability
of the sequencing or ordering of the scores produced by a method may be a
consideration. When a threshold is used, any score above that threshold is examined,
while with ranking, the highest scores should reflect the strongest associations.
Other considerations, including company goals, the medical knowledge and safety
evaluation experience of individual evaluators, and other tools available for the
pharmacovigilance effort, also contribute to the prioritization effort.
What are the data mining statistics?

Some of the data mining statistics that are widely used for signal detection are:
• EBGM – Empirical Bayes Geometric Mean
• IC – Information Component
• PRR – Proportional Reporting Ratio
• ROR – Reporting Odds Ratio
Each of these statistics is the result of a different statistical algorithm. All
of the algorithms were designed to uncover the same type of information: a
disproportionately high occurrence of reports for an event and drug, when compared
to reports for that event in the entire database. As a result, for large sample sizes, the
score that each of these statistics produces for any given product-event combination is
likely to be similar.
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Note:
The sample size (N) generally is defined as large if there are 20 or more
instances of a product-event combination in the database.
Drugs that are new to the market, or that are prescribed to a small number of patients,
may have a small presence in the database. For these drugs, the N may be quite low,
which tends to make scores calculated for their product-event combinations low also.
Some data mining algorithms include statistical techniques that compensate for
disparate sample sizes in the safety database and the extreme scores that can result.
How does the method cope with statistical uncertainty?

The PRR and ROR statistics do not in themselves indicate a level of certainty or
uncertainty due to a small sample size. Rather, each product-event combination is
often accompanied by an additional statistic, a chi squared test statistic, and its
corresponding p (significance) value. When you assess a PRR or ROR value, you
are supposed to suspect the reliability of large values unless the chi squared value is
very large (or, equivalently, the p value is very small). However, there is no clear rule
for evaluating a large PRR value that has a moderate p value. Similarly, there is no
rule for adjusting for the “multiple comparisons” problem, in that you are focusing on
the few largest values of PRR or ROR out of millions that may have been computed in
a data mining run.
The algorithms that calculate IC and EBGM address both statistical variability due to
small N and multiple comparisons by using a technique called “Bayesian shrinkage.”
This statistical technique results in a single relative reporting ratio (with confidence
limits) that is easier to interpret directly without the added complexity of a separate
chi squared or p value. Reporting ratios that are based on small counts (and that
are therefore less reliable) are “shrunk” or moved toward the value 1 using an
appropriate Bayesian probability formula. The set of EBGM scores across all product-
event combinations is more restricted than the set of unshrunk scores, so focusing on
more extreme EBGM scores is less likely to lead to overestimates of the true reporting
ratios than would searching for the largest values of PRR or ROR. The IC method has
a similar advantage.
The Bayesian shrinkage technique primarily affects estimates of product-event
reporting ratios based on small counts or small expected counts (that is, when reports
mentioning either the drug or the event are quite rare in the database.) Other statistical
issues, such as confounding, can cause biased relative reporting ratios even for more
frequent product-event combinations.
Can the method adjust for confounding?

When data mining scores are calculated, adjustments can be made for “confounding”
variables. Confounding variables occur in any database that is not completely random.
In a drug safety database, for example, a drug that is administered only to the elderly,
or only to male subjects, or that is new on the market, has the subject’s age group or
gender or the report’s receipt year (or all three) as a confounding variable.
The presence of confounding variables in the data can result in high scores
for product-event combinations that otherwise would not have a strong statistical
association. For example, a drug that is generally prescribed for women over 50, and
an event that occurs more frequently for women over 50, may well result in a high
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score for the combination of that drug and event, based only on the coincidence of the
gender and age group involved.
Statistical techniques are available to adjust for confounding variables: for example, a
technique called Mantel-Haenszel stratification (used in MGPS) divides the database
into groups, one for each value that the variable in question has in the database,
and then recalculates an overall score. When a technique like stratification is used,
the result is often a lower score (and investigational priority) for a product-event
combination that is affected by a confounding variable, while the effect is minimal
on scores for combinations that are not subject to confounding.
Why do statistics for significance matter?

Each of the data mining statistics listed above, IC, EBGM, PRR, and ROR, indicate
the strength of the association between a drug and an event. Each one can also
have associated scores that indicate the statistical significance (or uncertainty) of the
relationship. As mentioned above, for the PRR and ROR statistics, the chi-squared
test of statistical significance can be used to calculate a p value. Unfortunately, the
chi squared and p values are in different units than are the basic reporting ratio
values, making it hard to interpret them all together. The algorithms for EBGM and
IC represent statistical uncertainty with confidence limits, which are less likely to be
misinterpreted.
Calculations for significance incorporate information about the sample size. The p
value indicates the likelihood that such a large reporting ratio could occur by chance
alone if the drug and the event are completely unrelated, but does not provide
information about what range of reporting ratios are most likely. A confidence interval
shows what range of reporting ratios are consistent with the data. A small N results in
a wide confidence interval: the larger the N, the narrower the confidence interval.
Using significance scores

A pharmacovigilance group might choose to prioritize investigations based on scores
for statistical significance, rather than for association, to avoid following up potential
associations that could have arisen merely by chance. However, using a PRR or ROR
p value to rank associations may result in excessive focus on drugs and events that
are common overall in the database. This may occur because frequently reported
drugs and events may have reporting ratios that are only slightly greater than 1, but
have very tiny p values. Investigating these product-event combinations can potentially
eclipse larger reporting ratios for less-frequently reported drugs or events.
Both the statistical significance and the reporting ratio can contribute to a prioritization
system. This is easier to accomplish with confidence limits than with p values. Ranking
product-event combinations by their lower confidence limits (for MGPS, by using EB05
rather than EBGM) provides an extra layer of protection against false alarms due to
chance fluctuation (beyond that afforded by the Bayesian shrinkage discussed above).
Comparing significance and association scores

Comparing the scores for both types of statistics can also be revealing. This illustration
shows two product-event combinations that have identical EB05 scores. The higher
EBGM score for the first combination, however, indicates a stronger likelihood of an
association than the EBGM score for the second combination. This graph also gives
an indication of the relative number of reports in the database for each combination:
Combination 1 has fewer reports than Combination 2, since its confidence interval is
relatively wide.
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Some pharmacovigilance groups may find it effective to prioritize investigations based

on both significance and association scores, rather than relying on only one score.
For example, a threshold of EBGM>2 AND EB05>1 could be used. This is roughly
equivalent to the common recommendation for PRR, which requires PRR > 2 AND N >
2 AND chi squared > 4.
Benefits: automated, objective analysis

Signal detection methods are an independent and automated process for assessing
all of the product-event combinations in a safety database, which may contain millions
of records. Using these statistics can provide earlier warning than methods that rely
on human knowledge, skill, and intuition, and reduce the amount of effort needed to
discover signals in safety data.
The value of using a signal detection method is highest when scores
alert pharmacovigilance professionals to previously unknown, unexpected, or
uncharacteristic events that happen more frequently in combination with one drug
than with most all other drugs. These objectively produced alerts can then be
evaluated using other pharmacovigilance tools to determine the possibility of a causal
relationship.
Costs: false alarms

When a pharmacovigilance group uses data mining scores to prioritize investigation,
resources may be spent investigating “false positives,” or high scores that do not, in
fact, indicate a relationship or causal relationship.
Conversely, a “false negative” can occur when a low score is calculated for a product-
event combination that is, in fact, causally related. Errors of both types can occur with
any signal detection method.
If data mining scores are used alone to determine investigational priorities, the
group is faced with a conundrum: if you investigate fewer high scores to reduce
false positives, you may also increase the number of false negatives. The need for
efficiency must be balanced against the cost of missing any true signals.
Fortunately, pharmacovigilance professionals have access to other tools to help make
the best choices they can for the situations they need to address. Impact analysis,
tracking changes in scores over time, and the “other factors to consider” described
above can help a department make the best use of the information that the statistical
scores are designed to give them.
Summary: comparing signal detection methods

One way to assess the comparative value of different signal scores is to evaluate
the results of different algorithms when used to data mine the same database. When
setting up such a test, these questions can act as guidelines for the comparison:
• Is the same minimum sample size used by all of the algorithms?
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Chapter 1
• Is stratification used for all of the algorithms? What confounding variables were
selected?
• Are the scores selected for comparison all scores for statistical association, or are
they all scores for statistical significance?
• How many signal scores does each algorithm generate over all?
• Is the same threshold used for all scores?
It may be difficult to know how many true signals there are in the database used for
the test. If the number is known, then the number of false positives and false negatives
produced by each algorithm can also be compared.
Improving statistical algorithms

With WebVDME 5.0, Oracle introduced a new statistical method for evaluation of
database disproportionately ratios: Logistic Regression. This statistical technique is
intended to support focused investigations into possible polypharmacy effects. Logistic
Regression currently alerts WebVDME users to potential signals in cases where the
scores calculated by other algorithms do not adjust for confounding by polypharmacy
or cloaking. Oracle is also researching the potential for this statistical technique to
serve as a database screening tool.
Data mining bibliography

The following articles can provide additional information and detail.
Faich G. Department of Health and Human Services, Food and Drug
Administration. Risk Management Public Workshop: Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment. Transcript of April 11, 2003: 53-65 [online].
Available from URL: www.fda.gov/cder/meeting/ RMtranscript3.doc [Accessed 2005
Sep 12]
Clark JA, Klincewicz SL, Stang PE. Spontaneous Adverse Event Signaling Methods:
Classification and Use with Health Care Treatment Products. Epidemiologic Reviews
2001; 23 (2): 191-210
DuMouchel W. Bayesian data mining in large frequency tables, with an application to
the FDA Spontaneous Reporting System (with discussion). The American Statistician
1999; 53 (3): 177-202
DuMouchel W, Pregibon D. Empirical Bayes screening for multi-item associations.
In: Conference on Knowledge Discovery in Data. Proceedings of the seventh ACM
SIGKDD international conference on Knowledge discovery and data mining. 2001 Aug
26-29; San Francisco (CA). New York: ACM Press, 2001: 67-76
Fram DM, Almenoff JS, DuMouchel W. Empirical Bayesian data mining for discovering
patterns in post-marketing drug safety. In: Conference on Knowledge Discovery in
Data. Proceedings of the ninth ACM SIGKDD international conference on knowledge
discovery and data mining. 2003 Aug 24-27; Washington, D.C. New York: ACM Press,
2003: 359-368
Hauben M, Reich L. Safety related drug-labelling changes: findings from two data
mining algorithms. Drug Saf 2004; 27(10):735-44
Lilienfeld DE. A challenge to the data miners. Pharmacoepidemiology and Drug Safety
2004 Dec; 13 (12): 881-884
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Common tasks and tools
van Puijenbroek EP, Bate A, Leufkens HGM, Lindquist M et al. A comparison of

measures of disproportionality for signal detection in spontaneous reporting systems
for adverse drug reactions. Pharmacoepidemiology and Drug Safety 2002; 11: 3-10

You can update your preferences.
Set user preferences

1. Your username appears in the upper right-hand corner of each page. Click the
down-arrow and select Preferences.
2. On the Set User Preference page, enter or edit your preferences for working with
Oracle Empirica Signal.
Navigate
The left navigation pane contains actions that are always available. The list of actions
depends on your permissions and the site options.
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Chapter 1
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Chapter 1
Set your user preferences
• Home: Click to return to your Oracle Empirica Signal home page.
• Signal Review: Click to display the Products and Product-event combinations

pages.
• Topic Management: Click to display Topics.
• Data Analysis: Click to access the data analysis pages. The menu options vary
depending on your permissions and can include data mining runs, data mining
results, queries, case series, reports, and drug profiles.
• Feedback: Click to provide feedback about Oracle Empirica Signal to Oracle

(about the product or user assistance).
• Settings: Click to display settings you can specify or change depending on your
permissions.
• Help: Click to display the help topic associated with the current page.

A user preference is a setting that customizes Oracle Empirica Signal for your
username. Your user preference settings have no effect on any other Oracle Empirica
Signal users.
Note:
If you have the permission to create user profiles, you can also set user
preferences for a user profile.
1. At the top of the main page, click your user name and select Preferences.
2. Modify the user preferences described in the table below.
3. Click Save.
General user preferences

The following user preferences apply to all users and take effect immediately unless
otherwise noted.
Category Preference Description

Preference for dates and Time Zone From the Time Zone drop-
times: down list, select the time
zone to be used for server
datetimes that are displayed
in Oracle Empirica Signal for
your username. This user
preference has no effect on
the source safety data (for
example, an event date shown
in case details) or on the
display of As Of dates for
timestamped data.
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Chapter 1

Preferences for logging in: On login, display this page From the drop-down list,
choose a page to display
automatically when you log in
to Oracle Empirica Signal. The
available options may depend
on your user permissions,
as well as Oracle Empirica
Signal site options set for your
organization.
Preferences for logging in: Show table scrollbars on left Select this check box to
display vertical scrollbars on
the left side (instead of
the right side) of tables of
information. This option is not
available on the Signal Review
pages but is available for
pop-up windows opened from
Signal Review.
Note: This option may not
take effect until the next time
you log in.
Preference for Query Show case count by default on Show the count of cases
Wizard: preview page on the Preview Query page.
On the Queries page, select
Display Case Count in Query
Preview. Computation of the
case count can be time-
consuming. Display it only
when necessary.
Note: This preference appears
only if appropriate Allow Case
Count on Query Preview
Page checkbox of site option
has been enabled.
Preferences for Default download file type From the drop-down list, select
downloading data: the file type you use most
frequently to download data.
Preference for viewing Graph color palette From the drop-down list, set
graphs: a default color scheme for the
graph key for graphs based on
the results of data mining runs
(this preference has no effect
on graphs based on report
data).
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Chapter 1

Preferences for viewing Days to retain visited status for Specify the number of days
case details: case ID link that an underlined case ID
that you can click to view
case details appears in a
different color. This preference
applies to case IDs for only
your username and to all data
associated with configurations
within the same database
group. The default number of
days, which is used if you
leave the number of days
empty, is 45. If you specify 0
as the number of days, the
color of a visited link does
not change. This preference
affects only data associated
with data configurations that
are in database groups. See
Case ID Links.
Preferences for viewing Wrap Wide Tables Check to wrap table displays
case details: on the Case Details page.
Wrapping tables makes the
vertical display longer. Not
wrapping tables makes the
horizontal display wider and
can necessitate scrolling to
the right to see all columns in
the tables.
Preferences for viewing Show Table of Contents Check to show a table of
case details: contents on the Case Details
page. The table of contents
consists of links that jump
to the data displayed on the
page.
Preferences for selecting and viewing run results
Note:
These preferences are available only to users with the View Data Mining
Results permission.
When you set the following user preferences, they take effect immediately.
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Chapter 1
Preference Description
Default Run From the drop-down list, select a data mining
run to appear by default in the Run Name field
on the Select Criteria page when you go to the
Data Mining Results page for the first time in
an Oracle Empirica Signal session. You can
select any run listed on your Data Mining Runs
page. You can also specify <Last Used> or
<No Run>.
Display Only Results with score-type Scores Specify a default minimum score for viewing
Over number results of a data mining run for the first time.
The score type and value that you specify
appear on the Select Criteria page as a
default, but you can change them as needed
before reviewing results. You can set a default
minimum for:
• EBGM —Applies to MGPS runs only.
• EB05 —Applies to MGPS runs only.
• N —Applies to run results for any type
of data mining run (however, does not
apply to the tables of results for covariates
or interactions if they are produced for a
logistic regression run).
This preference affects only run results that
you have never viewed. Once you have viewed
a run, the setting that you choose on the
Select Criteria page is used for that run until
you change it.
If you select a statistic other than N, a default
of LROR>0 is used for logistic regression run
results.
Enable Adverse Event Hierarchy Browser Check to browse and select terms from the
hierarchy for tasks that require you to select
event values. For an event variable that is
set up in the data configuration to have an
associated hierarchy, the Select <hierarchy>
Terms link appears for these tasks; for
example, Select MedDRA Terms.
Enable Drug Hierarchy Browser Check to browse and select terms from the
hierarchy for tasks that require you to select
drug values. For a drug variable that is set up
in the data configuration to have an associated
hierarchy, the Select <hierarchy> Terms link
appears for these tasks; for example, Select
ATC Terms.
Include SQL WHERE Clause for Advanced Check to enable use of a SQL WHERE
Results Selection clause for selecting results criteria. To view all
advanced options, click Show Advanced on
the Select Criteria page.
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Preference for creating runs
Note:
These preferences are available only to users with the Create Data Mining
Run permission.
Minimum Count Specify a default for the Minimum Count field
on the Data Mining Parameters page. You can
override this default as needed.
Replace Missing Values with Specify text to represent missing values for
variables in the results of data mining runs
that you execute. For example, if you set
this preference to ^missing^ the results table
shows ^missing^ for any item that has no value
in the database. You cannot use spaces or
the following characters in your replacement
string: * \ ” : / ? > <
This preference affects only the appearance
of run results, and not the source data. When
you access source data, as when drilling down
from a case series, missing values display as
blank.
The Job Details page for a run's extraction job
(accessible from the Jobs for Run page) shows
the value that was in effect for missing data for
the run.
Note:
Other users who
view results of a
run that you
executed will
also see the
missing value
that was set as
your user
preference at the
time you
executed the run.
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Chapter 1
Exclude associations if items are of the same Check to include a default for a field on
type (all drugs, all events) the Data Mining Parameters page when you
create a new MGPS data mining run. You
can override this default as needed. The
recommended setting is checked. Checking
this preference improves time and space
utilization because fewer results are loaded
into the results table.
Preferences for viewing drug profiles
Note:
These preferences are available only to users with the View Drug Profiles
permission.
Drug Profile Configuration From the drop-down list, select the drug profile
configuration. The drug profile configuration
determines the source of graphs and reports
that you can add as charts to a drug profile
layout. You must set this preference to access
the Drugs Profiles page. Available drug profile
configurations are those that you created or
that are published to you. (If you have the
Administer Users permission, they also include
unpublished configurations created by users in
your login group.)
Drug Profile Layout From the drop-down list, select the drug
profile layout, the name of a saved collection
of charts, as well as their placement and
display options. Layouts are not associated
with a particular drug profile configuration.
Available layouts are those that you created
or that are published to you. (If you have the
Administer Users permission, they also include
unpublished layouts created by users in your
login group.)
Use this setting in the following situations:
• You have not previously used a drug
profile layout on the Drug Profile page.
• You delete the layout you were last using
and then return to the Drug Profile page
without having selected a layout.
• You click a drug name on the Signal
Review Products page.
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Chapter 1
Preferences for viewing signals

If your organization uses the signal review component of Oracle Empirica Signal, there
are additional user preferences. If you set the following user preferences, they take
effect the next time you log in.
Note:
These preferences are available only to users with the View Signal
Management permission.
Signal Management Configuration From the drop-down list, select a signal
configuration. Available signal configurations
are those that you created or that are
published to you.
If you set the preference to --, the signal
configuration associated with your login group
is used.
You can also update this preference directly on
the Signal Review page by selecting another
Signal Management configuration from the
dropdown box at the top of the page.
Allow SQL WHERE Clause on the Signal Check to enable the user of a SQL WHERE
Review Page clause to restrict rows that appear on the
Products page, Automatic Assignments page,
Product-Event Combinations page, and Event
Comments page.
Preferences for working with topics
Note:
This preference is available only to users with access to at least one
topic workflow configuration. To change the configuration on the Topic
Management page, the user must have View Topics permission and more
than one topic workflow configuration published to the user's login group.
If you set the following user preference, it takes effect immediately.
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Chapter 1
Topic Workflow Configuration From the drop-down list, select a topic
workflow configuration. Available topic
workflow configurations are those that you
created or that are published to you.
This setting overrides the association between
your login group and a topic workflow
configuration. For example, if your login group
is associated with configuration A, but you
specify configuration B as the preference,
configuration B is in effect the next time you
log in. The override is intended to facilitate
testing of configurations that you create or edit.
Note:
You can change
your topic
workflow
configuration
selection on the
Topic
Management
and the User
Preferences
pages. A change
from one of
these pages
updates the
selection on the
other page.
If you set the preference to –, the topic

workflow configuration associated with your
login group is used.
Note:
If you select a
topic workflow
configuration that
requires each
topic to be visible
to one and only
one work team,
you must also
define
membership in a
work team and
assign
appropriate work
1-24
Chapter 1
Change your password
team
permissions.
Change your password

Each username has an associated password. You can change your own password at
any time. For example, you might want to change it periodically for security reasons.
A user who has the Administer Users permission can also change your password. For
example, if you have forgotten your password, that user can set a new password for
you.
If your password is due to expire, a warning message appears when you log in. Click
the link in the message and go to step 3, below.
Note:
If your authentication method is single sign-on or LDAP, you cannot change
your password in Oracle Empirica Signal.
1. At the top of any page, click Settings.

2. Click Change Password.
3. In the Old Password field, enter your current password.
4. In the New Password field, enter a new password. Site options determine
the required password length and the types of characters allowed (alphabetic,
numeric, non-alphanumeric, lowercase, uppercase, and so on). There may be
restrictions on the re-use of old passwords.
To log in to Oracle Empirica Signal application, you must enter your exact
password in the correct case (upper, lower, or mixed).
5. In the Confirm Password field, re-enter your new password.
Oracle Empirica Signal updates your password. The next time you log in, you must
use your new password. The password expiration period, if one has been set as a site
option, begins for the new password.
Print a table
To print the entire table:
1. Set up the displayed table as you want it to appear when printed. The table prints
with the same columns and sort order as the displayed table.
2. Click Print.
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Chapter 1
Use Help
To print only the data on the currently displayed page of the table:
1. From the browser File menu, select Print. (This option is available only if the table
appears in a browser window and not a separate dialog box.)
2. Optionally, change the orientation of the paper (Portrait or Landscape) and make
other printing choices. If all displayed columns do not print in Landscape mode,
you can remove columns from the table before printing it.
3. Select a printer.
4. Click Print.
Use Help
The Oracle Empirica Signal Online Help system provides information about pages,
procedures for performing Oracle Empirica Signal activities, and conceptual and
instructional topics.
The Help system is context-sensitive; that is, if you click the Help link on an Oracle
Empirica Signal page, information about that page appears.
• Help topics include underlined links that you can click to display more information.
• Help topics remain open until you close them. You can leave the Help open in the
background while you are using the application.
1. In the left navigation pane, click the Help icon ( ) or click Help on an Oracle
Empirica Signal page. Help for the page that you are viewing appears in a new
browser window.
2. To view the main help page, click Show Table of Contents at the top of the help
page. The main help window includes a toolbar with the following buttons:
Button Description
Table of Contents Display the table of contents for the Help
system.
1. In the table of contents, expand a top-level
entry in the table of contents by clicking
either its name or the closed book icon
before its name. The icon changes to
2. Click a topic name to display the topic in
the right-hand side of the Help window.
Search To find help topics containing a particular word

or phrase:
1. Click the Search button ( ) on the left.

2. Select Search this book.
3. Type a word or phrase and click the
Submit button ( ).
4. Click a listed topic to display it.
Download Click the Download button ( ) to download

a PDF version of the help for offline use and
printing.
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Chapter 1
Send feedback
Send feedback
Oracle welcomes your comments, problem reports, suggestions, or requests about the
Oracle Empirica Signal application.
You can send feedback to the email address specified as a site option.
1. In the left navigation pane, click the Feedback icon ( ).

2. In the Subject field, enter the subject of your message.
3. In the Please enter your comments text box, type the text of your message.
4. Click Send.
5. When informed that your message has been sent, click Continue.
The user who is set up to receive feedback receives an email message. In the
email message:
• The date and time of the message is the date and time when you clicked
Send.
• The From line shows the email address associated with the username with
which you are logged in.
• The Subject line shows the text you entered in the subject line of the feedback.
• Above your comments is a line identifying the application and your full name.
Exit Oracle Empirica Signal

You should ensure that you exit the Oracle Empirica Signal application before closing
your browser. If you close your browser without exiting, your session continues to
run for some time before the automated timeout and may retain system resources
unnecessarily.
You can exit the Oracle Empirica Signal application, however, while background
processing jobs are running. Background processing jobs are not affected by your
logout, and continue running after you exit the application.
If you logged in using your single sign-on username and password, exiting the Oracle
Empirica Signal application may log you out of your single sign-on environment,
or from Oracle Empirica Signal only, depending on your Oracle Empirica Signal
configuration.
1. Click the down arrow next to your user name, visible in the upper right-hand corner
of each page. Select Exit.
A message appears, indicating that you are logged out of the application.
If you logged in using your single sign-on username and password and your site
administrator specified a custom logout page, that page appears.
2. To log in to Oracle Empirica Signal again, with the same or a different username,
click the link provided on the logout page.
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Chapter 1
FAQs
Note:
From outside of the Oracle Empirica Signal application, your system
administrator can specify the number of minutes before automated session
timeout occurs for Oracle Empirica Signal users. The session timeout occurs
if you have not performed any action within the time period, regardless of
whether or not a job you initiated, such as a data mining run, is running in the
background.
FAQs
• What is a project?
• Data mining FAQs
• About tables
• Specify a SQL WHERE clause
• How do I select hierarchy terms?
• How do I select values from a list?
• Specify hierarchy versions for timestamped data
• Use hierarchy tables
• What is an alias?
• How can a saved list keep me from having to select values individually?
• Typing values in text boxes
What is a project?
A project in the Oracle Empirica Signal application is an organizational tool (similar to
a folder) that allows you to group certain objects for reference, searching, and retrieval
purposes.
On the Oracle Empirica Signal pages that list objects (such as data mining runs,
queries or case series), you can select a project to filter the list to only objects in that
project. Projects have no effect on any computations.
When creating an object, you can assign it to an existing project or create a new
project. The list of existing projects includes projects for objects that you created or
that are published to you. You can also choose not to use projects at all. By default,
objects are unassigned.
Note:
A project remains available until all objects associated with it have been
deleted.
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Chapter 1
FAQs
Data mining FAQs

Why data mining?
1. What is the primary motivation for applying statistical data mining to the
AERS database?
The Oracle Empirica Signal application acts as a screening device to sort through
several million potential drug/event combinations. You can use the application to
prioritize tasks and decide what is random noise versus associations that need
further investigation. The output is available as new questions are raised.
2. How might the availability of a safety data mining system affect the way that
safety evaluators go about doing their work?
The data mining feature identifies and investigates potential problems in
spontaneous safety data. You can use data mining to identify potential signals,
prioritize pharmacovigilance activities, and complete evidence-based reviews.
Interpretation of results
1. How can you determine that you are seeing more of some AE than expected
for a particular drug when you do not know the number of prescriptions
filled for that drug (the denominator)?
The technique of disproportionality analysis, upon which the Oracle Empirica
Signal application is based, uses all reports that mention a drug as a surrogate
for the exposure.
2. Does the lack of exposure data make it impossible to differentiate between
a relatively safe drug that reports few events and another drug that reports
more events?
The method looks at particular adverse events rather than overall reporting rate.
If prescription data is available, then overall reporting rate is worth looking at. In
most circumstances, however, the method is less biased than a reporting rate for a
particular AE.
3. Does the fact that you do not know the reporting rate for a drug and/or
event (for example, what percentage of true drug-related adverse events
are actually reported to FDA) create a problem in obtaining quantitative
estimates of product-event association?
The fact that the reporting rate is unusually high or low for a particular drug does
not affect the results as long as the reporting rate for that drug is uniformly high
or low across all events. An unusually high or low reporting rate for a particular
event does not affect the results as long as the reporting rate for that event is
uniformly high or low across all drugs. It is possible that publicity about a particular
problem with a drug might cause the report rates for particular product-event
combinations to increase without corresponding increases in the overall report
rates for the drug or the event. If that happens, the corresponding associations
from disproportionality methods, such as MGPS, becomes biased upward.
Counts
1. Where does the notion of an expected count come from?
Observed counts for each product-event combination of interest:
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Chapter 1
FAQs
Event Drug of interest All other drugs

Event of interest a=N b
All other events c d
Expected counts (E):

Event of interest E(a) = ((a+b)(a+c))/ E(b) = ((a+b)(b+d))/
(a+b+c+d) (a+b+c+d)
All other events E(c) = ((c+d)(a+c))/ E(d) = ((c+d)(b+d))/
(a+b+c+d) (a+b+c+d)
The quantity E(a) is the number of product-event combinations of interest that

would be expected if the event of interest appears in reports independently of the
drug of interest.
Observed count / Expected count = Relative Reporting Ratio (N/E = RR).
Do not confuse the use of RR as an abbreviation for Relative Reporting Ratio
in the Oracle Empirica Signal application with the concept of relative risk, which
cannot be estimated from spontaneous report frequencies. Relative Reporting
Ratio is also different from reporting rate, which can only be estimated if you
know both the number of reported and unreported events. RR in the context
of data mining of a spontaneous report database is the ratio of the number of
occurrences of the product-event combination of interest to the expected number
if the proportion of reports with that event among reports involving that drug were
the same as the overall proportion in the database. RR is a disproportionality
measure.
2. What does it mean if the expected count is less than 1?
Based on the total number of reports separately for the drug and event, it is
expected, statistically, that there would be less than one report of the combination
if the drug and event are not associated. The expected count (E) for a product-
event combination can be less than 1 when either the number of reports for the
drug, or the number of reports for the AE, is small. It is common for E to be less
than 1 (sometimes even E < .001) for a rarely reported drug combined with a
rarely reported event. This causes the ratio N/E to fluctuate wildly when N goes
from 0 to 1 or more.
3. How does the EBGM statistic differ from the concept of an observed count
(for a product-event combination) divided by an expected count?
EBGM is an improved estimate of the Relative Reporting Ratio (RR). Technically,
EBGM is defined as the exponential of expectation value of log(RR), where, in this
case, the probabilities determining expected value are not based on assuming
independence of drugs and events, but are based on statistical measures of
the dependencies exhibited in the database overall and for each product-event
combination. (In Bayesian terminology, this is called the posterior distribution.)
EBGM has the property that it is nearly identical to N/E when the counts are
moderately large, but it shrinks towards the average value of N/E (typically ~1.0)
when N/E is unreliable, because of instability issues with small counts.
The posterior probability distribution also supports the calculation of lower and
upper 95% confidence limits (EB05, EB95) for the relative reporting ratio.
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FAQs
EB05 and EB95

1. Explain the meaning of EB05 and EB95.
The Oracle Empirica Signal application distinguishes between the observed value
of RR = N/E and the true value of the Relative Reporting Ratio that would
be observed if a much larger database (so large that sampling error would be
negligible) were to be drawn from the same conceptual population of reports. This
unknown quantity, sometimes abbreviated as true RR or true N/E, can be bounded
probabilistically:
EB05 is a value such that there is about a 5% probability that the true value of N/E
lies below it.
EB95 is a value such that there is about a 5% probability that the true value of N/E
lies above it.
The interval from EB05 to EB95 is the 90% confidence interval. The confidence
interval is a way to describe the uncertainty in an estimate due to small sample
size (the larger the number of reports, the narrower the confidence interval). EB05
and EB95 describe the probability distribution for the correct answer. For example,
an EB05 of 3 means that there is a 95% chance that the true Relative Reporting
Ratio is at least 3.
2. What is the relationship of other safety data mining report statistics, such
as the Proportional Reporting Ratio, the Reporting Odds Ratio, and the
Information Component, to EBGM (EB05, EB95)?
These different disproportionality statistics all get at basically the same things, and
the values for each in any given situation are likely to be similar, provided the
sample size is large.
MGPS allows the use of stratification for elimination of some confounding effects,
so it will typically provide lower and more realistic scores if there is a confounding
variable involved, such as age or gender, compared to a statistic that does not
involve stratification. (Randomized trials are the only way of being sure there is no
confounding in a dataset.)
You can specify whether or not you want to calculate Proportional Reporting
Ratios (PRR) and Reporting Odds Ratios (ROR) for a data mining run. Further,
for a data mining run that is stratified, the PRR and ROR calculations can also be
computed using stratification.
3. When we apply data mining to evaluate the significance of many different
product-event combinations, are we making a multiple comparison? Does
this cause problems?
Multiple comparisons refers to searching out the largest association (such as the
largest value of N/E among a large number of product-event pairs) in a database
and then evaluating it statistically as if that product-event pair had been the focus
of the study before looking at the data. Bayesian shrinkage estimates shrink
(modify the estimate of N/E towards 1 based on a theoretically sound statistical
method) and the raw values of N/E so that all values of EB05 have the same 95%
chance of being no larger than the true RR (Relative Reporting Ratio), even if you
search out the largest value of EB05 in the output table.
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Threshold EB05
1. If MGPS yields a ranked list of associations according to the EBGM signal
score, what threshold should be used for determining that an association is
an alert that warrants further investigation?
There is no absolute threshold. An alert is an indication that there may be
a signal. Where to put the cut-off point demanding further investigation is a
business decision that is based, among other considerations, on the nature of
the data, seriousness of the AE, available resources, and other signal discovery
mechanisms.
2. Why has the threshold EB05 > 2 been recommended?
Although the threshold EB05 > 1 might meet a typical definition of statistical
significance, there are many biases in spontaneous report data and costs to
following up each alert. Therefore, Oracle suggests you use a somewhat higher
threshold. The value 2 is a round number that is often reasonable for relatively
rare AEs. (For a rare AE, a doubling of the number of reports may not be a large
absolute increase.)
For further discussion, see:
Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and
computer systems to efficiently signal higher-than-expected combinations of
drugs and events in the US FDA's spontaneous reports database. Drug Saf.
2002;25(6):381-92.
3. If there is a product-event combination with an EB05 greater than my chosen
threshold (for example, EB05>2), what can I say with certainty about the
relationship between the drug and the event? Are they definitely related?
Are they causally related?
This value suggests only that there is a statistical association between this drug
and event. The association may indicate a causal relationship or a reverse causal
relationship; that is, the AE is an indication for the drug. It may indicate a
relationship that is already labeled, or it may indicate a relationship that is not
clinically significant for other reasons. The most frequent explanation is that there
is a third variable common to both the drug and the event, often related to the
drug’s indication (confounding by indication).
You should conduct further investigation, including reading the label, doing a
literature review, or, at the very least, expert evaluation of the individual medical
records leading to the series of reports, to determine whether they seem causally
related. Additional studies, such as clinical trials or case control studies, may be
warranted in some cases.
False positives and negatives

1. What is meant by alerts potentially being false positives?
A false positive occurs when any signaling system, such as the EBGM or EB05
value, exceeds a pre-set threshold (such as EB05 > 2), while, in reality, the drug is
either not related to the event or is related, but not causally.
2. What is meant by alerts potentially being false negatives?
A false negative occurs when any signaling system, such as the EBGM or EB05
value, did not exceed a pre-set threshold (such as EB05 > 2), while, in reality, the
drug is causally related to the event.
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3. How do I set up an alerting system that gives hardly any false positives and
hardly any false negatives. Is this possible?
No. While the chances of finding false positives or false negatives can be reduced,
you cannot eliminate them. It is possible to decrease the chances of finding
false positives or false negatives by improving the current statistical algorithms
with the addition of extra information, such as stratification, or by improving the
data collection itself. Otherwise, any decrease in false positives is automatically
accompanied by an increase in false negatives, and vice versa.
There are two possible reasons for a false positive: there actually is no correlation
between the drug and event, or there is a correlation, but it is not causal. The
first can be dealt with to some degree statistically (although there will always be
unresolved uncertainty for small sample sizes). The second is not a statistical
issue, and can only be dealt with through medical knowledge.
Similarly, a false negative can be due to a small sample or be the result of
masking from another signal. Given a hypothesis based on medical knowledge
you can reduce the masking. Oracle is experimenting with techniques for providing
clues about when such masking may be occurring.
A third reason for either a false positive or a false negative is that you are using
the wrong threshold.
Signaling sensitivity
1. What is meant by the sensitivity and specificity of signaling systems?
Sensitivity is defined as the percentage of truly causal associations that are
identified by the alerting system. Low sensitivity means a high number of false
negatives. For example, in a database with counts for 10,000 product-event pairs
where 1,000 of the pairs have a truly causal relationship, if MGPS identifies 700
out of the 1,000 true associations, the sensitivity of MGPS is 700/1000 or 70%.
This calculation assumes that the true status of every product-event pair is known.
You have to have a gold standard.
Specificity indicates the percentage of noncausal (including nonexistent)
associations for which the system does not show an alert. Low specificity means
a high false positive rate. If MGPS declares that 3,000 of the 99,000 non-causal
pairs are associated, that is a 96,000/99,000 = 97% specificity rate or a 3% false-
positive rate. Again, this calculation assumes that you know the actual negatives.
Because there is no gold standard in most pharmacovigilance situations, you
cannot usually estimate the values of sensitivity and specificity very well.
Sometimes, the gold standard is whether a reaction is on the label. This is
problematical. It is a difficult and subjective task to transform the language on
a label into an accurate and complete list of MedDRA terms. The label itself may
be wrong or incomplete.
2. If EB05 is large, does that mean that you can be 95% sure that there is a true
signal?
No, you can only be 95% sure that an association this large will hold up as
the database becomes larger and larger. When EB05 > 2, almost all the false
positives are due to noncausal associations that are reliably likely to continue as
more data is collected, such as events being related to indications for the drugs,
or publicity effects. A large EB05 rules out mere statistical fluctuation, but not other
spurious causes of the association. Thus, medical knowledge is very important for
interpretation of data mining results.
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FAQs
3. If my threshold for signaling is EB05 > 2, is a product-event combination

with an EB05 < 2 definitely not a signal?
The application distinguishes between an alert that occurs when a data mining
statistic exceeds a predetermined threshold and a signal that might be declared
upon review of all relevant information. Since there can easily be strong evidence
of causality from other information in the absence of a data mining alert, EB05 < 2
would not rule out the possibility of a signal. Considering the data mining results,
you would require EB95 < 1, rather than EB05 < 2, to say that there is strong
statistical evidence against a positive association between the drug and the event.
Remember, all of the values of true RR that lie within the interval (EB05, EB95) are
reasonably compatible with the observed data.
4. Are there any guidelines regarding the smallest N (for a product-event
combination) for which you can get a meaningful signal score?
It is not necessary to take the sample size into account. The methodology does
that. In practice, however, the built-in conservatism of the MGPS methodology,
and the choice of threshold, prevents EB05 > 2 when analyzing AERS data unless
N is at least 3. This suggests that reducing the threshold to EB05 > 1 might be
advised as part of screening for very serious adverse events, if you want to be
warned whenever the first two reports show up significantly earlier than expected
for a new drug.
Working with new drugs and small sample sizes

1. If a drug is new and only has a handful of reports (e.g., 50) overall in the
AERS database, can useful data mining signals be obtained?
Yes, the EB05 statistic takes the sample size into account.
2. What about the case of an event term for which there is a small number of
reports (<100) overall?
Yes, the EB05 statistic takes the sample size into account.
Stratification and subsets

1. What is the difference between stratification and subsetting?
Stratification is a way of normalizing data to eliminate confounding by some
variable or variables. You generally stratify by age group, gender, and receipt year.
The Oracle Empirica Signal application calculates the expected count separately
for each stratum, then sums those counts and uses this total expected count for
the RR and EBGM calculations. This process can be used, for example, to deal
with confounding due to a drug being administered only to the elderly or only
to males, or to the drug being new on the market. This process is often called
adjustment for confounding variables in the epidemiology literature. Other possible
confounding variables are not generally available in AERS data.
Subsetting is a way of repeating the entire data mining analysis using different
subsets of the database. Subsets are typically used to study how the strength of
a product-event association evolved over time, but can also be used to compare
strength of associations for different age or gender subsets. For each subset, the
application calculates the observed count and expected count, then uses those
values to calculate a separate RR and EBGM value for each subset. Different
subsets of the reports can be overlapping or non-overlapping, depending on how
the subset run parameters are specified.
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2. Is it meaningful to compare signal scores across subsets (e.g., signal scores

for males versus signal scores for females)?
Yes. Non-overlapping confidence intervals can alert you to the possibility of a
gender difference in response to the drug.
Cross-drug comparisons
1. Under what circumstances might it be meaningful to compare signal scores
across different drugs?
Non-overlapping confidence intervals can alert you to the possibility of a difference
between the safety profiles of the drugs. Alternately, if the confidence intervals
overlap a lot, the signal scores can help corroborate evidence that there is no
difference.
2. What are the advantages and disadvantages of including concomitant
medications (as well as suspect drugs) in the data mining analysis?
An advantage of including concomitant medications is that you can eliminate
the bias from physicians who pre-determined the suspect drugs. Each drug will
be weighted equally. In addition, including both concomitant and suspect drugs
provides a larger background case set for each drug and may reveal associations
unsuspected by the reporter.
A disadvantage is that potentially valuable judgments from physicians regarding
which drug(s) is/are suspect are not taken into account.
More research is needed to understand whether it is advantageous to include
concomitant drugs in an MGPS analysis. Because logistic regression analysis is
specifically designed to assess the results of polytherapy, Oracle advises always
using a data configuration that includes concomitant drugs in logistic regressions.
3. What are the advantages and disadvantages of fully breaking apart
combination drugs into their component ingredients for purposes of data
mining?
An advantage is that the number of unique drugs in the database becomes much
smaller, and the counts of each unique ingredient are higher. It is also easier to
implement drug classification.
A disadvantage is that ingredients are equally weighted no matter whether they
were part of combination drugs or not.
Combining reports in a single data mining analysis

1. Is it acceptable to combine foreign and domestic reports in a single data
mining run?
Yes, although there is only a small proportion of foreign reports (12%) in the FOI
FDA AERS+SRS data. WHO data contains approximately 50% cases reported
in the US and 50% with foreign sources. It is possible to specify that report
source (US/non-US) be used as an additional stratification variable, which may
help protect from biases due to differential reporting rates in US and non-US
reports.
2. Is it acceptable to combine health professional and consumer reports in a
single data mining analysis?
It can be interesting to compare the two to see whether there is a significant
difference. It is not clear that consumer reports are more likely to give false
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positives or negatives than health professional reports, given that the application
examines disproportional reporting as opposed to absolute numbers.
Subsetting by the report source or occupation code of the reporter allows
comparison of values calculated for reports by consumers to those reported by
health care professionals. Also, you can use stratification on these variables to
eliminate the possibility of confounding based on report source.
3. Is it acceptable to combine serious and non-serious adverse events in a
single data mining analysis? What if some drugs have non-serious reports
entered into AERS and others you are interested in, for purposes of
comparing signal scores, do not?
Yes, although AERS contains mostly serious events. Including large numbers of
non-serious events probably improves the performance of the system, since some
analyses have shown that the ratios of non-serious event reports are a reasonable
surrogate for the exposure ratios. If, for some reason, non-serious reports have
been suppressed to a much greater degree for some drugs than for others, the
result would be to bias comparisons of alerting scores across the two sets of
drugs.
Data issues
1. What is the meaning of a drug showing a positive alerting score with a
particular event sometimes being confounded by polytherapy?
If a drug is typically co-prescribed with another drug that causes a particular event,
then the first drug is statistically associated with the event as well.
2. What is the impact of cloaking, where a very strong association with one
drug masks your ability to see a moderately strong association with another
drug?
If a drug has a very strong association with a given event, this may mean that
it accounts for a relatively large proportion of the reports for that event in the
database. This would tend to raise the expected value for this event for all drugs
and, thus, mask the signal (lower observed / expected) for another drug.
3. If a potential signal of interest may be spread across multiple MedDRA
Primary Terms (different reporters may choose to use slightly different
terminology to describe essentially the same effect), will this reduce the
ability to see the signal of interest?
Yes, this is possible, although significant associations for several of the possible
PTs are a good indication of something real. If you suspect that this spreading is
happening, then it is possible in the Oracle Empirica Signal application to map the
suspect PTs into a new pseudo PT, called a custom term, to look at the combined
score. Alternatively, data mining analysis can be based on MedDRA HLT or HLGT,
rather than PT.
4. MGPS essentially compares the safety profile (relative frequency of different
AEs) of each drug against a background comparator of all drugs. Would it
be better to choose a more narrowly defined background? For example, to
understand the profile of Cerivastatin, why not limit the background to all
other statins?
Given that noise is a surrogate for exposure, the bigger the denominator, the
better. Oracle performed an experiment to look into this; the results showed more
noise with smaller databases. To compare a drug against others in its class to see
differences, look at the EB05 scores for each of the drugs run against the entire
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background. Looking at a drug against its own class also means that it is unlikely
that you would find a previously unknown class effect.
5. Are data mining results skewed by publicity effects?
This can occur, and it is one of the possible causes to consider when doing case
evaluation of the potential signals.
Comparing EBGM values

1. When comparing different EBGM values, if a given drug D has an EBGM
signal score of 4.0 for event E1 and 8.0 for event E2, is it correct to say that
the risk of E2 appears to be twice as high?
No. At most, you could say (if the confidence interval was very narrow) that the
drug had 4 times as many reports for E1 as expected and 8 times as many reports
for E2 as expected. To estimate risks you have to know about reporting rates and
exposure rates, neither of which are estimable from spontaneous reporting data
alone.
2. What about comparing EBGM values across two drugs? Suppose, for event
E, drug D1 has an EBGM score of 10 and drug D2 has an EBGM score of 20.
Is the risk of the event twice as high with drug D2 as with drug D1?
Confidence intervals can be used for comparisons, provided they do not overlap.
In this example, the interpretation is that the association between D2 and the
event is twice as high as the association between D1 and the event. But
associations can differ for reasons unrelated to causation.
3. What do EBGM scores < 1 signify?
A score of EBGM < 1 indicates that the product-event combination is occurring
less frequently than expected statistically. If EBGM were < 1 and N were high, this
might indicate a possible therapeutic effect.
About tables
Many of the Oracle Empirica Signal pages present information in a tabular format. This
topic describes how to work with this tabular information.
If you are using Signal Review, see Arrange table columns.
To work with information in tables, you can use the following options:
To Click this link Help topic

Select, arrange, sort, and filter the Columns or Arrange table columns
columns that display in the table. Columns and Rows
On the Signal Review page, select
the header action menu, then select
Columns.
Print the contents of the table. Print Print a table
Download the contents of the table to Download Download data
a variety of file formats.
Oracle Empirica Signal saves the display choices that you make for a particular table.
Your choices remain in effect for that table across Oracle Empirica Signal sessions,
until you make different choices.
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Navigating between pages

To specify how many rows display at a time, enter a number in the Rows per Page
field and press Enter. In general, you can display up to 999 rows on each page.
On the Signal Review page, to change the number of rows per page, select a different
value from the Rows Per Page dropdown.
The default number of rows is typically 50, but may vary for different Oracle Empirica
Signal pages.
To go to another page, on most pages, do the following:
1. To view the next page, click .
2. To view the previous page, click .

3. To view a specific page, type a number in the Page field and press the Enter.
To go to another page in Signal Review, do the following:
1. To view the next page, click .
2. To view the previous page, click .
3. To view the first page, click .
4. To view the last page, click .

5. To view a specific page, type a name in the Page field and press Enter.
Finding text
To find specific text on a page:
• In Chrome, select the Chrome menu, then Find.
• In Edge, select the Edge menu, then click Find on page.
• In Internet Explorer, select the Edit menu, then click Find on this page.
In all of these browsers, you can press CTRL+F to select Find. For efficiency, you may
want to set the Rows per Page to a large number before using the Find feature.
Vertical scrollbars
A site option determines whether vertical scrollbars for tables of information are always
on the left side, always on the right side, or determined by the user preference Show
table scrollbars on left side. This option does not apply to the Signal Review Products
or Product-Event combinations pages.
Column descriptions
In some tables, when you hover on a column heading, a description of the column
appears:
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Sorting the table

You can sort a table by up to three columns. The current sort order appears above the
table. You can sort a column as follows:
1. To sort a column, click the column header. The column is sorted and an arrow is
displayed next to the column name to indicate the sort order. To sort in reverse
order, click the column header again.
Note:
Numeric and date columns initially sort higher-to-lower numbers or more
recent-to-earlier dates. Alphanumeric columns initially sort in order from
A to Z, and are not case-sensitive.
2. Click Columns or Columns and Rows or, on the Signal Review page, click the
Header Action menu ( ), and then click Columns. (See Arrange table columns.)
When you click the column header to sort a column, that column is the primary
sort order based on the column type. For example, suppose that the current sort
order is Generic_Name, PT, and EBGM (desc):
If you decide to sort by EB05 in descending order, click the header in that column.
The sort order becomes:
• The most recent sort order you specify becomes the primary sort order.
• Other columns continue to be used for sorting (secondary and third sort
orders).
• For most tables, empty columns appear first, if you sort in ascending order,
and last, if you sort in descending order.
If you want to clear a sort order or explicitly specify levels of sorting, use the
Columns (or Columns & Rows) dialog box. For example, you can change the
above sort order as follows:
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Specify a SQL WHERE clause

At certain places in Oracle Empirica Signal, you can specify a SQL WHERE clause to
restrict rows of a table or a report.
Note:
When specifying a SQL WHERE Clause, you can click Show Columns to
display the Select Table Columns page listing variables (columns) that you
can include in the WHERE clause. To insert a variable into the WHERE
clause, click the column name.
At certain places in Oracle Empirica Signal, you can specify a SQL WHERE clause to
restrict rows of a table or a report.
When specifying a SQL WHERE clause, do not enter the word WHERE. Oracle
Empirica Signal adds WHERE internally to the start of the condition that you enter.
For example, to view all results for which EBGM is greater than 5, type EBGM > 5.
To connect conditions, use AND or OR. For example:
• N > 5 AND EBGM > 8
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• EBGM > 5 OR EBGMDIF > 6

If you provide a SQL expression with incorrect syntax or unsupported SQL functions,
an error message appears at the top of the page when you save the expression.
Common errors are a wrong or misspelled column name, and unclosed or mismatched
parentheses.
The way in which a variable is stored in the Oracle database determines how you can
search for it.
Text variables
If a variable is stored as a text field in the Oracle database, you must enclose the
text string in single quotes. Capitalization within the quoted string must match the text
string in the database exactly.
To find a value that includes a single quotation mark, or apostrophe, precede the
quotation mark or apostrophe with another single quotation mark in the quoted string.
For example, to find Bell's palsy for the PT variable, type PT like 'Bell''s palsy'.
You can use any valid SQL operators, including the following commonly used
operators:
Operator Meaning Example

LIKE matches SUBSET LIKE 'F'
NOT is not the condition that follows SUBSET NOT LIKE 'F'
% is a wildcard character that you can use in a text string after LIKE; it matches any
characters in its position, as follows:
Type of Match Example

Exact match ITEM1 LIKE 'Asthma NOS'
Starts with specified string ITEM1 LIKE 'As%'
Includes specified string ITEM1 LIKE '%th%'
Ends with specified string ITEM1 LIKE '%NOS'
Numeric variables
If a variable is stored as a number field in the Oracle database, you can use any valid
SQL operators, including the following commonly used operators:
Operator Meaning Example

= is equal to EBGM = 3
!= or <> is not equal to EBGM != 3 EBGM <>3
> is greater than EBGM > 98.6
>= is greater than or equal to EBGM >= 98.6
< is less than EBGM < 8.5
<= is less than or equal to EBGM <= 8.5
BETWEEN is between (includes both 6.5 EBGM BETWEEN 6.5 AND
and 8.0) 8.0
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Date variables
If a date variable is stored as a text field in the Oracle database, you can search for it
as you would search for any text string.
If a date variable is stored as a date field in the Oracle database, you can use the
Oracle function TO_DATE to change a text string to an Oracle date. Then you can
use the same operators as for numeric variables. For example, if you want to find
RCVD_DATE dates later than 2019-01-17, you specify:
RCVD_DATE > TO_DATE('2019-01-17', 'yyyy-mm-dd', 'NLS_DATE_LANGUAGE =
American')
If you do not specify a time, the time is considered to be midnight of the specified date.
Column names
To select table columns (variables) to include in the WHERE clause, from the Header
Action menu ( ) on the Products or Product-Event Combinations tables, click

Columns. On the Columns dialog, enter the WHERE clause in the Where Clause
text box. To copy an existing column into the WHERE clause, click the Show columns
link.
When using a SQL WHERE clause to select criteria for run results that you are
viewing or to filter a source table that you are viewing, avoid referring to the product or
event variables or related hierarchy terms. The actual column names in the underlying
table are not the same as the labels for fields on the Select Criteria page or as the
column headers in the results table. The actual column names are ITEM1, ITEM2, etc.
Note:
The alphabetical order of prefixes defined in the configuration for the drug
and event variables determines whether the variables are ITEM1 or ITEM2.
For example, if the prefix for the drug variable is D and the prefix for
the event variable is E, the drug variable is ITEM1 because D is first
alphabetically.
SQL functions
Oracle Empirica Signal supports the following SQL functions in WHERE clauses:
acos length soundex

ascii lower sqrt
asciiStr last_day substr
asin ln tan
atan log tanh
atan2 lpad to_date
BitAnd ltrim to_dsinterval1
Ceil mod to_multi_byte
Chr months_between to_number
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acos length soundex

Compose new_time to_single_byte
concat next_day to_timestamp
convert power to_timestamp_tz
cos remainder translate
cosh replace tz_offset
decompose round abs
dump rpad to_yminterval
exp rtrim add_months
floor sign upper
initcap sin vsize
from_tz sinh to_char
instr - -
The following are caveats of the SQL functions:

• Functions with no parameters are permitted (for example, sysdate)
• Functions with optional arguments (for example, to_date) require ALL arguments
How do I select hierarchy terms?

Adverse events and drugs can be associated with a dictionary, thesaurus, or other
standardized terminology that organizes terms into a hierarchical structure. For
example, adverse event terms may be associated with a version of the Medical
Dictionary for Regulatory Activities (MedDRA1), and drugs may be associated with the
WHO Anatomical Therapeutic Chemical (ATC) classification system. The hierarchical
terms and their relationships are stored in a special account, then associated with
variables in data configurations.
To select specific drug or event values for a variable, you can click the Select
Available Values link to view and select values from an alphabetized list. If the drug
or event variable has an associated hierarchy, another link appears so that you can
browse through the hierarchy. For example, you can click Select MedDRA Terms to
browse for Preferred Terms (PT) in the hierarchy. The variable must be set up in the
data configuration and you must check the user preference, Enable Adverse Event
Hierarchy Browser or Enable Drug Hierarchy Browser.
Note:
The name of the hierarchy associated with the variable appears as part of
this link. For example, for a drug variable, Select ATC Terms appears. This
help system uses Select <hierarchy> Terms as a general reference to this
link.
1 MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers

Associations (IFPMA). MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international
medical terminology developed under the auspices of the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
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When you click Select <hierarchy> Terms, the Hierarchy Browser dialog box opens
and enables you to browse the hierarchy and review, search for, and select terms at
the appropriate level of the hierarchy.
Browsing terms
The section on the left of the Hierarchy Browser lists the terms at the highest, most
general level of the hierarchy. For example, System Organ Class (SOC) terms appear
for the MedDRA hierarchy, and Level 1 terms appear for the ATC hierarchy. To expand
the list to show terms at the next level, click the icon next to a term. Repeat to
expand the list to show terms at all levels through the lowest, most specific level in the
hierarchy. Click to collapse sections of the list.
When you hover over terms in this list, an underline appears if you can click on a term
to review and, potentially, select terms at the appropriate level of the hierarchy.
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Reviewing terms
The Available <level> Values section in the center of the Hierarchy Browser lists terms
at the level of the hierarchy that you are browsing. For example, if you are browsing
for PTs, the Available <level> Values section lists all of the PTs in the hierarchy below
the term you clicked. If you click on a Higher Level Group Term (HLGT), all of the PTs
under that HLGT appear for review.
Note:
Not every term at every hierarchical level shown on the left can be clicked.
For example, if you select MedDRA PTs, you cannot click on a lower level
term (LLT) to review or select PTs above that LLT in the hierarchy.
Searching for terms

Another way to find and review terms at the hierarchical level of interest is to enter
text in the Match field at the bottom of the window and click Search. (The Match
field is not case sensitive.) The list of Available <level> Values appears on the right
and contains all terms that match your text at the appropriate hierarchical level. The
hierarchy section on the left also refreshes; only terms at the top-most hierarchical
level appear, and each term that has a matching term in its path appears in italics.
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When you click next to an italicized term, the hierarchy expands all of the levels
for that term to show the complete path to the term that matches. Italics appear at
every level in the path to assist you in following the path to the matching term or terms.
Boldface highlights the actual match.
Alternatively, you can click a term in the Available <level> Values list to expand the
hierarchy section to show the primary path for that term. The icon indicates the
primary path.
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If the term also has a secondary path in the hierarchy, that path also expands and
marked by the symbol . You can scroll through the hierarchy to review any alternate
paths for the term.
Note:
• When you click a term in the Available <level> Values list, its full name
appears as pop-up text. This enables you to see the complete value in
case the displayed value is cut off because of its length.
• Terms that appear in the hierarchy multiple times appear only once in the
Available <level> Values list.
• The terms shown in this dialog box are from the special account that
contains hierarchy data. As a result, custom terms do not appear in the
hierarchy list, and cannot match entered search values.
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Selecting terms
After you review terms in the Available <level> Values list, you can make selections. To
select values, you highlight and move them as follows:
• To highlight a value, click it.
• To highlight multiple non-contiguous values, hold down the Ctrl key while clicking
each value.
• To highlight multiple contiguous values, click a value, hold down the Shift key, and
click another value. Values between and including those values are highlighted.
• To remove highlighting from a value, hold down the Ctrl key while clicking the
selected value.
When your selections are complete, click OK. The window closes and you return to
the task you were performing.
To create a saved list of terms for future use, click Save As List.
How do I select values from a list?

One of the ways that the Oracle Empirica Signal application facilitates your work
is to provide lists of accepted values for many functions. These values appear in
alphanumeric order in a dialog box and often include an All option as well as individual
values.
Selecting a single value

If the dialog box includes a list of available values but no list of selected values, you
can select only one value.
• Click a value to highlight it and then click OK.
Note:
When you highlight a single value, the full value is displayed as pop-up text.
This enables you to see the full value in case the displayed value is cut off
because of its length.
Selecting multiple values

1. To select values from a list, click Select Available Values
2. To select values, you highlight and move them as follows:
• If the dialog box includes a list of available values and a list of selected
values, you can select multiple values (up to 1,000 values).
• To highlight a value, click it.
• To highlight multiple non-contiguous values, hold down the Ctrl key while
clicking each value.
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• To highlight multiple contiguous values, click a value, hold down the Shift
key, and click another value. Values between and including those values are
highlighted.
selected value.
• To move values back and forth between the list of all values and the list of
selected values, you can double-click a highlighted value or use the arrow
keys as follows:
Button Use To
Move highlighted values from the

list of all values to the list of
selected values.
Move all values from the list of

all values to the list of selected
values.
Move highlighted values from the

list of selected values to the list of
available values.
Move all values from the list

of selected values to the list of
available values.
If up and down arrows are available for the list of selected values, you
can use them to order the selected values. For example, when specifying
breakdown details in a report definition, you can order the selected values as
you want them to appear in the report.
3. When you are satisfied with the selected values, click OK.
Note:
In some contexts, you can click Save As List to create a saved list of
values for future use.
Filtering available values

You can filter the available values if the Show Filter Options link appears.
1. Click Show Filter Options.
2. In the Filter field, type a value on which to filter the available values.
3. Specify filtering options:
• Case-sensitive —If checked, the application lists only available values
exactly matching the case (upper, lower, or mixed) of your entry in the Filter
field.
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• Show values —From the drop-down list, select Starting with Filter to list
available values that start with your entry in the Filter field. Select Containing
Filter to include any values containing the specified filter in any position.
Select Ending Filter to list values that end with the entry in the Filter field.
If there are more than 100 possible values in total (regardless of filter options), the
following additional options are available:
• Minimum filter length —Select the minimum number of characters you must
enter in the Filter field before any available values will be listed. (0 indicates
no minimum.)
• Maximum values to show —Select the maximum number of available
values to be listed. If the maximum number is n, the first n matching values
found in the list appear. Note that as you move values to the Selected Values
list, more values appear in the Available Values list.
A message informs you if any values have been filtered out of the Available
Values list by the Maximum values to show field.
Note:
If network performance is not fast, avoid using No Limit. This can be slow
when used with Generic_Name, for example, since there are thousands of
values.
Specify hierarchy versions for timestamped data

If a data configuration supports timestamped data, you must specify a hierarchy
version for each time period in the source data. A time period is a range of dates
during which only one hierarchy version was used to code the source data.
For example, suppose that the source data includes the following rows:
Case ID Start Stop

100 01-01-2004 06-01-2004
200 06-01-2004 01-01-2005
300 01-01-2005 NA
Additionally suppose that different versions of MedDRA were used to code the source
data:
• MedDRA Version 6.1 was used until June 1, 2004.
• MedDRA Version 7.0 was used between June 1, 2004 and January 1, 2005.
• MedDRA Version 7.1 was used on January 1, 2005.
In Oracle Empirica Signal, you must specify the version of MedDRA used to code the
source data for each time period as described below.
1. In the left navigation pane, click the Settings icon ( ).

2. In the Configure System section, click Manage Configurations.
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3. Click the Row Action menu ( ) for the configuration, and select Edit.
4. In the top table, click Edit in the far right column for the data configuration.
5. On the Edit Configuration Details page, in the Event Hierarchy Version Table
field, click Select/Edit Table.
6. To specify only one hierarchy version for all of the source data, type the Oracle
database account name for the hierarchy version in the first row of the Hierarchy
Account column, for example:
7. To specify different hierarchy versions:

a. In the first row of the Date column, type the last date of the earliest time period
in the source data.
The date must be in the mm/dd/yyyy format
Note:
Each date includes a time stamp of 12:00:00 a.m. For example,
if you specify that MedDRA Version 6.1 was used until (<=)
06/01/2004 and MedDRA 7.0 was used thereafter, then MedDRA 7.0
is applied to source data coded at 12:00:01 a.m. on June 1, 2004.
b. In the first row of the Hierarchy Account column, type the Oracle database
account name for the hierarchy version.
c. Fill in one row for each time period in the source data, for example:
If you need additional rows, you can select Add additional empty rows upon
saving and click Save.
For the last time period, type only the Oracle database account name for the
hierarchy version.
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8. Click Save.
Use hierarchy tables

Data configurations defined in older versions of the Oracle Empirica Signal application
might have used hierarchy tables instead of an event hierarchy account to set up
hierarchies for events. The following information is for reference only. See Drug and
event hierarchies for information about the newer method of setting up hierarchies for
drugs or events.
When you use hierarchy tables, users must select from a list of event or drug values,
instead of using the hierarchy browser. The Select Criteria page and results table
use general labels for the hierarchical levels: Level 0, Level 1, and Level 2. If both
a hierarchy account and a hierarchy table are specified by the configuration, the
hierarchy table takes precedence.
A hierarchy table specifies a hierarchy of terms (such as drugs and events) available
for selecting criteria for data mining results before viewing them. A hierarchy table has
no effect on the generation of statistical results for a run.
For each configuration variable for which you want to use a hierarchy, there must be
a hierarchy table. If there is a hierarchy table specified for one or more variables in a
configuration, then a run creator has the option to use the hierarchy or not.
You can create a hierarchy table outside of the Oracle Empirica Signal application
using tools that provide access to the Oracle database. The table must be in the
Oracle account containing the source database tables. You refer to the table from a
configuration variable within the Oracle Empirica Signal application. You can also edit
an existing configuration variable to add a hierarchy table to it.
Note:
You can also create a hierarchy table while you are editing a configuration
variable. In this situation, an empty hierarchy table is created and you must
populate it outside of the application.
For the table name, Oracle recommends that you use a name that identifies the table
as a hierarchy; for example, DRUG_HIER or EVENT_HIER. A hierarchy table must
include the following columns:
• ITEM_VALUE —Drug or event name. This is Level 0 of the hierarchy. There must
be one value for each unique drug or event name.
• H1_VALUE —Middle-level term of the drug or event hierarchy. This is Level 1 of
the hierarchy.
• H2_VALUE —Top-level term of the drug or event hierarchy. This is Level 2 of the
hierarchy. If you are creating a two-level hierarchy, this column can be empty.
There can be zero levels, one level, or two levels in a hierarchy, as in the following
example:
1-52
Chapter 1
FAQs
Each Level 0 term can have only one Level 1 term associated with it. Each Level 1
term can have only one Level 2 term associated with it.
Note:
If a drug is not included in the hierarchy table, it is not available when the
results reviewer filters results according to a Level 1 or Level 2 term. For
example, all drugs except DrugA are in the hierarchy table and have a Level
2 value of OTC or RX. If the reviewer filters according to the Level 2 terms
OTC and RX, DrugA is not in the displayed results. (However, DrugA is still
available as a Level 0 term even if it is not in the hierarchy table.) When
source data is updated and includes new drugs or events, this situation may
occur unless the hierarchy table is updated as well.
You can view hierarchy tables on the Data sources page.
What is an alias?
An alias is a named reference to a data mining run, report output, or data
configuration.
Currently, aliases can be used in setting up a drug profile configuration, interactive
signal management, and run definition files (managed by Oracle).
Interactive signal management configurations can reference configuration aliases
for all reports, 2D runs and 3D runs. When the signal management configuration
is refreshed, any aliases referenced by the signal management configuration are
resolved.
A drug profile configuration can reference aliases for data mining runs or report
outputs. When a user navigates to the Drugs page, any aliases referenced by the
drug profile configuration are resolved. When source data is updated and new runs
and report outputs are created, you can modify the aliases to point to different runs
and report outputs, rather than modifying the drug profile configuration.
How can a saved list keep me from having to select values

individually?
A saved list can contain up to 1,000 drugs or event terms. In activities where you need
to specify values for a drug, event, or item variable, you can select a saved list instead
of selecting values individually.
1-53
Chapter 1
FAQs
Your available saved lists are ones you have created, or ones you have been given
Read or Edit permission. They must also be compatible with the data configuration of
the object with which you are working.
To select a saved list, click the row for the saved list, and then click OK.
The Select Saved List page provides the following information about each saved list.
See Field descriptions—Saved List page for more information.
Typing values in text boxes

Throughout Oracle Empirica Signal, you have the option of selecting or typing values.
For example, you might specify the value of an Event item variable by doing one of the
following:
• Selecting a MedDRA term using the hierarchy browser.
• Selecting a value from a list of available values.
• Selecting a saved list of values.
• Typing a value.
To prevent spelling and capitalization errors, Oracle recommends that you select
rather than type values. However, if you prefer to type values, do the following:
• Match the spelling and case of the intended values exactly.
• Separate the values using commas.
• To type a value that contains a comma, enclose the value in double quotation
marks, for example, "Diabetes, Type II".
• To type a value that includes a backslash or double quotation mark, precede the
backslash or double quotation mark with a backslash, for example, Cold\\flu or
\"Terrible \"headache.
1-54
2
Review signal information
• Overview of Signal Review
• Signal Review configurations: interactive vs. scripted
• Configured alerts: tracked vs. informational
• Start with the Signal Review pages
• Keyboard shortcuts for the Products and Product-Event Combinations tables
• View aggregate information for a selected group or product
• Step 1: Choose a published configuration
• Step 2: Select a product or group of products to investigate
• Step 3: Investigate product-event combinations for a product
• Step 4: Submit the review
Overview of Signal Review

Signal Review is an optional feature in the Oracle Empirica Signal application to view
disproportionality analysis statistics for successive updates of safety data, allowing
monitoring of alerts and evaluating of changes in safety signals over time.
The user interface for the optional Signal Review component has a modern,
hierarchical structure that helps users visualize and prioritize activities. The Products
and Product-Event Combinations pages provide graphical and tabular alert information
at all levels. Reviewers can easily assess the review completeness of alerts for all
products or specific product groupings.
This browser-independent user interface provides a rich experience that helps safety
reviewers perform periodic surveillance efficiently. The emphasis of this approach is on
visual tracking and interaction with alerts, including user-defined alerts.
Additional information is built throughout the user interface. If you hover over most
fields, a pop-up shows additional information. Alerts Reviewed is a column in the
Products table that provides a graphical view of the percentage of tracked alerts that
have been reviewed. If you hover over the value in the Alerts Reviewed column for a
product, a popup shows the reviewed percentage, the number of alerts that have been
reviewed, and the total alerts for the product.
Signal Review configurations: interactive vs. scripted

There are two types of signal configurations: interactive and scripted.
• Interactive signal configurations allow a user, with appropriate permissions, to
create, validate, and refresh the configuration in the Oracle Empirica Signal
application.
2-1
Chapter 2
Configured alerts: tracked vs. informational
Interactive signal configurations are currently available for proprietary data

maintained in Oracle Argus Mart and for public safety data from the Adverse Event
Reporting System (AERS).
• Scripted signal configurations require modifying most aspects of the signal
configuration outside of the Oracle Empirica Signal application, based on
your organization's requirements, and running command-line scripts to perform
refreshes. Scripted signal configurations are available for other data sources,
including proprietary databases.
To set up the configurations, you must have the Manage Signal Configurations
permission. See Edit a signal configuration.
Interactive signal configurations

For interactive signal configurations, you can modify the signal configuration in the
Oracle Empirica Signal application. For example, you can:
• Select the data configurations used for reports and data mining runs.
• Select drug and event variables used in data mining runs as well as stratification
and subset variables.
• Add and edit signal comment types.
• Enable or disable review periods.
• Edit the column headers and column descriptions on the Products table.
• Edit the column headers and column descriptions on the Product-Event
Combinations tables.
• Add, edit, activate, and deactivate alert types.
• Define values for Category, Complexity, and Organization product properties.
• Manually refresh the signal management data.
Scripted signal configurations

For scripted signal configurations, most aspects of the signal configuration are
defined or modified outside of the Oracle Empirica Signal application based on your
organization's requirements. You can modify some aspects of the signal configuration.
For example, you can:
• Add and edit signal comment types.
• Enable or disable review periods.
• Edit the column headers and column descriptions on the Products table.
• Edit the column headers and column descriptions on the Product-Event
Combinations tables.
• Define values for Category, Complexity, and Organization product properties.
Configured alerts: tracked vs. informational

As part of interactive signal management, you can configure alerts. Configured alerts
are defined by a user with Manage Signal Configurations permission. There are two
types of configurable alerts:
2-2
Chapter 2
Start with the Signal Review pages
• Tracked: In Signal Review, tracked alert types are alerts for which product-event
combinations require an initial signal review in the current period. After a refresh,
tracked alerts have Reviewed/Total counts. If you submit a review of a product-
event combination with an unreviewed tracked alert, the Reviewed count for that
alert goes up.
• Informational: In Signal Review, non-tracked alert types are alerts for which
product-event combinations do not require review. No tracking is performed;
that is, these alerts do not contribute to Reviewed/Total counts. After a refresh,
informational alerts only have a Total count. If you submit a review of a product-
event combination with an unreviewed informational alert, Reviewed counts are
not impacted.
You can base a configurable alert on product review period or on product complexity
level. A configurable alert based on complexity level is calculated only when it is “due”;
that is, based on each product’s birthdate and the alert periodicity.
Note:
Scripted signal managements have built-in alerts, which are not configurable
through the user interface and do not provide tracking.
Start with the Signal Review pages

The Oracle Empirica Signal Products and Product-Event Combinations pages
summarize alert information and track review of alerts for products and product-event
combinations in a visually intuitive and interactive manner.
Two pages provide your entry into all Oracle Empirica Signal review functions:
• Products is your first entry into Signal Review. The Products page shows a
summary of the monitored products and alerts and it is where you can narrow
your focus to a single product.
• Product-Event Combinations show product-event combinations for the selected
product and selected System-Organ class (SOC) card. The cards are used to
group the product-event combinations and display Reviewed/Total counts for
tracked alerts aggregated by SOC. Select an SOC card to filter the product-event
combinations by SOC. Tabs with the alerts are displayed below the cards. Tabs
associated with tracked alerts show the number of product-event combinations for
the alert. Select a tab to display the product-event combinations table for the tab.
For the Products and Product-Event Combinations tables, the cards summarize
the number of tracked alerts that have been reviewed and the total count of alerts.
Use the Header Action Menu ( ) on the table to access functions such as
adding and removing columns. Use the Row Action menu Row Action Menu ( )
to access functions specific to the table row.
The right panel graphically depicts tracked alerts, informational alerts, event
combinations with open topics, and recent notes. This panel changes with your
Products By and card selection and your Product selection. You can collapse and
expand the cards and right graphic detail panel.
Display the Products and Product-Event Combinations pages
2-3
Chapter 2
Keyboard shortcuts for the Products and Product-Event Combinations tables
1. Log in to Oracle Empirica Signal.
2. In the left navigation pane, click the Signal Review icon ( ).

The Products page appears. The Products page is the starting point for visualizing
alerts for all monitored products. The page allows you to visualize grouped product
and individual product alerts.
3. To view the Product-Event Combinations page for a product: Click the product's
Row Action menu ( ) and select View Product-Event Combinations, or click

the product name, or click a product alert total count.
The Product-Event Combinations page appears and groups product-events by
System Organ Class and allows you to review product-event combinations.
4. To return to the Products page, click the back arrow ( ) to the left of the product
heading at the top of the page.
Keyboard shortcuts for the Products and Product-Event

Combinations tables
To interact with the Products and Product-Event Combinations tables:
1. To set focus to the table, press Tab or Shift+Tab.
2. To navigate up or down rows in the table, press the Up or Down arrow.
3. To display the row action menu when a row has focus, press Enter.
4. To select a menu item, press Enter.
5. To dismiss the menu, press Esc.
To interact with cells in a row in the table:

1. To restrict focus within a table row, press F2.
2. To focus on the next or previous cell, press Tab or Shift+Tab.
3. To select a link or display a menu in a cell that is in focus, press Enter.
4. To turn off navigation within a table row, press F2 again.
To interact with the table header:

1. To navigate to the table, press Tab or Shift+Tab.
2. To navigate to the table header, press the Up or Down arrow.
3. To display the header action menu, press F2 and Enter.
5. To dismiss a menu item, press Esc. To set focus back to the table header, press
Esc again.
6. To navigate between header cells, press the Left or Right arrow.
7. To sort a table column, press Enter.
2-4
Chapter 2
View aggregate information for a selected group or product
To interact with the select rows mode in the Product-Event Combinations table:
1. To restrict focus within a row, press F2.
2. To check or uncheck a check box, press Space.
3. To exit focus from within a row, press F2 again.
4. To check or uncheck other rows, repeat steps above.
View aggregate information for a selected group or product

When you select a Products By card or select a row in the Products table, the right
graphical details panel updates.
The details shown include:
• Tracked Alerts: Shows a graph of all tracked alerts and their reviewed and
unreviewed counts. Oracle Empirica Signal updates tracked alert counts when
product-event combinations are reviewed. When users submit for review perform
a product-event combination, all tracked alerts associated with that product-event
combination are considered reviewed. The panel is expanded by default.
• Informational Alerts: Shows a graph of non-tracked alerts and their total counts.
These alerts do not contribute to the triage progress. The panel is collapsed by
default.
• Open Topics: Shows how many product-event combinations have been
associated with open topics. This section does not appear if the selected signal
configuration is not integrated with Topics. The panel is expanded by default.
• Notes: Shows the most recently entered product note. This is displayed when a
row in the Products table is selected and not when a Products By card is selected.
The panel is collapsed by default.
Step 1: Choose a published configuration

• Choose a published configuration
• Why you might have multiple configurations
Choose a published configuration

To use signal review, you must have access to a signal configuration. The signal
configuration defines the behavior and content of the Signal Review page.
1. In the left navigation pane, click the Signal Review icon ( ) to display the
Products page. You can also get to the Products page by clicking the back arrow
( ) from the Product-Event Combinations page.
2. From the drop-down to the right of the Signal Review page title, choose a signal
configuration.
Why you might have multiple configurations

There are a variety of public and company-specific pharmacovigilance databases
that share a common conceptual organization (case reports that contain information
2-5
Chapter 2
Step 2: Select a product or group of products to investigate
on demographics, drugs, and events) but differ in details of field and table naming,
presence or absence of specific attributes, and use of specific medical coding
dictionaries. These configurations can be set up by expert users who are familiar
both with the target database schema and the pharmacovigilance application; medical
end-users work with the application-specific variables so defined (end-users do not
need to be aware of the target database schema). Multiple configurations can support
user access to several different databases (e.g., to do a data mining run—first, on
the public data and, then, on in-house data), and also to several different versions of
the same database (e.g., different chronological snapshots or versions that include or
exclude so-called “concomitant” medications).
To insulate both Oracle Empirica Signal and users from superficial variation in the
detailed formatting of the target safety database, Oracle Empirica Signal supports
multiple database configurations, each of which defines a mapping between user-
visible “variables” and specific database tables and columns, including specification
of plausible roles for the variables (e.g., a drug name, an event name, an attribute
suitable for use in stratification or subsetting, etc.).
When Oracle Empirica Signal is installed, a master configuration table that contains
all configurations for all source databases is created in another Oracle account. This
master configuration table is populated automatically as configurations are added,
copied, or imported. When a configuration is created, a configuration table is created
automatically in the same Oracle account as the source data. Multiple configurations
(and configuration tables) may exist for an Oracle account.

• Start with the Signal Review Products page
• Panels on the Products page
• Choose a grouping from the Products By drop-down
• Filter the Products table to the selected group
• Focus on a single product from the Products table
Start with the Signal Review Products page

You access all the functions you can perform on an individual product from the
Products page.
1. In the left navigation pane, click the Signal Review icon ( ) to display the
Products page. You can also get to the Products page by clicking the back arrow
( ) from the Product-Event Combinations page.
2. Select how to group monitored products by selecting one of the five product
properties defined for the configuration using the Products By drop-down list:
• Category: Customer-definable product field value set when adding or editing
a product to monitor. A user with Manage Signal Configuration permission
defines the acceptable product field values. Examples include Drug, Vaccine,
or Cosmetics, or separation by therapeutic use or chemical class.
• Complexity: Customer-definable product field value set when adding or
editing a product to monitor. A user with Manage Signal Configuration
permission defines the acceptable product field values.
2-6
Chapter 2
Complexity can be used in alert type definitions. Complexity level, periodicity,

and birthdate determine if the alert type rule will be part of the data
refresh. The default values are High, Medium, and Low. For example, a high-
complexity-level product would get scheduled more frequently for review than
a product with a lower complexity level.
• Organization: Customer-definable product field value set when adding or
permission defines the acceptable product field values. Your products can,
optionally, be assigned to a (sub-)organization in the enterprise. For example,
companies might define organizations for branded versus generic drugs, or
regional products in an organization located in a separate country.
• Product Group: (Default) Customer-definable grouping set when the product
was added or edited. Examples include therapeutic areas and cardiovascular
products.
• Reviewer: Person responsible for reviewing the product-event combinations.
3. When you select a group, the Products By cards update. Select a card to filter the
Products table.
The Products table lists the products you are monitoring, filtered by your Products
By card selection.
4. To customize the columns in the Products table, click the Header Action menu
( ) and select Columns. You can select columns to include, reorder them, and
sort the Products table using up to three different columns.
5. To download the Products table, click the Header Action menu ( ) and select
Download.
6. Perform additional actions on this product by choosing an action from the Row
Action menu ( ):
• View Product-Event Combinations: Select this link from the Row Action menu,
click a product name, or click a total alert count to investigate product-event
combinations for the product.
• Enter Note: Enter or edit a note for a product to indicate:
– Issues that have been identified and investigated for the product.
– Signals that require further evaluation.
• View Notes: View notes that have been entered about the product.
• View Event Comments: View comments entered about product-event
combinations.
• View Sector Map for All: View a visual representation for a particular product
across all System Organ classes (SOCs).
• Manage Targeted Medical Events: Maintain a list of adverse events your
organization wants to closely monitor for a particular product. You must have
the View Signal Management and the Manage Signaling Terms permissions.
This applies to Interactive Signal Configurations only.
• Manage Listed Events: Maintain a list of adverse events listed on the product
label. You must have the View Signal Management and the Manage Signaling
2-7
Chapter 2
Terms permissions to manage listed events. This applies to Interactive Signal

Configurations only.
• Edit: Edit monitored product properties. You must have the View Signal
Management and the Manage Signaling Terms permissions to perform this
task.
• Rename: You can rename monitored products if you have the View Signal
Management and the Manage Signaling Terms user permissions. This applies
to Interactive Signal Configurations only.
• Delete: When you delete a product, Oracle Empirica Signal removes it
from the Products and Product-Event Combinations tables. Deletion will not
succeed if there are notes for the product or comments about a product-event
combination that include the product. You must have the Manage Signaling
Terms user permission to delete a product.
The right graphic details panel updates to match your card or product selection.
7. To see details about a product, click a non-linked value in the Products table row.
If you click a link, such as the product name or a total count, the Product-Event
Combinations page displays.
Panels on the Products page

The Products page is organized into three panels for easy access to a variety of
functions and comprehensive alert tracking statistics. You don't have to drill down
through assorted menus and pages to get to the function you want to perform.
• Products By drop-down and cards: Using the Products By drop-down list,
you can display the products you are tracking by product group, category,
complexity, organization, or assigned reviewer. The grouping is reflected in the
cards displayed below the Products By drop-down. For each grouping, a card
aggregates all products in that group and displays elements of the group. You
can move back and forth through the pages of cards by clicking the dots or page
numbers below them. You can also scroll the cards using the left and right arrows.
Selecting a card updates the right graphic details panel and filters the Products
table.
• Products table: Below the cards is a table with the individual products filtered by
the Products By card selection. If you select the All card, all monitored products
appear. If you select a group card, only the products in that group appear. The
right graphic details update to match the selection.
• Graphic details panel: To the right of the Products By panel and the Products
table is a summary panel of the selected Products By card or the selected product.
The panel contains sections that can be expanded or collapsed. The available
sections depend on the selected item and the signal configuration. The Tracked
Alerts and Informational Alerts sections are always available. The Open Topics
section is available if your signal configuration is integrated with Topics. The Notes
section is available when you select a product. You can show ( ) or hide ( ) the
sections in the graphic details panel.
Choose a grouping from the Products By drop-down

From the Products By drop-down list on the Products page, you can choose how to
group the products you are tracking:
2-8
Chapter 2

2. (Optional) From the Products By drop-down list, select a product group, then
select a card to filter the Products table.
• Category: Customer-definable product field value set when adding or editing
a product to monitor. A user with Manage Signal Configuration permission
defines the acceptable product field values. Examples include Drug, Vaccine,
or Cosmetics, or separation by therapeutic use or chemical class.
• Complexity: Customer-definable product field value set when adding or
permission defines the acceptable product field values.
Complexity can be used in alert type definitions. Complexity level, periodicity,
and birthdate determine if the alert type rule will be part of the data
refresh. The default values are High, Medium, and Low. For example, a high-
complexity-level product would get scheduled more frequently for review than
a product with lower complexity level.
• Organization: Customer-definable product field value set when adding or
permission defines the acceptable product field values. Your products can,
optionally, be assigned to a (sub-)organization in the enterprise. For example,
companies might define organizations for branded versus generic drugs, or
regional products in an organization located in a separate country.
• Product Group: (Default) Customer-definable grouping set when the product
was added or edited. Examples include therapeutic areas and cardiovascular
products.
• Reviewer: Person responsible for reviewing the product-event combinations.
2-9
Chapter 2
Filter the Products table to the selected group

2. (Optional) Use the Products By drop-down menu to group products. Oracle
Empirica Signal displays cards that match that group by selection. Selecting a
Products By card filters the Products table to include just the monitored products
contained in that group. If you select the All card, the Products table is unfiltered.
The corresponding products appear in the Products table.
Field descriptions—Products table
2-10
Chapter 2
Field Description
Summary line Shows the number of products, the sort order,
the number of rows per page, the current
page, and links to navigate between pages. If
rows are filtered using the Where Clause in the
columns dialog, the summary line displays the
text (filtered) to indicate that rows are filtered.
Header row Contains the Header Action menu and column
headers. You can arrange these columns in
any order.
Header Action Menu Provides access to functions for the whole
table.
Alerts Reviewed The cells in this column contain a progress
gauge with the percent of reviewed tracked
alerts associated with the product on that row.
Oracle Empirica Signal calculates the percent
reviewed from x/y:
x = sum of reviewed tracked alerts.
y = sum of all tracked alerts.
Alert columns For tracked alerts, the number of alerts
reviewed and the total number of alerts are
displayed as Reviewed/Total. For informational
alerts, only the total alert count is displayed.
Row for each product Includes a Row Action menu and alert counts.
The Total alert counts are links to further
information about that alert.
Row Action menu Includes actions that provide access to
product-specific activities.
Focus on a single product from the Products table

• Enter a note about a product
• View notes about a product
• View event comments
• Change the name of a monitored product
• Use sector maps
Enter a note about a product

You can enter or edit notes about issues that have been identified and investigated
for the product, signals that require further evaluation, or any information you want to
associate with the product.

2. (Optional) From the Products By drop-down list, select a product grouping, then
3. Click the product's Row Action Menu ( ) and select Enter Note.
2-11
Chapter 2
The Note dialog shows the product you selected and the date when the note was
last entered or edited. Today's date and current time indicate that this is the first
note for this product. There is a text box for each type of note that can be entered.
4. Enter notes in the text boxes.
5. Click Save.
To view the note, select that product row on the Products table and click the right
arrow to the left of the Notes heading in the right details panel, or select View Notes
from the product’s Row Action Menu ( ).
View notes about a product

3. Click the product's Row Action Menu ( ) and select View Notes.
The following information about each note appears on the Drug Notes History
page.
Column Description
Drug Name of the drug.
Entered By Name of the user who entered the note.
Entry Date The date that the version of the drug note
was entered.
Notes are ordered by their Entry Date, with the most recent version of the note
appearing first in the list.
4. Choose one of the following:
• To view a note, click the View Note link in the last column on the right.
• To view all notes for the product, click Show All Notes.
View event comments
1. In the navigation pane on the left, click the Signal Review icon ( ).
3. Click the product's Row Action Menu ( ) and select View Event Comments.
4. From the View comments drop-down list, select All or Most Recent.
5. From the Comment type drop-down list, select Private, Public, or All.
6. (Optional) To limit comments to a specific date range, enter a Start date, an End
date, or both.
2-12
Chapter 2
7. Click Apply.
8. To show information about the comments, click Show Notes.
The notes appear below the table and Oracle Empirica Signal includes them if you
print or download table data.
9. To exclude notes, click Hide Notes.
10. To save comments to a topic, click Save to Topic.
The comments appear as an attachment to the topic.

Field descriptions—View Event Comments page
Field Description
Drug Name of the selected drug.
Event Name of an event that is reported in
combination with the drug.
Created Date and time the comment was added.
Created by Name of the user who added the comment.
Filtered • Yes, if you added the comment when
the product-event combination was
suppressed.
• No, if you added a comment for a
product-event combination that was not
suppressed.
• Empty (blank), for private comments (if
the signal configuration has the private
comments feature set up).
Comment Comment for the product-event combination.
Private Appears if the signal configuration has the
private comments feature set up.
• Yes, a private comment.
• No, a public comment.
Detailed Comment The optional free text description added with
the comment. This column appears only if the
corresponding site option has been set.
Change the name of a monitored product

Before you begin, consider the following:
• You must have the Manage Signaling Terms user permission to rename a product.
• Product names must be unique within the signal management configuration.
• Product names must match what's in the data configuration.
• Renames do not take effect until you refresh the signal configuration.
• If you rename a product multiple times between signal management refreshes, the
most recent rename is applied during the next refresh.

2-13
Chapter 2
3. Click the product's Row Action Menu ( ) and select Rename.

4. In the New name text box, type the name. You can also select a product name
from a list using the following links:
• Select < hierarchy > Term—Appears if the product is associated with a
hierarchy such as the Anatomical Therapeutic Chemical (ATC) Classification
System. For more information, see Select hierarchy terms.
• Select Available Value—Displays valid product names. For more information,
see Selecting values from a list.
Note:
To prevent spelling and capitalization errors, we recommend that you
select rather than type values.
5. Click Save.
Use sector maps

• View a sector map for a particular product
• Set display options for a sector map
• Zoom in on a sector map
• View sector map statistics
View a sector map for a particular product

A sector map for signal management data is a visual presentation of data for a
particular product across all System Organ Classes (SOCs). Each System Organ
Class (SOC) is represented by a large tile in the sector map. Smaller tiles within each
SOC tile represent Preferred Terms (PTs). The color, size, and ranking of tiles provide
a big picture overview of the adverse event profile of a product. Data represented in
the sector map includes all available data up through the current time period and is for
a particular signal set.
You view a sector map for a particular product. PTs are ranked in descending order
of values of the statistic (EBGM, EB05, Chi-statistic, or PRR) that you choose. A color
key indicates relative ranking. You can also list the ranked PTs below the sector map.

3. Click the product's Row Action Menu ( ) and select View Sector Map for a
Signal set (such as All).
4. To set display options for the sector map, click Options below the sector map.
5. If you point to a PT tile, the MedDRA PT, HLT, HLGT, and SOC appear. The
following information for the combination of the product and the term that the tile
represents also appears:
2-14
Chapter 2
• N—Observed number of cases with term.

• EBGM—Empirical Bayesian Geometric Mean. A more stable estimate than
RR; the so-called shrinkage estimate. For more information, see MGPS
computations.
• EB05—A value such that there is approximately a 5% probability that the true
Relative Ratio lies below it.
• PRR—Proportional Reporting Ratio. For more information, see PRR
computations.
• Chi-statistic—Chi-statistic associated with PRR. (If EBGM < 1, the Chi-
statistic is expressed as a negative number, indicating that the product-event
combination is more rare than expected). The Chi-statistic is the signed
square root of Chi-square.
6. To zoom in on a particular SOC, click anywhere on the SOC tile and select Zoom
from the menu.
7. If you click a tile for which N is at least 1, a menu appears and you can drill down
to cases that include the PT represented by the tile or view statistics for the tile.
8. To save the graph as an attachment to a topic, click Save to Topic. (This option is
available if the Links option is checked and the Topics feature has been set up.)
9. To close the Sector Map window, click Cancel.
For information about copying or printing a graph, see Work with results graphs. For
best results, print the sector map in landscape mode.
Set display options for a sector map

1. In the Sector Map window, click Options (below the sector map).
2. Change any of the following options:
Column Description
Color controlled by Name of the statistic whose values is ranked
and is used for coloring the sector map
tiles. Possible values are any of the following
that are available in the signal management
data prepared for your organization: EBGM,
EB05, PRR, Chi-statistic (signed).
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Column Description
Term box size controlled by One of the following options indicating what
controls the size of PT tiles:
Relative importance of term—Bases the
size of PT tiles on an algorithm that
determines the relative public heath impact
of PTs. Using a recent version of AERS
data, the public health impact for a PT
is computed as: (number of times the PT
occurs in serious cases) * (proportion of
cases with that PT that are serious or fatal).
A higher Public Health Impact score—
Corresponds to a larger tile in the sector
map. Because size is based on the number
of cases of the PT alone (not the number
of cases that have the PT and a particular
product), the tile size is stable over sector
maps for different products.
Note:
For PTs that are new in the
MedDRA version associated with
the AERS data used to assess
public health impact, the tile size
cannot be determined. Such PTs
are represented as small tiles.
All terms have equal size—All PT tiles

have the same size.
Display maximum intensity at signal score of All tiles for which scores are above
this value are displayed at the maximum-
intensity color, as shown in the color key
below the graph.
Use gray-scale instead of colors Use only shades of gray in the color key to
represent score ranking.
Show low scores in green for color graph Check to show low scores in varying shades
of green. Clear to show low signal scores in
black.
Note:
This setting has no effect if you
display the sector map in gray-
scale.
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Column Description
Omit rare terms used fewer than __ times in Number indicating how many times a PT
AERS must be in the AERS database (the same
one used for Relative importance of term)
for that PT to be shown in the sector map.
Note:
The notes for a sector map
indicate any rare terms that
are omitted because of this
restriction.
Group by HLT Within a SOC tile, group in the same

rectangular area the tiles for PTs that are
in the same HLT. If you also group by HLGT,
the tiles for PTs are grouped by HLT within
each HLGT.
Group by HLGT Within a SOC tile, group in the same
rectangular area the tiles for PTs that are in
the same HLGT.
List __ top scores Number indicating how many (up to 1000)
terms with the top scores are ranked and
listed below the sector map. The score is the
statistic selected for Color controlled by.
If multiple terms have the same score, each
term is counted separately. For example,
suppose that you enter 20 as the limit. If
the 20th row has a score that other terms
after that also have, those additional terms
are shown as well.
Show top score indexes If checked, tiles in the sector map are
numbered to show their rank, up to the
number of scores specified in List __ top
scores. For this option to take effect, there
must also be a value specified for List __
top scores.
Key Display a color key below the graph.
Notes Display information about graph display
options below the graph.
Links Show the following:
• Information about what a tile represents
when you place the mouse over the tile.
• A menu that appears when you click a
tile.
• A Print link for printing the graph.
• A Save to Topic link to save the graph
as an attachment to a topic (if the topics
feature has been set up).
Before copying a graph (for example, with
copy and paste functions), you might want
to clear this check box so that links are not
included in the copy.
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Step 3: Investigate product-event combinations for a product
3. Click OK.
Zoom in on a sector map

If you zoom in on a particular SOC tile in the sector map, data only for that SOC
appears in the zoom window.
1. On the sector map, click a SOC tile.
2. From the menu, click Zoom.
3. You can perform all the same actions as when viewing the main sector map,
except that you cannot zoom in further. Note that the ranking of PTs changes
because you are viewing PTs for only one SOC.
4. To close the zoomed-in sector map, click Cancel.
View sector map statistics

1. On the sector map or in the zoom window, click a PT tile.
2. From the menu, click Statistics.
A dialog box appears showing the following statistics for the combination of the
product and event:
• N—Observed number of cases.
computations.
• EB05—A 5% probability value that the true Relative Ratio lies below it.
computations. The PRR and Chi-statistic are available only if the data mining
run was set up to compute PRR.
• Chi-statistic—Chi-statistic associated with the PRR. (If EBGM < 1, the Chi-
statistic is expressed as a negative number, indicating that the product-event
3. To close the dialog box, click Close.

• Panels of the Product-Event Combinations page
• Investigate product-event combinations for a product
• View product-event combinations for a card or tab
• Perform a periodic review
• Use Row Selection mode
• Save a modified product-event table as a new view
• Add a tab to the Product-Event Combinations panel
• Product-event combination statistics
• Focus on a product-event combination
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Panels of the Product-Event Combinations page

The Product-Event Combinations page is organized into panels that provide easy
access to a variety of functions and comprehensive product-event information and
statistics. You don't have to drill down through menus and pages to get to the function
you want to perform.
The Product-Event Combinations page is similar to the Products page. To display it, on
the Products page:
• From a Row Action menu ( ), select View Product-Event Combinations, or

• Click the product name, or
• Click a total count in a cell in the Products table.
The Product-Event Combinations page appears and contains these panels:
Product Summary information (across the top): Product statistics appear here
with the product name and Products By group, product group, percentage reviewed
gauge, count of reviewed/total tracked alerts, the number of pending (unreviewed)
alerts, product-event combinations associated with open topics (available if the signal
configuration is integrated with Topics), and count of product-event combinations with
comments.
System Organ Class (SOC) cards: The cards represent the alerts grouped by
MedDRA system organ class. The counts represent Reviewed/Total tracked alerts.
Selection of a card filters the Product-Event combinations table.
Product-Event Combinations panel: Tabs for each alert and optional tabs
associated with signal views are shown below the cards. A Product-Event
Combinations table for each selected tab shows product-event rows for the selected
product and alert or signal view. Each table displays a summary line with the number
of combinations, the sort order, the number of rows per page and the page number.
You can add tabs, change pages, and customize the columns.
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• Select another tab to show the Product-Event Combinations table associated with
a different tab such as the Fatal, Serious, or New product-event combinations.
• The Status column indicates if the product-event combination has been reviewed
and if there is a topic for the product-event combination.
• The Alerts column indicates which tracked alerts relate to the product-event
combination in the most recent refresh. The icon color and letter were set up when
the alert type was created and match the icons in the tabs. In the example above,
F stands for Fatal and D for Designated Medical Event.
• Each tab contains the table for that alert type or signal view and reflect the
current product and SOC selection. Hover over an alert tab for details about that
alert type. You can add more tabs with the icon on the right. Click the
hyperlinked (bold) value in a cell to display a menu to drill down to case-specific
information.
Graphic details panel: This graphical summary on the right shows Tracked Alerts,
Informational Alerts, Open Topics, and Notes for the selected product. Topics appear
only if your configuration is integrated with topics. You can show ( ) or hide ( )
the sections in the graphic details panel. Changes on the Product-Event Combinations
page do not update this panel.
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Investigate product-event combinations for a product

The Product-Event Combinations panel is a set of tables, accessed by clicking a
Product-Event Combinations tab. By default, there is a tab for each active alert type
and each additional tab defined by a view. You can add more tabs using the icon on
the right.

3. Click the product's Row Action Menu ( ) and select View Product-Event
Combinations, or click the product name or total count.
The Product-Event Combinations page appears.
4. (Optional) Select a System Organ Class (SOC) card to filter the Product-Event
combinations panel.
5. View product-event combinations for an alert type. Click an alert type tab at the
top of the table, such as DME. The Product-Event Combinations table displays
combinations that raised the alerts of this type in the current refresh and are
filtered by SOC selection. The columns reflect the alert type's view. By default, for
each combination, the table shows the product, event, status, alerts, statistics, and
comments columns.
6. View cases and reports. Some values in the table are links to a menu for
drilling down to case information and reports. Most case counts presented in the
table support drilling down for detailed information and open a menu to view or
perform operations on the underlying set of cases. Numbers with this capability
are displayed in bold, and a down-arrow appears when you hover over the field.
• View Cases: Lists cases associated with the count shown in the table. The
information shown is customizable through the data configuration. On the View
Cases page, if you click the case ID or the value in the ISR column, the Case
Details page displays with the case information. You can select Next or Prior
to move to the next or previous case in the series.
• Create Case Series: On pages and in reports that display a list of cases
identified by case ID, you can save the list of cases for future use. The named
and saved list of cases is referred to as a case series.
• Transfer to Case Series: On pages and in reports that display a list of cases,
you can transfer cases to an existing case series.
• Download Cases: When you view a table of cases, you can download the
information to various types of files.
• Download Case Details: When you view case details, you can download the
information to various types of files.
• Reports: This choice displays a list of available reports. To run the report,
select a report, click the Row Action menu ( ), and select Run.
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7. To customize the columns in the Product-Event Combinations table, click the
Header Action menu ( ) and select Columns. You can select columns to
include, reorder them, and sort the table using up to three different columns.
8. To download the Product-Event Combinations table, click the Header Action
menu ( ) and select Download. You can specify a file name, the format to use,
the maximum number of rows, and create a Zip archive file.
9. To apply Row Action menu choices to multiple rows of the Product-Event
Combinations table, click the Header Row menu ( ) and select Select Rows.
Then select the checkboxes of the rows to include. Click the Header Action menu
( ) and select the action to perform on all the selected rows.

10. To save your selections as a view that you can reuse, click the Header Action
menu ( ) and select Save As View. The saved view is available under the Add
Tab ( ). A signal view specifies the following for the Product-Event Combinations
page:
• Which columns are included.
• The sort order of columns.
• The SQL WHERE clause (if any) that applies selection criteria to product-
event combinations.
11. Perform additional actions on this product by choosing an action from the Row
Action menu ( ):
• Submit Review: Review a product-event combination, add a comment, and
associate a topic (optional). If the product-event combination had unreviewed
tracked alerts then, upon completion of Submit Review, the tracked alerts are
considered reviewed and alert reviewed counts are updated.
• Add Private Comment: Add a comment visible only to you for the product-
event combination.
• Assign Reviewer: Select a reviewer for the specific product-event combination.
• View Signal History: Display a graphic and detailed summary of the statistics
associated with the product-event combination.
• View Similar Combinations: View the statistical information for combinations
involving the same product and the same HLT, HLGT, or SOC as that of the
PT in the original combination.
• View Interactions: Information about an event and product interactions is
represented as a nested confidence interval graph of EB05-EB95 confidence
intervals and EBGM values for two products and the event.
• View Age Group Breakdown for a Signal Set (such as All): The breakdown
of case data by age group or gender for a product-event combination is
represented in a bar graph.
• View Gender Breakdown for a Signal Set (such as All): The breakdown of
case data by gender for a product-event combination is represented in a bar
graph.
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View product-event combinations for a card or tab

You can filter the product-event combinations panel to a specific System Organ Class
by selecting a System Organ Class card. The Product-Event Combinations tables only
include events for the selected System Organ class.
In the product-event combinations panel, select a tab to display a specific product-
event combinations table determined by the tab view. By default, there is a tab for
each active alert type.
To add tabs to the product-event combinations panel for views created by or made
public to you, click the Add Tab ( ) icon to the right of the tabs.
Some of the values in the table are links to a menu for drilling down to case detail and
reports.

3. Select the product, click the Row Action menu ( ) icon, and select View
Product-Event Combinations, or click the product name or total count.
4. View the product-event combinations for a tab by selecting the All SOC card
or filter the product-event combination tables by selecting a specific SOC card.
For example, to view only product-event combinations for blood and lymphatic
symptom disorders, click the Blood card. The Product-Event Combinations panel
refreshes to include only the combinations for that SOC.
• The number of combinations, the sort order, the rows per page, and the
number of pages in the table appear under the row of tabs.
• By default, the table contains Status and Alerts columns. These columns show
the review status and alerts associated with the product-event combination.
5. Click a tab to display the product-event combinations for that tab.
• Tracked alert tabs include an alert icon (letter and color as defined by the alert
type definition), an alert name and a count.
• Informational alert tabs include the alert name and a count.
• Alerts in scripted signal configurations show the alert name only.
• Added tabs show the view name only.
• Hover on the tab to show details. If the tab is for a configured alert, then the
hover text includes "Alert based on review period or complexity level."
• The Status column shows whether the product-event combination needs
to be reviewed or has been reviewed. If Topics has been integrated with
this configuration, the Status column indicates whether a topic has been
associated with the combination, by the presence of the ( ) icon.
• The Alerts column contains an icon for each tracked alert type that was raised
in the most recent refresh or any unreviewed tracked alert from a previous
refresh.
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6. Drill down on the case details for any product-event combination by clicking the
bolded case total in any column and selecting a menu item.
7. Rearrange the columns , download the table, perform operations on multiple rows
in the table, and save the table as a view from the Header Action menu ( ).
8. Select additional actions to perform on the product-event combination from the
Row Action menu ( ):

• Submit a review.
• Add a private comment.
• Assign a reviewer.
• View the signal history.
• View similar combinations.
• View the product interactions.
• View the age group breakdown.
• View the gender breakdown.
Perform a periodic review

Signal management configurations have a granularity, such as monthly or quarterly.
The review period is set up during installation based on this granularity. For example:
• FDA AERs review periods are 3, 6, 9, and 12 months.
• Argus review periods are typically 1, 3, 6, and 12 months.

The Product-Event Combinations table shows the events, status, alerts, review
periods, and comments related to the product-event combinations.
4. Select a product with the icon in the Status column. The icon denotes that
the product-event combination has alerts that haven't been reviewed. The icon
denotes that alerts have been reviewed. The icon denotes that topics are
associated with the product-event combination.
5. To view cases new since a specific review period, click the bold total in an N or
Nsince column to open a menu that provides access to case review functions and
reports.
6. Use the Row Action menu ( ) to access additional functions.
7. When your review is complete, from the Row Action menu ( ) select Submit
Review.
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8. Submit the review.

Frequency of evaluations
The frequency for evaluations is specified when the administrator selects the menu
item to add the product for monitoring; for example, every 3 months, 6 months, or 1
year. That choice is reflected on the Product-Event Combinations table.
The All column shows alerts since the previous quarter. Likewise, if a product has a
nine-month periodicity, the All column shows the alerts for the nine months prior.
Note:
To specify review periods, the administrator must enable the Review Period
column and Review Period filter on the Manage Signal Views page. To
disable review periods, the administrator selects the Disable review period
option on the Edit Signal Configuration page.
Use Row Selection mode

Row Selection mode allows you to apply actions available from the Header Action
menu to multiple rows at the same time.

4. To apply Row Action menu choices to multiple the rows of the Product-Event
Combinations table, click the Header Action menu ( ) and select Select Rows
to turn on Row Selection mode.
5. Select the check boxes of the rows to include.
6. Click the Header Action menu ( ) and select the action to perform on all the
selected rows. Submit Review, Download, Create Case Series, Transfer to Case
Series and Reports are available in the Header Action menu while in Select rows
mode.
7. Perform the tasks to complete the action you selected.
8. To turn off Row Selection mode, from the Header Action menu ( ) select Exit
Selection Mode.
Save a modified product-event table as a new view

A signal view specifies the following for the Product-Event Combinations page:
• Which columns are included.
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• The SQL WHERE clause (if any) that applies selection criteria to product-event
combination rows.
When you save the view, you can assign it to a category. These categories populate
the Select View menu.
Note:
At least one refresh should be run before creating views.

3. Click the product's Row Action menu ( ) and select View Product-Event
4. In the Product-Event Combinations panel, select a tab, arrange the columns,
and sort the columns as you would like them to appear in the view. If available,
you can add/modify the SQL WHERE clause.
5. From the Header Action menu ( ), click Save As View.

6. In the Name for view field, enter a name for the signal view.
Note:
If the signal configuration has the review period feature set up, each view
name should include the length of the review period; for example, New
Cases (3 months), New Cases (6 months), New Cases (1 year), and so
on.
7. In the Description text box, enter a description of the signal view. The description
appears as hover text when the view is added as a tab.
8. Assign the view to a category. The category determines the view's location on the
Select View menu.
• To assign the view to an existing category, click Add to existing category and
select a category that you created from the drop-down list.
• To create a new category and assign the view to it, click Add to a new
category named and enter a category name. The category name must be
unique for the signal configuration.
See Organize signal views for information about ordering categories and ordering
views within categories.
9. Click OK.
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Oracle Empirica Signal saves the view and adds it to the list of views available
in the Add Tab menu. The view can now be used when adding a tab to the
Product-Event Combinations panel.
Add a tab to the Product-Event Combinations panel

You can add a tab to the Product-Event Combinations panel. This tab provides another
view of the product-event information.

All product-event combinations that satisfy the SOC filter and meet the conditions
stated in the tab's view appear in the Product-Event Combinations panel. When
you click a tab; for example, DME, the Product-Event Combinations table displays
only the product-event combinations that satisfied the DME alert's condition and
the SOC filter.
4. To add a view, click the sign to the right of the tabs.

5. Choose from a list of views.
• The tab is added as the right-most tab.
• You can hover over the tab to see the full name and description.
• No count is provided on added tabs.
• You can click the X at the right of the tab to remove the tab.
The added tabs are retained when returning to the page for any product.
If you add a tab, and then modify the WHERE clause using the Columns dialog, an
asterisk appears to the right of the tab name to indicate that it has changed from the
original view. Select Reset View to Default in the Header Action menu to restore the
tab to the original view.
Product-event combination statistics

For each product-event combination, you can review a summary of statistics
presented in a trend graph and a histogram.
The trend graph is a confidence interval graph in which the x-axis represents dates
and the y-axis represents EBGM values for the product-event combination. In the line
for each time period:
• The point represents the EBGM value.
• The lower end represents the EB05 value.
• The upper end represents the EB95 value.
The histogram that appears below the trend graph shows reporting frequency for the
product-event combination. The x-axis represents dates and the y-axis represents
counts of cases that contain the product-event combination.
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Field descriptions—Statistical score

The statistical score that might appear for each product-event combination includes
the following rows:
Field Description
EB05 A value such that there is approximately a
5% probability that the true Relative Ratio
lies below it. The interval from EB05 to EB95
might be considered to be the 90% confidence
interval.
EB95 A value such that there is approximately a
5% probability that the true Relative Ratio
lies above it. The interval from EB05 to EB95
might be considered to be the 90% confidence
interval.
EBGM Empirical Bayesian Geometric Mean. A
more stable estimate than RR; the so-
called shrinkage estimate, computed as the
geometric mean of the posterior distribution of
the true Relative Ratio. For more information,
see MGPS computations.
N Observed number of cases with the
combination of items.
PRR Proportional Reporting Ratio for the
combination of a particular product and
particular event.
PRR_CHISQ Chi-square of PRR. For more information, see
PRR computations.
ROR05 Lower 5% confidence limit for ROR.
ROR95 Upper 5% confidence limit for ROR. The
interval from ROR05 to ROR95 might be
considered to be the 90% confidence interval.
ROR Reporting Odds Ratio. Computed as: ROR =
(PRR_A * PRR_D) / (PRR_B * PRR_C) With
stratification, ROR is computed as a weighted
average of the ROR within each stratum. For
more information, see ROR computations.
Field descriptions—Review information for the product-event combination

The review information for the product-event combination includes the following
columns:
Field Description
Date Date and time when the comment was added.
The comments are ordered by the date they
were added, with the most recently added
comment appearing first.
Created By Name of the user who added the comment.
The user name appears even if the user has
been deleted.
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Field Description
Filtered • Yes, if you added the comment when
the product-event combination was
suppressed.
• No, if you added a public comment
when you were documenting your review,
or when you un-suppressed the product-
event combination.
• Empty (blank), for private comments.
Private If the signal management configuration allows
private comments, displays Yes to identify
private comments and No to identify public
comments.
Comment The predefined comment added to the
combination.
Detailed Comment The optional free text description added with
the comment. This column appears only if the
corresponding site option has been set.
Field descriptions—Topic information for the product-event combination

If signal management is integrated with topics, the table also includes the following
columns:
Field Description
Topic Name (ID) Topic name and ID associated with the
product-event combination.
Topic Association Activity involving the associated topic. Values
include Created, Removed or Modified.
Focus on a product-event combination

• Add a private comment
• Add a private comment to multiple combinations
• Assign a reviewer to a product-event combination
• View the signal history
• View signals for similar product-event combinations
• View product-event interactions
• Suppress a product-event combination
• Limit the product-event combinations to a specific alert type
• View age group breakdown in a bar graph
• View gender breakdown for a product-event combination
Add a private comment

You can add a private comment to a product-event combination on the Product-Event
Combinations page if the signal management configuration allows private comments.
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4. Select a product-event combination, click that Row Action Menu ( ) icon, and
select Add Private Comment.
5. From the Comment drop-down list, select a predefined comment.
6. In the Detailed comment text box, enter a detailed comment (optional). This
option is available if the appropriate site option has been set.
7. Click OK.
The private comment appears for the product-event combination.
Note:
Private comments are visible to only you and superusers. However, if the
product-event combination becomes part of an attachment in a topic, the
private topic becomes visible to anyone who can view that topic attachment.
Add a private comment to multiple combinations

4. On the Product-Event Combinations page, from the Header Action menu ( ),

select Select Rows.
5. Select the check box of one or more product-event combinations.
6. To add a private comment, from the Header Action menu ( ), click Add Private
Comment.
a. Select a comment from the Comment drop-down.
b. (Optional) Enter a detailed comment.
c. Click OK.
The comment is added for all of the selected combinations. If a topic was
associated, then the attachment contains all of the selected product-event
combinations (up to the maximum set by the Site Option, Max number of rows
per table allowed in topic attachments).
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7. To exit multiple selection mode, from the Header Action menu ( ), click Exit
Selection Mode.
Assign a reviewer to a product-event combination

You can assign a reviewer to a product-event combination. To assign a reviewer, you
must have the Manage Signaling Terms permission.

4. Click the product-event combination's Row Action menu ( ) and click Assign
Reviewer.
5. From the Reviewer drop-down list, select the reviewer.
You can also select no reviewer (--) to remove an assignment. Available reviewers
for assignment are those in login groups to which the signal configuration is
published. This assignment does not overlap with the reviewer assignments to
products. For example, if User1 is assigned to the product Niacin, you can assign
User2 to the combination of the product Niacin and event Flushing.
6. Click OK.
You can add the Reviewer column to the Product-Event Combinations table to see
reviewer assignments.
View the signal history

Within Signal Review, Oracle Empirica Signal maintains a history that includes the
tracked alerts marked as reviewed at the time each comment was submitted.

4. Click the product-event combination's Row Action Menu ( ) and click View
Signal History.
5. From the Signal set drop-down lists, select the signal set for which you want to
view a history, or select All to include all data. You can select up to two different
signal sets at a time to display graphs for each of them.
The Signal History includes the following information:
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• The name of the product and event (PT) and the HLT, HLGT, and SOC that
include the PT.
• A trend graph that shows the EBGM, EB05, and EB95 values over time.
• A histogram that shows the total count of cases with the product-event
combination over time.
• Statistical scores for the PT and HLT and SOC, if available. The statistics that
are displayed depends on the signal management configuration.
• A list of comments for the product-event combination. If signal management
is integrated with topics, the list also includes topic associations. If any alerts
became reviewed by the addition of the comment, the list of alerts is displayed
as a group of alert type icons. Hovering over the icons displays the full Alert
Type name.
Note:
If the signal configuration includes public and private comments, the
list includes all public comments by any user and all of your private
comments. The list for a superuser includes all comments regardless
of author or type. If the signal configuration does not include private
comments, all comments by any user appear in the list.
The detailed information about the product-event combination might include

multiple signal sets.
6. To save the signal history as an attachment to a topic, next to the Signal Set
drop-down, click Save to Topic.
The signal set graphs and statistics are attached to a PDF file.
7. When you have finished viewing the signal history, click Close.
View signals for similar product-event combinations

You can view the statistical information for combinations involving the same product
and the same HLT, HLGT, or SOC as that of the PT in the original combination. You
can also view all combinations for the product. For example, if you are viewing signals
for the combination of Ascorbic Acid and Chest Pain, you might also want to view
combinations of Ascorbic Acid and any PT that is in the same HLGT as Chest Pain.

Similar Combinations.
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The product and event you selected for comparison appears above the Similar
Combinations table. The columns in the Similar Combinations table are identical to
those in the Product-Event Combinations table.
5. To filter the combinations by MedDRA hierarchy level, from the Show events
within drop-down list, select a MedDRA hierarchy level.
Note:
If the data have been prepared to use SMQ terms, signal management
might be set up so that when you are viewing a product-event
combination involving an SMQ, your choices in this field are PTs for
SMQ (which shows combinations for PTs related to the SMQ) or ALL.
6. (Optional) Perform activities on the list of similar combinations.

The following links appear at the top of the dialog box and affect the entire dialog
box:
• Columns
• Print
• Download
• Save to Topic (if configured)
7. (Optional) Perform additional activities on a specific combination from the Row
Action menu ( ) icon.

• Submit Review
• Edit Topic - Edit Topic appears if the combination includes an associated topic
that you have permission to edit.
• Add Private Comment - Add Private Comment appears if private comments
are supported in your signal management configuration.
• View Signal History
• Assign Reviewer
• View Interactions
• View Age Group Breakdown
• View Gender Breakdown
View product-event interactions

Information about an event and drug interactions is represented as a nested
confidence interval graph of EB05-EB95 confidence intervals and EBGM values for
two drugs and the event. Data represented in the graph includes all available data up
through the current time period. The signals were generated by a particular run that
was set up for the purpose of viewing interactions.

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Interactions.
For each combination of two drugs and the event, the graph displays a series of
confidence intervals, with the highest dimension shown first. The first confidence
interval is for Event+Drug+Drug. The other two confidence intervals are for
Event+Drug. You can compare the strength of the interaction between the two
drugs and the event with the strength of the interaction between the individual
drugs and the event.
In each confidence interval bar, the EB05 value is at the left end, the EBGM value
is the dot on the bar, and the EB95 value is at the right end. The count (N) of
cases with the combination is also shown at the end of each bar. Bars are colored
according to the color key below the graph. To indicate a possible interaction, the
confidence interval for the Event+Drug+Drug combination displays in red when the
INTSS (Interaction Signal Score) value is greater than a predefined threshold that
is set when signal management is configured. For more information about INTSS,
see MGPS computations and Logistic regression computations.
Note that:
• The Event+Drug+Drug combinations are shown in descending order of their
INTSS values.
• To conserve space in labeling, the event from the product-event combination is
referred to by the label, Event, in the graph.
• Below the graph, there may be additional text provided by a site option.
Note:
A message informs you if there are no combinations of the drug and
another drug with the event. Depending on how your signal management
data was prepared, this option might not be available at all for some
product-event combinations or there may be multiple links for different
runs.
5. If you point to a confidence interval, the names of the event and the two drugs
appear. The following information for the Event+Drug+Drug combination also
appears:
• N—Observed number of cases with this Event+Drug+Drug combination.
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computations.
Relative Ratio lies above it.
• INTSS—Interaction Signal Score. A way of measuring of the strength of a
higher-order association above and beyond what would be expected from any
of the component pairs of items of different types.
• EXCESS2—A conservative estimate of how many extra cases were observed
over what was expected assuming that only a single cross-item interaction is
present.
6. To work with the cases represented by an of the coincidence intervals, you can
click the bar to see an action menu of options.
7. To save the graph as an attachment to a topic, click Save to Topic (available if the
topics feature has been set up). The graph is attached to a PDF file.
8. Click Close.
Suppress a product-event combination

You can suppress a product-event combination so that it is not included on the
Product-Event Combinations page. For example, if you determine that a product-event
combination has already been reviewed, you might want to suppress that combination.

4. Click the product-event combination's Row Action Menu ( ) and select Submit
Review.
5. From the Comment drop-down list, select one of the comments defined for your
signal configuration that has been configured to support suppressing a product-
event combination.
If no comment yet exists for the product-event combination, then the Comment
drop-down list displays <Select a comment>. To clear the existing comment, from
the Comment drop-down list, select <Clear Comment>.
6. To suppress a product-event combination, so that it doesn't appear on the Product-
Event Combinations table after the next refresh, click the checkbox.
If the Suppress flag, called FILTER, is set it works only on views that include the
FILTER flag. When it has been set and is part of the WHERE clause, it has an
immediate effect.
7. (Optional) In the Detailed comment text box, enter a detailed comment.
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8. (Optional) If signal management is integrated with topics, then you can associate a
topic with a given product-event combination.
9. Click OK.
Limit the product-event combinations to a specific alert type

You can limit the Product-Event Combinations table to a specific alert type by clicking
a tab above the table. Under the tab, the Product-Event Combinations table displays
only product-event combinations for that alert type. The columns also reflect the alert
type.
Some of the values in the columns are links to a menu for drilling down to case detail
and reports.
View age group breakdown in a bar graph

The breakdown of case data by age group for a product-event combination is
represented in a bar graph. Data represented in the graph includes all available data
up through the current time period and is for the designated signal set. You cannot
view the age group or gender breakdown if there is no value of N.
The x-axis of the bar graph represents the percent of the total number of cases with
the product-event combination. The y-axis represents each value of Age Group. For
each value of Age Group, there are two bars that are differentiated by the color key
below the graph. The bars represent the following:
• Product—Cases with the product for the current time period. The total number of
cases with the product for the current time period appears in the color key.
• Product+Event—Cases with the product-event combination for the current time
period. The total number of cases with the product-event combination for the
current time period appears in the color key.
If there are no cases including the product-event combination for a particular age
group, 0 appears instead of a bar. Cases with NULL values for an age group are
represented by a bar for NULL values.

4. Click the product-event combination's Row Action Menu ( ) and click View Age
Group Breakdown for All.
If there are multiple signal sets for which you can view a breakdown, the signal set
is identified in the link name.
topics feature has been set up).
6. Click Cancel.
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Step 4: Submit the review
View gender breakdown for a product-event combination

The breakdown of case data by gender for a product-event combination is represented
in a bar graph. Data represented in the graph includes all available data up through
the current time period and is for the designated signal set. You cannot view the
gender breakdown if there is no value of N.
The x-axis of the bar graph represents the percent of the total number of cases with
the product-event combination. The y-axis represents each value of Gender. For each
value of Gender, there are two bars that are differentiated by the color key below the
graph. The bars represent the following:
• Product—Cases with the product for the current time period. The total number of
cases with the product for the current time period appears in the color key.
• Product+Event—Cases with the product-event combination for the current time
period. The total number of cases with the product-event combination for the
current time period appears in the color key.
If there are no cases including the product-event combination for a particular gender, 0
appears instead of a bar. Cases with NULL values for gender are represented by a bar
for NULL values.

4. Click the product-event combination's Row Action menu ( ) and click View
Gender Breakdown for All.
If there are multiple signal sets for which you can view a gender breakdown, the
signal set is identified in the link name.
topics feature has been set up). The graph will be attached in a PDF file.
6. Click Cancel.

• Submit a review for a product-event combination
• Submit a review for multiple combinations
Submit a review for a product-event combination

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4. Click the product-event combination's Row Action menu ( ) icon and select
Submit Review.
The Submit Review dialog opens.
• If there are unreviewed tracked alerts for the selected product-event
combination, then the header section of the Submit Review dialog contains
the Alerts and Alert Date columns. Otherwise, the header section does not
contain Alerts and Alert Date columns.
• If at least one of the unreviewed track alerts has a different Alert Date from the
others, the header panel can expand to display more rows.
signal configuration.
the comment drop-down list, select <Clear Comment>.
6. (Optional) If the selected comment has been configured to support suppressing
the product-event combination, then click the Suppress the product-event
combination checkbox so that it doesn't appear on the Product-Event
Combinations table after the next refresh.
Note:
If the Suppress flag, called FILTER, is set it works only on views that
include the FILTER flag. When it has been set and is part of the WHERE
clause, it has an immediate effect.
7. In the Detailed Comment text box, enter a detailed comment. This option is
available if the appropriate site option has been set.
This option is available if the Allow Free Text Signal Comments site option is
enabled. If the selected comment is configured with Requires Detailed Comment
= Yes, you are required to enter a detailed comment. The comment appears in the
Detailed Comment column on the Product-Event Combinations table.
8. (Optional) If Signal Management is integrated with Topics, then you can associate
a topic with a given product-event combination.
9. Click OK.
10. If the topic workflow configuration requires one and only one work team, there is a
Visible to work team drop-down above the Topic Template field that allows you
to select a work team from the list, and a Browse link to select the work team from
a popup list.
If the product-event combination had unreviewed tracked alerts, then a green
checkmark icon appears in the Status column to indicate that the review has been
submitted and the comment appears in the Comment column. If you added a topic
during Submit Review, a folder also appears in the Status column. Oracle Empirica
Signal also updates the alert counts for the product in the SOC cards, Product
Summary at the top of the page, and the right graphic details panel.
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Submit a review for multiple combinations

4. On the Product-Event Combinations page, from the Header Action menu ( ),

click Select Rows.
5. Select the check box of one or more product-event combinations.
6. From the Header Action menu ( ), click Submit Review.

7. From the Comment drop-down list, select a comment.
8. (Optional) Enter a detailed comment.
9. (Optional) If signal management is integrated with topics, you can associate a
topic with a given product-event combination.
10. Click OK.
The comment is added for all the selected combinations. If a topic is associated,
the attachment contains all of the selected product-event combinations (up to
the limit set by the Site Option Max number of rows per table allowed in topic
attachments.)
11. To exit multiple selection mode, from the Header Action menu ( ), click Exit
Selection Mode.
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3
Use Oracle Empirica Topics
• Overview of topic management
To manage the process of identifying and investigating product safety issues,
including organizing the collection and interpretation of information from different
sources over time, you can create topics.
• About topics, actions, and the calendar
By selecting Topic Management from the left navigation pane, you can organize
and track tables, graphs, and documents related to particular subject matter.
• Display the Topic Management page
A single page provides access to all Oracle Empirica Topics functions.
• Sections of the Topic Management page
The Topic Management page is your starting point for working with all Oracle
Empirica Topics features.
• Download the Topics or Actions table
You can download the information in the Topics and Actions tables to various types
of files.
• Sections of the Topics tab
The Topics tab of the Topic Management page provides information about existing
topics. There are three sections.
• Sections of the Actions tab
The Actions tab of the Topic Management page provides information about
existing actions. There are three sections.
• Sections of the Calendar tab
The Calendar tab of the Topic Management page provides information about
actions in an open state that have a Planned Completion Date.
• Keyboard shortcuts for the Topics and Actions tables
Use these keyboard shortcuts to facilitate your work with the Topics and Actions
tables.
• Select a topic workflow configuration
To use topic management, you must have access to a topic workflow
configuration. The topic workflow configuration defines the behavior and content of
the Topic Management page.
• Choose which items to view on the Topics, Actions, and Calendar tabs
To control the items shown on the Topics, Actions, and Calendar tabs, use these
procedures.
• Work with topics
This section includes procedures for working with topics and topic reports.
• Work with actions
This section includes procedures for working with actions.
• Work with the calendar
This section includes procedures for working with open actions.
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Overview of topic management
• Work with attachments

This section includes procedures for working with attachments.

To manage the process of identifying and investigating product safety issues, including
organizing the collection and interpretation of information from different sources over
time, you can create topics.
What are topics and actions?

A topic in Oracle Empirica Signal is a means to organize and track tables, graphs,
and documents related to particular subject matter. You can collect and record
issues identified through various means, such as automated signal detection, literature
reviews, and regulatory requests as well as your data mining, reporting, and product-
event analyses. A topic can help you and the other members of your work team
track an issue throughout the process of researching and resolving it. You update the
progress of the topic through different stages of work using statuses such as Initial,
Reviewed, or Completed. You can monitor topics from creation to completion on the
Topics tab and by using reports. You can also download all, or a selected subset, of
the information stored with a topic at any time to a PDF file.
For each topic you create, you can choose a template for entering the information
(if configured and made visible to a work team) and select the work teams whose
members can view or act on the topic.
Within a topic you can create an action. An action is an activity that has been identified
as contributing to the understanding or resolution of a topic. Examples of activities that
you may track with actions include:
• Research results
• Project meetings or milestones
• Follow-up work
Like topics, actions are given workflow states to track their progress from creation to
completion. An action can be assigned to the same user that is currently assigned to
the topic or to a different user.
On the Topic Management page you have access to topics and actions that you
created and those made visible to a work team of which you are a member.
Use topic workflow configurations to customize Oracle Empirica Topics

The title bar on the Topic Management page contains a topic workflow configuration
drop-down list that shows the configurations you have access to and allows you
to switch topic workflow configurations. If you have access to only one workflow
configuration, Oracle Empirica Signal displays the current configuration without a drop-
down list. To use Oracle Empirica Topics, you must have access to a topic workflow
configuration. The topic workflow configuration defines the behavior and content of
Oracle Empirica Topics.
When you create and edit topics, information is collected using a topic workflow
configuration. Although a standard template is provided with Oracle Empirica Topics, it
is likely that your organization has customized the topic workflow configuration to meet
the specific requirements of your organization. This means that the fields shown on the
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pages and dialog boxes described in this guide might not exactly match the details in
this guide. These customizations include:
• The fields that store information.
• The values that you can supply for each field.
• The workflow states that you can assign.
• The types of attachments you can add: Oracle Empirica Signal objects including
run result tables and graphs, reports, and query results, website URLs, text notes,
or files.
• The rules for sending automated email notifications triggered when a topic or
action is added or modified, a change is made to its workflow state, an action due
date is nearing, or the topic is assigned to a different user.
In addition, the fields that are available to store information when topics or actions are
in different states, or for different types of attachments, can be set to hidden, visible,
editable, or required for each defined field.
All of these attributes are stored in a topic workflow configuration that is managed by
an administrator at your organization.
You can design topic workflow configurations to meet the needs of different groups
in your organization. For example, a collaborative topic workflow configuration can
structure the participation of several members of a work team on every topic, while a
separate notebook topic workflow configuration allows individuals working in another
part of your organization to track their own issues over time without the participation of
other users.
Alternatively, a single topic workflow configuration allows you to work cooperatively
with others on projects using topics and also track your own issues by setting up topics
that you leave assigned just to yourself. If your organization defines more than one
topic workflow configuration, the topics that you enter are based on just one of them.
As a result, members of different groups in your organization might work with topics in
different ways, supplying different types of information or assigning different workflow
states.
If your organization uses the Signal Review feature, you can integrate a topic workflow
configuration with a signal management configuration. You can then store and manage
topics associated with product-event combinations in the integrated topic workflow
configuration. The integrated topic workflow configuration can differ from the one used
on the Topic Management page.
Note:
When describing topic-related activities, help topics reference the topic
workflow configuration supplied with Oracle Empirica Topics.
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About topics, actions, and the calendar
About topics, actions, and the calendar

By selecting Topic Management from the left navigation pane, you can organize and
track tables, graphs, and documents related to particular subject matter.
You can set up topics to follow your workflow through different states, such as Initial,
Reviewed, and Closed. You can also make topics visible to work teams and assign
them to a user or work team.
A topic is a way of organizing information about your work assignments

Topics organize and track tables, graphs, and documents related to a particular
subject matter. You can collect and record issues identified through various means,
such as automated signal detection, literature reviews, and regulatory requests.
You access topics through the Topic Management page. You must have the View
Topics permission and an administrator must set up Oracle Empirica Topics for your
use, including making at least one topic workflow configuration accessible to your
login group and, if needed, making you a member of work team and assigning work
team permissions. For information on setting up the topics feature see Set up Oracle
Empirica Topics.
Topics can be made visible to work teams. Visibility controls who can see the topic and
its actions. Work team permissions control what type of access a work team member
has to a topic or action. Topics and actions are assigned to a user or a work team. At
the top of the Topic Management page are the View items for selectors that control
the set of topics you can work with.
Actions are a way of organizing your work assignments

Within a topic, you can create an action. An action is an activity that has been
identified as contributing to the understanding or resolution of a topic. On the Topic
Management page, you have access to topics and actions that you created and those
made visible to a work team of which you are a member.
Use the calendar to see what you need to do

Use the Calendar tab to view your overdue and upcoming actions. The calendar
displays open actions with a planned completion date but with no actual completion
date. The tab contains a calendar with one, two, or four months, depending on the
space available on the screen, and a detailed list of actions. The actions are filtered by
the View items for selection (Me or Work Team) and, optionally, by a selected work
team or user. There are two views:
• List view: The List view provides the list of the available actions. Actions are
ordered by Planned Completion Date in ascending order. If more than one action
is available on any date, the actions are sorted in alphabetic order.
• Calendar view: The Calendar view displays the available actions on a monthly
calendar.
Display the Topic Management page

A single page provides access to all Oracle Empirica Topics functions.
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Sections of the Topic Management page
2. In the left navigation pane, click the Topic Management icon ( ).

The Topic Management page is your starting point for working with all Oracle Empirica
Topics features.
The Topic Management page contains the following sections:
Figure 3-1 Sections of the Topic Management page
Title bar
The Title Bar contains the page title, Topic Workflow Configuration drop-down list to
switch topic workflow configurations, and the View items for selectors.
Topic Workflow Configuration selector: This drop-down list appears to the right of
the page title and includes the topic workflow configurations you have access to. This
list is also available on the User Preferences page. If you have access to only one
configuration, you will see the configuration name and ID, but no drop-down list.
Note:
You can change your topic workflow configuration selection on the Topic
Management and the User Preferences pages. A change from one of these
pages updates the selection on the other page.
View items for selectors: These selectors control the set of topics you can work with
on the Topics, Actions, and Calendar tabs. For a topic and its actions to be available to
you on the Topic Management page, they must be visible to a work team that you are
a member of or the topic must have been created by you and not visible to any work
team. The selectors are:
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Chapter 3
• Me: Topics or actions visible to you and assigned to you.

• Work team: Topics and actions visible to you and assigned to the selected work
team. If you have access to more than one work team, select from the Work Team
drop-down list.
• All: All topics and actions visible to you. The Calendar tab is not available if you
select All.
Topics and Actions Tabs

The Topics and Actions tabs contain graphs of topic or action counts by a fillterable
field, table filters, and the Topics or Actions table. Use the Topics tab to add and
maintain topics. Use the Actions tab to add and maintain actions. Then use the
Calendar tab to manage your assignments by completion date and look at what your
team is doing and what actions are overdue and upcoming for you or your team.
The Topics and Actions tabs contain three sections:
• Graph: The Graph section graphically displays summary information of topics.
Your selection from the Topics By or Actions By drop-down lists determines the
type of graph displayed. If you select anything other than Current State or Action
State, a bar chart is displayed. Select Current State or Action State to display a
donut graph, as shown in Figure 3-1.
Select a different field from the Topics By or Actions By drop-down list to view a
different graph. Select the menu on any graph bar or donut section to modify the
filters on the Filter bar and to apply the filter to the Topics or Actions table below.
• Filter bar: Above the Topics and Actions tables is the Filter bar. You can add filters
and select one or more filter values for each filter to find topics or actions to work
with.
Note:
If you made a View items for selection or defined filters on the Filter bar
on the Topics and Actions tables, those selections are applied.
• Topics table/Actions table: The tables contain the set of topics or actions to work
with. They are filtered by the View items for selector and filters in the Filter bar.
The top line of the tables includes a count of the topics or actions. Also included
are controls for specifying the number of rows per page, the current page, and
arrows to page through the table. If you click the plus sign (+) at the far right of
the Topics table, you can add a topic. To the left of the top row of both tables is a
Header Action menu ( ) of functions you can apply to the table as a whole. To
the left of each topic or action row is a Row Action menu ( ) of functions you
can apply to a specific topic or action.
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Chapter 3
Download the Topics or Actions table
Note:
Changes made to any sections of the Topics or Actions tabs updates both of
these tabs. For example, if you view a topic that you select from the Recent
Topics list on the Actions tab, then edit the topic and create a new action,
these changes appear on the Actions tab. Deleting a topic also updates all
components on the Topics tab.
Calendar tab
The Calendar tab displays a list of actions ordered by planned completion date and a
calendar showing upcoming and overdue actions. Only open actions with a Planned
Completion Date and without an Actual Completion Date appear on the calendar. The
Calendar tab contains a List view and a Calendar view, both showing the actions by
Planned Completion Date. The View items for selectors, Me or Work Team, may
be applied to the calendar. The calendar is not available if you select All. To view
actions without planned completion dates, select the Actions tab and sort by Planned
Completion Date ascending. This puts the empty values on top.
Above the list is an Assign to drop-down list for filtering the list by work team or user.
At the top of the list are counts of overdue and upcoming actions.
Detail panel
The Detail panel appears on the right. It displays a list of recently viewed or edited
topics or detailed information about the selected topic or action. If a topic or action is
selected, it displays details for the topic or action. The View Items for selector does
not apply to the list of recent topics. When you close the topic or action details, the
Recent Topics list displays. You can select any topic in the Recent Topics list to view it.
Download the Topics or Actions table

You can download the information in the Topics and Actions tables to various types of
files.

2. Select the Topics or Actions tab.
3. Click the Header Action menu ( ) and then click Download.

4. In the Download popup, type the Base filename. Don't include a file extension.
5. Select the format of the file. For more information, see Download data.
6. In the Limit to field, enter the maximum number of rows to download.
Note:
When downloading to a spreadsheet format, the maximum number of
rows is 64K.
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Sections of the Topics tab
7. If you want a Zip archive file of the download, select the Create a Zip archive file
for download checkbox.
8. Click OK.
9. Open or save the downloaded file.

The Topics tab of the Topic Management page provides information about existing
topics. There are three sections.
In addition to the Title bar, containing the page title, Topic Workflow Configuration
selector, and the View items for selectors, the three sections of the Topics tab are:
Figure 3-2 Sections of the Topics tab
Graph section
The Graph section on the Topics tab graphically displays summary information of
topics. The Topics By drop-down list contains a list of filterable fields. The type of field
determines if a bar chart or donut chart is displayed. A donut chart is a pie chart with
a hole in the center that displays the total number of topics. The donut graph displays
when you select Current State.
You can perform a number of tasks in the Graph section that impact what you see in
the Graph section of the Topics tab.
• Make a selection from the Topics By drop-down list to graph the distribution of
topics by this field. The graph displays counts (number of topics) for each value
of the selected field. Data for which there is no value is displayed as (No Value).
There is no impact on the content in the Topics table below.
• For most Topics By fields, a solid bar is displayed with a count for each topic with
the field value. If the Topics By field is Assigned To and the value is a work team,
the bar is not solid.
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Chapter 3
• If the Topics By selection is Current State, the states and number of topics for
each state appears in a donut graph whose total area corresponds to 100%. If
there are many states, you may want to remove some of the states with larger
values to compare the states with smaller values. You can hide a state from the
donut by clicking the box to the left of the name in the legend.
• Select or deselect the Include Closed Topics check box to include or exclude
topics that have been closed in the Graph section. For bar charts, this adds a
bar in a lighter color for any closed topics. If there are open and closed topics for
the Topics By field, then a stacked bar is displayed. Hover over the two sections
to see the breakdown of the total shown by closed versus open topics. If you
have chosen Current State from the Topics By drop-down list and then select the
Include Closed Topics check box, a second donut chart shows the closed topics.
• Hide or show the Graph section by clicking the up-arrow or down-arrow that
appears at the bottom of the Graphic section, respectively.
• If you click any element in the Graph section, a menu opens with two options:
– Add to filter: Add the filter to the Filter bar and filter the Topics table.
– Replace filter: Replace current filters on Filter bar with the graph selection
and filter the Topics table.
Filter bar
The Filter bar on the Topics tab appears above the Topics table and contains a Select
Filter button ( ) for adding custom filters to filter the table below. Available filters are
defined in the topic workflow configuration. The Current State filter always appears on
the Filter bar but you can change the selected state values.
• Click the Select Filter button ( ) to add or remove filters. You can add as many
filters as you want. After you add the filter, you select values for the filter by
clicking the filter.
• Click the Reset button to clear the values of the selected filters and set the
Current State filter to All Open States. The filters stay on the Filter bar; however,
you can redefine the values for each filter.
• To remove filters from the Filter bar, uncheck the filter from the Select Filter menu.
Topics table
The Topics table on the Topics tab includes standard and custom topic fields, as
defined by the selected topic workflow configuration, such as Work teams, Project,
Topic Name, Current State, Assigned to, Attachment Count, Action Count, Created,
and Modified.
• The View items for selection and the filters in the Filter bar determine the set of
topics shown.
• The Header Action menu ( ) provides access to column management and

download options, Oracle Business Intelligence Enterprise Edition (OBIEE) topic
reports, and allows you to add a topic to the table.
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Sections of the Actions tab
Note:
OBIEE topic reports are not available for customers that do not integrate
with OBIEE.
• The Row Action menu ( ) provides the following options, whose availability
depends on your work team and user permissions, and the topic state.
Row Action menu options and permissions
Row Action menu option Work team permission

View View Topics/Actions/Attachments (or user
has View Topics across Work Teams user
permission).
Edit Edit Topics/Actions.
Delete Delete Topics/Actions.
Reopen Reopen Topics/Actions (Topic is in a final
state and the topic workflow configuration
supports a transition from this final state.).
Create PDF Create a Portable Document Format (.pdf)
version of the table for downloading.
Create ZIP Create a compressed .zip file (which
contains a .pdf file) version of the table for
downloading.

The Actions tab of the Topic Management page provides information about existing
actions. There are three sections.
In addition to the Title bar, containing the page title, Topic Workflow Configuration
selector, and the View items for selectors, the three sections of the Actions tab are:
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Figure 3-3 Sections of the Actions tab
Graph section
The Graphic section on the Actions tab graphically displays summary information of
actions. The Actions By drop-down list contains a list of filterable fields. The type of
field determines if a bar chart or donut chart is displayed. A donut chart is a pie chart
with a hole in the center that displays the total number of actions. The donut graph
displays when you select Action State.
You can perform a number of tasks in the Graph section that impact the Graph section
of the Actions tab.
• Make a selection from the Actions By drop-down list to graph the distribution of
actions by this field. The graph displays counts (number of actions) for each value
of the selected field. Data for which there is no value is displayed as (No Value).
• For most Actions By fields, a solid bar is displayed with a count for each action
with the field value. If the Actions By field is Assigned To or Topic Assigned To
and the value is a work team, the bar is not solid.
• If the Actions By selection is Action State, the states and number of actions for
each state appear in a donut graph whose total area corresponds to 100%. If there
are many states, you may want to remove some of the states with larger values
to compare the states with smaller values. You can hide a state from the donut by
clicking the box to the left of the name in the legend.
• Select or deselect the Include Closed Actions check box to include or exclude
actions that have been closed. For bar charts, this adds a bar in a lighter color for
any closed actions. If there are open and closed actions for the Actions By field,
then a stacked bar is displayed. Hover over the two sections to see the breakdown
of the total shown by closed versus open actions. If you have chosen Action
State or Topic Current State from the Actions By drop-down list and then select
the Include Closed Actions check box, a second donut chart shows the closed
actions.
• Hide or show the Graph section by clicking the up-arrow or down-arrow that
appears at the bottom of the Graph section.
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• If you click any item in the Graph section, a menu opens with two options:
– Add to filter: Add the filter to the Filter bar and filter the Actions table.
– Replace filter: Replace current filters on Filter bar with the graph selection
and filter the Actions table.
Filter bar
The Filter bar on the Actions tab appears above the Actions table and contains a
Select Filter button ( ) for adding custom filters to filter the table below. Available
filters are defined in the topic workflow configuration. The Action State filter always
appears on the Filter bar but you can change the filter values.
• Click the Select Filter button ( ) to add or remove filters. You can add as many
filters as you want. After you add the filter, you select values for the filter by
clicking the filter.
• Click the Reset button to clear the values of the selected filters and set the Action
State filter to All Open Actions. The filters stay on the Filter bar; however, you can
redefine the values for each filter. To remove filters from the Filter bar, uncheck the
filter from the Select Filter menu.
Actions table
The Actions table section on the Actions tab includes standard and custom topic and
action fields, as defined by the selected topic workflow configuration, plus Action ID,
Action Attachment Count, Created By, Created, Modified By, and Modified.
• The View items for selection and the filters in the Filter bar determine the initial
set of actions shown.
• The Header Action menu ( ) provides access to column management and

download options.
• The Row Action menus ( ) provide the following options, whose availability
depends on your work team and user permissions.
Row Action menu options and permissions
Row Action menu option Work team permission

View View Topics/Actions/Attachments (or user
has View Topics across Work Teams user
permission).
Edit Edit Topics/Actions.
Delete Delete Topics/Actions.
Reopen Reopen Topics/Actions (Topic/action is
in final state and the topic workflow
configuration supports a state to transition
to from final state.).
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Sections of the Calendar tab
Sections of the Calendar tab

The Calendar tab of the Topic Management page provides information about actions in
an open state that have a Planned Completion Date.
There is both a List view and Calendar view. Content displayed in both views is filtered
by the View items for selectors. You can further filter the actions using the Assigned
to filter when you have the View items for a work team selected to see actions
assigned to individual users in a work team or to actions assigned directly to the work
team itself. The Calendar tab also contains counts for past due and upcoming actions.
The number of months displayed depends on the available space on the page and will
show one, two, or four months.
Figure 3-4 Sections of the Calendar tab
List view
The List view contains a single list, sorted in ascending order by Planned Completion
date (earliest first). The List view initially scrolls to an area that includes today’s date.
There are three sections in the List view:
• Overdue actions
• Today's actions
• Upcoming actions (after today)
An action is considered Past Due if the Planned Completion Date is less than today.
An action is considered Upcoming if the Planned Completion Date is Today or after
Today. If more than one action is available on any date, multiple actions are displayed
below the date.
Above the list is a count of the overdue and upcoming actions. You can scroll through
the list from beginning to end.
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Keyboard shortcuts for the Topics and Actions tables
Calendar view
The Calendar view displays up to four months at a time and includes actions in an
open state that have a value for Planned Completion Date, but no value for Actual
Completion Date. If a date has one action associated with it, there is one circle on the
calendar. If a date has more than one action associated with it, there are two circles
on that date. Colors in the Calendar view match those in the List view and indicate
whether an action is past due (orange), due today (teal), or upcoming (blue).
Above the calendar are buttons for Previous (<), Today, and Next (>). If there are two
or more months showing, then, initially, today’s month is the second month from the
left. If there is only month showing, then, initially, it is today’s month.
Reading from left to right, starting in the upper left, Today's month appears in the
second month shown. Use the Previous and Next buttons to scroll through the
calendar month-by-month. Click Today to center the Calendar view on today's date.
Click a month name link to select a different month and click a year link to select a
different year. The available months and years to select or to scroll to are based on the
first month with an action and the last month with an action.
Keyboard shortcuts for the Topics and Actions tables

Use these keyboard shortcuts to facilitate your work with the Topics and Actions
tables.
To interact with the Topics and Actions tables:

1. To set focus to the table, press Tab or Shift+Tab.
2. To navigate up or down rows in the table, press the Up or Down arrow.
3. To display the row action menu when a row has focus, press Enter.
5. To dismiss the menu, press Esc.
To interact with cells in a row in the table:

1. To restrict focus within a table row, press F2.
2. To focus on the next or previous cell, press Tab or Shift+Tab.
3. To select a link or display a menu in a cell that is in focus, press Enter.
4. To turn off navigation within a table row, press F2 again.
To interact with the table header:

1. To navigate to the table, press Tab or Shift+Tab.
2. To navigate to the table header, press the Up or Down arrow.
3. To display the header action menu, press F2 and Enter.
5. To dismiss a menu item, press Esc. To set focus back to the table header, press
Esc again.
6. To navigate between header cells, press the Left or Right arrow.
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Select a topic workflow configuration
7. To sort a table column, press Enter.
To check the Current State filter on the Topics table:

1. Press Tab until keyboard focus is on the filter button.
2. Press Spacebar.
Select a topic workflow configuration

To use topic management, you must have access to a topic workflow configuration.
The topic workflow configuration defines the behavior and content of the Topic
Management page.
When you select Topic Management from the left navigation pane, the Topic
Management page appears. Before you select the Topics, Actions, or Calendar tab,
select the topic workflow configuration to work with and filter the topics and actions
available in the tables and calendar.
Note:
You can change your topic workflow configuration selection on the Topic
Management and the User Preferences pages. A change from one of these
pages updates the selection on the other page.

2. From the Topic Workflow Configuration drop-down in the Title bar, select a
different topic workflow configuration if you have access to more than one topic
workflow configuration.
Note:
You must have View Topics permission for the topic workflow
configuration to appear in the Title bar of the Topic Management
page. If only one topic workflow is assigned to you, the topic workflow
configuration name appears as text and there is no drop-down list.
3. (Optional) Select a View items for selector:

• Work team: Topics and actions visible to you and assigned to the selected
work team. If you have access to more than one work team, select from the
Work Team drop-down list.
• All: All topics and actions visible to you. The Calendar tab is not available if
you select All.
4. Select the Topics, Actions, or Calendar tab.
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Choose which items to view on the Topics, Actions, and Calendar tabs
Choose which items to view on the Topics, Actions, and

Calendar tabs
To control the items shown on the Topics, Actions, and Calendar tabs, use these
procedures.
• Define the set of topics to work with
The View items for selectors at the top of the Topics, Actions, and Calendar tabs
filter the topics and actions that appear in the Topics and Actions graphs, Topics
and Actions tables, and on the calendar by items assigned to you, one of your
work teams, or all items visible to you.
• Graph the distribution of topics and actions by a specific field
The Topics By and Actions By drop-down lists that appear in the Graphic section
of the Topics and Actions tabs graph the distribution of topics and actions by the
selected field.
• Filter the Topics and Actions tables
Use the Select Filter button and the Filter buttons on the Filter bar to filter the
content of the Topics and Actions tables.
• Manage the columns on the Topics and Actions tables
You can add and remove columns, reorder columns, and sort columns.
Define the set of topics to work with

The View items for selectors at the top of the Topics, Actions, and Calendar tabs
filter the topics and actions that appear in the Topics and Actions graphs, Topics and
Actions tables, and on the calendar by items assigned to you, one of your work teams,
or all items visible to you.

2. (Optional) From the Topic Workflow Configuration drop-down list, select a
different topic workflow configuration.
3. Select a View items for button:
you select All.
If you select All, the calendar displays a message that it is not available.
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Note:
When you navigate between the Topics and Actions tabs, Oracle Empirica
Signal remembers your most recent topic workflow configuration and the
following items for each topic workflow configuration that you select: the
View Items for selection, the Topics By and Actions By selection, whether
you included closed topics and actions in the graph area, the selected filters
and their filter values in the Filter bar, and the Assigned to selection in
the Calendar tab. These are remembered when you navigate back to the
Topics, Actions, or Calendar tab or switch back to a previously selected topic
workflow configuration and also remembered the next time that you log in.
Graph the distribution of topics and actions by a specific field

The Topics By and Actions By drop-down lists that appear in the Graphic section of
the Topics and Actions tabs graph the distribution of topics and actions by the selected
field.

4. In the Graphic section, change the graph shown by selecting a different field from
the Topics By or Actions By drop-down list.
• The graph displays counts (number of topics or actions) for each value of the
selected field. If the Topics By or Actions By selection is an Assigned To
field and the value is a work team, the bar is not solid. Data for which there is
no value is displayed as (No Value).
• If you choose Current State or Action State, a donut chart shows the states
and number of topics for each state in a donut graph whose total area
corresponds to 100%. You can remove a state from the donut by clicking
the box to the left of it in the legend. If you select the Include Closed Topics
or Include Closed Actions check boxes, a second donut shows the closed
topics or actions.
Note:
Changing the graph does not filter the topics in the Topics or Actions
tables.
5. Click any element in the Graphic section to open a menu with two options:
• Add to filter: Add the filter to the Filter bar and filter the Topics table.
• Replace filter: Replace current filters on Filter bar with the graphic selection.
6. Hide or show the Graphic section by clicking the up-arrow or down-arrow that
appears at the bottom of the Graphic section.
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Filter the Topics and Actions tables

Use the Select Filter button and the Filter buttons on the Filter bar to filter the content
of the Topics and Actions tables.
The topics that appear in the Topics and Actions tables are those you can work
with and that correspond to your View items for selection at the top of the Topic
Management page. You can further filter the topics using the Select Filter button to
apply additional filters to the table.

2. Click the Topics or Actions tab.
3. To add or remove filter buttons from the Filter bar, click the Select Filter button
( ) at the top left of the Filter bar. Check a filter to add it to the bar. Uncheck
a filter to remove it from the bar. The filter choices include: Project, Assigned To,
plus a set of fields that are configured in the topic workflow configuration to appear
as filter fields.
• The Current State filter always appears on the Filter bar of the Topics table.
The Action State filter always appears on the Actions Table. You can't remove
these filters, but you can change their values.
• You can add as many filters as you want.
• Each filter impacts the topics or actions shown in the table.
Note:
If the graph displayed in the Graph section provides a view of the topics
or actions you want to work with, you can click an item and open a menu
with these choices:
• Add to filter: Add the filter to the Filter bar and filter the Topics table.
• Replace filter: Replace current filters on the Filter bar with the graph
selection and filter the Topics table.
4. To assign the values for a filter, click the filter, select values for the filter, then click
Apply. Each filter value you add or remove impacts the topics or actions shown in
the table. As you modify filter values, the number of topics or actions shown may
be changed significantly.
There are different types of filters. This means that possible values differ
depending on field type associated with the filter. For a filter to be available,
administrators must define topic and action fields as filterable in the topic workflow
configuration. See Edit a field.
• Current State or Action State: You can pick all open or closed states or
select individual state values. The default setting is all open states. All Open
or All Closed states appear as a toggle that you can turn on and off. When
on, all states are included. When off, you can select individual states by
selecting their check box.
The individual state check boxes vary based on set of states in the current
filtered topics or actions. The All Open or All Closed state toggles always
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include all open or closed states, even the states that are not currently
represented in the topics or actions table. If more than one state is available,
Select All/Deselect All is available. Clicking this either selects or deselects all
the check boxes grouped underneath.
• Assigned to: The values are grouped by work team and user. You can pick
multiple work teams and users.
• String and integer fields: Available values depend on how the field is defined
in the topic workflow configuration. You can pick multiple values.
• Date fields: From the Select Filter button, select the check box for an action
or topic field that relates to a date; for example, Planned Completion Date.
Enter a range of dates in the From and To text boxes or select the From and
To dates by clicking the Calendar icon and selecting a date. Add a single
date by making the To and From dates the same.
5. To clear the values of a filter, click the Filter button, then click the Clear button and
the Apply button.
Clear removes any selected values for the filter. The filter remains on the Filter
bar. For state filters, Clear sets the filter to All Open States and All Closed States.
6. To revert to the previous filter values and dismiss the dialog, click Cancel.
7. To reset the values of all of the filter buttons back to their defaults, in which no filter
values are selected and the Current State/Action State filter is set to All Open
States, click the Reset button.
Note:
If you log out and then log in again, or change topic workflow
configurations, Oracle Empirica Signal remembers your filter selections
and the filter values for each topic workflow configuration. This also
applies after you log out and log in again.
Manage the columns on the Topics and Actions tables

You can add and remove columns, reorder columns, and sort columns.
The Header Action menu ( ) on the Topics and Actions tables has a Columns
choice. It allows you to add selections from the Available Columns list to the Selected
Columns list, add and remove columns, reorder columns, sort columns, and specify
the order in which the columns appear in the tables.

3. Click the Header Action menu ( ) and then click Columns.

Oracle Empirica Topics displays the Columns dialog box. If this is the first time you
are working with the columns, the columns that appear in the Selected Columns
list are the default columns, shown below. These names will vary if your company
has modified the column names.
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• Work teams
• Project
• Topic - Topic Name
• Current state
• Assigned to
• Attachment Count
• Action Count (includes open and closed actions)
• Created
• Modified
4. Select columns to include in the table from the Available Columns list and move
them to the Selected Columns list using the right-arrow buttons. To remove
columns, select columns in the Selected Columns list and use the left-arrow
buttons to move them back to the Available Columns list.
When adding columns to the Actions table, both action fields and topic fields
appear in the Available Columns list. Action-related fields appear at the top of the
list, then topic-related fields, prefixed with Topic -.
5. To change the order in which columns display in a table, in the Selected Columns
list, click the column name and:
• Click to move the column up in the list.
• Click to move the column down in the list.

6. To move multiple columns, hold down the Ctrl key while you click the column
names, and then use the up or down arrows or click the first column you want to
move and Shift-click the last column.
Note:
For most tables, rows with empty cells appear first when you sort that
column in ascending order, and last if you sort in descending order.
Empty columns are always displayed last, regardless of the sort order.
7. If you want to replace your choices with the Oracle Empirica Signal defaults, click
Reset. The table columns and sorting return to the default values.
8. Specify the sort order:
a. From the Column Name drop-down lists, select a column name for up to three
columns.
b. From the Sort Order drop-down lists, select Asc (ascending order: A-Z, 1-9)
or Desc (descending order: Z-A, 9-1).
9. Click OK.
Oracle Empirica Topics updates the columns on the Topics or Actions table.
If a table includes a lot of columns or the columns contain long values, the entire
table may not fit across your browser window. Scroll to the right to see the rest of
the table.
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10. You can further sort the table by column values by clicking a column header.
Depending on the nature of the column, the information appears in ascending or
descending order.
Work with topics

This section includes procedures for working with topics and topic reports.
• View topics
You can view topics you created and topics you have permission to see from your
work teams.
• Filter the Topics table
Use the Select Filter button and modify filter values to filter the content of the
Topics table.
• View a topic
You can view general information about a topic and the topic links, comments,
attachments, actions, and history associated with the topic.
• Quickly access topic information
If you click on any row in the Topics table, the Recent Topics panel is replaced with
a Detail panel with details about the selected topic.
• Open a topic from the Recent Topics list
If you click a topic in the Recent Topics list, it opens for viewing.
• View Topic and Edit Topic pages
From the Topics table, you can view and edit topic information.
• Edit the general information about a topic
On the Edit Topic page, you can make changes to the general information about a
topic.
• Associate a topic with a product-event combination
Follow these steps to associate a topic with a product-event combination.
• Make a topic visible to a work team
A work team is a group of users who have an interest in a set of topics. When a
topic is made visible to a work team, the members of that team can view the topic
and any actions defined for it.
• Add or view comments for a topic
You can add comments to a topic and view comments associated with a topic.
• Link topics
When you edit a topic, you can add a cross-reference from that topic to another
topic by adding a topic link.
• Remove a link
You can remove a link added to a topic that provides a cross-reference to another
topic.
• Add a topic
You can add a topic on the Topic Management page.
• Reopen a topic
You can reopen a topic if the topic is in a closed state and your topic workflow
configuration includes a transition from that state to another state, such as
Assigned or Reopened.
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• Delete a topic
You can delete topics from the Topics table.
• View the history of a topic
You can view the history of topics you created and topics you have permission to
see from your work teams.
• Viewing topic reports
Predefined Oracle Business Intelligence Enterprise Edition reports are optional
topic reports that provide greater detail on topic information.
• Create a topic PDF or ZIP file
You can create a PDF or Zip file to document the contents of a topic and include
attachments.
View topics
You can view topics you created and topics you have permission to see from your
work teams.

2. Select the Topics tab.
3. (Optional) From the Topic Workflow Configuration drop-down list, select a
you select All.
5. (Optional) In the Graph section, change the graph shown by selecting a different
field from the Topics By drop-down list.
Note:
Changing the graph does not filter the topics in the Topics table.
6. In the Filter bar, click the Select Filter button to add or remove filters and then
modify the filter values to limit the Topics table to those topics you want to work
with.
7. Add a topic by clicking the plus sign ( ) above the table at the far right.
8. Click the Header Action menu ( ) to perform the following actions on the table
as a whole:
• Add or remove columns, sort columns, and specify the order in which the
columns appear in the table.
• Download the Topics table to various types of files.
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• Produce topic-related Oracle Business Intelligence reports.

• Add a topic.
9. Click a topic's Row Action menu ( ) to perform the following actions on the
selected topic:
• View: Display the general information about the selected topic, links to other
topics, comments, attachments, actions, and history. You can have up to five
view windows open at once. To edit a topic you're viewing, click the Edit Topic
icon ( ) in the upper-right corner of the View Topic window.

• Edit: Edit the general information about the selected topic. You can only have
one edit window open. If you have already opened a topic for editing and you
try to edit another topic, Oracle Empirica Topics asks you to confirm that any
unsaved changes on the other topic you started to edit will be discarded.
• Delete: Confirm that you want to delete the topic and, if so, deletes the topic.
• Reopen: Reopen a topic that is in a closed state.
• Create PDF: Select attachments and actions to include and additional content
about the topic. The PDF includes the general information and you can include
the topic comments, attachment source details, and general information
history.
• Create ZIP: Select attachments and actions to include and additional content
about the topic. The PDF includes the general information and you can include
the topic comments, attachment source details, and general information
history.
Note:
Some options are available based on your work team permission and the
Visible to work team field.
Default field descriptions—Topics tab

The Topic Management page provides information about topics that are visible to a
work team of which you are a member. If you have created any topics, those topics
also appear.
The table might include these standard columns, and additional columns customized
for your organization:
Column Description
ID Unique identifying number for the topic.
Work teams The work team(s), if any, to which this topic is visible.
Project Project, if any, with which the topic is associated.
Name Name of topic.
Topic description Description of the topic.
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Column Description
Current state The state of the topic in the topic workflow. States
are defined by your organization to represent expected
workflow stages and are specified in the topic workflow
configuration.
Reason for change Last reason for change, if any, provided for the topic.
Assigned to User or work team to whom the topic is assigned.
Keywords Keywords, if any, associated with the topic. This is the
column that is searched if you select a keyword at the
top of the page.
Resolution Last resolution, if any, provided for the topic.
Resolution date Date and time when a resolution was provided for the
topic.
Size Total size of all attachments, including attachments to
the topic and to any actions. Also includes attachments
that have been deleted from the topic or its actions.
(Deleted attachments are retained in the database,
although they cannot be accessed from within the
application.)
Attachment Count Total count of attachments to the topic and to any of its
actions. (Deleted attachments are not included in this
count.)
Action Count Number of actions in the topic.
Created Date and time when the topic was created.
Created By Name of the user who created the topic.
Modified Date and time when the topic was last modified.
Modified By Name of the user who last modified the topic, including
modifying links, comments, attachments, or actions.
The table also includes columns for custom fields added by your organization. For
information about viewing, printing, or downloading tables or changing the way data
displays in the table, see About tables.
Filter the Topics table

Use the Select Filter button and modify filter values to filter the content of the Topics
table.
The topics in the Topics table are those you can work with and that correspond to your
View items for selection at the top of the Topic Management page. You can further
filter the topics using the Select Filter button to apply additional filters to the table.

2. Click the Topics tab.
3. To add or remove filter buttons from the filter bar, click the Select Filter button
( ) at the top left of the Filter bar. Check a filter to add it to the bar. Uncheck
a filter to remove it from the bar. The filter choices include: Project, Assigned To,
plus a set of fields that are configured in the topic workflow configuration to appear
as a filter fields.
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4. To assign the values for a filter, click the Filter button. Select the filter value
choices and click Apply. To cancel your selection, click Cancel.
Oracle Empirica Signal applies the filter to the Topics table.
5. To clear a filter, click the Filter button, then click the Clear button, and then click
the Apply button.
View a topic
You can view general information about a topic and the topic links, comments,
attachments, actions, and history associated with the topic.

3. (Optional) From the Topic Workflow Configuration drop-down list select a
you select All.
field from the Topics By drop-down list.
Note:
Changing the graph does not filter the topics in the Topics table.
6. In the Filter bar, click the Select Filter button to add or remove filter buttons and
modify the filter values in the Topics table to those topics you want to work with.
7. Click a topic's Row Action menu ( ) and then click View.

The general information about the topic appears, along with links to additional
information, including:
• Topic Links: Related topics linked to this topic.
• Comments: Comments added to the topic.
• Attachments: Information about items attached to the topic.
• Actions: A list of each activity identified for the topic.
• History: Changes made to the general information for the topic.
For details, see View Topic and Edit Topic pages.
8. To edit the topic, click the Pencil icon ( ) in the upper-right corner.
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Quickly access topic information

If you click on any row in the Topics table, the Recent Topics panel is replaced with a
Detail panel with details about the selected topic.

3. Click anywhere in a row on the Topics table.
The Detail panel replaces the Recent Topics panel. The information shown is a
summary of the information you would see if you selected the topic's Row Action
menu ( ), and then clicked View.

There are four sections:
• General Information
• Comments (only available if the Topic Workflow Configuration - allow topic
comments property is enabled).
• Attachments
• Actions
4. Collapse or expand the sections of the Detail panel by clicking the arrow to the
left of the section name. If there are no comments, attachments, or actions, None
appears below the section name.
5. To open the topic and see all details, click the arrow to the right of the topic name.
6. To close the Topics Detail panel and return to the Recent Topics list, click Close
(to the left of the topic name).
Open a topic from the Recent Topics list

If you click a topic in the Recent Topics list, it opens for viewing.

3. On the Recent topics list, click a topic.
The View Topic page opens to the topic's General Information section.
4. To edit the topic, click the Pencil icon ( ) in the upper-right corner.
Note:
If you have another topic open for editing, Oracle Empirica Topics warns
you that the current Edit Topic window will be replaced with the topic you
are opening from Recent Topics.
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View Topic and Edit Topic pages

From the Topics table, you can view and edit topic information.
The menu items in a topic's Row Action menu ( ) take you to a View Topic or Edit
Topic page to view or edit general information about the topic, topic links, comments,
attachments, actions, and history. When the page is in Edit mode, you can perform
activities based on your permissions and topic workflow configuration.
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Work with topics
Menu Item Description Available Actions

General Information Displays the current field values that None
describe a topic:
• The fields are read-only,
editable, or required. If a field is
required, an asterisk (*) appears
next to it. You cannot save the
topic until you provide a value for
the field.
• Each field accepts text, numeric,
or date values, or provides a list
of values you can select. If a
value is not required, you can
leave the value empty to indicate
no value for the field. Fields may
also offer a Select Available
Values link so you can select
one or more values from a list.
• Arrow icons may appear after
the names of a pair of fields
to show that they are a linked
pair. For example, if fields for
MedDRA SOC( ) and MedDRA
HLGT ( ) appear, the arrows
indicate that you must select a
value for the MedDRA SOC field
first and then select a value for
the MedDRA HLGT field. You
cannot select an HLGT value
first: the values available for
HLGT depend on the SOC you
select.
• The Visible to work teams field
displays a list of work teams
whose members can access the
topic.
• In edit mode, to save changes to
the General Information section,
click Save. The changes are
shown as entries in the History
section.
Note:
The
Save
button
affects
only
the
Genera
l
Informa
tion
section
of the
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topic.
Do not
click
Save
after
you
work
with
other
section
s of this
page.
Any
change
s to
other
section
s are
saved
to the
topic
immedi
ately.
Topic Links Displays related topics that are linked View

to this topic. When the page is in edit Remove Link
mode, you can click Add Topic Link
Columns
to select a topic and link it to this
one. For each linked topic, you can Print
click Remove Link to remove the link Download
or View to view the linked topic.
A set of filters appear for the section,
determined by the Filter attribute
on the Topic fields in the Workflow
Configuration. These might include
some of the following, plus filters
customized for your organization:
• Project—Includes projects with
the linked topics.
• Current state—Includes current
topic states of the linked topics.
• Assigned to—Includes names
of users and work teams
assigned to the linked topics.
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Comments Displays all comments added to Add Comment
the topic. When in edit mode, you
can click Add Comment to add
a comment. You cannot modify or
remove a comment.
Note:
This
section
appear
s only if
your
topic
workflo
w
configu
ration
allows
topic
comme
nts.
Attachments Displays information about items View

attached to the topic. Your topic View Source Details
workflow configuration determines
Comments
the types of attachments you can
add, such as files, URLs, free-text Edit
notes, or Oracle Empirica Signal Delete
objects. When in edit mode, you can Columns
click Add Topic Attachment to add a
file, URL, or note attachment. Print
You can attach Oracle Empirica Download
Signal objects using the Save to
Topic link that is displayed on
different Oracle Empirica Signal
pages.
Actions Displays a list of each activity View
identified for the topic. Actions may Edit
reflect research activities, such as
Delete
literature searches and scheduled
meetings, or any other activity you Columns
wish to track for the topic. In edit Print
mode, you can click Add Action to Download
add an action, or click the Row
Action menu ( ) to edit the action.

When editing an action, you can
add attachments or comments to the
action.
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History Displays changes to general Columns
information for the topic. A new row Print
is added to the table each time you
Download
click Save in the General Information
section.
Note:
The
Assign
ed to
column
shows
work
teams
and
users
to
which
the
topic
has
been
assigne
d
Edit the general information about a topic

On the Edit Topic page, you can make changes to the general information about a
topic.
Note:
If you have already opened a topic for editing and you try to edit another
topic, Oracle Empirica Topics asks you to confirm that any unsaved changes
on the other topic you started to edit will be discarded.

3. Click a topic's Row Action menu ( ), and then click Edit.

4. On the Edit Topic page, select General Information from the left menu.
5. Enter values in the fields. See the field descriptions below.
6. Click Save.
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7. (Optional) Edit additional information about the topic by selecting a page from the
left-hand navigation pane:
• To display related topics that are linked to this topic, click Topic Links.
• To edit public and private comments associated with the topic, click
Comments.
• To edit attachments associated with this topic, click Attachments.
• To display a list of actions related to this topic, click Actions.
• To edit the history of this topic, click History.
Depending on your organization’s workflow configuration, the following fields appear
in this section. Additional fields, customized by your organization, may also appear.
Required fields are marked with a red asterisk.
Field descriptions—General Information
Field Description
Visible to work team(s) The work team or teams whose members can
view or act on the topic. Click Browse to
display a descriptive list of work teams. If your
topic configuration is visible to only one work
team, you can click Browse to select the work
team.
Topic Name Name of the topic.
Topic Description Description that identifies content of the topic.
Current State State of the topic in the topic workflow.
States are specified in the topic workflow
configuration to represent your organization's
expected workflow for topics.
A topic may require all of its associated actions
to be in a final state before you can assign
a final state to the topic itself. In this case, a
message appears if you try to assign a final
state to the topic with actions that are not in a
final state.
Assigned to User or work team to whom the topic is
assigned. By default, a topic that you add is
assigned to you.
Available users and work teams are
determined by the Visible to work team
selection.
• Users: Members of the Visible to work
team(s) selection with Edit Topic/Action
work team permission.
• Work teams: All work teams with the
Assign to work team property enabled
and at least one active member in the
Users list.
Keywords Free text to filter the topics that appear in a
table.
If another user edits a topic at the same time, the first one to save the topic will have
their changes saved. The second user will get an error indicating the topic has been
changed since the edit session began. In some cases, the General Information section
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remains visible, allowing the user to print or take a screen shot, so that the information
can be re-entered.
Associate a topic with a product-event combination

Follow these steps to associate a topic with a product-event combination.

4. Click the product-event combination's Row Action Menu ( ) and click Submit
Review.
the Comment drop-down list, select <Clear Comment>.
6. To suppress a product-event combination, select the Suppress product-event
combination check box.
7. (Optional) In the Detailed comment text box, enter a detailed comment.
8. If signal management is integrated with Oracle Empirica Topics, then you can
associate a topic with a given product-event combination. If the product-event
combination is already associated, click Change to modify the association. The
topic workflow configuration in use appears above these choices. Select one of the
following:
• None—Use this option if you do not want to associate a topic with the product-
event combination. This is the default option if no topic has been associated
with the product-event combination. If you select this option, comments and
detailed comments are still logged but no topic is associated with the product-
event combination.
• Existing topic—Use this option to associate an existing topic with the
product-event combination. As you type characters, a drop-down list of
matching topic names is displayed. You can click Browse to select from a
list of existing topics. Available topics are those that you can edit, ones you
created, or topics that have been made visible to work teams you are in. If you
select this option, comments and detailed comments are logged along with a
topic association. The product-event combination is saved to the existing topic
as an attachment.
• New topic—Use this option to create a new topic and associate it with a
product-event combination. If topic templates are available, the new topic can
be based on the topic template that you selected from the Topic template
drop-down list. In addition, you can click Browse to select from a list of
existing topic templates. Available topic templates are those that have been
made visible to a work team that you are in.
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The comments and detailed comments are logged along with a topic association.
The product-event combination is saved to the new topic as an attachment. When
you click OK, the Edit Topic page is displayed and you can edit the associated
topic. This includes adding attachments to the topic as well as viewing source
details of attachments, and adding comments to the attachments. When you are
finished, click Save or Close.
9. Click OK.
Make a topic visible to a work team

A work team is a group of users who have an interest in a set of topics. When a topic
is made visible to a work team, the members of that team can view the topic and any
actions defined for it.
The topic and its individual actions can also be assigned to different members of the
work team. Users with appropriate work team permissions can then edit the topic or
action in addition to viewing it.
2. Click the topic's Row Action menu icon ( ), and then click Edit.
3. On the Edit Topic page, select General Information from the left menu.
4. Next to the Visible to work team field, click Browse.
The Browse Work Teams dialog box appears and provides information about each
work team for which you have the edit topics/actions permission, in a table that
might include these standard columns:
Column Description
Name The name of the work team.
Description Descriptive text about the work team.
Login Group The name of the login group. Each work
team is a subset of a login group.
All Users Yes, if all users in the login group are
members of the work team.
No, if users have been individually added to
the work team.
Users The full name and Oracle Empirica Signal
username of each member of the work
team.
Blank, if all users in the login group are
Topic Visibility Whether or not the topic is visible to the
work team.
Topic-Action Assignment Whether or not topics and actions can be
assigned to the work team.
Created By Name of the user who created the work
team.
Created Date and time when the work team was
created.
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Column Description
Modified By Name of the user who last modified the work
team.
Modified Date and time when the work team was last
modified.
The table may also include columns for custom fields added by your organization.
5. If the topic is configured for only one work team, you can select the row for the
work team and click OK.
Note:
Changing work team property settings impacts future adding and editing
of topic and actions and topic templates only. For example: A topic is
visible to and assigned to a work team. Subsequently, the Allow topic
visibility and Allow assignment of topics and actions properties are
unchecked for the work team. You can continue to edit and save the
topic. However, once you select a different value for either the Visible
to work team(s) or Assigned to fields, the work team is no longer
available.
Add or view comments for a topic

You can add comments to a topic and view comments associated with a topic.
Your topic workflow configuration might give you the ability to add comments to all,
some, or none of the following:
• A topic as a whole.
• Individual actions.
• Topic attachments and action attachments.
If this feature is available for one or more of these contexts, when you view a topic,
action, or attachment, you can also view all of its comments. When editing a topic,
action, or attachment, you can both view and add comments.
Note:
Once you have added a comment, you cannot edit or delete it.
Add comments for a topic


4. On the Edit Topic page, select Comments from the left menu.
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5. Click Add Comment.

6. In the text box, enter the comment.
7. Click Save.
View comments for a topic

3. Click a topic's Row Action menu ( ), and then click View.

4. On the Topics page, select Comments from the left menu.
Any comments that have been added to the topic appear.
Link topics
When you edit a topic, you can add a cross-reference from that topic to another topic
by adding a topic link.
After you link two topics, information about the link appears on the Topic Links page
when you view or edit either of the topics.
Note:
Your topic workflow configuration defines whether you can link a topic to any
other topic, or only to topics that are currently in a final state such as Closed.


4. On the Edit Topic page, select Topic Links from the left menu.
5. Click Add Topic Link.
6. Optionally, limit the display using the lists that appear above the table. For
example, select a project or enter a keyword to list only topics that match the
specified project or keyword.
7. Click the radio button of the row for the topic that you want to select.
8. Click OK.
The count of the links is incremented and displayed to the right of the Topic Links
item in the menu.
Remove a link
You can remove a link added to a topic that provides a cross-reference to another
topic.
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4. On the Edit Topic page, from the left pane, click Topic Links.
5. Click a link's Row Action menu ( ), and then click Remove Link.
6. Confirm the deletion by clicking OK.
Add a topic
You can add a topic on the Topic Management page.

3. Do one of the following:
• Click the plus sign ( ) on the far right side above the table.
• Click the Header Action menu ( ), and then click Add Topic.
The fields that appear on the Add Topic page depend on your topic workflow
configuration.
Note:
You may also be able to add a topic when you save an attachment to a
topic from other pages in the application.
4. In the Topic template field, select a topic template that can provide default values
for the topic's General Information and Actions, or click Browse to select from a
detailed table of topic templates.
The topic template field is available only if there are templates that are visible to a
work team of which you are a member.
5. In the Visible to work team field, select the work team or teams whose members
can view or act on the topic, or click Browse to select from a detailed table of work
teams.
Available work teams are those for which you have the edit topics/actions
permission. Your topic workflow configuration defines whether you must specify
a single work team (from the Visible to work team drop-down list) or you can
select zero, one, or multiple work teams (from the Visible to work team list box).
Note:
If you do not select any work teams, only you are able to view and act on
the topic.
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To select multiple work teams in the list box, hold down the Ctrl key while clicking
each work team. Deselect a work team by holding down the Ctrl key while clicking
the work team.
6. Specify values for the rest of the fields.
• Each field may be read-only, editable, or required. If a field is required, an
asterisk (*) appears next to it and you cannot save the topic until you provide a
value.
Note:
When a topic is created during the process of saving another Oracle
Empirica Signal object as an attachment, requirements for the initial
state are not enforced until the topic is edited.
• Each field accepts text, numeric, or date values, or provides a list of

predefined values that you can select. If a value is not required in such a
field, you can select leave the value empty to indicate no value for the field.
A field that accepts text or numeric values might also offer a Select Available
Values link so that you can select one or more values from a list.
• Arrow icons might appear after the names of a pair of fields to show that they
are a linked pair. For example, if fields for MedDRA SOC and MedDRA
HLGT appear, the arrows indicate that you must select a value for the
MedDRA SOC field first and then select a value for the MedDRA HLGT field.
You cannot select an HLGT value first. The values available for HLGT depend
on the SOC you select.
The fields listed below are standard fields that might appear on the Topic
Management page when you add a topic. Required fields are marked with a red
asterisk.
Field descriptions—Standard topic fields
Fields Description
Visible to work team The work team or teams whose members
can view or act on the topic. Click Browse
to display a descriptive list of work teams. If
your topic configuration is visible to only one
work team, you can click Browse to select
the work team.
Topic Name Name of the topic.
Topic Description Description that identifies content of the
topic.
Current State The state of the topic in the topic workflow.
States are defined by your organization to
represent the expected workflow, and are
specified in the topic workflow configuration.
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Fields Description
Assigned to User or work team to whom the topic is
assigned. By default, a topic that you add
is assigned to you.
selection.
team selection with Edit Topic/Action
Users list.
Additional, custom fields might also be available.

7. Optionally, assign the topic to a project.
• To assign the topic to an existing project, click Add to existing project and
select from a list of projects associated with objects that you created or that
are published to you.
• To create a new project and assign the topic to that project, click Add to a
new project named and enter a project name.
8. Click Save or, to edit topic links, attachments, etc., click Save & Edit.
To cancel this addition, click Cancel.
Reopen a topic
You can reopen a topic if the topic is in a closed state and your topic workflow
configuration includes a transition from that state to another state, such as Assigned or
Reopened.
This option may only be available if you have the work team permission to reopen
topics.

3. Click the Row Action menu ( ) of a topic whose current state is Closed, and
then click Reopen.
4. From the Current state drop-down list, select a state. Your topic workflow
configuration defines the states that can be assigned to a topic that is in a final
state.
5. Click Save.
Delete a topic
You can delete topics from the Topics table.
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3. Click the topic's Row Action menu ( ), and then click Delete.
Note:
Deleted topics cannot be accessed through the application. However,
they are not deleted from the database.
View the history of a topic

You can view the history of topics you created and topics you have permission to see
from your work teams.

3. Click a topic's Row Action menu ( ) and then click View or Edit.
4. From the left menu, click History.
The table displays changes to general information for the topic. A new row is
added to the table each time you click Save in the General Information section.
Viewing topic reports

Predefined Oracle Business Intelligence Enterprise Edition reports are optional topic
reports that provide greater detail on topic information.
• About topic reports
Predefined Oracle Business Intelligence Enterprise Edition (OBIEE) reports
provide information on topics and attachments.
• Generate a predefined topic report in Oracle Business Intelligence
You can produce topic-related Oracle Business Intelligence reports. Several
predefined reports are built into Oracle Empirica Topics and accessible from the
Topics table.
• Predefined Oracle Business Intelligence topic reports
Predefined Oracle Business Intelligence reports are available from a link on
the Topic Management page if your database administrator and IT administrator
installed and configured Oracle Business Intelligence and its components.
About topic reports

Predefined Oracle Business Intelligence Enterprise Edition (OBIEE) reports provide
information on topics and attachments.
Predefined OBIEE reports are optional topic reports that provide greater detail on
topic information. These reports require additional software and are available if
your database administrator and IT administrator installed and configured Oracle
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Business Intelligence and its components. You access the reports in Oracle Business
Intelligence from the Header Action menu ( ) on the Topics tab.

The following predefined OBIEE reports are available:
• Action State Timelines
• Actions by Status
• Actions by Topic
• Attachments in Topics
• Topic Counts by Work Team/User
• Topic State Timelines
• Topics by State
For more information on the OBIEE reports, see Predefined OBIEE Topic Reports.
For more information on installing Oracle Business Intelligence and its components
and enabling the OBIEE topic reporting feature, see the Oracle Empirica Topics
Reporting and Oracle Business Intelligence Configuration Guide.
Generate a predefined topic report in Oracle Business Intelligence

You can produce topic-related Oracle Business Intelligence reports. Several
predefined reports are built into Oracle Empirica Topics and accessible from the Topics
table.
The Oracle Business Intelligence reports include only the topics that are visible to you
when working on the Topic Management page. The reports include the topics that you
created and those that are visible to the work teams to which you are assigned.
Note:
The Report link is available only when your database administrator and
IT administrator have completed the Oracle Business Intelligence reporting
setup.

3. Click the Header Action menu ( ), and then click Report.
Note:
You must have at least the BI Consumer user permission and the View
Topics permission to access the reports.
4. Log in to Oracle Business Intelligence using your Oracle Empirica Signal

username and password, and click Sign In.
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5. Click Open next to a report.

If you don't see the Topics page:
a. Click Catalog at the top of the page.
b. In the Folders pane, expand Shared Folders.
c. Expand the Topics subfolder.
d. Expand My Dashboard, and click Topics to see a list of reports.
e. Click Open next to a report.
Predefined Oracle Business Intelligence topic reports

Predefined Oracle Business Intelligence reports are available from a link on the Topic
Management page if your database administrator and IT administrator installed and
configured Oracle Business Intelligence and its components.
The following sections describe the predefined reports that are available.
Note:
Options in drop-down lists appear in case-sensitive alphabetical order.
Action State Timelines
Description Filters for Data Retrieval Columns

Provides the total elapsed time • Project • Project
in days that each Action spent • Topic name • Topic ID
in a specific state. Computes • Action Name • Topic Name
the elapsed time using the • Action ID
Action Modification Date. If
• Action Name
this date is unavailable,
computes the time using the • Action States
Action Creation Date.
Sorted in order by Topic ID
by Action ID by Action Version
ID. Action Version ID is not a
visible field.
Action State Timelines Sample Report
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Actions by Status

Provides topic information • Action Status • Action Status
based on action status. • Project • Planned Completion Date
Sorted in order by Action • Topic Action Modified • Action ID
Status by Planned Completion Date From/To • Action Name
Date by Action Name. Note: To ensure that the query • Action Description
retrieves all data for a specific • Action State
day, you should increase the • Action Assigned To
date in the To field by 1 day. • Action Created By
For example, to retrieve topics
• Action Created Date
with Action Modified dates
from 02/01/2012-02/04/2012, • Actual Completion Date
specify a From date of • Action Modified By
02/01/2012 and a To date of • Action Modified Date
02/05/2012. • Topic ID
• Topic Name
• Topic Description
• Topic State
• Project
• Topic Assigned To
Actions by Status Sample Report (partial)
Actions by Topic

Provides topic information • Project • Project
based on topic action. • Topic Name • Topic ID
Sorted in order by Project by • Topic State • Topic Name
Topic Name by Topic Modified • Action State • Topic Description
Date by Action Name. • Topic Created Date
• Topic Modified Date
• Topic State
• Resolution Date
• Search Keywords
• Action Name
• Action Description
• Action State
• Action Assigned To
• Action Status
• Planned Completion Date
• Actual Completion Date
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Actions by Topic Sample Report (partial)
Attachments in Topics

Provides topic attachment • Project • Project
information. • Topic Name • Topic ID
Sorted in order by column • Source • Topic Name
from left to right. • Topic Modified Date • Source
From/To • Topic Attachment Name
Note: If a topic has not • Topic Attachment Created
yet been modified, the topic By
Creation Date is used in topic • Topic Attachment Created
retrieval. Date
• Topic Attachment
Modified By
• Topic Attachment
Modified Date
Attachments in Topics Sample Report
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Topic Counts by Work Team/User

Provides the number of topics • Work Team Name • Topics (count)
in each state assigned to each • Topic State (one column
user on one or more work for each)
teams, and the total number
Note: If no topics are in a
of topics assigned to the work
given state, the Topic State
team.
column does not appear.
There is one table for each
work team.
Sorted in order by work team
user.
Note: Topics that are visible
to a work team but are not
assigned to a member of the
work team are not included in
the Work Team Total.
Topic Counts by Work Team/User Sample Report
Topic State Timelines

Provides the total elapsed time • Project • Project
in days that each topic spent • Topic Name • Topic ID
in a specific topic state. • Topic Name
Sorted in order by Topic • Topic Description
Version ID. Topic Version ID is • Topic State
not a visible field.
Note: If the total elapsed time
is less than 12 hours, the time
period appears as 0 days.
Topic State Timelines Sample Report
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Topics by State

Provides topic information • Topic State • Topic State
based on topic state. • Project • Project
Sorted in order by State by • Topic Modified Date • Topic ID
Project by Topic ID. From/To • Topic Name
Note: To ensure that the query • Topic Description
retrieves all data for a specific • Topic Assigned To
day, you should increase the • Topic Created By
date in the To field by 1 day. • Topic Created Date
For example, to retrieve topics
• Topic Modified By
with Topic Modified dates
from 02/01/2012-02/04/2012, • Topic Modified Date
specify a From date of • Resolution
02/01/2012 and a To date of • Resolution Date
02/05/2012.
Note: If a topic has not
yet been modified, the topic
Creation Date is used in topic
retrieval.
Topics by State Sample Report
Create a topic PDF or ZIP file

You can create a PDF or Zip file to document the contents of a topic and include
attachments.
• You can document changes to the current contents of a topic
You can create a PDF or Zip file to document the current contents of a topic. You
can include attachments and additional content such as attachment source details,
topic comments, attachment comments, action comments, and change logs.
• Select attachments to include information about a topic in a PDF or ZIP file
When you create a Portable Document Format (.pdf) file or a compressed .zip file
(which contains a .pdf file) for a topic, you select the attachments to include.
• Select content attributes for a topic PDF or ZIP file
When you create a Portable Document Format (.pdf) file, or a compressed .zip file
(which contains a .pdf file) for a topic, you can select additional content to include.
A Change log includes a Topic History section that provides a summary of the
changes made to the Topic General Information.
• About the Topic History section of a topic exported to PDF
You can create a PDF or Zip file of a topic to document the contents of a topic. You
select which topic or action attachments to include. You can also add attachment
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source details, topic comments, attachment comments, action comments, and

change logs.
You can document changes to the current contents of a topic

You can create a PDF or Zip file to document the current contents of a topic. You can
include attachments and additional content such as attachment source details, topic
comments, attachment comments, action comments, and change logs.
In the PDF, the topic change log provides a summary of the topic’s history. Each row in
the change log represents a row in the topic’s history table and contains the following
columns:
• Version
• Current State (or Display name for CURRENT_STATE_ID)
• Assigned to (or Display name for ASSIGNED_TO_USER_ID)
• Modified By
• Modified
• Reason for Change
• Other Changes
The Other Changes column appears only in the PDF and summarizes Visible to
work team and topic field changes from the previous row. This means that the Other
Changes column is empty in the first row. If there are no changes, the value displayed
in the Other Changes column is <No other changes>. The column content does not
include Assigned to, Current State, and Reason for Change.
Select attachments to include information about a topic in a PDF or ZIP file

When you create a Portable Document Format (.pdf) file or a compressed .zip file
(which contains a .pdf file) for a topic, you select the attachments to include.
You also select additional content for the included items. The resulting .pdf file
contains a section for information about the topic, followed by additional sections for
information about each selected attachment.
1. In the left navigation pane, click Topic Management (

3. Click the Row Action menu ( ) for the topic, and then click Create PDF or
Create ZIP.
The Select Attachments page appears and lists all topic attachments followed by
the action attachments for each action.
Note:
If the topic does not have any attachments, or you do not wish to include
attachments in the .pdf, click Next.
4. From the Available list, choose one or more attachments to include in the .pdf file.
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a. To include all attachments, click .

b. To select an attachment, in the Available list, click the attachment to highlight
it, and then click . The attachment appears in the Selected list. You can
also:
• Highlight multiple non-contiguous attachments. Hold down the Ctrl key
while clicking each attachment. Click .

• Highlight multiple contiguous attachments. Click an attachment, hold down
the Shift key, and click another attachment. Attachments between and
including those attachments are highlighted. Click .

• Remove the highlighting from an attachment. Hold down the Ctrl key while
clicking the selected attachment.
5. To move attachments back and forth between the list of available attachments and
the list of selected attachments, you can double-click a highlighted attachment or
use the arrow keys as follows:
Button Use To
Move highlighted attachments from the

list of available attachments to the list of
selected attachments.
Move all attachments from the list of

available attachments to the list of selected
attachments.
Move highlighted attachments from the

list of selected attachments to the list of
available attachments.
Move all attachments from the list of

selected attachments to the list of available
attachments.
6. When you are satisfied with the selected attachments, click Next.
The Select Attributes dialog box appears. Continue with Selecting content
attributes for a topic PDF or ZIP file.
7. Open or save the PDF or ZIP file.
Select content attributes for a topic PDF or ZIP file

When you create a Portable Document Format (.pdf) file, or a compressed .zip file
(which contains a .pdf file) for a topic, you can select additional content to include. A
Change log includes a Topic History section that provides a summary of the changes
made to the Topic General Information.
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1. On the Topics tab of the Topic Management page, select a topic's Row Action
Menu ( ) and click Create PDF or Create ZIP.

2. On the Select Attachments dialog box, select the attachments and click Next.
The Select Attributes dialog box appears and lists the topic and each attachment
that you selected for inclusion. The first row that appears, with Topic -
<topic-name> in the Content column, represents the topic as a whole.
• To include information about the source of an attachment, check Source
Details.
The .pdf file includes Source Details in the section for that attachment with
the help text that appears when you hover on the name of the attachment
on the Topic page. Additionally, if more information is available for the type of
attachment, it appears after the attachment in the PDF file.
• To include source details for every attachment, check the Source Details
column heading.
• To include all comments made about the topic as a whole, or about an
attachment, check Comments.
The .pdf file includes a section for Topic Comments, or a subsection for the
attachment's comments.
• To include comments for the topic and for all of the attachments, check the
Comments column heading.
• To include a log of changes made to the topic or an attachment, check
Change Log.
The .pdf file includes a Topic History section that shows the information from
the History section of the topic, or an attachment-name Log subsection with
changes to the attachment.
• To include a change log for the topic and for all of the attachments, check the
Change Log column heading.
6. To specify the order in which attachment information will be presented in the .pdf
file, click a row to highlight it, and then use the following buttons:
Button Use To
Move the attachment information to the top

of the PDF file.
Move the attachment information up in the

PDF file.
Move the attachment information down in

the PDF file.
Move the attachment information to the

bottom of the PDF file.
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Note:
The section with information about the topic as a whole is always first in
the .pdf. You cannot move the Topic - <topic-name> row (top row).
7. Click Create PDF or Create Zip Archive

The application creates the .pdf or .zip file. The .pdf file includes links on the first
page to navigate to various sections. Files or URL attachments within the .pdf file
are linked to from within the PDF file.
Note:
Security features in Adobe Acrobat Reader might prevent you from
opening a .zip file from within the .pdf file. See the Adobe website for
instructions on modifying this behavior.
8. Open or save the PDF or ZIP file.
About the Topic History section of a topic exported to PDF

You can create a PDF or Zip file of a topic to document the contents of a topic.
You select which topic or action attachments to include. You can also add attachment
source details, topic comments, attachment comments, action comments, and change
logs.
In the PDF file, the Change log includes a Topic History section that provides a
summary of the changes made to the Topic General Information. Each row in the
Change Log represents a row in the Topic History section and contains these columns:
• Version
• Assigned to (a user or a work team)
• Modified By
• Modified
• Current State
• Other Changes
The Other Changes column appears only in the PDF output. For each row, the Other
Changes column summarizes changes from the previous row. This means that the
Other Changes column for the first row is empty and represents creation of the topic.
In subsequent rows, the Other Changes column lists specific changes or is labeled
<No other changes>. The Other Changes column does not include changes to Project,
Modified By, Modified, Current State, Reason for Change, or Assigned to.
Work with actions

This section includes procedures for working with actions.
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• Work with actions

An action is an activity that has been identified as contributing to the
understanding or resolution of a topic.
• View all actions
You can view all the actions that have been added to the topics you created or
topics that have been made visible to a work team of which you are a member.
• View a topic from the Actions table
You can view a topic from the Actions table.
• View actions for a topic
You can view actions that have been added to a topic.
• View Action and Edit Action pages
On the Actions table, you can view and edit action information.
• Edit the general information about an action
You can edit the name, description, and any custom fields defined for actions by
the topic workflow configuration.
• Add or view comments for an action
You can add comments to an action and view comments associated with an
action.
• Add an action
An action is an activity that has been identified as contributing to the
understanding or resolution of a topic.
• Delete an action
You can delete actions from the Actions table. This option is also only available if
you have the Delete Topics/Actions work team permission.
• View the history of an action
You can view the history of actions you created and actions you have permission
to see from your work teams.
• Reopen an action
You may be able to reopen an action in the Closed state.
Work with actions

An action is an activity that has been identified as contributing to the understanding or
resolution of a topic.
Examples of activities that you may track with actions include:
• Performing research such as literature searches.
• Scheduling project meetings or milestones.
• Documenting follow-up work.
Like topics, actions store information in a structured set of fields, and are given
workflow states to track their progress from creation to completion. An action can be
assigned to the same user that is currently assigned to the topic or to a different user.
After selecting the Actions tab from the Topic Management page, click an action's Row
Action menu ( ), then click View to view all of the information on the View Action
page.
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View all actions

You can view all the actions that have been added to the topics you created or topics
that have been made visible to a work team of which you are a member.

2. Select the Actions tab.
3. (Optional) From the Topic Workflow Configuration drop-down list select a
you select All.
field from the Actions By drop-down list.
Note:
Changing the graph does not filter the actions in the Actions table.
6. (Optional) In the Filter bar, click the Select Filter button to add or remove filters
and limit the Actions table to those actions you want to work with.
7. Click the Header Action menu ( ) to perform the following actions on the table
as a whole:
• Add or remove columns, sort columns, and specify the order in which the
columns appear in the table.
• Download the Actions table to various types of files.
8. Click an action's Row Action menu ( ) to perform the following actions on the
selected action:
• View: Display the general information about the selected action, comments,
attachments, and history. You can have up to five view windows open at once.
• Edit: Edit the general information about the selected action, comments,
attachments, and history. You can only have one edit window open. If you
have already opened an action for editing, and you try to edit another topic or
action, Oracle Empirica Topics asks you to confirm that any unsaved changes
on the other action you started to edit will be discarded.
• Reopen: Reopen an action that is in a closed state.
• Delete: Confirm that you want to delete the action.
Default field descriptions—Actions tab
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Column Description
ID Unique identifying number for the action.
Action name Name of the action.
Action description Description of the action.
Action state Indicates the state of the action in the workflow. States
are specified in the topic workflow configuration to
represent the expected workflow.
Assigned to User or work team to whom the action is assigned.
Planned completion date Due date for performing this action. If a value is defined
for this field, then the open action will appear in the
Calendar tab.
Actual completion date Date on which the action was completed.
Attachment Count Total count of attachments to the action. (Deleted
attachments are not included in this count.)
Created By Name of the user who created the action.
Created Date and time when the action was created.
Modified By Name of the user who last modified the action, including
adding comments.
Modified Date and time when the action was last modified.
The table also includes columns for custom fields added by your organization. For
View a topic from the Actions table

You can view a topic from the Actions table.

3. From the Topic - Topic Name column, click a topic name.
The general information for the selected topic appears on the View Topic page.
View actions for a topic

You can view actions that have been added to a topic.

• Click an action's Row Action menu ( ), and then click View.

• From the Action Name column, click an Action Name.
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4. To view all actions for the topic, on the View Action page, click the back arrow (<)
in the upper left under the Topic name.
Any actions that have been added to topics appear. The table might include these
standard columns:
Column Description
Topic Name Name of the topic to which the action is associated.
Action Name Name of the action.
Action Description Description of the action.
Action State Indicates the state of the action in the workflow. States
are specified in the topic workflow configuration to
represent the expected workflow.
Assigned to User or work team to whom the action is assigned.
Planned completion date Due date for performing this action. If a value is defined
for this field, then the open action will appear in the
Calendar tab.
Actual completion date Date on which the action was completed.
Attachment Count Total count of attachments to the action. (Deleted
attachments are not included in this count.)
Created By Name of the user who created the action.
Created Date and time when the action was created.
Modified By Name of the user who last modified the action, including
adding comments.
Modified Date and time when the action was last modified.
View Action and Edit Action pages

On the Actions table, you can view and edit action information.
The View and Edit links in an action's Row Action menu ( ) take you to a View
Action or Edit Action page that includes a left menu to view or edit general information
about the action, comments, attachments, and history. When the page is in Edit
mode, you can also perform activities based on your permissions and topic workflow
configuration.
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General Information Displays the current field values that None
describe an action:
• The fields are read-only,
editable, or required. If a field is
required, an asterisk (*) appears
next to it and you cannot save
the action until you provide a
value for the field.
• Each field accepts text, numeric,
or date values, or provides a list
of values you can select. If a
value is not required, you can
leave the value empty to indicate
no value for the field. Fields may
also offer a Select Available
Values link so you can select
one or more values from a list.
• In edit mode, to save changes to
the General Information section,
click Save. The changes are
shown as entries in the History
section.
Note:
The
Save
button
affects
only
the
Genera
l
Informa
tion
section
of the
action.
Do not
click
Save
after
you
work
with
other
section
s of this
page.
Any
change
s to
other
section
s are
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saved
to the
action
immedi
ately.
Comments Displays all comments added to the Add Comment

action. When in edit mode, you
can click Add Comment to add
a comment. You cannot modify or
remove a comment.
Note:
This
section
appear
s only if
your
topic
workflo
w
configu
ration
allows
topic
comme
nts.
Attachments Displays information about items Add Action Attachment

attached to the action. Your topic Columns
workflow configuration determines
Print
the types of attachments you can
add, such as files, URLs, free-text Download
notes, or Oracle Empirica Signal
objects. When in edit mode, you
can click Add a document-style
attachment to add a file, URL, or
note attachment.
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History Displays changes to general Columns
information for the action. A new row Print
is added to the table each time you
Download
click Save in the General Information
section.
Note:
The
Assign
ed to
column
shows
work
teams
and
users
to
which
the
action
has
been
assigne
d
Edit the general information about an action

You can edit the name, description, and any custom fields defined for actions by the
topic workflow configuration.
You can select an action from the Actions table on the Actions tab. You can also
edit actions associated with a specific topic from the Topics tab by selecting a topic,
displaying the actions associated with the topic, and choosing an action to edit. In
either case, you make your edits on the Edit Action page.

2. Click the Actions tab.
3. Click an action's Row Action menu ( ), and then click Edit.

4. Update the general information as needed. Required fields are indicated by a red
asterisk.
5. Click Save.
6. (optional) View or edit additional information about the topic action by selecting a
page from the left-hand navigation pane:
• To view or add comments associated with the action, click Comments.
• To view or edit attachments associated with this action, click Attachments.
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• To view the history of this action, click History.

Field descriptions—General Information
Field Description
Action State Indicates the state of the action in the
workflow. States are specified in the topic
workflow configuration to represent the
expected workflow.
Action Name Name of the action.
Action Description Description of the action.
Keywords Free text to filter the topics that appear in a
table.
Assigned to User or work team to whom the action is
assigned. By default, an action that you add
is assigned to you.
selection.
team(s) selection with Edit Topic/Action
Users list.
Planned completion date Anticipated completion date for the action.
Enter the date in the text box or click the
Calendar control and select a date.

Actual completion date Actual date that the action was completed.
Enter the date in the text box or click the
Calendar control and select a date.
Add or view comments for an action

You can add comments to an action and view comments associated with an action.
Your topic workflow configuration might give you the ability to add comments to all,
some, or none of the following:
• A topic as a whole.
• Individual topic actions.
• Topic attachments and action attachments.
If this feature is available for one or more of these contexts, when you view a topic,
action, or attachment, you can also view all of its comments. When editing a topic,
action, or attachment, you can both view and add comments.
Note:
Once you have added a comment, you cannot edit or delete it.
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Add comments for an action

3. Click an action's Row Action menu ( ), and then click Edit.

4. On the Edit Action page, select Comments from the left menu.
5. Click Add Comment.
6. In the text box, enter the comment.
7. Click Save.
View comments for an action

3. Click an action's Row Action menu ( ), and then click View.

4. On the View Action page, select Comments from the left menu.
Any comments that have been added to the topic appear.
Add an action
An action is an activity that has been identified as contributing to the understanding or
resolution of a topic.


4. On the Edit Topic page, select Actions from the left menu.
5. Click the Add Action link.
6. Specify values for the fields.
• Each field is display-only, editable, or required. If a field is required, an asterisk
(*) appears next to it and you cannot save the action until you provide a value.
• Each field accepts text, numeric, or date values, or provides a drop-down list
of predefined values that you can select. If a value is not required in such a
field you can leave the field blank to indicate no value for the field.
• Arrow icons may appear after the names of a pair of fields to show that they
are a linked pair. For example, if fields for State and Area Code appear,
the arrows indicate that you must select a value for the State field first and
then select a value for the Area Code field. You cannot select an Area Code
value first. The values available for Area Code depend on the State you select.
The fields listed below are standard fields that might appear with the same or
different field names.
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Field Description
Action State The progress of the action in the
workflow. Action states are defined by
your organization to represent expected
workflow stages and are specified in the
Action Name Identifying name for the action (required).
Assigned to User or work team to whom the action is
assigned. By default, an action that you add
is assigned to you.
selection.
team selection with Edit Topic/Action
Users list.
Planned completion date Date when the action is expected to be
complete. If a value is defined for this field,
the open action will appear on the Calendar
tab.
Actual completion date Date when the action was completed.
Additional custom fields might also appear.

7. Click Save.
Delete an action
You can delete actions from the Actions table. This option is also only available if you
have the Delete Topics/Actions work team permission.
This option's availability is based on your permissions and the topic workflow
configuration.

3. Click the action's Row Action menu ( ), and then click Delete.
The action is removed from the table.
Note:
Deleted actions cannot be accessed through the application. However, they
are not deleted from the database.
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View the history of an action

You can view the history of actions you created and actions you have permission to
see from your work teams.

3. Click an action's Row Action menu ( ) and then click View or Edit.
4. From the left menu, click History.
The table displays changes to general information for the action. A new row is
added to the table each time you click Save in the action's General Information
section.
Reopen an action
You may be able to reopen an action in the Closed state.
This option's availability is based on your permissions and the topic workflow
configuration.

3. Click a closed action's Row Action menu ( ), and then click Reopen.
Note:
The Reopen item appears if action states include a transition following
a final action state and your user administrator assigns you the Reopen
Topics/Actions permission.
4. From the Action State drop-down list, select a state.

5. Click Save.
You can view and edit the action as necessary. The action state change is also
recorded and you can see the changes if you click History on the Edit Action page
menu.

This section includes procedures for working with open actions.
• View actions on the calendar
The Calendar tab, selected from the Topic Management page, provides
information about open actions that have a value for Planned Completion Date
and do not have a value for Actual Completion Date.
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• Pick a date from the Calendar view

Depending on the available space on your browser, the Calendar view displays up
to four months at a time, including the month with today's date. If you zoom, resize
the window, or expand or collapse the Detail panel, the number of months shown
may change.
View actions on the calendar

The Calendar tab, selected from the Topic Management page, provides information
about open actions that have a value for Planned Completion Date and do not have a
value for Actual Completion Date.
The Calendar tab shows actions as a list and on a monthly calendar, along with total
counts for past due and upcoming actions. It is filtered by your selection from the
Assigned to drop-down list. If you select the All button for the View Items for field,
the calendar is not available.

2. Click the Calendar tab.
3. (Optional) From the Topic Workflow Configuration drop-down select a different
The overdue and upcoming actions are listed and shown on a month-by-month
calendar. Totals appear above the list.
5. To further filter the list and calendar, from the Assigned to drop-down list select a
work team or user.
The List and Calendar views update accordingly.
Pick a date from the Calendar view

Depending on the available space on your browser, the Calendar view displays up to
four months at a time, including the month with today's date. If you zoom, resize the
window, or expand or collapse the Detail panel, the number of months shown may
change.
At the top of the calendar are Previous (<), Today, and Next (>) buttons. Use the
Previous and Next buttons to scroll the months backwards and forwards one month at
a time. Click the Today button to display a month with today's date.

2. Click the Calendar tab.
3. Choose from these options:
• To see today's required work, click today's date on the calendar. The List
view scrolls to show actions required for today. The Details pane shows
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the associated Action Information, Topic Information, Action Comments, and

Action Attachments.
• To see a different day's action list during the current month, click any date with
a circle on it.
• To go to another month by scrolling through the calendar, use the Previous
and Next arrows at the top of the calendar. The calendar scrolls one month at
a time.
• To go to a specific month, click the name of one of the months shown, then
select a specific month name.
• To go to a specific year, click the year of one of the up to four months
displayed, then click a year in the list.
Use the Previous and Next arrows in the year view to display years that are
not currently visible. The months and years that you can select are limited by
the current open actions in the calendar.

This section includes procedures for working with attachments.
• About attachments
Depending on your topic workflow configuration, you can attach one or more types
of data to topics and actions.
• Save Oracle Empirica Signal objects as attachments
You can save tabular, graphical, statistical, and results from your work as
attachments to topics and actions.
• Add other types of attachments
You can save document-style attachments to topics and actions.
• Work with attachments
You can edit attachment information, add comments, view the source of that
attachment and add an attachment count column to the Topics or Actions table.
About attachments
Depending on your topic workflow configuration, you can attach one or more types of
data to topics and actions.
These include:
• Oracle Empirica Signal objects, such as run results or report output.
• Any type of file, including .docx, .pdf, .pptx, .xlsx, .xml, .xpt, .png, .jpg, and .zip
formats.
• The URL of a web page.
• A note.
Save Oracle Empirica Signal objects as attachments

You can save tabular, graphical, statistical, and results from your work as attachments
to topics and actions.
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• Oracle Empirica Signal objects types

Oracle Empirica Signal objects include tabular, graphical, statistical, and results.
You can save these objects as attachments.
• Select a topic to save an Oracle Empirica Signal attachment to
When working with Oracle Empirica Signal, you might generate output, such as
data mining results, queries, or cases series that you want to save as attachments
to specific topics.
• Save to Topic dialog box
The Save to Topic dialog box saves tabular data or graphs as an attachment.
• Save Oracle Empirica Signal tables and graphs as attachments
You can save the tables and graphs you create while working with Oracle
Empirica Signal, such as run results and report output, to topics and actions as
attachments.
• View tabular data as an attachment
Tabular data, such as graphs, can be saved as topic attachments and viewed.
Oracle Empirica Signal objects types

Oracle Empirica Signal objects include tabular, graphical, statistical, and results. You
can save these objects as attachments.
You can save the following objects as attachments:
• Drug Profile—Collection of charts displayed on the Drug Profile page.
• Data Mining Results—Tabular results of a data mining run.
• Data Mining Results Graph—Graphical results of a data mining run.
• Query—Results of a query.
• Case Series—Case series lists.
• First Level drill-down—List of cases resulting from drill-down on a count of cases.
• Cases—Case details displayed upon drill-down for a particular case.
• Report Output—Saved report output or a displayed report for an output that was
not saved.
• Report Graph—Graph based on a saved report output or on a displayed report for
an output that was not saved.
Note:
You can save objects to a topic only if you have the work team permission to
add, edit, and delete attachments in open topics/actions.
You can save these additional objects if your organization uses the Signal
Management module of Oracle Empirica Signal:
• Product-Event Combinations—Combinations selected from the Product-Event
Combinations page.
• Event Comments—Comments associated with a product on the Products page.
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• Similar Combinations—Combinations selected from the Similar Combinations

page.
• Interactions Graph—Interactions graph for a combination on the Product-Event
Combinations page.
• Age Group Breakdown—Age group breakdown graph for a combination on the
Product-Event Combinations page.
• Gender Breakdown—Gender breakdown graph for a combination on the Product-
Event Combinations page.
• Sector Map Graph—Sector map for a product on the Products page.
Note:
If you save data from a Signal Management table as an attachment and your
signal configuration has the private comments feature set up, all of the Signal
Management comments, public and private, are attached to the topic and are
visible to all users who can view the topic.
Select a topic to save an Oracle Empirica Signal attachment to

When working with Oracle Empirica Signal, you might generate output, such as data
mining results, queries, or cases series that you want to save as attachments to
specific topics.
When saving an attachment to a topic, available topics are those that you can edit,
which may include those that you created, that are assigned to you, or that have been
made visible to a work team that you are in.
Note:
You can’t add an attachment to a closed topic.
1. On the page in Oracle Empirica Signal where the information to save appears,
click the Save to Topic link at the top of the page.
When you save tabular data, such as run results, only the first n rows of the
displayed tabular data can be saved, where n is determined by a site option. A
message is displayed if not all the rows are saved. The number of saved rows and
the total number of rows appear as hover help on the attachment name. Click OK.
2. On the Save to Topic page, enter the attachment name and optional description.
3. Select the Add to existing topic option.
4. In the Topic name field, enter the topic name or click Browse.
5. If you browse for the topic, you can filter the Select Topic table using the drop-
down lists that appear above the table. (Lists appear above the table if the topic
workflow configuration you are using offers this feature.) For example, if you select
a project, only topics matching the specified project appear.
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Oracle Empirica Signal displays standard information about each topic. Additional
columns appear depending on the topic workflow configuration for your
organization.
Note:
If the topic workflow configuration has changed, when you click OK on
the Save to Topic dialog, Oracle Empirica Signal will warn you that the
topic workflow configuration has changed and won't save your changes.
Close the dialog and perform your Save to Topic again.
6. Click the radio button to the left of the row for the topic that you want to select, and
then click OK.
7. (Optional) From the Action name drop-down, select an action associated with the
selected topic.
8. Click OK.
Save to Topic dialog box

The Save to Topic dialog box saves tabular data or graphs as an attachment.
Note:
You can save objects to a topic only if you have the work team permission to
add, edit, and delete attachments in open topics/actions.
When you save signal objects to a topic, you either create a new topic with minimal
information or add the attachment to an existing topic or one of its actions.
Another user can edit a topic while you are saving an attachment to that topic;
however, if the other user closes or deletes the topic during this time, you are
prevented from saving the attachment and an error message is displayed.
Note:
If the topic workflow configuration has changed, when you click OK on the
Save to Topic dialog, Oracle Empirica Signal will warn you that the topic
workflow configuration has changed and won't save your changes. Close the
dialog and perform your Save to Topic again.
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Field descriptions—Save to Topic dialog box
Note:
The topic workflow configuration name and ID always appears when you
open the Save to Topic page; for example: Save to Topic in GVP Module
IX (5), where GVP Module IX (5) is the name of the topic workflow
configuration.
Field Description
Attachment name Name of the attachment.
Attachment description Description of the attachment.
Add to existing topic You can select an open topic that is visible to a
work team of which you are a member. Or you
can select a topic that you created.
• You can attach the object to an existing
topic. In the Topic name field, type the
topic name. or click Browse to select from
a list of topics.
• To attach the object to an action
associated with the topic, from the Action
name drop-down list, select an action
name or --none--.
Create new topic You can attach an object to a new topic.
• You might be required to select a Visible
to work team value from the drop-down
list, based on the definitions for your topic
workflow configuration. You can also click
Browse to select from a descriptive list of
work teams.
• If templates exist, from the Topic
template drop-down list, optionally select
a template or click Browse to choose
from a descriptive list of templates.
• Type a Topic name and, optionally, a
Topic description for the new topic.
• Optionally, you can assign the new topic
to either an existing or new project.
Save Oracle Empirica Signal tables and graphs as attachments

You can save the tables and graphs you create while working with Oracle Empirica
Signal, such as run results and report output, to topics and actions as attachments.
1. On the page where the table or graph appears, click Save to Topic.
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Note:
For a graph on the Data Mining Results page or Report pages, the Links
check box must be selected for the Save to Topic link to appear below
the graph.
When you save tabular data, such as run results, only the first n rows of the
displayed tabular data can be saved, where n is determined by a site option. A
message is displayed if not all the rows are saved. The number of saved rows and
the total number of rows appear as hover help on the attachment name.
Note:
On the Product-Event Combinations page, you can select rows, so the
first n selected rows are saved.
You might want to select different columns before you save. Only the currently
displayed columns appear by default when the attachment is viewed. However,
the application stores all available columns with the attachment. To customize the
columns shown when viewing the attachment within the topic, click Columns and
select the columns.
2. Enter an attachment name and optional description.
3. Choose to add the attachment to an existing topic or create a new topic.
• To add the attachment to an existing topic:
a. Click the Add to existing topic radio button.
b. Click the Browse link to the right of the Topic name field.
c. Filter the topics on the Select Topic page by making selections from the
drop-down lists above the table.
d. Select the radio button for the topic.
e. Click OK.
f. To add the attachment to a specific action associated with the selected
topic, from the Action name drop-down list, select the action.
g. Click OK.
• To create a new topic and save the attachment to that new topic:
a. Click the Create new topic radio button.
b. From the Visible to work team drop-down list, select a work team or click
the Browse link to display a list of work teams. Select the radio button of a
work team and click OK.
c. Enter the topic name and description.
d. Choose whether to add the topic to an existing or new project.
– If you select Existing, choose the project from the Project name
drop-down list.
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– If you select New, enter the project name in the Project name text
box.
e. Click OK.
If you have created a topic, it is assigned to you by default. You can edit the topic
as needed.
Note:
Your administrator may establish a maximum size for the Oracle
Empirica Signal tables that you can attach with a site option. If you
attempt to save a larger table an error message informs you of the
defined limit.
After you add an attachment, you can access it when you view or edit the topic or
action to which it is attached. See Edit an attachment.
Note:
Changes to, or deletions of, the original object do not affect the
attachment. For example, if you save report output as an attachment
to a topic and then that report output is deleted, the topic attachment
remains unchanged.
If the topic workflow configuration has changed, when you click OK on
the Save to Topic dialog, Oracle Empirica Signal will warn you that the
topic workflow configuration has changed and won't save your changes.
Close the dialog and perform your Save to Topic action again.
View tabular data as an attachment

Tabular data, such as graphs, can be saved as topic attachments and viewed.
If a tabular Signal object was saved as an attachment, the display of that table can be
modified.

2. Click the Topics tab or the Actions tab.
3. Click the topic's or action's Row Action menu ( ), and then click View.
4. On the View Topic or View Action page, select Attachments from the left menu.
5. Click Columns to show other columns.
By default, only the columns that were displayed in the table when the attachment
was saved appears. However, Oracle Empirica Signal stored all available columns
with the attachment.
6. If the source of the table is data mining results, reports, report output, or event
comments:
a. Click Show Notes to display the notes.
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b. Click Hide Notes to hide the notes.

7. If the source of the table is a case series, the Reviewed, Excluded, and
Comments columns refer to whether, on the Case Series page, the case was
marked as reviewed or excluded and whether comments were added to the case.
Note:
Modifications to the displayed table are not saved.
Add other types of attachments

You can save document-style attachments to topics and actions.
• Add an attachment to a topic or action
You can save document-style attachments; that is, files, URLs, or notes, when you
edit a topic or action.
Add an attachment to a topic or action

You can save document-style attachments; that is, files, URLs, or notes, when you edit
a topic or action.

3. Click the topic's or action's Row Action menu ( ), and then click Edit.
4. On the Edit Topic or Edit Action page, select Attachments from the left menu.
5. Click Add Topic Attachment or Add Action Attachment.
6. Select the attachment type. One or more of the following standard types might be
available:
• URL
• File
• Note
7. Enter values in the remaining fields. If a field is required, an asterisk (*) appears
next to it and you cannot save the attachment until you provide a value. The fields
that display vary based on the type of attachment selected:
• For a URL, typically a name and the URL are required, and you can also enter
a description. You must enter the protocol (http, https, ftp) when you enter the
URL. The application does not add the protocol (such as http://) automatically.
Additional fields might also appear.
• For a file, typically a name and the file name (including its path) are required.
Click Browse to select the file name and path. You can also enter an
attachment description. Additional fields might also appear. Supported file
types include, but are not limited to: .docx, .jpg, .pdf, .pptx, .xlsx, .xml, .xpt,
and .zip.
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• For a note, typically a name is required. You can also enter a more detailed
description. Additional fields might also appear. This option is useful for adding
a row that is purely descriptive. For example, you can add a note to describe a
set of different documents that you are about to add to the topic or action.
8. Click OK.
Note:
Your administrator can set a site option for the maximum size of files that
you can attach. If you attempt to save a larger file, an error message
informs you of the defined limit.
9. After you add an attachment, you can view or edit it when you view or edit the
topic or action to which it is attached.
Note:
Changes to, or deletions of, the original document do not affect the
attachment. For example, if you save a document as an attachment to
a topic and then that document is edited, the topic attachment remains
unchanged.

You can edit attachment information, add comments, view the source of that
attachment and add an attachment count column to the Topics or Actions table.
• Edit attachment information
You can modify information about topic and action attachments.
• Add or view comments for an attachment
You can add and view comments for a topic or action attachment.
• View source details for an attachment
You can review the source detail information about an attachment.
• Add an attachment count column to the Topics or Actions table
You can include an Attachment Count column in the Topics and Actions tables to
show the total count of attachments.
Edit attachment information

You can modify information about topic and action attachments.

3. Click the topic's or action's Row Action menu ( ), and then click Edit.
4. From the left navigation pane, click Attachments.
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5. Select the attachment's Row Action menu ( ), and then click Edit.
6. On the Edit Attachment page, update values as needed. Required fields are
indicated by a red asterisk.
You can edit the name, description, and any custom fields defined for attachments
by your topic workflow configuration.
7. Click Save.
Add or view comments for an attachment

You can add and view comments for a topic or action attachment.
Add comments for an attachment
1. On the left navigation pane, click the Topic Management icon ( ).

3. Click a topic's or action's Row Action menu ( ) , and then click Edit.
4. On the Edit Topic or Edit Action page, select Attachments from the left menu.
The attachments to the topic or action appear.
5. Select the topic's or action's Row Action menu ( ), and then click Comments.
6. On the Comments page, click Add Comment.
7. On the Add Comment page, type your comment and click Save, then Close.
Your comment appears at the bottom of the Comments page.
8. Add another comment or click Close.
The attachment shows that you have modified it and the count in the Comments
column is increased by one. Click the value in the Count column to view it.
View comments for an attachment
1. On the left navigation pane, click the Topic Management icon ( ).

3. Click a topic's or action's Row Action menu ( ), and then click View.
5. Select the attachment's Row Action menu ( ), and then click Comments.
Oracle Empirica Signal displays the comments associated with the attachment.
6. Click Close.
View source details for an attachment

You can review the source detail information about an attachment.
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3. Click the topic's or action's Row Action menu ( ), and then click View.
5. Select the attachment's Row Action menu ( ), and then click View Source
Details.
6. Review the information about the attachment. For an Oracle Empirica Signal
object, the page provides information on the attachment 's origin. For a document-
style attachment, the complete URL or file name appears.
7. Click Close.
Add an attachment count column to the Topics or Actions table

You can include an Attachment Count column in the Topics and Actions tables to show
the total count of attachments.

3. From the Header Action menu ( ), and then click Columns.

4. On the Columns dialog, move Attachment Count from the Available Columns
list to the Selected Columns list.
5. Click OK.
When you view or edit a specific topic or action, you can view or edit all of its
attachments from the Attachments page available from the left menu. The Topic
Attachments page or the Action Attachments page provide information about each
attachment in a table that might include these standard columns:
Field descriptions—Attachments
Column Description
ID Unique identifying number for the attachment.
Created By Name of the user who added the attachment.
Created Date and time when the attachment was saved.
Modified By Name of the user who last modified the attachment,
including adding comments to the attachment.
Modified Date and time the attachment was last modified.
Source Type of data saved as an attachment: file, URL, note, or
a brief description of the object.
Attachment name Name of the attachment.
Hover help on an attachment name describing the
attachment. For tabular data, if only a certain number
of rows were saved (as determined by a site option), the
number of rows saved and the total number of rows is
shown.
Attachment description Description of the attachment.
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Column Description
URL address The URL attached to the topic or action. Applies to URL
attachments only.
File name The name of the file attached to the topic or action.
Applies to file attachments only.
The table includes columns for custom fields added by your organization. For
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Initiate and monitor data mining runs
• What is a data mining run?
• View data mining runs
• Data Mining Runs page
• Create a Data Mining Run
• Manage custom terms
• Define subsets for an MGPS run
• View source data
• Manage data mining runs
• Logistic regression log files
What is a data mining run?

A data mining run is a three-step process: 1) extraction of data from source data;
2) application of statistical algorithms to the extracted data; and 3) generation of
statistical values.
When these statistical values, or scores, exceed a predetermined threshold, they alert
reviewers to a potential safety signal. The two primary types of data mining runs are
MGPS runs and logistic regression runs. Within a two-dimensional MGPS run, you can
include:
• Information Component (IC) computations
• Regression-Adjusted GPS Algorithm (RGPS) computations
• Proportional Reporting Ratio (PRR) computations
• Reporting Odds Ratio (ROR) computations
Data mining runs are batch jobs that Oracle Empirica Signal submits to a queue for
processing. Depending on the number of processors on the Oracle Empirica Signal
server, it is possible for several data mining runs to run at the same time. However,
Oracle Empirica Signal queues RGPS jobs so that two do not run simultaneously. The
run submitter can request that the run be performed immediately, when a processor
is available, or at a scheduled date and time. When a user submits a data mining
run, the run appears on the Data Mining Runs home page and can be published
to other users, even if it has not started running. A user can also cancel, delete, or
re-run a data mining run. The data mining runs that appear on the Data Mining Runs
home page and the tasks that you can perform for specific runs depend on your user
permissions and the publication level of runs.
To create a data mining run, you must select a data configuration that determines
the source data on which the run is based. You can base multiple runs on the same
configuration. You then specify the type of run and other run parameters. When the
run is complete, Oracle Empirica Signal can display the results in tabular or graphical
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View data mining runs
format. When reviewing the results, users with appropriate permissions can drill down
on counts to view case details.
View data mining runs

The Data Mining Runs page provides information about existing data mining runs and
enables you to define new runs if you have the required permission.
For the selected project and data configuration, the Data Mining Runs home page
lists data mining runs that you created or that are published to you. If you have the
Administer Users permission, the page also lists unpublished runs created by any
users in your login group.
1. In the left navigation pane, hover on the Data Analysis icon ( ), then click Data
Mining Runs.
2. From the Project drop-down list, select a project, or select -- to include all
projects.
3. From the Configuration drop-down list, select a data configuration , or select -- to
include all configurations.
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Data Mining Runs page
The selected data mining runs appear.
Data Mining Runs page

What is a data mining run?
A data mining run is a three-step process:
1. Extraction of data from source data.
2. Application of statistical algorithms to the extracted data.
3. Generation of statistical values.
When these statistical values, or scores, exceed a predetermined threshold, they alert
reviewers to a potential safety signal.
What can I do on the Data Mining Runs page?

Create a data mining run
View the results of a data mining run
Rename a data mining run
View details of a data mining run
View job details of the data mining run
Cancel or delete a data mining run
Re-run a data mining run
Publish a data mining run
Create a definition file
Create a Data Mining Run

• Step 1: Select the run type and data configuration
• Step 2: (For timestamped data only) Select the as-of date
• Step 3: Select the variables
• Step 4 for MGPS runs: Specify data mining parameters
• Step 4 for logistic regression runs: Select the events and specify drugs
• Step 5: Define data mining run options
• Step 6: Name the data mining run
• Step 7: Submit the data mining run
• Reference
Step 1: Select the run type and data configuration

To create a data mining run, you start by selecting the type of run and the data
configuration to use. After these selections, you specify a series of parameters that
tell the application how to restrict or combine data, and which types of statistics to
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compute. You then submit the run and it is executed in batch mode. When the run is
complete, you can view the results in tabular or graphical format.
If you have superuser permissions, you can create a run definition file to execute
MGPS or logistic regression data mining runs from outside of the application. To do so,
use the Create Definition File link. For more information about executing data mining
runs externally, contact Oracle.
Note:
If you have exceeded the disk space quota for your username, an error
message appears when you attempt to create a run. To proceed, delete
one or more of your existing runs or contact your system administrator to
increase your quota.
Mining Runs.
2. At the top left of the Data Mining Runs home page, click Create Run.
3. On the Create Data Mining Run page, select the type of run to create:
• MGPS data mining run—The analytical core of Oracle Empirica Signal is a
high-performance implementation of the MGPS (Multi-Item Gamma Poisson
Shrinker) algorithm. MGPS is based on the metaphor of the market basket
problem, in which a database of transactions (adverse event reports) is mined
for the occurrence of interesting (unexpectedly frequent) itemsets. For more
information about MGPS runs, see MGPS computations.
• Logistic regression data mining run—Logistic regression is a statistical tool
for modeling how the probability of a response depends on the presence of
multiple predictors, or risk factors. In Oracle Empirica Signal, the predictors
are drugs and, optionally, covariates such as report year, gender, or age
group, and the responses are adverse events. For more information about
logistic regression, see Logistic regression computations.
4. If you selected Logistic regression (LR) data mining run, select the LR Type:
• Extended—Use the best alpha computational model.
• Standard—Use 0.5 as the alpha value for every response.
5. From the Configuration drop-down, enter a value or click Browse to select from a
list of data configurations.
Tip:
For a logistic regression data mining run, we recommend a data
configuration that includes concomitant drugs, such as an AERS
S+C configuration. For more information, see Logistic regression
computations.
6. To limit the run to cases that meet specified criteria only, check Define database
restriction.
7. Click Next.
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• If you selected a data configuration that supports timestamped data, the Select
As Of Date page appears so that you can specify the As Of date.
• If you selected the Define data base restriction box, follow the steps in Define
a database restriction.
• Then select variables.
Note:
Once you have selected a run type and continued to the next page, you
cannot change the run type.
Step 2: (For timestamped data only) Select the as-of date

Mining Runs.
3. On the Create Data Mining Run page, select the type of run to create:
• MGPS data mining run
• Logistic regression data mining run
4. Click Next.
5. On the Select "As Of" Date page, choose the latest date and time, as shown. Or,
select Other to choose a date and time.
a. Enter a time in hh:mm:ss am/pm format.
b. Click Next.
6. Click Next to select the variables to include.
Step 3: Select the variables

A variable is a data item in the source data referenced by the configuration that you
selected for the data mining run.
• An MGPS data mining run includes a drug (or vaccine) variable and an event (or
symptom) variable.
• For logistic regression runs, you select the drug (predictor) and event (response)
variables. You also have the option to select one or more variables as covariates
(additional predictors).
Mining Runs.
3. On the Create Data Mining Run page, select the type of run to create and click
Next.
4. (For timestamped data) On the Select "As Of" Date page, choose the latest date
and time or select Other to choose a date and time. Then click Next.
For an MGPS data mining run:
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2. On the Select Variables page, select at least one Item Variable by clicking its
name.
Tip:
To study drug-event combinations, select two or more items that are
listed as Drug or Event variables.
3. If you want to use stratification, select one or more Stratification variables.

• You cannot select the same variable as both an item variable and a
stratification variable.
• A warning message appears if there are more than 500 values for all selected
stratification variables. Too many stratification values can cause reduced
sensitivity in the EBGM and EB05 statistics. To avoid reduced sensitivity, the
number of cases divided by the number of unique stratification values should
be at least 100. For example, if there are 5,000 cases in the source data, there
should not be more than 50 strata values.
4. To define custom terms, follow the steps in Define custom terms.
5. To define subsets, check Define subsets.
6. Click Next.
If you didn't choose to define custom terms or subsets, the Data Mining
Parameters page appears and you can go on to Step 4 for MGPS runs: Specify
data mining parameters.
For a logistic regression data mining run:
1. On the Select Variables page, click one variable in the Event variable list and
one variable in the Drug variable list.
Tip:
To treat combination drugs as if the subject had taken separate drugs,
select a variable, such as Single Ingredient, as the drug variable.
2. To include more variables, select them from the Additional covariates list.
Tip:
Typically, a logistic regression run includes one or more additional
covariates as predictors. Otherwise, the logistic regression can
be subject to confounding due to potentially highly associated
covariates being left out. Recommended covariates for an AERS-
based configuration include the AgeGroup4, Gender, and Subset_Year
variables.
3. (Optional) To set up a custom term for this data mining run, check Define custom
terms.
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4. Click Next.
5. If you selected Define custom terms, follow the steps in Define custom terms.
6. Click Next to go to Step 4 for logistic regression runs: Select the events and
specify drugs.
Step 4 for MGPS runs: Specify data mining parameters

After you have selected item variables for data mining, the Data Mining Parameters
page appears.
Mining Runs.
Next.
5. On the Select Variables page, select an item variable and, optionally, stratification
variables. Define custom terms and subsets if you wish then click Next.
6. Specify the MGPS data mining parameters shown in the table below.
7. Click Next to enter the data mining run options.
Parameter descriptions
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Field Description
Specify highest dimension Maximum number of ways that the item variables
you selected are combined during the run. For more
information, see Dimensions and patterns.
• 2—Provide a count for each item variable
(one dimension), and generate scores for each
item variable+item variable combination (two
dimensions).
Note:
If you plan to include RGPS calculations
in the run, you must set the dimension to
2.
• 3—Provide a count for each item variable

(one dimension), generate scores for each
item variable+item variable combination (two
dimensions), and generate scores for each item
variable+item variable+item variable combination
(three dimensions).
Note:
Three-dimensional runs require very
large amounts of space for intermediate
storage and to save the final results
(potentially hundreds of gigabytes).
Use of other data mining parameters,
including the minimum count, to reduce
the computational effort required for
these runs, and restricting results to
those results you plan to analyze, is
strongly recommended.
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Field Description
Specify minimum count How many times an item variable combination must
occur in the data for the combination to be included in
the MGPS computations.
For example, if you specify a minimum count of 5, only
combinations that occur in at least 5 cases appear.
The purpose of the minimum count is to decrease
computational time and space requirements. The higher
the minimum count, the shorter the computational time.
When you specify the minimum count, consider whether
or not you are using a subset variable. For example,
suppose that the subset categories are report years
2005, 2006, and 2007 and that there are 4 drug-event
combinations for DrugA+Rash in 2005, 3 new ones in
2006, and 5 new ones in 2007. If the minimum count
is 5, only the 2007 results show any DrugA+Rash
combinations. If you are using cumulative subsetting,
both 2006 and 2007 show DrugA+Rash combinations.
If you specify a minimum count of less than 5, or the
run uses cumulative subsetting, a warning message
appears. In these situations, the results table takes a
very long time to generate and can be very large in size.
Note:
To supply a default setting
for this field, you can set
the Minimum Count user
preference.
Include drug/event hierarchies' primary paths in run Whether to include hierarchy levels in the results.
results For example, if the data mining run is for drug and
Preferred Term (PT) combinations, and the MedDRA
Version 12.0 hierarchy is being used, the results include
the HLT, HLGT, and SOC representing the PT's primary
path in MedDRA Version 12.0, and this will allow you
to view results easily for PTs in a higher level of
the hierarchy. This option is only available if the data
configuration for the run is set up to use a drug or event
hierarchy.
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Field Description
Fit separate distributions for the different item type Whether to take item types into account during MGPS
combinations processing.
Observed Count (N), Expected Count (E), and Relative
Reporting Ratio (RR) values are not affected, but
EBGM and other statistical values are affected. The
statistical values for each combination are based on the
counts and statistical computations of other occurrences
of the same type of combination. For example, in
computing EBGM values for Drug+Event combinations,
only the distribution of RR values for Drug+Event
combinations is considered. The distributions of RR
values for Drug+Drug or Event+Event combinations are
not considered.
Note:
This parameter does not
affect the computation of
PRR or ROR.
Include calculations for PRR and ROR Whether to include PRR and ROR computations in the
run. If you select this option, the following additional
options appear:
• Base counts on cases rather than drug-event
combinations.
• For PRR, include drug of interest in the comparator
set.
• Apply the Yates correction in computing the value of
chi-squared.
• Use stratified computation for PRR and ROR.
For more information, see PRR computations and ROR
computations.
Include calculations for Information Component Whether to include Information Component
computations in the run. For more information, see
Information Component computations.
Include calculations for RGPS Whether to include RGPS computations in the run
(available only when the highest dimension is 2, and
the run does not include subsets). If you select this
option, the Specify minimum count field is set to 1 when
RGPS computations are included, and the Restrictions
of results will have a default value of N>=1. The following
additional option appears:
Include Interactions—Whether to include calculations
for Drug+Drug interactions using RGPS. If you select
this option, set the Specify minimum interaction
count field. The default value for the Specify minimum
interaction count field is 25. Interaction estimates are
calculated for a drug if the number of Drug+Event
reports exceeds the specified minimum interaction
count.
For more information, see RGPS computations.
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Field Description
EBGM >= Whether to limit the results based on signal scores. For
N >= each statistic you select, specify a limit as an integer or
floating point number.
EB05 >=
Combinations for which the signal score is less than
PRR >=
the specified limit are not kept in the results. This limit
considers all combination types that are included in the
results table.
Note:
You can also restrict
the results using these
values on the Specify
Criteria page when you are
viewing results.
Top <n> combinations based on <score> Whether to retain results only for the highest scoring
combinations. If you select this option, do the following:
1. Specify the number of combinations that you want
to include.
2. In the drop-down list select EBGM or EB05.
Only the top scoring combinations of the statistic you
selected are included in the results.
Exclude associations if items are of the same type (all Whether to exclude combinations of item variables of
drugs, all events) the same type in the results, for example, Drug+Drug.
Oracle recommends that you select this option.
Note:
To supply a default setting
for this field, you can set
the Exclude associations if
items are of the same type
(all drugs, all events) user
preference.
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Field Description
Keep only results that include the following values of Restricts the results such that Oracle Empirica Signal
<item variable> retains only results that include certain values for the
item variables. To restrict the results, do one of the
following:
• Use the links to the right of each item variable to
select the values that you want to include.
– Select Available Values—Includes custom
terms for the run.
– Select Saved List—Includes custom terms for
the run.
– Select < hierarchy > Terms —Does not include
custom terms for the run. For example, if an
item variable uses the MedDRA hierarchy and
the Enable adverse event hierarchy browser
user preference is enabled, you can select only
MedDRA terms.
– Trade Generic Lookup—For data configurations
that include trade name-generic name
mapping. You can find the generic name for a
drug if you know its trade name, or vice versa.
• Type the values that you want to include separated
by commas.
Note:
To prevent spelling and capitalization
errors, Oracle recommends that you
Computations during the run include all item

variable values. However, if you restrict the results,
only results that include the values that you
selected are retained. For example, if you select
DrugA, Rash, and Vertigo as values to include, the
displayed results include scores for combinations
that meet the following criteria:
• If there are drugs in the combination, at least one of
them is DrugA.
• If there are events in the combination, at least one
of them is Rash or Vertigo.
If you do not restrict the results, results for all values of
the item variables are retained.
Step 4 for logistic regression runs: Select the events and specify drugs
When defining a logistic regression run, you specify values (that is, responses) for the
event variable that you are investigating with the run on the Select Event page. Oracle
Empirica Signal computes separate results for each specified event value.
Oracle Empirica Signal computes values for an event only if it finds a sufficient number
of reports. Results are not produced for an event if either of the following situations
exists:
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• For all drugs explicitly included in the run no reports are found with the event and,
in addition, the drugs that do occur in combination with the event most frequently
do not meet the specified minimum number of occurrences for inclusion. (For more
information on specifying drug values see Specifying drugs for logistic regression.)
• For the covariate variables selected for the run, the number of reports that include
the event and each of the possible covariate values averages less than 10. This is
determined as follows:
10 * the total number of possible values for all covariate variables that occur with
this event > count of reports for the event.
If an event is specified for the run but results are not produced, one of these reasons
appears in the logistic regression log file produced for the run.
If you specify a single event and that event is not found in the data used in the run, the
run fails and an error appears on the Jobs for Run page. If you specify multiple events
and any one of them is not found, the run fails and a message appears in the error
log. You can access the logistic regression log file and the error log from the Job Detail
page.
Typically, logistic regression data mining runs do not include every possible
drug+event combination. Instead, they are generally used to focus on specific
medically related adverse events (response values) and drugs of interest (predictors).
For some investigations, you may wish to compute scores for all adverse events in the
selected data configuration (after database restrictions are applied).
Note:
When selecting events, keep in mind that there is a logistic regression
computation for each response value. The more events you select as
responses, the longer the LR run takes
Mining Runs.
Next.
4. On the Select "As Of" Date page, choose the latest date and time or select Other
to choose a date and time. Then click Next.
5. On the Select Variables page, select an event variable and a drug variable.
Include additional covariates and define a custom term if you want, then click
Next.
6. On the Logistic Regression: Select Events page, select the Select all available
values check box to include all of the events in the configuration in your run,
type the events in the text box, or select events using the links to the right of the
(Event) HLGT box.
7. Click Next to open the Logistic Regression: Select Drugs page, and continue with
specifying drug values.
8. Read the description of the events you selected and accept or change the values
shown for the model.
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9. Specify the (Drug) Product Family Name by typing it in the text box or selecting
using the Select Available Values and Select Saved List links.
10. (Optional) Select the Compute interactions check box to include drug
interactions.
11. Click Next to define the run options.
Step 5: Define data mining run options

After you specify parameters for a data mining run, the Run Options page appears.
Mining Runs.
Next.
5. Specify the MGPS data mining parameters or logistic regression events and drugs
and click Next.
6. On the Run Options page, specify when to perform the run:
• Run as soon as possible—Perform the run right away.
• Do not run until—Schedule the run for a future date or time.
Tip:
Schedule large runs, such as three-dimensional MGPS runs, for after
your workday.
7. If you selected Do not run until, do the following:
• Type a date in mm / dd / yyyy format, or click the calendar icon and

select a date.
• Type a time in hh : mm : ss < am|pm > format.
8. To receive an email notification when the run is complete, select Email me when
complete and specify one or more email addresses separated by commas.
• You receive an email whether the run succeeded or failed.
• By default, the email address associated with your Oracle Empirica Signal
user name appears. To change the address associated with your user name,
see your site administrator.
9. To save the intermediate data files that Oracle Empirica Signal produces during
the data mining run, select Save intermediate data files.
Intermediate data files can include item dictionaries, count files, and so on.
The files can be useful for understanding what occurred during the run and for
troubleshooting.
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Note:
This option appears only if you have the Save Intermediate files user
permission.
If you save intermediate data files, you can view the files on the Jobs for Run
page.
10. For a logistic regression run, you can select Save coefficients to include the
coefficient and standard error values computed for each predictor+response
combination in the run in the logistic regression coefficients log file.
11. Click Next to continue by naming the run.
Step 6: Name the data mining run

After you define run options you name the data mining run.
1. In the Run name field, type the name of the run. The name does not need to be
unique, although we recommend that you use a unique name.
Oracle Empirica Signal assigns a unique run ID to each run.
2. (Optional) in the Description text box, enter a description of the run. This helps
other users to know what results to expect and choose the appropriate run.
• To assign the run to an existing project, select the project from the drop-down
list.
• To add the run to a new project, select Add to new project named: and enter
a project name.
4. Click Next to confirm the run parameters and submit the run.
Step 7: Submit the data mining run

After naming a data mining run that you are creating, you confirm the run parameters
and submit the run.
1. On the Confirm Run Parameters page, review the parameters chosen for your
run to make sure that they are correct. Different parameters display for MGPS
runs and logistic regression runs.
2. To change any parameters, click Back until you are on the appropriate page and
make the necessary changes. Then click Next until you are back on the Confirm
Run Parameters page
3. When you are satisfied with the run parameters, click Submit.
4. Click Continue.
The run status appears on the Data Mining Runs page. To monitor the progress of
a run, you can view jobs for the run.
All data mining runs are batch jobs, which continue to run on the Oracle Empirica
Signal server even if you log out of the application. The next time you log in to
the Oracle Empirica Signal application, you can check on the Data Mining Runs
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home page to determine if your run has completed. If you selected the Email me
when complete run option, the application notifies you by email when your run
completes.
MGPS run parameters
Field Description
Type MGPS.
Name Name supplied for the run.
Description Description supplied for the run.
Project Name of the project to which the run is assigned.
Configuration Name of the data configuration used for the run.
Configuration description Description of the data configuration used for the run.
As of date As Of date for the run, if the run is for timestamped data.
Database restriction Database restriction, if any, associated with the run.
Item variables Names of the item variables to be used in the run.
Drug Hierarchy Name and version of the drug hierarchy used by this run
if the data configuration specifies a drug hierarchy.
Event Hierarchy Name and version of the event hierarchy used by this
run if the data configuration specifies an event hierarchy.
Custom terms Custom terms, if any, specified for the run.
Stratification variables Stratification variables, if any, to be used for the run.
Subsets Subset variable, if any, as well as whether the subsets
are cumulative, the order of subsets, and the subset
labels and values.
Highest dimension The maximum number of ways in which items are
combined. See Specify data mining parameters.
Minimum count Minimum number of cases in which a combination of
items must occur in order for the combination to be
included in the run's MGPS computations. See Specify
data mining parameters.
Calculate PRR Whether the run includes PRR computations.
Calculate ROR Whether the run includes ROR computations.
Base counts on cases For a run that includes PRR and ROR computations,
indicates if counts are based on cases rather than drug-
event combinations.
Use "all drugs" comparator For a run that includes PRR computations, indicates
whether the drug of interest are included in the
comparator set.
Apply Yates correction For a run that includes PRR computations, indicates
whether the Yates correction is applied.
Stratify PRR and ROR For a run that includes PRR and ROR computations,
indicates whether the PRR or ROR computations are
stratified.
Include IC Whether the run includes Information Component
computations.
Include RGPS Whether the run includes RGPS computations.
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Field Description
Calculate RGPS interactions Whether the run includes Drug+Drug RGPS interaction
scores.
Minimum interaction count Minimum number of times that a drug must appear
in Drug+Event reports for the application to calculate
RGPS interaction estimates for the drug.
Fill in hierarchy values Whether the run option to use hierarchy information was
checked.
Limit results to Limitations, if any, on which results will be kept based
on statistical thresholds or specified values of item
variables. See Specify data mining parameters.
Exclude single itemtypes Whether the run excludes combinations of items of the
same type. See Specify data mining parameters.
Fit separate distributions Indicates the run's setting for the advanced parameter
to fit separate distributions for the different item type
combinations.
Save intermediate files Whether intermediate processing files for the run are
saved. See Define data mining run options.
Source database Information about the source data (from the source
description table).
Scheduled to run Date and time at which the run is scheduled to be run.
See Define data mining run options.
Logistic regression run parameters
Field Description
Type LR. For runs completed prior to the installation of Oracle
Empirica Signal version 7.1, LR (Legacy) appears.
Project The name of the project to which the run is assigned.
LR type Indicates the algorithm type selected for the run:
standard or extended. See Logistic regression
computations.
For runs completed prior to the installation ofOracle
Empirica Signal version 7.1, an Extended logistic
regression field appears instead, with a Yes or No value.
Configuration Name of the data configuration used for the run.
Configuration description Description of the configuration used for the run.
As of date As Of date for the run, if the run is for timestamped data.
Database restriction Database restriction, if any, associated with the run.
Item variables Names of the run's selected event and drug variables.
Custom terms Custom terms , if any, specified for the run.
Covariates Variables, if any, selected as covariates for the run.
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Field Description
Drug values Explicitly specified values of the drug variable included
in the run, even if they do not meet the minimum number
of times a drug must occur in combination with specified
events.
Event values Values of the event variable used in the run.
Minimum count Minimum number of cases in which a drug must occur in
combination with specified events in order to be included
in the run (except for drugs specifically selected as Drug
values). See Select drugs for logistic regression.
Number of events Number of event values specified.
Save intermediate files Indicates whether intermediate processing files for the
run are saved. See Define data mining run options.
Run interactions Indicates whether the run calculates statistics for two
predictors (such as Drug+Drug or Drug+Covariate) and
a response.
Save coefficients Indicates whether the lr_coefficients.log file produced for
the run include the coefficient and standard deviation
values calculated for the run.
Source database Information about the source data (from the source
description table).
Scheduled to run Date and time at which the run is scheduled to be run.
See Define data mining run options.
Reference
• About MGPS runs
• MGPS computations
• MGPS independence model
• Information Component computations
• RGPS computations
• Use the PRR calculator
• PRR computations
• Select a case series for PRR computation
• ROR computations
• About logistic regression runs
• Logistic regression computations
• Guidelines for specifying drugs for logistic regression
• Drug and event hierarchies
• Timestamped data
• Specify an As Of date
• Stratification variables
• Dimensions and patterns
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• View interactions
About MGPS runs

The main statistical scores computed by an MGPS run are EBGM, EB05, EB95,
representing the Empirical Bayes Geometric Mean and the 90% confidence interval
from 5% to 95%. The application calculates these scores for each combination of
items (such as drugs and events) included in the run. The data configuration that you
select determines the items that are available for selection in the run.
Optionally, you can include computations of the following in an MGPS run:
• Information Component (IC)
• Disproportionality estimates and interaction scores using Regression-Adjusted
Gamma Poisson Shrinker Algorithm (RGPS)
• Proportional Reporting Ratios (PRR)
• Reporting Odds Ratios (ROR)
When you define an MGPS run, you select the items to combine and for which to
generate scores. You typically select a drug (or vaccine) variable and an event (or
symptom) variable. You can also select items, such as gender, age group, or report
receipt year, for the purposes of subsetting or stratification. You can define a database
restriction to limit which cases in source data to include in the run, and custom terms,
to select cases meeting specified criteria.
The execution of an MGPS run includes the following steps. Dotted lines represent
optional steps.
As a data mining parameter, you can restrict which results from the run to retain.
For example, you can keep only results for drug-event combinations that include
certain drugs and certain events. Restricting results does not affect the statistical
computations. The application performs the statistical computations first and then
keeps only results that meet the restriction.
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MGPS computations
The analytical core of the Oracle Empirica Signal application is a high-performance
implementation of the MGPS (Multi-Item Gamma Poisson Shrinker) algorithm. MGPS
is based on the metaphor of the market basket problem, in which a database
of transactions (adverse event reports) is mined for the occurrence of interesting
(unexpectedly frequent) itemsets. For example, these itemsets can represent simple
drug-event pairings, or more complex combinations of multiple drugs and events
representing interactions and/or syndromes. Interestingness is related to the factor by
which the observed frequency of an itemset differs from a nominal baseline frequency.
For each itemset in the database, a Relative Reporting Ratio (RR) is defined as
the observed count (N) for that itemset divided by the expected count (E). MGPS
allows for the possibility that the database may contain heterogeneous strata with
significantly different item frequency distributions occurring in the various strata. To
avoid concluding that an itemset is unusually frequent just because the items involved
individually all tend to occur more frequently in a particular stratum (Simpson's
paradox), MGPS uses the Mantel-Haenszel approach of computing strata-specific
expected counts and then summing over the strata to obtain a database-wide value for
the expected count.
To improve the estimation of true value for each RR (especially for small counts), the
empirical Bayesian approach of MGPS assumes that the many observed values of
RR are related in that they can be treated as having arisen from a common super
population of unknown, true RR-values. The method assumes that the set of unknown
RR values is distributed according to a mixture of two parameterized Gamma Poisson
density functions, and the parameters are estimated from a maximum likelihood fit to
the data. This process provides a prior distribution for all the RRs, and then the Bayes
rule can be used to compute a posterior distribution for each RR. Since this method
improves over the simple use of each N/E as the estimate of the corresponding RR,
it can be said that the values of N/E borrow strength from each other to improve the
reliability of every estimate.
The improved estimates of RR are actually derived from the expectation value of the
logarithm of RR under the posterior probability distributions for each true RR.
If you select subset variables for the run, MGPS computations are performed for each
subset. If you select stratification variables for the run, the MGPS computations are
modified to use stratification.
Item variables
When you create an MGPS run, you select item variables. Typically, the item variables
represent drugs and events. The counting and estimation that the MGPS computation
performs divides the combinations of the selected item types into separate itemsets,
based on the combinations possible for the number of dimensions in the run. For the
two items D and E in a three-dimensional run, MGPS performs computations on the
itemsets DD, DDD, DE, DDE, DEE, EE, and EEE.
Drug-event combination scores

For a combination of drug and event (a two-dimensional or 2D combination), the signal
score is the EBGM (Empirical Bayes Geometric Mean) value.
EBGM is defined as the exponential of the expectation value of log (true RR). EBGM
has the property that it is nearly identical to N/E when the counts are moderately large,
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but is shrunk towards the average value of N/E (typically ~1.0) when N/E is unreliable
because of stability issues with small counts. The posterior probability distribution also
supports the computation of lower and upper 95% confidence limits (EB05, EB95) for
EBGM, which is an estimate of the relative reporting ratio.
Interaction scores
Computations for combinations of dimensions greater than 2 focus on measuring and
scoring cross-item type combinations, but allow any observed dependence within item
types to be fit completely without generating a score. The only exception to this is
during the analysis of a homogeneous itemset, such as three events (E1,E2,E3) where
all items are of the same type and in which case high EBGM scores do alert reviewers
to a potential within-item type association. Thus, for a mixed-type 3D combination like
(D1,D2,E1), the values of EBGM, EB05 and so on measure how many times more
frequently the pair (D1,D2) occurs with E1 than would be expected if the pair (D1,D2)
were independent of E1, without making any statement about whether the drugs D1
and D2 appear in the same reports more frequently than independence would predict.
The signal score for a 3D combination is the INTSS (Interaction Signal Score) value,
which is essentially a way of measuring the strength of a higher-order association
above and beyond what would be expected from any of the component pairs of items
of different types. INTSS is computed as follows:
INTSS = EB05 / EB95MAX
where:
• EB05 is the conservative estimate score for the 3D combination.
• EB95MAX is the highest EB95 score found for the component pairs of items of
different types.
An INTSS of greater than 1 indicates a stronger association than is found for the
component pairs of items.
Note:
Typically, it would not be concluded that the potential interaction was
interesting unless the EB05 score for that DDE combination is large (for
example, over 1.5 or 2.0).
To support backward compatibility with versions of the application prior to 5.0, signal
scores based on the independence model are still computed for dimensions higher
than 2. These values are stored in columns ending in _IND. See MGPS independence
model.
Custom terms and synthetic values

When estimating shrinkage parameters for EBGM scores, MGPS does not consider
the following:
• Custom terms.
• Excluded synthetic values, such as Standardized MedDRA Queries (SMQs), that
have been defined for the appropriate data configuration variable.
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The raw RR scores for combinations involving custom terms and the excluded
synthetic values are shrunk by the Bayesian formula, but they do not participate in
the determination of the formula itself.
Note:
Users creating a data mining run do not need to take any additional steps to
exclude custom terms or already-excluded synthetic values.
MGPS independence model

Prior to Version 5.0 of WebVDME (which was the previous name of the Oracle
Empirica Signal application), signal scores for 3D data mining results were computed
using the MGPS independence model described here. Starting in WebVDME 5.0,
the primary way of computing signal scores for 3D results changed to the MGPS
interaction model. For compatibility with older data mining runs, the application
continues to compute scores using the independence model as well.
The MGPS interaction model computes values of INTSS, described in MGPS
computations. The independence model computes values of EBGMDIF_IND. The
names of columns related to the independence model end in _IND.
The difference between the independence model and the interaction model affects
only 3D results. Thus, the values of EBGM and EBGM_IND, which are for 2D results,
are the same.
2D results
For a 2D result, it is assumed that the probability of finding items i and j in the same
report is the same as the probability of finding i times the probability of finding j:
P(i,j) = P(i) x P(j)
For a two-dimensional run that is not stratified, expected counts are computed are as
follows:
E(i,j) = Ntotal x P(i,j) = Ntotal x P(i) x P(j)
For a two-dimensional run that is stratified, computations are as follows:
E(i,j) = ΣEc(i,j) = ΣNtotal,c x Pc(i,j) = ΣNtotal,c x Pc(i) x Pc (j)
where the summations occur over the C strata.
The signal score is the EBGM_IND value, which is a more stable estimate than RR;
the so-called shrinkage estimate. The EBGM value is computed as the geometric
mean of the posterior distribution of the true Relative Ratio.
3D results
For a 3D result, it is assumed that the probability of finding items i, j, and k in the same
report is the same as the probability of finding i times the probability of finding j times
the probability of finding k:
P(i,j,k) = P(i) x P(j) x P(k)
For a three-dimensional unstratified run, the expected count is computed as follows:
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E(i,j,k) = Ntotal x P(i,j,k) = Ntotal x P(i) x P(j) x P(k)

In the stratified independence model, it is assumed the above equations hold for each
stratum. So, if there are C strata:
Pc(i,j,k) = Pc(i) x Pc(j) x Pc(k)
for a given stratum c.
For a three-dimensional stratified analysis, the expected count is computed as follows:
E(i,j,k) = ΣEc(i,j,k) = ΣNtotal,c x Pc(i,j,k) = ΣNtotal,c x Pc(i) x Pc(j) x Pc(k)
where the summations occur over the C strata.
The signal score for a 3D combination is the EBGMDIF_IND value, computed as
follows:
EBGMDIF_IND = EBGM_IND - E2D_IND / E_IND
where E2D_IND is the expected count based on the all-2-factor log linear model.
Information Component computations

When you specify data mining parameters for an MGPS run, you can include
Information Component (IC) computations.
The IC is a measure of disproportionality between the observed and expected number
of reports for a drug-event combination. A positive IC indicates that the number of
observed reports is greater than the number of expected reports. Similarly, a negative
IC indicates that the number of observed reports is less than the number of expected
reports.
Oracle Empirica Signal computes IC values only for drug-event combinations. For
example, if you create a three-dimensional MGPS run, Oracle Empirica Signal
computes IC values for each drug-event combination, and disregards the following:
• Combinations of one drug and two events.
• Combinations of two drugs and one event.
• Combinations of three drugs.
• Combinations of three events.
IC values include the following:
• IC—Information component
• IC025—Lower limit of the 95 percent confidence interval for IC
• IC975—Upper limit of the 95 percent confidence interval for IC
If you selected stratification variables for the run, the expected number of reports (E) is
adjusted using the Mantel-Haenszel approach. For more information, see Stratification
variables.
If you defined a subset variable for the run, Oracle Empirica Signal computes results
for each value of the subset variable with observed cases in the data.
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1. Oracle Empirica Signal determines the observed counts for each drug-event
combination as follows:

Event of interest a b
• a—Number of reports of the drug of interest and the event of interest.

• b—Number of reports of the event of interest and not the drug of interest.
• c—Number of reports of the drug of interest and not the event of interest.
• d—Number of reports of neither the event or drug of interest.
2. Oracle Empirica Signal computes the expected counts for each drug-event
combinations as follows:

Event of interest E(a)=((a+b)(a+c))/(a+b+c+d) E(b)=((a+b)(b+d))/(a+b+c+d)
All other events E(c)=((c+d)(a+c))/(a+b+c+d) E(d)=((c+d)(b+d))/(a+b+c+d)
Note:
If you specify a stratification variable for the run, Oracle Empirica Signal
adjusts the expected count (E) using the Mantel-Haenszel approach.
3. Oracle Empirica Signal computes the IC and IC confidence interval for each drug-
event combination as follows:
IC = log2 ((O + α1) / (E + α2))
IC025 = log2 ((O + α1) / (E + α2)) - 3.3 * (O + α1)-1/2 - 2 * (O+ α1)-3/2
IC975 = log2 ((O + α1) / (E + α2)) + 2.4 * (O + α1)-1/2 - .5 * (O+ α1)-3/2
where:
α1=α2= 1/2
O is the observed count.
E is the expected count.
RGPS computations
When you specify data mining parameters for a two-dimensional MGPS run without
subset variables, you can include Regression-Adjusted Gamma Poisson Shrinker
Algorithm (RGPS) computations. RGPS is a hybrid algorithm, which combines the
methodology of Extended Logistic Regression (ELR) and MGPS.
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Note:
You must install R as described in the Oracle Empirica Signal and Topics
Installation Guide to enable RGPS computations.
In general, RGPS differs from MGPS, PRR, and ROR computations in that it adjusts
for the effects of polypharmacy and therefore reduces the likelihood of masking biases
and "innocent bystander" biases. These biases occur when a drug other than the drug
of interest is highly associated with the event of interest.
Masking bias occurs when a highly associated drug other than the drug of interest
appears in greater number in reports that do not also include the drug of interest.
Masking bias inflates the expected count for a drug-event combination of interest.
Consequently, the disproportionality estimate for the drug-event combination of interest
is reduced. A lower disproportionality estimate can lead to a missed signal.
"Innocent bystander" bias occurs when a drug with no causal connection to an adverse
event is often co-prescribed with a highly associated drug. In this case, both drugs can
appear to be associated with the adverse event.
Like MGPS, RGPS calculates a Relative Reporting Ratio (RR) for each itemset in the
database. The RR is defined as the observed count (N) for the itemset divided by the
expected count (E). However, RGPS computes E using the results of an Extended
Logistic Regression (ELR) analysis rather than the Mantel-Haenszel approach.
Note:
The Oracle Empirica Signal application allows you to run only one RGPS
computation at a time.

For a combination of a drug and event, the signal score is the ERAM (Empirical-
Bayes Regression-adjusted Arithmetic Mean) value. ERAM is the shrunken observed-
to-expected reporting ratio adjusted for covariates and concomitant drugs.
The 5 percent (ER05) and 95 percent (ER95) confidence intervals for the ERAM are
also calculated.
Drug interaction scores

For an RGPS run, you have the option of including drug-drug interaction computations.
Interaction estimates are calculated for drugs where the number of drug-event reports
exceeds the specified minimum interaction count.
Use the PRR calculator

When creating a data mining run, you can specify that Proportional Reporting Ratio
(PRR) and Chi-square should be computed and included in the results for each drug-
event combination against a specified background database.
Before you use the PRR calculator, you must specify three case series (based on the
same configuration) to represent a background database, the events of interest, and
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the drugs of interest. For example, to compute PRR for combinations of analgesics
and respiratory ailments in women over age 65, use a case series that includes cases
for women over age 65, a case series that includes cases for analgesics, and a case
series that includes cases involving respiratory ailments.
1. Click the Case Series page.
2. On the Case Series page, identify or define the three case series to use.
3. Click PRR Calculator.
4. From the Configuration drop-down list, select a data configuration.
5. For the following types of case series, click Browse and select a case series. You
must base all three case series on the same configuration.
• Background Definition Case Series—Defines the customized background for
the computations.
• Event Definition Case Series—Defines the set of events.
• Drug Definition Case Series—Defines the set of drugs.
6. To define the chi-square calculation method, check or clear Apply the Yates
correction for chi-square.
7. To define the PRR calculation method, check or clear Include drug of interest in
the comparator set.
8. Click Calculate.
The observed counts and results appear.
• Observed counts of cases with drug-event combinations are represented as a,
b, c, and d in a 2x2 table as follows:
Note:
When PRR is computed by a data mining run, a, b, c, and d
represent counts of drug-event combinations by default. You can
select an option to count cases with those combinations instead.
However, the PRR calculator always counts cases.
Observed counts of cases with drug-event combinations are represented in

the 2x2 table as follows:
Cases Specific drug All other drugs

Specific event a b
• The PRR for the combination of a particular drug and particular event is
computed as follows:
– PRR = (a / (a + c)) / (b / (b + d))
• If b=0 (and Include drug of interest in the comparator set described below
is cleared), then the formula is adjusted as follows to avoid the possibility of
division by zero:
– PRR = ((a+0.5) / ((a+0.5) + (c+0.5))) / ((b+0.5)/((b+0.5) + (d+0.5)))
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• If you checked Include drug of interest in the comparator set, the

application computes PRR as:
– PRR=(a / (a + c)) / ((a + b) / (a + b + c+ d))
For each cell in the 2x2 table, the expected count is computed as follows:
Cases Specific drug All other drugs

Specific event E(a) = ((a+b)(a+c))/ E(b) = ((a+b)(b+d))/
(a+b+c+d) (a+b+c+d)
(a+b+c+d) (a+b+c+d)
The chi-square of PRR (PRR_CHISQ) for the combination of a particular drug and
particular event is computed as follows, where E represents the expected count
under the assumption of no relationship between drugs and events:
• PRR_CHISQ = ((a-E(a))2)/E(a)+ ((b-E(b))2)/E(b)+ ((c-E(c))2)/E(c)+((d-E(d))2)/
E(d)
If you checked Apply the Yates correction for chi-square, PRR_CHISQUARE is
computed as follows:
• PRR_CHISQ = ([max(0, |a - E(a)| - 0.5)]2)/E(a) + ([max(0, |b - E(b)| - 0.5)]2)/
E(b) + ([max(0, |c - E(c)| - 0.5)]2)/E(c) + ([max(0, |d - E(d)| - 0.5)]2)/E(d)
Note:
|a - E(a)| = |b - E(b)| = |c - E(c)| = |d - E(d)| for every 2x2 table; this
formula can also be expressed as:
PRR_CHISQ = (1/E(a) + 1/E(b) + 1/E(c) + 1/E(d)) [max(0, |a - E(a)| -
0.5)]2
The P-values for chi-square values are also computed. The P-value
is the probability that chi-square would be as large as the value for
PRR_CHISQ by chance alone if there were no causal relationship or
consistent association between the drug and the event.
Note:
If any of E(a), E(b), E(c), or E(d) is zero, the chi-square and P-value
cannot be computed and are defined arbitrarily as -1.
9. In the table for observed counts, you can click the value of N in a column to
display a menu. Click View Cases to drill down to cases that have the specified
drugs and specified events.
PRR computations
When specifying data mining parameters for a run, you can perform PRR and ROR
computations. For information about ROR, see ROR computations.
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The Proportional Reporting Ratio (PRR) computation relates to drug-event

combinations, only, in two-dimensional data mining runs. If you specify a dimension
of 3 for the run, the application computes PRR only for the 2D pairs; that is, the
drug-event combinations, but not the combinations of one drug and two events, two
drugs and one event, three drugs, or three events.
Default PRR computations

If you check Base counts on cases rather than drug-event combinations but no
other PRR options, the application computes PRR as follows. If you select a subset
variable for the run, the application computes PRR separately for each subset.
1. Assume that observed counts of cases with drug-event combinations are named a
through d as follows:
Type of event Specific drug All other drugs

Specific event a b
• a is the number of cases with the specific event and the specific drug.
• b is the number of cases with the specific event but not the specific drug.
• c is the number of cases with the specific drug but not the specific event.
• d is the total number of cases with neither the specific event nor the specific
drug.
2. The PRR for the combination of a particular drug and particular event is computed
as follows:
PRR = (a / (a + c)) / (b / (b + d))
If b=0 (and the Include drug of interest checkbox is not checked), then the
formula is adjusted to avoid the possibility of division by zero:
PRR = ((a+0.5) / ((a+0.5) + (c+0.5))) / ((b+0.5)/((b+0.5) + (d+0.5)))
3. For each cell in the table in step 1, the application computes the expected count
as follows:
Event Specific drug All other drugs

Specific event E(a) = ((a+b)(a+c))/ E(b) = ((a+b)(b+d))/
(a+b+c+d) (a+b+c+d)
(a+b+c+d) (a+b+c+d)
4. The application computes the chi-square of PRR (PRR_CHISQ) for the

combination of a particular drug and particular event as follows, where E
represents the expected count under the assumption of no relationship between
drugs and events:
PRR_CHISQ = ((a-E(a))2)/E(a)+ ((b-E(b))2)/E(b)+ ((c-E(c))2)/E(c)+((d-E(d))2)/E(d)
The P-values for Chi-square values are also computed. The P-value is the
probability that Chi-square would be as large as the value for PRR_CHISQ
by chance alone if there were no causal relationship or consistent association
between the drug and the event.
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Chapter 4
Note:
If any of E(a), E(b), E(c), or E(d) is zero, the Chi-square and P-value
cannot be computed and are defined arbitrarily as -1.
Counts based on drug-event combinations

By default, the PRR computation counts the occurrence of cases. On the Data
Mining Parameters page, if you clear Base counts on cases rather than drug-event
combinations , then a through d represent counts of drug-event combinations. If
a case has more than one drug or event, the case supplies several drug-event
combinations to the computation. This option is not recommended, especially if data
mining results include custom terms or Standardized MedDRA Queries (SMQs).
If you select stratification variables for the data mining run, the application checks
Base counts on cases instead of drug-events combinations automatically and
cannot be cleared. The PRR calculator also always bases counts on cases.
Drug of interest in comparator set

On the Data Mining Parameters page, if you check For PRR, include drug of interest
in the comparator set, then PRR is computed as:
PRR = (a / (a + c)) / ((a + b) / (a + b + c+ d))
Yates correction
On the Data Mining Parameters page, if you check Apply the Yates correction in
computing the value of chi-square, then PRR_CHISQUARE is computed as:
PRR_CHISQ = ([max(0, |a - E(a)| - 0.5)]2)/E(a) + ([max(0, |b - E(b)| - 0.5)]2)/E(b) +
([max(0, |c - E(c)| - 0.5)]2)/E(c) + ([max(0, |d - E(d)| - 0.5)]2)/E(d)
Note:
|a - E(a)| = |b - E(b)| = |c - E(c)| = |d - E(d)| for every 2x2 table. This formula
can also be expressed as:
PRR_CHISQ = (1/E(a) + 1/E(b) + 1/E(c) + 1/E(d)) [max(0, |a - E(a)| - 0.5)]2

If you select stratification variables for the data mining run, this option is available only
if you do not check Use stratified computation for PRR and ROR.
Stratified PRR computation

Even if you select stratification variables for the data mining run, Oracle does not
recommend using stratified computation for PRR and ROR. However, on the Data
Mining Parameters page you have the option to check Use stratified computation
for PRR and ROR. The PRR computation is performed as follows.
If there are K strata, then for stratum k (k = 1, 2, .., K), let ak, bk, ck, dk be the four cell
counts in stratum k, and let
• M1k = ak + bk
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Chapter 4
• M0k= ck + dk
• N1k = ak + ck
• N0k = bk + dk
• T = M0k + M1k = N0k + N1k = ak + bk + ck + dk
PRR = (ΣKakN0k/Tk) / (ΣKbkN1k/Tk)
Note:
If the run uses subsetting, only those strata that contain cases for a given
subset are used in the PRR computation for that subset.
The Chi-square statistic for stratified PRR is computed as:

PRR_CHISQ = ΣK(ak - N1k*M1k/Tk)2 / ΣK((N0k*N1k*M0k*M1k)/((Tk-1)*T2))
Note:
For instances where the denominator in the PRR or the chi-square formulas
would be zero, the computation adds 0.5/K to ak, bk, ck, and dk, where K is
the number of strata.
Select a case series for PRR computation

1. On the PRR Calculator page, select the configuration that you want to use.
2. Next to a case series field, click Browse.
The Select Case Series dialog box appears, listing case series that you have
created or that have been published to your login group, and that are based on the
selected data configuration.
Note:
If you have the Administer Users permission, all published case series
based on the selected configuration appear.
The following information is provided for each case series:
Column Description
Name Name of the case series.
Description Description of the case series.
Project The name of the project to which the case
series is assigned.
# Cases Number of cases in the case series.
Configuration Configuration used by the case series.
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Chapter 4
Column Description
Created By Name of the user who created the case
series.
Created Date and time when the case series was
created.
Modified By Name of the user who last modified the case
series.
Modified Date and time when the case series was
last modified.
3. Click the row for the case series that you want to select.
4. Click OK.
ROR computations
When specifying data mining parameters for a run, you can specify that PRR and ROR
computations be performed. For information about PRR, see PRR computations.
In two-dimensional data mining runs, the application computes the Reporting Odds
Ratio (ROR) only for drug-event combinations. If you specify a dimension of 3 for the
run, the application computes ROR only for the 2D pairs. This means that the ROR is
computed for the drug-event combinations, but not for the combinations of one drug
and two events, two drugs and one event, three drugs, or three events.
ROR computations
Note:
If you select a subset variable for the run, the applications computes ROR
separately for each subset.
Assume that observed counts of drug-event pairs are named a through d, as follows:
Type of Event Specific drug All other drugs

Specific event a b
• a is the number of cases with the specific event and the specific drug.
• b is the number of cases with the specific event but not the specific drug.
• c is the number of cases with the specific drug but not the specific event.
• d is the total number of cases with neither the specific event nor the specific drug.
The ROR for the combination of a particular drug and particular event is computed as:
ROR = ad/bc
The 90% confidence interval is defined by:
• ROR05 = elog(ROR)-1.645 x sqrt(V)
• ROR95 = elog(ROR)+1.645 x sqrt(V)
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Chapter 4
where: V = 1/a + 1/b + 1/c + 1/d

In cases where division by zero would arise, 0.5 is added to each of a, b, c and d.
Counts based on drug-event combinations

By default, the ROR computation counts the occurrence of cases. On the Data
Mining Parameters page, if you clear Base counts on cases rather than drug-event
combinations, a through d represents counts of drug-event combinations. If a case
has more than one drug or event, the case supplies several drug-event combinations
to the computation. Oracle does not recommend this option, especially if data mining
results include custom terms or Standardized MedDRA Queries (SMQs).
If you select stratification variables for the data mining run, the application
automatically checks Base counts on cases instead of drug-events combinations
and cannot be cleared.
Stratified ROR computations

If you select stratification variables for the data mining run, Oracle does not
recommend using stratified computation for PRR and ROR. However, on the Data
Mining Parameters page you do have the option to check Use stratified computation
for PRR and ROR. The application computes stratified ROR. Assume that a, b, c and
d are counts of drug-event pairs for a given stratum.
ROR = ΣR/ΣS
where:
• R = ad/T
• S = bc/T
• T=a+b+c+d
• The sums are taken over all strata.
The 90% confidence interval is defined by:
• ROR05 = elog(ROR)-1.645 x sqrt(V)
• ROR95 = elog(ROR)+1.645 x sqrt(V)
where:
• V = ΣPR/2(ΣR)2 + Σ(PS + QR)/2ΣRΣS + ΣQS/2(ΣS)2
• P = (a+d/)T
• Q = (b + c)/T
Note:
In cases where division by zero would arise, 0.5/K is added to each of a, b, c
and d for each stratum, where K is the number of strata.
Reference
Robins J, Greenland S, Breslow N. A General Estimator for the Variance of the Mantel-
Haenszel Odds Ratio. American Journal of Epidemiology 1986; 124: 719-23.
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Chapter 4
About logistic regression runs

Logistic regression is a statistical tool for modeling how the probability of a response
depends on the presence of multiple predictors, or risk factors. In the Oracle Empirica
Signal application, the predictors are products and, optionally, covariates such as
report year, gender, or age group, and the responses are adverse events.
The main statistical scores computed for the predictors and responses in a logistic
regression run are LROR, LR05, and LR95, representing the Logistic Regression
Odds Ratio and the 90% confidence interval (LR05, LR95). The scores from a logistic
regression run, when compared to the results of an MGPS run, can help identify
confounding or masking effects.
To create a logistic regression run, you select a data configuration and one drug
variable (the predictor) and one event variable (the response) variable to combine for
score generation. You can also explicitly specify drug and event values to include in
the computation. Because the logistic regression computation assesses the results
of polytherapy, selecting configurations that include concomitant as well as suspect
products, and drug variables, such as Single Ingredient, that treat combination
products as if the patient had taken separate products, are recommended.
You can also select one or more other variables, such as gender, age group, and
report receipt year, as covariates (additional predictor variables) for the computation.
Each value of a covariate is used in the logistic regression computation as its own
predictor, except for the value with the highest frequency among all reports in the
analysis, which is used as the standard to which the other values are compared. For
example, if you select Gender as a covariate and Gender has the unique values F, M,
and U, with M occurring most frequently, computations are made for the two predictor
values GENDER_F and GENDER_U. For the relatively rare situations in which the
covariate value that occurs most frequently overall, such as M, does not occur in
combination with a certain event, such as Uterine cancer, then the value occurring
most frequently with that event is used instead. Logistic regression is then performed
with product values and these covariate values as predictors for each response.
For more information about logistic regression computations, see Logistic regression
computations.
In addition to selecting the variables for the run, you also have options to:
• Use either extended logistic regression, which includes the computation of the
best alpha value to use for each response, or standard logistic regression, which
uses 0.5 as the alpha value for every response.
• Define a database restriction, which limits the cases in the source data that are
included in the run.
• Define custom terms, which are pseudo-values.
• Specify events of interest for the run.
• Explicitly supply drugs and/or provide the application with guidelines (minimum
number of occurrences with the event, total number of drugs to include) for
selecting drugs that occur frequently with specified events.
• Include computations for interactions, such as drug+drug+event or
drug+covariate+event, for each response.
• Include the computed coefficients and standard errors of the run in the
lr_coefficients.log log file.
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Chapter 4
The execution of a logistic regression run includes the following steps. Dotted lines
represent optional steps.
Logistic regression computations

The Oracle Empirica Signal application offers two types of logistic regression: standard
logistic regression and extended logistic regression. In standard logistic regression,
users select an LR type of Standard on the Create Data Mining Run page. Extended
logistic regression is performed when user select LR type of Extended.
Both models describe the relative weight of the presence of various drugs and other
factors in a report in predicting the occurrence of a particular adverse event in the
same report, but they provide different methods for fitting the model.
• In the standard model, computations always use the same alpha value of 0.5.
When the probability of an AE occurring is small, as in the case of a relatively rare
AE, the result of the standard computation is an assumption that drug effects are
more multiplicative than additive. If this assumption is false, logistic regression is
likely to detect associations correctly, but the relative effects of drugs may not be
correct. The standard model is equivalent to the logistic regression method found
in statistics textbooks.
• The extended logistic regression model allows an extended family of link functions
that connect the estimated coefficients to the event probabilities. Whereas, the
standard model assumes that this link function is the well-known S-shaped logistic
curve, the extended model allows other shapes of curves, if another curve in the
family fits the data better. The family is parameterized by the scalar alpha, where
0 < alpha < 1, and where alpha = 0.5 corresponds to the standard logistic. An
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Chapter 4
interpretation of alpha is that value of the fitted event probability where the curve
has a point of inflection, meaning that the curve is linear there and so the effects of
multiple predictors are additive in the neighborhood of P(response event) = alpha.
When the extended model option is chosen, the system estimates the maximum
likelihood value of alpha and uses that value to form model predictions.
To compare scores calculated by each of these models, you can re-run a logistic
regression data mining run that used one of these models and change only its LR
type, name, and description for the second run.
The alpha value calculated for each response is available for review in the
lr_coefficients.log file produced by the run.
To review this file:
Mining Runs.
2. From the Row Action menu ( ), for the completed run, select View Jobs for
Run.
3. On the Jobs for Run page, click the LR_<number>_0 job, then at the bottom of
the Job Detail page click lr_coefficients.log.
Logistic Regression
Logistic regression has long been a standard statistical tool for modeling how the
probability of an event (the response) depends on multiple predictors. The estimated
coefficients can be interpreted as the logarithm of an odds ratio. Especially for medical
applications, where so much of statistical analysis consists of analysis of 2 x 2
frequency tables, the odds ratio, the simple ad/bc ratio, where (a, b, c, d) are the
familiar counts in the 2 x 2 table examining the association of two values, has become
a preferred measure of association. The preference for expressing associations in
terms of odds ratios developed because the odds ratio is invariant to the choice of
sampling plan of a study.
For example, consider a prospective study in which 1,000 patients are either exposed
to a drug or not and then followed for signs of an adverse event such as irregular
heartbeat. The data might look like this:
Drug exposure Irregular Normal Total

Drug a=300 b=700 1000
No Drug c=100 d=900 1000
Total 400 1600 2000
The risk ratio is (300/1000)/(100/1000), which equals 3.00. The odds ratio is (300/700)/
(100/900), which equals 3.86.
The risk ratio and the odds ratio are both large compared to the null hypothesis value
of 1 that would be expected if there were no association between drug and irregular
heartbeat. In other words, the probability (chance, risk) of irregular heartbeat is 3.00
times greater for patients taking the drug than for those not taking the drug. The odds
(in favor) of irregular heartbeat are 3.86 times greater for patients taking the drug. This
corresponds to a conversion between probabilities and odds. If a probability is p, the
odds are p/(1-p), or if the odds are X:1 the probability is X/(X+1). Thus, odds of 3:1
mean that the probability is 3/4 = 0.75 and vice versa.
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Chapter 4
Consider now a retrospective study that has determined whether or not all those with
irregular heartbeat took the drug, involving the same 400 patients as in the above
table, but only 400 other patients with normal heartbeat are sampled instead of 1600.
Without bias, the results looks like the following table, in which the Irregular column of
the table is unchanged, and the counts in the Normal column have been divided by 4.

Drug 300 175 475
No Drug 100 225 325
Total 400 400 800
The risk ratio is (300/475)/(100/325), which equals 2.05.

The odds ratio is (300/175)/(100/225), which equals 3.86.
Note that the risk ratio has changed from 3.00 in the first table to 2.05 in the second
table, while the odds ratio is unchanged at 3.86 in both tables. The odds ratio as a
measure of association is invariant to multiplying either a row or a column of the 2x2
table by a constant. If the risk factor and the adverse event are each rare, then the risk
ratio and the odds ratio are almost the same.
Consider the following table, where the Irregular column and the Drug row of the first
table above have each been divided by 10 (so that the Irregular-Drug cell is reduced
by a factor of 10x10=100).

Drug 73
3 70
No Drug 10 900 910
Total 13 970 983
The risk ratio is (3/73)/(10/910), which equals 3.74.

The odds ratio is (3/70)/(10/900), which equals 3.86.
Note that the risk ratio is now quite close to the still unchanged odds ratio of 3.86.
In many instances, a relatively small fraction of the population as a whole is exposed
to a risk factor for an adverse event, and a relatively small fraction of the population
actually suffers the adverse event. In such cases, you can loosely interpret the odds
ratio as if it were a multiplier of the probability of the event rather than a multiplier
of the odds of the event, since if p is small, p/(1-p) ~ p, so probabilities and odds
are about the same. In such a case, even though you might have collected data that
misestimates the proportion of those suffering the event by some unknown multiplier,
and/or your data over- or under-samples those exposed to the risk by some other
unknown factor, the odds ratio in your observed table may be a better estimate of the
population risk ratio than the risk ratio computed from your 2x2 table, because the
odds ratio is robust to bias in the row and column reporting rates. It is possible for a
flawed data collection process to cause an excess frequency in just one cell of a table,
without a corresponding increase in the other cell of its row or column. In that case,
no measure of association from your data table is able to accurately measure the true
association in the population.
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Chapter 4
Estimating odds ratios for multiple risk factors

It is common to collect data retrospectively when patients have been exposed to
multiple risk factors. In such cases, you want obtain a measure of association between
an adverse event and each of the risk factors, and separate out the associations
with each risk factor. This can be a difficult task, especially when there are many risk
factors that occur in multiple combinations across patients. No method of analysis is
guaranteed to provide a best solution to this problem and, in fact, there may be no
best answer, since interactions among the risk factors can create great ambiguities as
to the interpretation of any association measures. However, ignoring such difficulties,
the most common approach to this problem is logistic regression, which uses a
multifactor analysis to compute a separate odds ratio for each risk factor.
In the ideal application of logistic regression, the odds ratio associated with multiple
risk factors is the product of the estimated odds ratios for each of the risk factors being
considered. For example, if one risk factor is being over age 65 (odds ratio = 1.5)
and another is taking a particular drug (odds ratio = 2.0), then the logistic regression
model assumes that the odds of having the adverse event are (1.5)(2.0) = 3.0 times
as great for those over 65 who take the drug, compared to those under 65 who do
not take the drug. The assumption that every risk factor's association with the adverse
event can be summarized in a single odds ratio, and that simply multiplying them can
describe the associations of multiple risk factors with the adverse event, is usually an
oversimplification. Nevertheless, logistic regression has proven to be a very useful tool
for summarizing associations among multiple risk factors and an event, and for finding
those factors that seem to be consistently associated with the event no matter what
other factors are present.
A typical logistic regression analysis produces a prediction equation of the form:
loge[p/(1-p)] = B0 + B1(Factor 1) + B2(Factor 2) + B3(Factor 3) + B4(Factor 4)
For example:
loge[p/(1-p)] = -5.0 + 1.1(Age > 65) + 0.6(Gender Male) + 0.3(Drug 1) + 0.8(Drug 2)
where loge[p/(1-p)] is the natural log of the odds of observing the adverse event,
and the coefficients B0, B1, … are estimated from the database. The odds ratios
for each factor are the exponentials of the coefficients. Therefore, in this example,
the over 65 year age group has an odds ratio of e1.1 = 3.00 for the adverse event,
males have an odds ratio of e0.6 = 1.82, and users of the two drugs have odds
ratios of e0.3 = 1.35 and e0.8 = 2.23, respectively. The implicit assumption is that the
combined odds ratio would be (3.00)(1.82)(1.35)(2.23) = 16.4 for males over 65 taking
both drugs, compared to females under 65 taking neither drug. However, even when
these complex associations are not estimated very exactly, the coefficients and their
corresponding odds ratios often are good estimates of the relative overall strength of
association of each factor with the adverse event. In this example, the association with
age is greater than that of gender or of either drug.
Including potentially highly associated covariates in the computation is important,
because otherwise the logistic regression might be subject to confounding due to the
left-out covariates. For example, assume that (age > 65) was not in the model and that
Drug1 was almost exclusively taken by the elderly in the database. In that situation,
the estimated coefficient for Drug1 increases, since Drug1 is, in effect, a partial proxy
for being elderly. The result might be an odds ratio for Drug 1 estimated to be 2 or
3 rather than the value 1.35 estimated when the variable (age > 65) is in the model,
resulting in an inflated estimate of the association of Drug1 with the adverse event.
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Chapter 4
Specifying predictors
In general, it is important to include all covariates that might be associated with the
adverse event as predictors in the logistic regression equation. For analysis of adverse
event databases, Oracle recommends including covariate variables for age groups,
‫اﻻدوﯾﺔ اﻻﺧرى‬ gender, and report year, and explicitly including drugs that occur very frequently with
the event. Drugs that occur most frequently with the event are, by their very frequency,
‫اﻟﻣﺻﺎﺣﺑﺔ‬ more likely to be confounded with other drugs of interest in the database, and thereby
cause biases if they are left out of the model. The logistic regression user interface
makes it easy to enter all drugs in the data that occur more than a set number of times
with the response event automatically, up to the defined maximum number of drugs
allowed, including the drugs specifically requested.
Covariates must be categorical (stratification) variables having at least K > 1
categories, and every category value (K) must have at least one report with the
response event present to be included. The covariate category having the most
reports across all reports in the analysis is viewed as the standard for the odds ratio of
each of the other categories. If there are K categories for a covariate, there will be K-1
coefficients for that covariate, with a corresponding odds ratio for each coefficient. For
example, if the categories for the Gender covariate are M, F, and U (for unknown), and
if F is the most common gender category, then the output will only have odds ratios
for M and for U. The odds ratio for M is the estimated reporting odds ratio comparing
M to F, and the odds ratio for U is the estimated reporting odds ratio comparing U to
F. Selecting the most common category to be used as the standard is arbitrary, but it
allows you to interpret an odds ratio of 1 for a category as meaning that the selected
category can be pooled with the most frequent category.
The logistic regression analysis provides a standard error for each coefficient that can
be used to produce a confidence interval for each coefficient. The 90% confidence
interval (CI) is computed as:
(estimated coefficient) +/- 1.645*(standard error of coefficient)
Taking the exponential of the endpoints of the coefficient CI produces a CI for the
associated odds ratio. These are then labeled (LR05, LR95) in the logistic regression
output tables.
To handle the relatively rare situation in which the most common category of a
covariate has no reports with the response event (such as the most common gender
category F and the event Prostate cancer), for that response a different category
is selected as the most common. The computation does not leave out the gender
covariate entirely in these situations as the confounding of gender with drugs taken
primarily by one gender would distort the LOR estimates.
Each logistic regression data mining run generates a logistic regression log file
( lr.log ), that identifies the most common category found for each covariate. If any
events in the run used a different category, the most common category for that event is
noted.
Logistic regression models: standard and extended

Logistic regression (without explicit interaction terms) assumes that odds ratios (OR)
are multiplicative in the presence of polypharmacy; that is, logistic regression predicts
that a drug with OR=3 combined with a drug with OR=4 produces an OR=3*4=12 for
the event of interest when both drugs are reported together. This simple relation holds
for the OR scale but, for the probability scale, the predicted combined effect of risk
factors is more complex. When the probabilities of events are in a middle range of 0.2
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Chapter 4
to 0.8, the joint effect of two risk factors on probabilities (according to standard logistic
regression) is more additive than multiplicative.
For example, if the base rate (probability) for an event is 20%, the rate after applying
an OR of 3 is 43%; the rate after applying an OR of 4 is 50%; and the rate after
applying an OR of 12 is 75%. Compare these three rates to the original rate both as
rate differences and as rate ratios:
Base rate = 0.20 Rate difference Rate ratio____
Risk factor with OR=3: .43 - .20 = .23 .43/.20 = 2.15
Both factors with OR=12: .75 - .20 = .55 .75/.20 = 3.75
Thus, the combination of the two risk factors (if the odds ratios multiply) is more
nearly additive than multiplicative on the probability scale, since .23 + .30 = .53 is
close to .55, whereas 2.15*2.50 = 5.38 is not as close to 3.75.
On the other hand, suppose the base rate were 0.002, which is more in the range
of most adverse event probabilities. In this case, applying odds ratios of 3, 4, and
12 results in probabilities of 0.0060, 0.0079, and 0.0234, respectively. Comparing rate
differences to rate ratios in the low base rate example:
Base rate = 0.0020 Rate difference Rate ratio_______
Both factors with OR=12: .0234 - .0020 = .0214 .0234/.0020 = 11.7
In this case, the effect of both factors is more multiplicative than additive on the
probability scale, since .0040 + .0059 = .0099 is not as close to .0214, whereas
3.00*3.95 = 11.85 is close to 11.7.
In summary, logistic regression makes the following assumptions: the joint risk of two
risk factors is nearly additive on the probability scale if the base rate is relatively large
(e.g., about 0.2), but is nearly multiplicative if the base rate is very small (e.g., about
0.002). When modeling spontaneous reports, you are considering relative reporting
ratios in a database of reports rather than risk. The question remains, which is more
likely to fit spontaneous report ratios better? An additive model or a multiplicative
model? Since most individual adverse events occur in a very small proportion of
spontaneous reports, applying standard logistic regression fits the data well if the
multiplicative model is approximately true.
To allow for the possibility that a nearly additive model for spontaneous report
ratios might fit better than a nearly multiplicative model, the Oracle Empirica Signal
application provides an alternative model called extended logistic regression. This
family of models has a parameter, denoted (alpha), that specifies the region of
near-additivity to be centered at an arbitrary base rate. If = 0.5, then extended
logistic regression reduces to standard logistic regression. If you select the extended
option, then the system performs an estimation of the best coefficients for each of
many values of , and selects the value of that gives the best fit to the observed
data.
If the estimated value of is near 0.5, this means that the standard logistic regression
fits the data (that is, predicts the presence or absence of the response for individual
reports) about as well as the extended logistic model. In practice, if the estimate of
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is between 0.4 and 0.6, then the odds ratio estimates for individual predictors is
close to the corresponding estimates for standard logistic regression. In such a case,
for simplicity in explaining your methodology to someone unfamiliar with extended LR,
use the standard LR estimates. Another approach to choosing between standard and
extended LR is to compare the difference ( - 0.5) to the standard error of . You can
compute:
(Z-score for )=( - 0.5)/(standard error of )
If the Z-score is less than -3 or greater than +3, there is strong statistical evidence that
extended LR fits the data better than standard LR.
The estimates of and their standard errors (separate estimates for each response
value in the run) can be found in the Logistic regression coefficients log file
(lr_coefficients.log) that is produced for each logistic regression data mining run.
It is difficult to say in advance whether extended LR fits any particular data much
better than standard LR. Different response events give different choices. It takes
more computation time to find the best fitting , so, if you want to get quicker answers
for hundreds or thousands of response events, selecting standard LR accomplish
that. But, in most situations, the estimation and examination of the values of and its
standard errors, using extended LR, are recommended. If the data being used in the
LR is voluminous, the standard error of may be very small; perhaps just 0.01 or
even smaller. Then, even if is near 0.5, there may be strong evidence that it is not
exactly 0.5. For example, if = 0.41, standard error =0.005, then the Z-score is 18,
but the individual estimated odds ratios do not differ much from those of standard LR.
Two caveats apply to this model selection problem. First, even if one model fits the
spontaneous reports better, there is still no guarantee that the resulting estimated odds
ratios for each drug are valid estimates of the prospective risk to takers of the drug of
an adverse reaction. Second, even in terms of fit to the relative reporting ratios, the
better fitting model is not necessarily a perfect guide to which of the many drugs in the
regression model are truly significant. If there are 100 drugs in the model, it may be
that extended logistic regression fits better than standard logistic regression because it
models the polytherapy effects involving 80 of the drugs better, while modeling those
involving the other 20 drugs worse. That is, many of the drugs may combine in their
effects additively, while others combine multiplicatively (or, in some more complicated
combining formula), so that neither model can estimate the effects of every drug
reliably. As statisticians often say, "no model is perfect, but many are useful."
The extended model is technically described as a binomial regression with a different
link function. Suppose that z = B0 + B1X1 + B2X2 + … is the linear combination used
for prediction, where the Bs are coefficients and the Xs are predictors. The standard
logistic regression defines the probability of event occurrence as p(z), where:
p(z) = 1/(1 + exp(-z))
Extended logistic regression uses the formula:
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A two-dimensional plot of the probability distribution function of the extended logistic

regression computation follows:
For a predictor X whose standard LR coefficient is B, the odds ratio comparing the
probabilities of the event at X = 0 versus X = 1 is OR = eB. In the case of extended
logistic regression with estimated link parameter , the odds ratio is defined as:
OR = (1 – p0) p(z0 + B, ) / p0 (1 – p(z0 + B, ))
Where p0 = (# response events)/(# Reports) [proportion of reports with the response
event] and z0 is the solution to the equation p(z0 + B, ) = p0.
This formula for OR reduces to eB when = ½. The 90% confidence intervals for OR
are computed by replacing B in the above formula by B +/- 1.645*standard error(B),
analogous to the procedure for standard logistic regression.
Each logistic regression data mining run generates a tab-delimited log file,
lr_coefficients.log, with the alpha value computed for each response and its standard
error. When you define options for the run, you can check Save coefficients to
include the coefficient and standard error calculated for each predictor and response in
this log.
For more information about logistic regression, see any intermediate-level statistics or
biostatistics textbook, such as Statistical Methods in Epidemiology by HA Kahn and
CT Sempos, Oxford U Press, 1989.
Guidelines for specifying drugs for logistic regression

For a logistic regression run, you define the number of predictor values (that is, how
many drugs) to include in computations for each of the events you select for the run.
You also define the minimum number of reports in which a selected event must occur
in combination with a drug for that drug to be included. Optionally, you can supply a list
of drug values to include in the run.
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Using these values, the Oracle Empirica Signal application determines what drugs to
include for each event in the run, including any explicitly specified drug values and
selecting additional drugs that occur in combination with each run event frequently,
based on the defined total number of drugs and the minimum number of occurrences.
• If you explicitly specify fewer drug values than the defined total number, the
application finds additional drugs in the configuration to make up the difference.
The application uses the defined minimum to limit the possible set of drugs to
include in the run to those found most frequently in combination with each of the
selected run events. For each event, only drugs found in combination at least that
number of times are included.
• Each of the drug values that you explicitly supply are included in the run, even
if they do not meet the specified minimum for a given run event. (However, the
drug+event combination must occur at least once to be included.) If you supply
more drug values than the defined total number to include in the run, the Oracle
Empirica Signal application orders the drug values alphabetically and includes only
the first <total number> from the list.
For example, assume that you specified a single event, Rash, for the logistic
regression run. You keep the default, 10, as the minimum number of cases in which
the drugs must occur, and you explicitly include DrugD. The following table lists
sample drugs in the data configuration, the number of occurrences of Rash, and
whether the run computes scores for the drug:
Drug Number of Cases in Whether the run computes

which Drug Occurs in scores for the drug
Combination with Rash
DrugA 11 Yes
DrugB 10 Yes
DrugC 5 No
DrugD 1 Yes
DrugE 0 No
Oracle recommends that you include drugs that occur most frequently with an event,
as computational biases can result if they are left out. For more information, see
Logistic regression computations.
Drug and event hierarchies

A hierarchy determines how adverse event terms and drug terms are organized in
the source data. For example, the FOI FDA Adverse Event Reporting System (AERS)
database uses the Medical Dictionary for Regulatory Activities (MedDRA) classification
system. Other databases might use the Coding Symbols for a Thesaurus of Adverse
Events (COSTART) or the WHO Anatomical Therapeutic Chemical (ATC) classification
systems.
Hierarchy terms are stored in an Oracle database account called the hierarchy
account. You associate each variable in a data configuration with a hierarchy level
in the hierarchy account. For example, if the source data contains MedDRA terms, you
associate each variable in the data configuration with a MedDRA hierarchy level such
as PT, HLT, HLGT, or SOC in the hierarchy account.
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during which only one hierarchy version was used.
When you set up hierarchy information, users can:
• Select the Enable Drug Hierarchy Browser user preference.
• Select the Include drug/event hierarchies' primary paths in run results option
in the Data Mining Parameters page.
• Display a sector map for data mining results.
Note:
You can also set up hierarchy information using hierarchy tables. Hierarchy
tables are supported for backward compatibility.
Timestamped data
Timestamping is a technique for representing multiple versions of the same source
data within one database. The source data must include dates (VALID_START and
VALID_END columns) that can be used to determine the period for which each record
is valid. This enables the Oracle Empirica Signal application to reconstruct data for
different periods of time. As a result, you can base data mining runs, queries, and case
series on source data as of a date that you specify. This date is referred to as the As
Of date.
In the data mining run, query, or case series, data is used if the following is true:
VALID_START (if present) <= Specified As Of Date < VALID_END (if present)
For example, suppose that the source data includes the following DRUGS table,
where an edit occurred for case ID 100:
CASE_ID DRUG ROUTE VALID_START VALID_END

100 DrugA IV 01-01-2005 06-01-2005
100 DrugA ORAL 06-01-2005 No end date
• If a run is performed as of 2/1/2005, the Route for DrugA is IV.

• If a run is performed as of 7/1/2005, the Route for DrugA is ORAL.
• If a run is performed as of 6/1/2005, the Route for DrugA is ORAL.
Specifying an As Of date
On pages where you specify an As Of date, a default date appears. You can change
the date to another date that is within the range determined by the source description
table for the data configuration.
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Specify an As Of date
During some activities, if you select a data configuration that supports timestamped
data, the Select 'As Of' Date page appears and you must specify an As Of date and
time. See Timestamped data for more information.
1. To specify an As of Date and time, choose one of the following:
• To use the displayed date, click Latest Date.
• To enter a date in mm/dd/yyyy format, click Other.
• To display a calendar and select a date, click

2. Enter a time in hh:mm:ss am/pm format.
3. Click Next.
Stratification variables
Item values can be associated in an MGPS data mining run because they are
associated jointly with other variables, such as gender or age. To minimize the
occurrences of this type of spurious association, use stratification variables in the
results of an MGPS run.
For example, Drug X is generally prescribed for women above age 50 and Event Y
also occurs more frequently for women above age 50. A data mining run indicates
a strong association between Drug X and Event Y, based on the coincidence of
the gender and age groups involved. To minimize the occurrence of this type of
association, stratify the data mining run by Gender and Age Group. To do this, Gender
and Age Group must be available as stratification variables in the configuration.
Stratification divides all cases into groups, based on one or more variables, for the
computation of expected values (E). The Oracle Empirica Signal application sums
these expected values across all of the strata to provide a single expected value for
all of the cases in the background. This has the effect of adjusting the expected value
(and the other statistics computed with E, including the Relative Reporting Ratio (RR)
used in the MGPS computation) for the effects of such covariates as age, gender, and
receipt year. In this way, you can perform data mining across the entire background
set, yet still be protected from false results that can come from coincidental association
with age, gender, and so on. With stratification, there is one set of results (as opposed
to the multiple result sets generated by a subset variable).
Like item variables, stratification variables map to columns in the safety database. You
cannot select the same variable as both an item variable and a stratification variable at
the same time.
If you select stratification variables for your MGPS data mining run, and also choose to
compute PRR (Proportional Reporting Ratios) and ROR (Reporting Odds Ratios), you
can specify stratification to apply to those computations as well.
Example
The following example shows how reports are divided and then recombined during
data mining when you use the stratification variable Gender:
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Dimensions and patterns

On the Select Criteria page, you can specify the dimension and pattern for an MGPS
run as criteria for viewing data mining results. To display these controls, click Show
Advanced.
Dimensions
The dimensions in a run are the number of ways in which items combine to generate
scores. When specifying data mining parameters for MGPS runs, the run creator
specifies the highest dimension to compute. The run results include combinations of
all dimension combinations, from 1 to the specified highest dimension. For example,
a two-dimensional (2D) data mining run performed for drug and event item variables
produces scores for the following combinations:
Drug (1D)
Event (1D)
Drug+Drug (2D)
Drug+Event (2D)
Event+Event (2D)
where
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Drug and Event represent the names of the item variables used for the data mining
run.
Note:
One-dimensional results are useful to determine the total count (N) for a drug
or event. Other statistics are not generated for 1D results, and you cannot
display graphs for 1D results.
A 3D run for the same drug and event item variables produces results for these
combinations:
Drug (1D)
Event (1D)
Drug+Drug (2D)
Drug+Event (2D)
Event+Event (2D)
Drug+Drug+Drug (3D)
Drug+Drug+Event (3D)
Drug+Event+Event (3D)
Event+Event+Event (3D)
Note:
If you include PRR, RGPS, or ROR computations in an MGPS run,
Oracle Empirica Signal produces PRR, RGPS, and ROR scores only for
Drug+Event (2D) combinations.
When specifying criteria to view data mining results, you can indicate the number of
dimensions to view. You can include 1 dimension up to the highest dimension included
in the run. To include all dimensions, select All. The default is the highest dimension
included in the run. If you change the default number of run dimensions, consider
changing the default pattern for the run.
Note:
Combinations of two or more dimensions that include only multiple drugs
or only multiple events (such as Drug+Drug or Event+Event) are only
included in the results table if the run creator specified (on the Data Mining
Parameters page) that results for items of the same type should be kept.
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Patterns
You select a pattern to define the item types (such as drugs and events) to appear in
the results table or graph. The default pattern depends on the number of dimensions
in the run. The following table shows the default pattern for each dimension. Drug and
Event represent the names of the item variables used for the data mining run.
Dimensions Default Pattern

1D Drug
2D Drug+Event
3D Drug+Any Drug+Event
The results table or graph includes results only for the selected pattern. You can
change the types of items supplied by the default pattern as needed. The following
table describes the options for the pattern fields:
Option Description
<variable-name> Lists each item variable used in the data
mining run; for example, Generic_Name and
PT. (Item variables can also represent other
types of data, such as Gender or Age_Group.)
For any pattern that includes <variable-name>,
you can specify terms for the variable. If you
specify terms, the results table displays only
those terms and the scores calculated for
them; otherwise, the results table displays all
values for the <variable-name>.
Any <variable-name> Lists each of the item variables used in
the data mining run with the prefix Any; for
example, Any Trade_Name and Any PT.
These pattern options allow you to display
results for specified terms as though you had
supplied an OR between those terms. For
example, if you choose the pattern PT+PT and
specify the terms Headache and Rash, the
results table displays only rows that contain
both Headache and Rash. However, if you
choose the pattern PT+Any PT, then specify
Headache and Rash, the results table displays
rows that contain either Headache or Rash.
Any Item The Any Item option is a wildcard that
represents any of the other item variables in
the run. You can use Any Item in a pattern for
a 3D run that uses the Generic_Name and PT
item variables. When you choose the pattern
Any Generic_Name+Any Item+PT and specify
the term DrugA, the results table displays
DrugA+Event+Event combinations and also
DrugA+Drug+Event combinations.
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Manage custom terms
View interactions
Each row in the table presents two predictor values, which appear in the columns
labeled Item1 and Item2, and a response, which appears in the column labeled for the
selected event variable, such as PT.
Note:
You can also include columns in the table that indicate the type of variable
selected: the P_Item1 and P_Item2 columns contain either D, to indicate the
drug variable, or the name of a covariate variable.
The scores appearing for each predictor1+predictor2+response combination include

LROR1 (LROR for predictor1+response) and LROR2 (LROR for predictor2+response),
which are repeated from the main results table. They reappear in the interactions table
as a reminder of the individual predictor disproportionalities with the response.
The table displays the following information:
• N_TOT—The total number of times the pair of predictor items appeared together,
irrespective of the responses.
• INT_LOF (lack of fit interaction ratio)—A Bayesian “shrunk” version of N/E. For
example, if INT_LOF = 2, then the response seems to be appearing with this
pair of predictor items 2 times as frequently as the standard or extended logistic
regression model formula indicates. That is, the model doesn’t “fit” well when
these items are both present.
• INT_REGR—Compares the standard or extended logistic regression expected
adverse event frequency when both items are present to the expected frequency
when only the item (of the two) having the larger LROR is present. That is, if
INT_REGR = 2, then the regression model predicts that the response is 2 times
as likely when both items are present than when just the more associated item is
present.
• INT_TOT = INT_REGR x INT_LOF—Shows the combined relative effect of having
both items present versus having the more associated item present.
Manage custom terms

• What are custom terms?
• Define custom terms
What are custom terms?

A custom term is a pseudo-value specified in a data mining run for inclusion in cases
that meet specified criteria. When you perform data mining, Oracle Empirica Signal
acts as if the custom term is present for those cases and generates statistics for the
custom term. Custom terms are defined and used within the context of data mining
runs and do not affect the source data.
You can define multiple custom terms in a data mining run. Oracle Empirica Signal
adds the suffix, (Custom Term), to the term that you specify.
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Manage custom terms
A typical use of custom terms is to group together similar terms for products or events
as a way to prevent the signal dilution that may occur when similar, but not the same,
terms are used in reporting. For example, you can create the custom term, Hepatic
Terms, to group the following PTs: Coma hepatic, Hepatic encephalopathy, Hepatic
failure, Hepatorenal failure, and Hepatorenal syndrome. The data mining run then
computes statistics for Hepatic Terms as if it is a PT in the source data, although the
custom term is not added to the source data. The data mining run also computes
statistics for the constituent PTs.
When estimating the shrinkage parameters for EBGM scores, MGPS does not
consider custom terms. The raw RR scores for combinations involving custom terms
are shrunk by the Bayesian formula, but they do not participate in the determination of
the formula itself. For more information, see MGPS computations.
Note:
For another way of mapping values to a term for use in a data mining
run, see Map text values. For information on the differences between these
features, see Custom terms and mapped text values.
Custom terms are defined using queries. Reports that match the query condition are
considered to have the pseudo value. When defining a new query, you have the option
to save it to the Query Library. You can then use it to define custom terms for other
data mining runs.
When you re-run a run, the same custom terms are used in the run. However, you
cannot switch run types. Thus, if you plan to use a custom term for different run types,
make sure that you save the query you define for the custom term for the first run you
set up; then you can select that query as the custom term for the other run type(s).
Define custom terms

When you define a custom term, you create a new query or use an existing query to
determine which cases meet the criteria for the term. When defining a new query, you
have the option to save it to the Query Library. You can then use it to define custom
terms for other data mining runs.
When you re-run a run, Oracle Empirica Signal uses the same custom terms in the
run. However, you cannot switch run types. Thus, if you plan to use a custom term for
different run types, make sure that you save the query you define for the custom term
for the first run you set up. Then you can select that query as the custom term for the
other run type(s).
Mining Runs.
2. Click Create Run.
3. Select the type of run to create:
• MGPS data mining run
• Logistic regression data mining run
4. Select a data configuration.
5. Click Next.
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Manage custom terms
6. Select your variables and check Define custom terms. For information about
variable selection, see Select the variables.
7. Click Next.
8. Click Create Custom Term.
9. In the Name field, enter the name of the custom term.
If a custom term name includes an invalid character, the application changes
it automatically, and a message appears to inform you of the change. Invalid
characters are replaced with a pound sign (#). Invalid characters for this field are:
• Invalid filename characters: \, /, <, :, >, |, ?, *, ”, &, and null
• Control characters
• Non-ASCII characters
10. In the Item Variable field, select the variable to which the custom term will be
assigned. Available variables are those that you selected as item variables for the
MGPS data mining run, or as the Event or Drug variable in a logistic regression
data mining run. A variable is not available if it is mapped via a data transformation
or is associated in the data configuration with a hierarchy table (rather than a
hierarchy account).
• To create a custom term by defining a new query, click Create Using Query
Wizard. The Define Query page appears. You can save the new query to the
Query Library so that you can re-use it for other runs.
• To create a custom term based on an existing query, click Create from Existing
Query. The Select Query from Library page appears. Subsequent changes to
the query in the library will not affect the custom term.
The screen refreshes and displays the query you created or selected in the Query
field. If you click Edit Query, the Define Query page appears and you can change
query variables, values, and logic.
Note:
If you saved the query to the library and then you edit it from this page,
your changes are not saved to the library.
12. If the data configuration selected for an MGPS run specifies a drug or event
hierarchy, you can select an existing term that has the primary path that you
want to associate with the custom term. Next to Hierarchy Path, click Select
<hierarchy> Term to view the hierarchy. If you select a term, the results table
includes its hierarchy values for the custom term. If you do not select a term, the
results table does not include hierarchy values for the custom term.
The term that you select to indicate the primary path is always a PT (Preferred
Term), even if the variable for which you are creating a custom term is a HLT,
HLGT, or SOC. The option to specify a hierarchy path applies only to MGPS runs,
and has no effect on logistic regression runs.
To remove a previously specified hierarchy path click Clear Hierarchy Values.
(Before changing a hierarchy path, you should clear the hierarchy path.)
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Define subsets for an MGPS run
Note:
Custom terms do not appear, and are not available for selection, from
the hierarchy.
13. When you are satisfied with the custom term, click OK.
The new custom term appears on the Define Custom Terms page.

• Select a subset variable
• Define subset values
• Define subset labels
• Subset variables
Select a subset variable

To use subsetting in an MGPS data mining, you must select a subset variable.
Mining Runs.
Next.
5. On the Select Variables page, select at least one Item variable by clicking its
name, and, optionally, select Stratification variables.
6. Select Define subsets.
7. Click Next.
The Select Subset Variable page appears. If you also checked Define custom
terms on the Select Variables page, the Select Subset Variable page appears
after you add custom terms.
8. From the Subset variable list, select the variable to use for subsetting.
You can select only one subset variable, and you cannot select the same variable
to be both an item variable and a subset variable in the same data mining run.
9. Click Next.
10. Continue with Define subset values.
Define subset values

When you have selected a subset variable for an MGPS run, you must specify
subsets, with each subset representing one or more values of the subset variable.
For example, if you use Received Year as the subset variable, you can create one
subset for each year except 1998, 1999, and 2000, which you group together into one
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subset. Oracle Empirica Signal generates a set of data mining results for each subset
that you specify.
The source of subset values is either the source database or values that have been
defined by data transformations in the data configuration. For example, if the source
database contains report received dates, the creator of a configuration can transform
the received dates into years, half-years, or quarter-years.
If a value for the subset variable is missing from the source data, the value of your
user preference, Replace Missing Values with, appears in place of a value.
Note:
When specifying subsets, keep in mind that there is an iteration of MGPS for
each subset. The more subsets you specify, the longer the MGPS run takes.
Mining Runs.
Next.
5. On the Select Variables page, select at least one item variable by clicking its
6. From the Available values list, select the variables for subsetting and use the
arrow keys to move values from the Available values list to the Subset values
list:
Button Use To
Create a single subset containing all

values that are selected in the Available
values list, for example, one subset for
1998,1999,2000.
Create a subset for each of the values that

is selected in the Available Values list, for
example, a separate subset for each of 2007
and 2008.
7. To include data from all previous subset categories in the results for each subset,
select Subsets will be cumulative. Typically, a cumulative subset variable
represents an ordinal value, such as report year. A non-cumulative subset variable
may represent a categorical value, such as age group.
8. If you checked Subsets will be cumulative, click one of the following under
Subsets will be ordered:
• As listed —Generates data mining results for subsets in the order of the
subsets.
• As reverse of listed —Generates data mining results for subsets in the
reverse of the specified sort order.
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The sort order is important for cumulative subsetting. The computations to

determine results for each subset include data from all previous subsets. (The sort
order also affects the order of columns in map graphs.) For example, the listed
order of subsets is:
• 2004
• 2005
• 2006
If you use cumulative subsets (as listed), there are subsets for:
• 2004
• 2004 and 2005 combined
• 2004, 2005, and 2006 combined
If you reverse the listed order, there are subsets for:
• 2006
• 2005 and 2006 combined
• 2004, 2005, and 2006 combined
See Define subset labels for more examples.
9. Click Next and continue with Define subset labels.
Define subset labels

Mining Runs.
Next.
5. On the Select Variables page, select at least one Item variable by clicking its
6. Select the variables for subsetting, specify their values, and click Next.
7. (Optional) In the Label field on the Define Subset Labels page, replace the
default label with a different label. There must be a label for each subset.
Note:
If a label includes an invalid character or space, the application changes
it automatically and a message appears to inform you of the change. The
application replaces invalid characters with a pound sign (#) and spaces
with an underscore (_).
Invalid characters for this field are:

*, \, ", :, /, ?, >, <, &, |, \t, \r, \n, ^, $, @, and '
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plus any non-ASCII characters.

8. Click Next to continue by defining the data mining parameters.
Default labels
When you define subsets, Oracle Empirica Signal assigns default labels. You can
change the default labels as needed. For a list of subset values, the default name is:
<first value>.<last value>
Default labels depend on whether the subsets are cumulative and the order of the
subsets, the listed order or the reverse orders. The table shows default labels for
different types of subsets:
Subsets As Listed Default Labels Default Labels for Default Labels for
on Define Subset for Non-Cumulative Cumulative Subsets Cumulative Subsets
Values page Subsets in Reverse Order of
Listed
1998 1998 1998 2000.2006
1999 1999 1998-1999 1999-2000.2006
2000, 2001, 2002, 2000.2006 1998-2000.2006 1998-2000.2006
2003, 2004, 2005,
2006
Subset variables
When you use a subset variable for an MGPS data mining run, Oracle Empirica
Signal divides source data into separate backgrounds, one for each value of the
subset variable, and performs a separate run for each of those different backgrounds.
You use subsets to study how the strength of a combination of variables evolved
temporally. You can also use subsets to study the strength of variable combinations
for age differences, gender differences, and so on. For example, to review separate
signal scores for males and for females, you subset the data mining run by gender.
Two separate sets of statistics result, one set computed against the background of
cases involving males and the other against the background of cases with females.
You can select only one subset variable for a data mining run. That variable must
have only one value for each case in the database. For example, indication, route, or
dose cannot be used directly as subset variables because any case with more than
one drug has multiple values for these variables, one for each reported drug. After
selecting a subset variable, choose which values of that variable to use for subsetting.
The application generates a set of results for each subset.
Note:
You cannot select the same variable as both an item variable and a subset
variable.
Example
The database contains information on the age of patients reporting adverse reactions.
The age has been categorized as Pediatric, Adult, and Elderly, and stored in a variable
named AgeGroup. To compare associations of variables for different age categories,
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you can select AgeGroup as the subset variable (assuming that AgeGroup has been
made available as a subset variable by the configuration).
With subsetting, the application computes expected counts, Relative Ratio, and EBGM
for each subset separately:
For a data mining run that uses cumulative subsets, there is one set of results for each
subset and the computations to determine results for each subset include data from all
previous subsets. A previous subset may or may not be previous chronologically. For
more information, see Define subset values. Typically, a variable used for cumulative
subsetting represents a time period.
For example, suppose that you use Report Year as the subset variable and the
possible report years are 2002 through 2004:
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View source data

• What is source data?
• View a data source table
• Source database tables
• Set viewing options for a data source table
• Filter a data source table
What is source data?

The product safety data to be used in the Oracle Empirica Signal application might
include:
• Public safety data, such as data from the Adverse Event Reporting System
(AERS) or Vaccine Adverse Event Reporting System (VAERS), covered by the
Freedom of Information (FOI) Act.
• Subscription data, such as data from Vigibase, the World Health Organization's
Adverse Drug Reaction (ADR) database.
• Your company's own safety data.
Typically, product safety data in the original, base tables is cleaned and prepared for
useful data mining. The prepared data is stored in an Oracle database and is the
source data used by Oracle Empirica Signal.
Each source database resides in a separate Oracle account. In addition to the Oracle
tables and views that contain safety data, the source database might include other
tables that support the use of source data in the application:
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• A data configuration is a group of variables that correspond to items (database

columns) in the source database. There must be at least one data configuration for
data mining to be performed. Typically, multiple data configurations are available.
For example, there might be a data configuration for SRS+AERS data and a
separate data configuration for AERS data (since 1997).
• A drilldown map table specifies which data appears when users drill down to case
information.
• A source description table provides a description of the source database, such as
its name and when it was loaded.
• Unique values tables enhance performance by listing unique values for variables.
If dictionaries of hierarchical data from a classification system such as the Medical
Dictionary for Regulatory Activities (MedDRA) are used, each version of dictionary
data is stored in a separate Oracle account. If hierarchy accounts are defined, users
can browse for and select event terms or drug terms in the hierarchy.
The following illustration shows the relationship between the original safety database
and the Oracle Empirica Signal source database:
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View a data source table

From within Oracle Empirica Signal, you can view the data source tables referenced
by the data configuration associated with the currently selected run. For more
information, see What is source data?
Note:
Only a superuser can view data source tables.
Mining Runs.
projects.
3. From the Configuration drop-down list, select a data configuration, or select -- to
4. Select the Row Action menu icon ( ) for a run, and then click View Jobs for
Run.
5. In the upper-right corner, click Sources.
6. Click the name of the data source table that you want to view.
7. (Optional) Perform actions on the table:
• To set viewing options, click Options.
• To filter the data that you want to view to certain specified characteristics, click
Filter.
• To download the data in the table, click Download (available if you have the
Download Raw Data permission).
Data Source Tables
The following data source tables might be available to view:
Table Description
Complete Results Table Complete, raw results table, intended for
troubleshooting purposes. For most purposes,
the results table available from Data Mining
Results is more appropriate. This complete
results table might contain more columns than
you need to see.
Drug Index Table and Event Index Table Oracle column indexes for drugs and events.
Master Configuration Table Oracle Empirica Signal master data
configuration table (named DM_CONFIGS),
which stores attributes of all data
configurations in all the source databases.
Configuration Table Table containing information about variables in
the specific data configuration that was used
for the run.
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Table Description
Drilldown Map Table The drilldown map table, which defines
which information (such as case outcomes or
narratives) appears when the results reviewer
drills down to case details.
Data Source Description Table Source description table , which defines
information (such as the date the data was
loaded) about the source database and
appears when the results reviewer drills down
to view case details and in the Notes section
of tables. This table is available only it was
defined for the data configuration.
Source Database Tables Referenced by Source database tables referenced by the data
Configuration configuration; for example, the demographics,
drugs, and events tables.
Hierarchy Tables Referenced by Configuration Available if an older method was used
for setting up drug and event hierarchies
by providing hierarchy tables for individual
variables in a data configuration, and if the
run used hierarchy information. For more
information, see Drug and event hierarchies.
Unique Values Tables Referenced by Unique values tables referenced by the data
Configuration configuration that was used for the run.
Source Database Tables Referenced by Source database tables referenced by the
Drilldown Map drilldown map table for the data configuration.
For example, the drilldown map table might
reference a table containing demographics
data, making demographics data available as
part of the case details.
Source database tables

Source database tables are the Oracle tables or views that store prepared safety data,
which has been cleaned and transformed for data mining. To prepare source database
tables, you can use standard Oracle tools or any application that enables you to work
with Oracle tables. In preparing the analysis tables, you must:
• Decide how many source database tables or views are needed.
• Ensure that all of the source database tables include an item that links them and
can serve as a case identifier in the Oracle Empirica Signal application.
• Ensure that, if the source data is timestamped, the source database tables include
dates that can be used as start and end dates for data.
• Ensure that the source database tables include the following:
– An item or items representing the therapeutic product being studied.
– An item or items representing the event or symptom being studied.
– Items that allow stratification during a data mining run.
– Items that allow subsetting during a data mining run.
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Examples of base tables

The base tables are as follows:
DEMO table:
CASE_ID GENDER COUNTRY REPORT_DATE BIRTH_DATE

123 M US 12/01/2001 01/16/1954
138 F France 01/05/2000 07/01/1965
147 M Japan 09/17/2001 03/11/1942
154 F US 10/04/1999 09/07/1966
ANTIGENS table:
CASE_ID VAX_NAME ANTIGEN VAX_LOT

123 VAX A ANTIGEN 1 15HR34
138 VAX B ANTIGEN 3 49J3
147 VAX C ANTIGEN 4 97WEO
147 VAX C ANTIGEN 2 97WEO
154 VAX D ANTIGEN 3 D90477F6
SYMPTOMS table:
CASE_ID SYMPTOM START STOP SEVERITY NARRATIVE

123 Rash 10/30/01 11/25/01 Moderate Red weeping
rash on left
side of neck
extending
from left back
of neck over
shoulder to
left clavicle.
138 Hearing loss 11/14/00 12/05/00 Severe Total hearing
loss, both
ears.
147 Rash 09/01/01 09/03/01 Mild Red weeping
rash on right
forearm.
154 Vertigo 09/30/99 10/03/99 Severe After walking
block, patient
experienced
abrupt feeling
of spinning
and almost fell
down.
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Source database tables preparation

Suppose that the following data is needed for data mining:
• All cases originating in the U.S.
• The year that the case report was received.
• Age groups of patients.
• The symptom duration.
To prepare source database tables, you can do the following:
• Create a DEMO_ANALYSIS view on the DEMO table. Rename the CASE_ID
to RPT_ID. Exclude case reports that did not originate in the U.S.
Derive AGE_GROUP from AGE, which is derived from REPORT_DATE and
BIRTH_DATE.
• Create a VACCINES_ANALYSIS view on the ANTIGENS table. Exclude case
reports that did not originate in the U.S. Rename the CASE_ID to RPT_ID.
• Create a SYMPTOMS_ANALYSIS view on the SYMPTOMS table. Rename the
CASE_ID to RPT_ID. Exclude case reports that did not originate in the U.S. Derive
RCVD_YR from CASE_DATE. Derive DUR_DAYS (symptom duration in days)
from START and STOP in the SYMPTOMS table.
• Create a DRILLDOWN view including a RPT_ID and any fields from the base
tables that the user needs to see upon drilling down to case-level information.
Exclude case reports that did not originate in the U.S. (This view is not the same
as the drilldown map table.)
Resulting source database tables

The resulting source database tables (or views) might look like this:
DEMO_ANALYSIS view:
RPT_ID GENDER RCVD_YEAR AGE_GROUP

123 M 2001 40-49
154 F 1999 30-39
VACCINES_ANALYSIS view:
RPT_ID VACCINE ANTIGEN LOT_NO

154 VAX D ANTIGEN 3 D90477F6
SYMPTOMS_ANALYSIS view:
RPT_ID SYMPTOM DUR_DAYS SEVERITY

123 Rash 27 Moderate
154 Vertigo 4 Severe
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View source data
DRILLDOWN view:
RPT_ ID GENDER VACCINE SYMPTOM DUR_ DAYS SEVERITY AGE_ NARRATIV

GROUP E
123 M VAX A Rash 27 Moderate 40-49 Red weeping
rash on left
side of neck
extending
from left
back of neck
over
shoulder to
left clavicle.
154 F VAX D Vertigo 4 Severe 30-39 After walking
a block,
patient
experienced
abrupt
feeling of
spinning and
almost fell
down.
Set viewing options for a data source table

Viewing options allow you to sort rows as needed and choose which columns to
include in a data source table. The options apply to the specific table during your
current session. When you exit and log back in, Oracle Empirica Signal resets the
options to the default settings.
While setting options, click Clear to reset the options to the default settings (except
for which columns to include).
Mining Runs.
projects.
Run.
7. Click Options.
8. Specify up to three columns by which to sort the table. You can sort on columns,
regardless of whether or not the columns appear in the displayed table. You can
also sort by clicking the column headers in the table itself.
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a. From the Sort By drop-down list, select a field to sort by. To sort data in
descending order, click the Descending check box. Otherwise, results appear
in ascending order.
b. Within the primary sort, specify up to two additional sort orders by selecting
them from the Then By drop-down lists. To sort data in descending order, click
the Descending check box. Otherwise, results appear in ascending order.
9. In the Rows per page field, type the number of rows to display per page. (The
default is 15.)
10. To show the number of rows and current filter information above the table, check
Show heading.
11. To show a description of the source database, check Show notes. The description
comes from the source description table for the configuration used by the run.
12. To show the SQL WHERE clause that the application used to construct the
displayed table, check Show SQL.
13. If you want the table to include columns for which no values exist, check Show
empty columns.
14. From the Include columns list, check the columns to include in the table.
15. Click Save.
Filter a data source table

When you filter a data source table, you use a SQL WHERE clause to indicate specific
characteristics for the data you want to view. You can access any data that is in the
source table. For example, suppose that you are viewing the DEMOG table in the
source database, and you want to look at only cases for females. If Gender is stored in
the DEMOG table, you can filter by Gender.
Mining Runs.
projects.
Run.
7. Click Filter.
8. In the SQL WHERE clause text box, type a SQL WHERE clause. You can refer
to any of the columns listed on the Table Viewing Options page, regardless of
whether or not you included them in the displayed table.
9. Click Apply Filter. To remove the filter, click Clear.
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Manage data mining runs

• Rename a data mining run
• View details of a data mining run
• Arrange the columns on the Data Mining Runs page
• View jobs for a data mining run
• View job details for a data mining run
• Define a database restriction
• Refine a query to create a database restriction or custom term
• Cancel or delete a data mining run
• Re-run a data mining run
• Data configuration and object compatibility
• Publish a data mining run
Rename a data mining run

Mining Runs.
projects.
4. Select the Row Action menu icon ( ) for a run, and then click Rename.
5. In the Run name field, enter a new name for the run. The name does not need to
be unique, although we recommend that you use a unique name.
6. In the Description field, enter a new description. Oracle recommends that you
provide an informative description of the run so that users who view run results
know which run to use.
• To assign the run to an existing project, click Add to existing project and
• To create a new project and assign the run to it, click Add to a new project
named and enter a project name.
8. Click OK.
View details of a data mining run

Mining Runs
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projects.
4. Select the Row Action menu icon ( ) for a run, and then click View Run
Details.
Different information appears for MGPS runs and LR runs.
MGPS runs
Field Description
ID Automatically assigned, unique numeric
identifier of the run.
Type MGPS.
Project The name of the project to which the run is
assigned.
Configuration Name of the data configuration used for the
run.
Configuration description Description of the configuration used for the
run.
As of date As Of date for the run, if the run is for
timestamped data.
Database restriction Database restriction, if any, associated with
the run.
Item variables Names of the item variables used in the run.
Stratification variables Stratification variables, if any, used for the run.
Subsets Subset variable, if any, as well as whether the
subsets are cumulative, the order of subsets (if
cumulative), and the subset labels and values.
Drug hierarchy If the data configuration specifies a drug
hierarchy, the name and version of the drug
hierarchy used by this run.
Event hierarchy If the data configuration specifies an event
hierarchy, the name and version of the event
hierarchy used by this run.
Highest dimension The maximum number of ways in which
items are combined. See Specify data mining
parameters.
Minimum count Minimum number of cases in which a
combination of items must occur for the
combination to be included in the MGPS
computations for the run. See Specify data
mining parameters.
Calculate PRR Whether the run includes PRR computations.
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Field Description
Calculate ROR Whether the run includes ROR computations.
Base counts on cases For a run that includes PRR and ROR
computations, indicates if counts are based on
cases rather than drug-event combinations.
Use "all drugs" comparator For a run that includes PRR computations,
whether or not the comparator set includes the
drug of interest.
Apply Yates correction For a run that includes PRR computations,
whether or not the Yates correction is applied.
Stratify PRR and ROR For a run that includes PRR and ROR
computations, whether or not the PRR or ROR
computations are stratified.
Include IC Whether the run includes Information
Component computations.
Include RGPS Whether the run includes RGPS computations.
Calculate RGPS interactions Whether the run computes Drug+Drug
interaction scores using RGPS.
Minimum interaction count Minimum number of times that a drug
must appear in Drug+Event reports for the
application to calculate interaction estimates
for the drug.
Fill in hierarchy values Indicates whether the run option to use
hierarchy information was checked.
Limit results to Limitations on which results are kept based
on statistical thresholds or specified values
of item variables. See Specify data mining
parameters.
Exclude single itemtypes Indicates whether combinations of items of the
same type were excluded from run results.
See Specify data mining parameters.
Fit separate distributions Indicates the setting for the advanced
parameter to fit separate distributions for the
different item type combinations.
Save intermediate files Whether or not intermediate processing files
for the run were saved. See Define data
mining run options.
Created by Name of the user who created the run.
Created on Date and time at which the run was submitted.
User Your username (name of the user who is
viewing run details).
Source database Information about the source data (from the
source description table).
Logistic regression runs
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Field Description
ID Automatically assigned, unique numeric
identifier of the run.
Type LR. For runs completed prior to the installation
of Oracle Empirica Signal version 7.1, LR
(Legacy) appears.
Project The name of the project to which the run is
assigned.
LR type The logistic regression used for the run, either
extended or standard.
run.
Configuration description Description of the data configuration used for
the run.
As of date If the run is for timestamped data, As Of date
for the run.
Database restriction Database restriction, if any, associated with
the run.
Item variables Names of the selected event and drug
variables.
Coveriates Variables, if any, selected as covariates for the
run.
Drug values Explicitly specified values of the drug variable
included in the run, even if they do not meet
the minimum number of times a drug must
occur in combination with specified events.
Event values Values of the event variable used in the run.
Minimum count Minimum number of cases in which a drug
must occur in combination with specified
events to be included in the run (except for
drugs explicitly specified as Drug values). See
Guidelines for specifying drugs for logistic
regression.
Run interactions Whether or not the run calculates statistics
for two predictors (such as drug+drug or
drug+covariate) and a response.
Save coefficients Whether or not the lr_coefficients.log file
produced for the run includes the coefficient
and standard deviation values calculated for
the run.
Save intermediate files Whether or not intermediate processing files
for the run were saved. See Define data
mining run options.
Created by Name of the user who created the run.
Created on Date and time at which the run was submitted.
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Field Description
User Your username (name of the user who is
viewing run details).
Source database Information about the source data (from the
source description table).
Arrange the columns on the Data Mining Runs page

Mining Runs.
projects.
4. In the upper-left corner, click Columns.
them to the Selected Columns list using the arrow buttons.
the table.

7. To move multiple columns, hold down the Ctrl key while you click the column
names, and then use the up or down arrows.
Note:
For most tables, rows with empty cells appear first when you sort that
column in ascending order, and last if you sort in descending order.
Empty columns are always displayed last, regardless of the sort order.
8. If you want to replace your choices with the Oracle Empirica Signal defaults, click
Reset. The table columns and sorting return to the default values.
9. Specify the sort order.
10. If you sorted the table by clicking column headers, that sort order appears in the
Column Name and Sort Order fields. Otherwise, the Column Sort Order fields are
empty. To specify a sort order:
columns.
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b. From the Sort Order drop-down list, select Asc (ascending order: A-Z, 1-9) or
Desc (descending order: Z-A, 9-1).
11. Click OK.
View jobs for a data mining run

The Jobs for Run page presents information about the batch jobs that make up a run
and provides access to input and output files for the jobs. The name and owner of
the run appears at the top of the page. If a run is scheduled for future processing, the
scheduled date and time appear.
• For runs that are in progress, this page refreshes automatically until the run
completes successfully or an error causes a job to fail.
• As the jobs in a run are performed, the Status column indicates Completed or
displays the error that caused that job to fail. If any of the jobs in a run fail, the
status of the run is Error Occurred.
Mining Runs.
projects.
Run.
The Jobs for Run page provides the following information about each job:
Column Description
ID Automatically assigned unique ID of the job.
IDs of deleted runs are not re-used.
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Column Description
Name The name of each job, including a descriptor
followed by the number of the run. The jobs
included in the run differ for MGPS and LR
runs, as follows.
An MGPS run includes the following jobs:
• extract—Extracts data from the source
database. The run ID follows the job
name.
• mgps—Applies MGPS to the extracted
data to produce scores. The run ID and
0 follow the job name.
• rgps—For runs that include RGPS
computations, applies RGPS to the
extracted data to produce scores. The
run ID and 0 follow the job name.
• Post_Process—Creates unique value
tables for the drugs and events that
appear in the run results (for use by the
results table) and adds column indexes
to the output table. There is only one
post-process job. The run ID and 0
follow the job name.
A logistic regression run includes the
following jobs:
• LR_extract—Extracts data from the
source database. The run ID follows the
job name.
• LR—Calculates logistic regression
scores. The run ID and 0 follow the
job name. Click the name of this job
to download the log files. These include
the tab-delimited lr_coefficients.log file,
which contains alpha values computed
for every event in an Extended LR
run; and, if selected as a run option,
the coefficients and standard errors for
each predictor+response combination;
and the lr.log file, which lists the most
common values found for run covariates
and summarizes convergence for each
response.
• LR_Post_Process—Creates unique
value tables for the drugs and events
that appear in the run results (for use
by the results table) and adds column
indexes to the output table. There is
only one post-process job. The run ID
and 0 follow the job name.
Description The text, Part of Run, followed by the run
ID.
Server The value, Any, appears if the next available
listener can perform the job. If multiple
listeners are in use and the MGPS or logistic
regression run is submitted externally using
a run definition file, a listener can be
specified to perform each job and the unique
ID of the listener appears.
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Column Description
Created Server date and time when the extraction
or base job was created. For a run that
is scheduled and may be queued for
processing after other runs, the creation
of the extraction or base job may be
substantially later than the creation date of
the run itself.
Start Date Server date and time when the job was
started.
Note:
Once an extraction completes,
there is internal preparation of the
extraction for the MGPS or LR
job. If you submit two runs, it is
possible for the extraction job of
the second run to start before the
MGPS or LR job of the first run.
End Date Server date and time when the job ended.
Runnable The value remains NO for each job until the
preceding job is complete; then the value
becomes YES.
Status The column remains empty until the job has
completed or failed. If the job completes
successfully, the status is Completed. If
the run is canceled when the job is being
performed, the status is Canceled. An error
message (and red background) appears if
the job failed.
5. To view job detail, such as the job parameters, and to access input and output files
for jobs, click the name of the job.
6. To view source tables, click Sources (if you are a superuser).
View job details for a data mining run

The Job Detail page provides a list of parameters used for a component job in a data
mining run, and a list of input and output files produced by the selected job. Certain
files are always saved and available from this page, while other files are saved and
available only if the run creator checked Save intermediate data files on the Run
Options page.
• An error log file called job_job-id_log-id.log is produced for each extract or
LR_extract job. This log contains the date and time that error logging began and
messages about any errors that occurred. For LR runs, this log also includes a line
for each process in the run.
• The lr_coefficients.log file is produced for each LR job. This file contains the
computed best alpha value for each response in an extended LR computation,
and also includes the coefficient and standard error values computed for each
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predictor-response combination if the run creator checked Save coefficients on

the Run Options page.
• The lr.log file is produced for each LR job. This file identifies the most common
value for each covariate in the run and summarizes convergence for each
response.
• For the mgps job, the datamine.log file shows the version of the MGPS engine
that you used. For the LR job in a logistic regression run, the lr.log file shows the
version. The version number is helpful to know when communicating with Oracle
about issues related to the data mining run.
Mining Runs.
projects.
Run.
5. Select the job and click its name.
6. Review the information on the Job Detail page.
7. To download the job detail file, from the Job Parameters section, click the input or
output filename.
8. To return to the Jobs for Run page, click Back.
Define a database restriction

A database restriction is a means of limiting which cases in the source data are
included in a data mining run (MGPS or logistic regression) by specifying or selecting
a query. Data mining statistics are based only on cases that meet the criteria of the
query. For example, you can limit a data mining run to only cases that have been
reported by health professionals. A data mining run can have only one database
restriction.
A database restriction limits cases, not records. For example, if you base a database
restriction on a query that finds a particular drug, the application includes each case
involving the drug in the run. Because there may be multiple drugs per case; however,
the application includes drugs other than the particular drug in the run.
When defining a database restriction, you can create a new query or use an existing
query. When defining a new query, you have the option to save it to the Query Library.
You can then use it to define database restrictions for other data mining runs.
When you re-run a run, the application applies the same database restriction. You
cannot switch run types. Thus, if you plan to use a particular database restriction for
different run types, make sure that you save the query you define for the database
restriction for the first run you set up. Then you can select that query as the database
restriction for the other run type(s).
Mining Runs.
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projects.
Run.
5. Select the Define database restriction check box.
6. Click Next.
• To create a database restriction by defining a new query, click Create Using
Query Wizard. You can save the new query to the Query library so that you
can re-use it for other runs.
• To create a database restriction based on an existing query, click Create from
Existing Query. Subsequent changes to the query in the library will not affect
the database restriction.
Note:
If you saved the query to the library and then you edit it from this page,
your changes are not saved to the library.
Refine a query to create a database restriction or custom term

To refine a query to create a database restriction or custom term, you specify values
for variables that are included in the query.
1. From the Select Query from Library page, select the query and click Next.
2. Specify values for query variables.
If all operators in the query are the same; that is, they are all AND, all OR, all
INTERSECT, or all UNION, you do not need to specify values for every variable.
If you do not specify a value for a variable and you clear Include Null values for
the variable, then the application ignores that variable. If any operators differ, you
need to specify values for all query variables.
The way in which you specify values depends on the type of variable. For more
information, see Specify query variables.
3. To include null (empty) values along with the other values that you specify for a
variable, check Include Null values. For more information, including how the NOT
operator works if you include null values, see Specify query logic.
4. Click OK.
Selecting values
• If the Select <hierarchy> Terms link appears for a variable, click it to select terms
from the hierarchy. For example, if an event variable is associated with a MedDRA
version and your user preference, Enable Adverse Event Hierarchy Browser, is
checked, you can click Select MedDRA Terms.
• To select values from a list, click Select Available Values.
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• To refer to a saved list of terms, click Select Saved List. You can specify a saved
list that uses the same data configuration as the query.
• To type the terms, review the rules in Typing values in text boxes.
Note:
To prevent spelling and capitalization errors, Oracle recommends that
you select rather than type values.
• To look up a drug name for a drug variable, click Trade/Generic Lookup. You
can find the generic name for a drug (if you only know its trade name) or vice
versa. (This link is available if the data configuration's source data included trade
name-generic name mapping.)
Matching a text string
If the options Contains, Starts with, Ends with, or Equals appear for a variable, enter a
text string and click a radio button to indicate the type of matching. You can also check
Ignore capitalization to retrieve matching values regardless of upper or lower case.
Specifying ranges
For numeric or date variables, specify a range by entering values in the From and To
fields. Values equal to or greater than the From value and equal to or less than the
To value are found. If you leave the From field empty, there is no lower bound. If you
leave the To field empty, there is no upper bound.
Enter date values in the format appropriate for your locale or use the calendar icon
to select a date. The application uses the Oracle TO_DATE function to change
the entered date to an Oracle date. For example, if you enter 03/26/2008 in
the From field for the FDA_DATE variable, in the SQL generated, FDA_DATE >=
to_date('2008-03-26 00:00:00', 'yyyy-mm-dd hh24:mi:ss').
If you do not specify a time, the time is considered to be midnight of the specified date.
Note:
If a date variable is stored as a text field in the Oracle database, you can
search for it as you would search for any text string.
Specifying report IDs

For a variable specified with the type Report ID in the data configuration, you can enter
a string of report IDs separated by commas.
Cancel or delete a data mining run

At any point before a data mining run has completed, you can cancel the run. A
canceled run remains on the Data Mining Runs page and can be re-run as is or with
modifications. For example, suppose there are several runs in the queue. You need
the one that was most recently submitted to run first. You can cancel all runs except
the most recently submitted one. Later, you can re-run the canceled runs.
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When a run has completed, the run status becomes either Complete or Error
Occurred, and you can delete the run. You can also delete a run that has been
canceled (the run status is Canceled). Data mining runs can take up a significant
amount of server space. Deleting runs that are no longer needed frees up this space
for other processes.
Note:
To learn more about the error that caused a run to fail, review the information
on the Jobs for Run page.
Which runs you can cancel or delete

You can always cancel or delete the data mining runs that you have created, even if
your username does not have the Delete Any Run permission.
You can cancel or delete runs created by any users in your login group if you have the
Delete Any Run permission.
Cancel a data mining run
The Cancel option is available as soon as the run is submitted. You can cancel a run
that is currently running or that is scheduled to run in the future. The status cannot be
Completed or Error.
Mining Runs.
projects.
4. Select the Row Action menu icon ( ) for a run, and then click Cancel.
5. Confirm the cancellation by clicking OK.
The status of the run changes to Canceled. You can delete or re-run the run.
Delete a data mining run
The Delete option is available only when the run has a status of Completed, Error
Occurred, or Canceled. If you want to delete a run that is currently running or is
scheduled to run in the future, you must cancel it first. Before a deleting a run, make
sure that it is not referenced by any drug profile configurations or signal configurations,
because such references are removed.
Mining Runs.
projects.
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4. Select the Row Action menu icon ( ) for a run, and then click Delete.
Any case series associated with the run are retained, but they no longer have an
associated run.
When you delete a run that is associated with an alias, the target status of the alias
becomes Broken.
Note:
If you want to delete multiple runs at the same time, on the Data Mining Runs
page, first choose Select Rows from the Header Action menu ( ).
Re-run a data mining run

Once a data mining run has been submitted, it can be re-run as is or with modified
parameters. For example, you need an MGPS run with 5 as the Minimum Count, and
another MGPS run with all of the same data mining parameters but with 10 as the
Minimum Count. Once you have submitted the first run, instead of creating a new run
and supplying all of the same selections again, except for the minimum count, you can
re-run and change one parameter.
You can re-run any of the data mining runs that appear on the Data Mining Runs
home page, including runs created by other users and runs that are currently running,
completed successfully, failed, were canceled, or have not started. You can also re-run
runs that are themselves re-runs.
Note:
• You cannot change the run type when re-running a run. For example,
you cannot change from an MGPS run to a logistic regression run.
• To learn more about the error that caused a run to fail, review the Status
column on the Jobs for Run page.
• The re-run option is not available for logistic regression runs created
prior to the installation of Oracle Empirica Signal version 7.1, which
included significant enhancements to logistic regression computations.
When you re-run a data mining run, Oracle Empirica Signal treats it as an independent
run that is not associated with the original run; you are the owner of the new run.
The run uses all parameters and options used for the original run (including the
As Of date of the run, if the data configuration supports timestamped data) unless
you explicitly modify them. In addition, the re-run uses the user preference, Replace
Missing Values with, setting that was in effect for the run creator when the original
run was created.
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Mining Runs.
projects.
4. Select the Row Action menu icon ( ) for a run, and then click Re-run.
5. To select a different data configuration, from the Configuration drop-down list of
compatible data configurations, select a data configuration.
6. To limit the run to only cases meeting specified criteria, check Add Database
Restriction.
7. Click Next.
If you added or modified a database restriction, the Define Database Restriction
page appears. Otherwise, the Run Options page appears.
8. Modify run options as needed. You can also click Back to review all of the
selections made for the original run and modify them as needed.
Note:
The run uses all of the variables, values, and parameters selected for
the original run unless you modify them in the new run. For example, if
there was a custom term for the original run, it is used as is unless you
modify it. Keep in mind that any changes made to queries on the Queries
page have no effect on database restrictions or custom terms that were
part of the original run. During the re-run, you must modify the database
restriction or custom term, if needed, including reselecting a query that
was modified on the Queries page.
9. Click Next.
10. On the Name Data Mining Run page, in the Run name field, enter a name for the
run. The name of the run does not need to be unique, although we recommend
that you use a unique name. Oracle Empirica Signal assigns a unique Run ID to
each run.
11. In the Description field, optionally enter a description. Oracle recommends that
you provide an informative description of the run so that users who view run
results know which run to use.
12. (Optional) To assign the run to a project, choose one of the following:
• To assign the run to an existing project, click Add to existing project and
• To create a new project and assign the run to it, click Add to a new project
13. Click Next.
14. On the Confirm Run Parameters page, review the parameters chosen for your run
to make sure that they are correct. Different parameters display for MGPS runs
and LR runs.
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15. If you want to change any parameters, click Back until you are on the appropriate
page and make the necessary changes. Then click Next until you are back on the
Confirm Run Parameters page.
16. When you are satisfied with the run parameters, click Submit.
17. Click Continue.
The run status appears on the Data Mining Runs page. To monitor the progress of a
run, you can view jobs for the run.
Data configuration and object compatibility

The Oracle Empirica Signal application checks the compatibility of data configurations
with other data configurations or other objects. For example, when you re-run a data
mining run using a different configuration, the application checks that the configuration
you specified is compatible with the original configuration used.
Compatibility-checking for various types of objects is as follows.
Data mining runs
Note:
Two variables match if they have the same variable name, the same variable
type and subtype, and the same settings for use as a subset variable or
When re-running a data mining run, you can select from configurations with variables
that match all variables in the original run's configuration. The configurations must also
have the same setting for whether the database is timestamped.
Saved lists
Note:
Two variables match if they have the same name, selection type, and Oracle
data type.
When selecting a saved list, you can select from lists where the variable referenced by
the saved list has a matching variable in the configuration associated with the object
on which you are working.
Queries and reports
Note:
Two variables match if they have the same name (ignoring underscores and
spaces), selection type, and Oracle data type.
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• When listing reports for a selected case series, the application lists only reports
based on configurations with variables that match the variables in the configuration
of the selected case series.
• When listing reports for cases that appear when you drill down on a count,
the application lists only reports where the variables used by the report match
variables in the configuration of the object from which you are drilling down.
• When running a query, you can select from configurations with variables that
match all variables referenced by the query.
• When creating a query-based interactive report, you can select from queries
where all referenced variables have a matching variable in the report
configuration.
• When defining a custom term or database restriction, you can select from queries
where all referenced variables have a matching variable in the run configuration.
• When running a query-based interactive report, you can select from configurations
with variables that match the union of all variables referenced by the query and all
variables referenced by the report.
• When running an All Cases Summary report, you can select from configurations
with variables that match all variables referenced by the report.
Case series (not query-based)
Note:
Two variables match if they have the same name and selection type.
When transferring cases to a case series, you can select from case series based on
configurations with variables that match variables in the configuration of the object
from which you are transferring cases.
Deleted data configurations
Note:
Two variables match if they have the same name (ignoring underscores and
spaces), selection type, and Oracle data type.
When deleting a configuration, you can transfer certain types of objects to another
data configuration with variables that match the all variables referenced by the objects.
Publish a data mining run

Publication of a data mining run is a way to make it available to other users. By
default, the publication level of every newly created object is Private.
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Logistic regression log files
Note:
Users without the Administer Users permission can publish only objects
they have created. Users with the Administer Users permission can publish
objects that they or any users in their login group created.
Mining Runs.
2. Click a data mining run's Row Action menu icon ( ) and click Publish.
3. To publish to all the users in your login group, click Publish.
• If you are a superuser, you can publish to multiple login groups, including
—All–. In the Publish to Login Groups drop-down list, click or Ctrl+click to
select login groups.
• If you publish to —All– and later add a new login group, the object is published
automatically to the new login group.
4. To view details of the selected data mining run, click View Run Details.
5. Click Back.

Logistic regression data mining runs produce log files to provide information on run
processing. These text files are available for download on the Job Detail page for the
LR job in the run.
The lr.log file identifies the most frequently occurring value for each covariate variable
in the run, such as the value F for the Gender variable. The value that occurs most
frequently is determined based on all reports in the analysis. If any of the events in
the run were not reported in combination with the most frequently occurring value for a
covariate, the application notes the value used in its place for that event.
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The lr.log file also provides information on convergence for each response and, if
necessary, the reason that an event specified for the run was not included in the
computation.
The lr_coefficients.log file contains the best alpha value computed for each response
in an extended logistic regression data mining run. For standard logistic regression
runs, the value 0.5 is always used as the alpha.
When you define the run options for a logistic regression data mining run, if you check
Save coefficients, the application includes coefficient and standard error values
computed for each predictor and response in the run in this file.
The following example shows the first few rows in an lr_coefficients.log file that has
been downloaded and opened in Microsoft Excel:
Note that the value of B0 is labeled <Intercept> in the Predictor column, and the value
of is labeled <Alpha> in that column. The computed value of appears in the Coeff
column.
For more information on logistic regression, see Logistic regression computations.
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Retrieve and review data mining results
• About data mining run results
• Load the run and select variables
• Look up drug names
• View results tables
• View results graphs
• Drill down through data
About data mining run results

Each data mining run produces a set of results that you can review in tabular
or graphical format. Run results are the scores that indicate the strength of the
association between the variables, such as drug and event, included in the run.
You view results on the Data Mining Results page after selecting results criteria (for
example, drugs or events of interest). You can view the results of runs that you have
created or that are published to you. If you have the Administer Users permission, you
can also view the results of any run, published or unpublished, created by any user in
your login group.
When reviewing results, you can drill down on counts to view case details if you have
appropriate permissions.
Load the run and select variables

To view data mining results, you specify criteria such as the drugs and events to
include in the table or graph of results on the Select Criteria page.
Mining Results.
2. On the Select Criteria page, choose the run from the Run name drop-down list.
Your Default Run user preference determines which run is selected by default.
• To view all available runs, click Browse.
• To see the details of the run, click View Run Details, examine the details, then
click Close.
3. Depending on the run you load, the available variables will differ. To specify item
variable values, use one or more of the following options:
• If a variable has an associated hierarchy of terms and your user preference
enables use of the hierarchy, you can click Select <hierarchy-name> Terms
and select terms from the hierarchy. Custom terms used in the run are not in
the hierarchy.
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Load the run and select variables
• If the run option to store the primary paths of terms in run results was used,
you can search for terms at various levels of the hierarchy. Click the radio
button for the level at which you want to search. If you select terms at a higher
level than the level of the term used in the run, you see results only for terms
that have that higher level in their primary path.
• To select values from a list, click Select Available Values. The available
values include custom terms used in the run.
• To use a saved list of terms, click Select Saved List. A saved list can include
custom terms.
• To look up a drug name, click Trade/Generic Lookup. You can find the
generic name for a drug (if you only know its trade name) or vice versa. (This
link is available only if the mapping of trade/generic names has been defined
as part of preparing source data.)
Note:
select rather than type values. Drugs or events that have a missing (null)
value in the source data have the value of the user preference, Replace
missing value with, that was in effect for the user who created the
run. (Your own user preference does not affect run results generated by
another user.)
4. To include only scores that exceed a minimum threshold value, use the Limit to
field to select a statistic and supply that minimum number. For a description of the
statistics that you can use to limit results, see Data mining results for MGPS runs
or Data mining results for logistic regression runs.
For example, to review only MGPS run results with an EB05 score greater than 2,
select EB05 and supply 2. Oracle Empirica Signal uses the setting as the default
(for results that you have not yet viewed) until you change it.
• If you provide a limit for an MGPS run and then view a graph, the application
applies the limit to the highest dimension in the graph only. For a sector map
graph, the limit is ignored.
• When you view one-dimensional run results for an MGPS run, the application
ignores this limit unless you specify a limit for the N statistic.
• This limit does not apply to sector map graphs or to the tables of covariate and
interaction results for a logistic regression run.
• To supply defaults for this statistic and value the first time you look at results
for a run, you can set the user preference, Display Only Results with
<score-type> Scores Over <number>. If you select a statistic other than
N, a default of LROR > 0 is used for logistic regression runs.
5. To select additional criteria, click Show Advanced. This link is available if
additional fields can be used to limit the results to display. (If you do not generally
use these fields you can click Hide Advanced.)
a. For an MGPS run In the Dimension field, select a dimension to limit the
results that appear. You can select 1, up to the highest dimension included in
the run, or All to display results for all of the dimensions included in the run.
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Look up drug names
By default, the dimension is the highest dimension that was selected when the
data mining run was created. You can change the dimension to less than the
default. The number of Pattern fields that appear depends on the number in
the Dimension field.
b. The Subset field appears if the run used subsetting and at least two subset
categories were specified for the run. Select the subset for which you want to
view results, or select All to display results for all subsets.
c. In the Pattern fields, specify a pattern such as Drug+Event. See Dimensions
and patterns.
d. If your user preference, Include SQL WHERE Clause for Advanced Results
Selection, is checked, you can specify a SQL WHERE clause to restrict
which run results you view. You can reference any of the columns that can be
displayed in the results table, regardless of whether they are currently included
in the display. To view the complete list of columns, click the Columns link
above the results table. The SQL WHERE clause entered here is ignored if
you view a table of covariates or interactions for a logistic regression run, or
when you view a sector map graph.
6. If you want to remove your selections from the fields on this page, click Clear All.
7. Click View Results Table to view a results table or click Choose Graph to choose
a graph type to display. To view a graph, you must specify at least one drug or
one event. For MGPS runs, you can view results graphically for two-, or three-
dimensional drug-event combinations.
Note:
When you view results for a logistic regression run, all criteria defined on this
page are used to select the combinations that appear in the results table.
However, only the drug and event values specified, if any, are used to define
the results that appear in the Covariates Table and Interactions Table.
Look up drug names

Oracle Empirica Signal provides an easy way for you to find the generic drug name
associated with a trade name that you provide, or the trade name associated with the
generic name that you provide.
This feature is available only if the mapping of trade and generic names has been
defined as part of preparing source data for use in the application.
Mining Results.
2. On the Select Criteria page, click Trade/Generic Lookup.
3. In the Search String field, type a drug name. You can use the % sign as a
wildcard character to match zero or more characters in that position. This field is
not case-sensitive; for example, if you enter F%IC ACID, both Folinic acid and
Folic acid match even though they use mixed case.
4. Click Search.
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View results tables
The first 100 drug names (in either the GENERIC_NAME or TRADE_NAME
column) that start with, end with, or include the text string are listed.
5. To sort the results by generic or trade name, click the column name.
6. To dismiss the dialog box, click Cancel.
View results tables

• View a data mining results table
• Data mining results for MGPS runs
• Data mining results for logistic regression runs
• Find and select a data mining run
• Precision of displayed values in data mining results
• Create a case series from a results table
View a data mining results table

Mining Results.
click Close.
3. Specify the selection criteria by completing steps 3 through 5 on Load the run and
select variables.
4. Click View Results Table.
One row appears in the table for each combination identified during data mining.
The results of the statistical computations performed for the combination are
shown in columns of the table. The data displayed differs for MGPS runs and
logistic regression runs.
5. Perform additional activities on the results table.
• To display a description of the column, rest the cursor on any column heading.
• To drill down to a listing of cases for a row, either click the Row Action menu
( ) or click the link in the N column and then click View Cases.
• To change your selection criteria and view a different set of results, click
Select Criteria. Follow steps 3 through 5 described in Load the run and select
variables.
• To view a graphical representation of the results, click Choose Graph and
choose a graph type. You can view data mining run results graphically
for logistic regression runs and for two- or three-dimensional drug-event
combinations in MGPS runs.
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View results tables
• To create a case series containing all cases for which there are rows in the
displayed table, click Add to Case Series. This option is available when the
results table contains 20 or fewer rows.
• To show information about the data mining run, click Show Notes. The notes
appear below the results table, and are included if you print or download table
data. Click Hide Notes to remove the notes.
• To view scores calculated for covariate(s) (if defined for a logistic regression
run), click View Covariates. A table of covariate results appears in a separate
window. See Data mining results for logistic regression runs.
Note:
Only the drug and event values specified as data mining results
criteria are used to define the results that appear in the Covariates
Table. Other criteria, such as a Limit to value, do not apply to this
table.
• To view interaction scores, click View Interactions. A table of interaction

scores appears in a separate window. Interaction scores are calculated for
logistic regression runs, or MGPS runs that include RGPS computations, if you
enabled interaction computations when you created the runs. See Data mining
results for logistic regression runs or Data mining results for MGPS runs.
Note:
Only the drug and event values specified as data mining results
criteria are used to define the results that appear in the Interactions
Table. Other criteria, such as a Limit to value, do not apply to this
table.
• To save the results as an attachment to a topic, click Save to Topic (available

if the topics feature has been set up).
• To print the table, click Print, view the print preview, specify the print options
and setting, then click Print.
• To download the table, click Download, specify the download parameters, and
click OK.
Data mining results for MGPS runs

The following sections describe the results of MGPS runs.
Note:
Hover over a column heading to display a description of the column.
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View results tables
Results table
Column Description
<variable-name> Each variable on which data mining was
performed. Typically, there is a drug variable
and an event variable.
If the run used drug or event hierarchies,
Oracle Empirica Signal adds a column for
each hierarchy level above the term for which
data mining was performed to the results
table. The primary path in the hierarchy is
represented in these columns. For example,
if the event variable is PT, the results include
HLT, HLGT, and SOC columns showing the
primary path of the PT.
When you display results for more than two
dimensions, the application identifies columns
for variables of the same type by adding
a numeric suffix to the column name. For
example, when you display results for the
pattern D+E+E, you see:
PT1 HLT1 HLGT1 SOC1 PT2 HLT2 HLGT2
SOC2
Note:
For runs with
three
dimensions,
these columns
cannot be used
to sort the results
table. The actual
column names in
the underlying
table are not the
same as the
labels for fields
on the Select
Criteria page or
as column
headers in the
results table. The
actual column
names are
ITEM1, ITEM2,
and so on.
DIM Dimension. The number of items combined.
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View results tables
Column Description
E The expected number of cases with the
combination. For a 2-dimensional (2D) run,
computed as:
(Observed # cases with ITEM1/Total # cases )
x (Observed # cases with ITEM2/Total #
cases) x Total # cases
For a stratified MGPS run, calculated as total
of expected values for all the strata, where the
expected number of cases for each stratum is
computed as:
(Observed # cases with ITEM1 for stratum/
Total # cases for stratum) x (Observed #
cases with ITEM2 for stratum/Total # cases for
stratum) x Total # cases for stratum
Overall Expected = Total of Expected values
for all strata
When E < .001, displays in scientific notation.
For a 3-dimensional (3D) MGPS run, the
calculations include ITEM3. For 3D runs,
the calculation of E depends on the mix of
item types in the set of items. If the set
of items includes at least two different types
and also includes at least two items of the
same type (such as D+D+E), then E is the
result of MGPS interaction calculations. In
this model, E incorporates observed within-
item-type associations, and uses only the
assumption of cross-item-type independence
in the computation of E.
EB05 There is approximately a 5% probability that
the true Relative Ratio lies below this value.
EB95 There is approximately a 5% probability that
the true Relative Ratio lies above this value.
The interval from EB05 to EB95 is the 90%
confidence interval.
EBGM Empirical Bayesian Geometric Mean. A more
stable estimate than RR. This so-called
shrinkage estimate is computed as the
geometric mean of the posterior distribution of
the true Relative Ratio.
EBMAX Applies to runs with more than 2 dimensions.
For each 3D itemset, EBMAX is the largest 2D
EBGM among all included cross-item-type 2D
combinations. If the itemset is homogeneous,
so that there are no included cross-item-type
combinations, EBMAX is the largest EBGM
among all the included 2D combinations. The
2D combination for which EBGM = EBMAX
is specified by the columns MAXITEM1 and
MAXITEM2.
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View results tables
Column Description
ERAM For runs that include RGPS computations,
the Empirical-Bayes Regression-adjusted
Arithmetic Mean. This estimate is computed as
the shrunken observed-to-expected reporting
ratio adjusted for covariates and concomitant
drugs.
ER05 There is approximately a 5% probability that
the ERAM lies below this value.
The interval from ER05 to ER95 is the 90%
ER95 There is approximately a 5% probability that
the ERAM lies above this value.
The interval from ER05 to ER95 is the 90%
EXCESS A conservative estimate of how many extra
cases were observed above what was
expected. Computed as:
(EB05 - 1) x E
EXCESS2 Applies only to runs with more than 2
dimensions. A conservative estimate of how
many extra cases were observed over what
was expected assuming that only a single
cross-item interaction is present. Computed
as:
E x EB95MAX * (INTSS - 1) = E * (EB05 -
EB95MAX)
where EB95MAX is the largest 2D
EB95 among all included cross-item-type
combinations.
F Applies only to runs created by Oracle, with
the advanced parameter, Do comparative
analysis, selected.
IC For runs that include Information Component
computations, the IC value:
IC = log 2 ((O + α 1 ) / (E + α 2 ))
where:
• α 1 = α 2 = 1/2
• O is the observed count.
• E is the expected count.
IC025 There is approximately a 2.5% probability that
the IC lies below this value.
The interval from IC025 to IC975 is the 95%
IC975 There is approximately a 2.5% probability that
the IC lies above this value.
The interval from IC025 to IC975 is the 95%
ID Identifies the unique row number assigned as
Oracle loads data from the run's output files.
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View results tables
Column Description
INTSS Interaction Signal Score. Applies only to 3D
runs. Essentially, this is a way of measuring
of the strength of a higher-order association
above and beyond what would be expected
from any of the component pairs of items of
different types. Computed as:
EB05 / EB95MAX
where EB95MAX is the largest 2D EB95
among component pairs of items of different
types.
JOB_ID The identifier assigned by the listener to the
sub-job in the run.
MAXITEM1 First item determining the 2D combination for
which EBGM = EBMAX.
MAXITEM1P Prefix, if any, assigned to the variable
MAXITEM1.
MAXITEM2 Second item determining the 2D combination
for which EBGM = EBMAX.
MAXITEM2P Prefix, if any, assigned to the variable
MAXITEM2.
combination of items. You can click the value
of N to display a menu from which you can drill
down to view or download case information or
run reports. (The same options are available
when you click the Row Action menu icon
( ) for the row.)

P_ <variable-name> Prefix, if any, assigned to the variable in
the data configuration on which the run is
based. The alphabetical ordering of prefixes
determines which of the underlying ITEM
column names is used for each of the item
variables in the results table. For example, if
the prefix for the drug variable is D and the
prefix for the event variable is E, values for
the drug variable appear in the ITEM1 column
and values for the event variable in the ITEM2
column.
P_VALUE For runs that include the calculation of PRR,
the probability that chi-square is as large as
or larger than the value in the PRR_CHISQ
column by chance alone if there is no causal
relationship or consistent association between
the drug and the event. Small values display in
scientific notation.
PRR For runs that include the calculation of
PRR, the Proportional Reporting Ratio for the
combination of a particular drug and particular
event.
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Column Description
PRR_A For runs that include the calculation of PRR,
the observed count for the combination of a
particular drug and particular event. This can
be the number of combinations or number of
cases, depending on the PRR options used in
the run.
PRR_B For runs that include the calculation of PRR,
particular event and all other drugs. This can
the run.
PRR_C For runs that include the calculation of PRR,
particular drug and all other events. This can
the run.
PRR_D For runs that include the calculation of PRR,
the observed count for the combination of all
other drugs and all other events. This can
the run.
PRR_CHISQ For runs that include the calculation of PRR,
the chi-square of PRR. For more information,
see PRR computations.
Q Intermediate computation in the calculation of
EBGM. Defined as the posterior probability
that the combination is in component 1 of
the mixture prior distribution estimated by the
Empirical Bayes algorithm.
ROR05 For runs that include the calculation of ROR,
the lower 5% confidence limit for ROR.
ROR95 For runs that include the calculation of ROR,
the upper 5% confidence limit for ROR.
The interval from ROR05 to ROR95 is the 90%
ROR For runs that include the calculation of ROR,
the Reporting Odds Ratio. Computed as:
ROR = (PRR_A * PRR_D) / (PRR_B *
PRR_C)
With stratification, ROR is computed as a
weighted average of the ROR within each
stratum. For more information, see ROR
computations.
ROW_NUM Identifies the row number assigned in one of
the output files. The value in this column may
not be unique in the results table for a given
run.
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Column Description
RR Relative Ratio. (The same as N/E.) Observed
number of cases with the combination
divided by the expected number of cases
with the combination. This is a sampling
estimate of the true Relative Ratio (that
would be observed if the database were
much larger, but drawn from the same
conceptual population of reports) for the
particular combination of drug and event. RR
is computed as:
Observed # cases with ITEM1+ITEM2 pair /
Expected # cases with ITEM1+ITEM2 pair
For a stratified MGPS run, RR is computed as:
Observed # cases with ITEM1+ITEM2 pair
for all strata / Final Expected # cases with
ITEM1+ITEM2 pair
For a 3D MGPS run, the computations include
ITEM3.
SUBSET If an MGPS run includes a subset variable
to categorize (subset) results, displays the
label for the subset that applies to each
combination.
Data in the following columns (ending in _IND) are computed using the MGPS
independence model and are provided to support runs completed in versions of the
Oracle Empirica Signal application prior to version 5.0:
Column Description
E_IND The expected number of cases with the
combination, as calculated by the MGPS
independence model. Computed as:
(Observed # cases with ITEM1/Total # cases )
x (Observed # cases with ITEM2/Total #
cases) x Total # cases
For a stratified MGPS run, calculated as total
of expected values for all the strata, where the
expected number of cases for each stratum is
computed as:
(Observed # cases with ITEM1 for stratum/
Total # cases for stratum) x (Observed #
cases with ITEM2 for stratum/Total # cases for
stratum) x Total # cases for stratum
Overall Expected = Total of Expected values
for all strata
When E_IND < .001, displays in scientific
notation.
For a 3D MGPS run, the calculations include
ITEM3.
E2D_DIV_E_IND Ratio computed as: E2D_IND/E_IND
E2D_DIV_F_IND Ratio computed as: E2D_IND/F
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Column Description
E2D_IND The expected count based on the all-2-factor
log linear model.
EB05_IND A value such that there is approximately a
5% probability that the true Relative Ratio lies
below it, where Relative Ratio is defined by the
MGPS independence model.
EB95_IND A value such that there is approximately a
5% probability that the true Relative Ratio lies
above it, where Relative Ratio is defined by the
MGPS independence model.
The interval from EB05_IND to EB95_IND
may be considered to be the 90% confidence
interval.
EBGM_IND Empirical Bayesian Geometric Mean, as
computed by the MGPS independence model.
A more stable estimate than RR; the so-called
shrinkage estimate.
EBGMDIF_IND Applies to 3D runs. Essentially, this is a
way of measuring of the strength of a higher-
order association above and beyond what
would be expected from previously computed
component two-factor associations. Computed
by the MGPS independence model as:
EBGM_IND - E2D_IND/E_IND
EXCESS_IND A conservative estimate of how many
extra cases were observed above what
was expected. Computed by the MGPS
independence model as:
(EB05_IND - 1) x E_IND
EXCESS2_IND Applies to 3D runs. An estimate of how
many extra cases were observed over what
was expected using the all-2-factor model.
Computed by the MGPS independence model
as:
(EBGM_IND x E_IND) E2D_IND
where E2D_IND is the expected count based
on the all-2-factor log linear model.
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Column Description
RR_IND Relative Ratio computed by the MGPS
independence model. (The same as N/
E_IND.) Observed number of cases with
the combination divided by the expected
number of cases with the combination. This
may be viewed as a sampling estimate of
the true value of observed/expected for the
particular combination of drug and event. RR
is computed as:
Observed # cases with ITEM+-ITEM2 pair /
Expected # cases with ITEM1+ITEM2 pair
For a stratified MGPS run, RR is computed as:
Observed # cases with ITEM1+ITEM2 pair for
all strata / Final Expected # cases with ITEM1-
ITEM2 pair
For a 3D MGPS run, the computations include
ITEM3.
Interactions table
Note:
Interaction estimates are calculated for a pair of drugs only if for both drugs
the number of drug+event reports exceeds the minimum interaction count for
the run.
Only drugs and events that you select as criteria appear in the table of interaction
results.
To include only interaction scores that exceed a minimum threshold in the table:
1. In the View Interactions pop-up window, click Columns and Rows.
2. In the Limit to field, select a statistic and type a minimum value for the statistic.
By default, this limit is set to N12 > 0.0.
Note:
To include reports in which Item1 and Item2 did not occur with the Event, you
can set the limit to a negative number such as -1.0.
If you enable the Include SQL WHERE Clause for Advanced Results Selection
user preference, you can specify a SQL WHERE clause to limit the results.
Column Description
Item1 Value of the first predictor in the interaction, for example,
Influenza Vaccine.
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Column Description
Item2 Value of the second predictor in the interaction, for
example, Anthrax Vaccine.
Event Response associated with the interaction, for example,
Back Pain.
ERAM1 RGPS logistic regression odds ratio for Item1. This
value is an exponential function of the logistic regression
coefficient.
ERAM2 RGPS logistic regression odds ratio for Item1. This
value is an exponential function of the logistic regression
coefficient.
NREPORTS12 Observed number of cases reporting Item1 and Item2.
N12 Observed number of cases reporting Item1, Item2, and
Event.
E12 Expected value of N12 under the null hypothesis that
both Item1 and Item2 have no relative ratio reporting
effect.
This value is adjusted for covariates and concomitant
drugs using the RGPS prediction formula.
When E < .001, the value displays in scientific notation.
INTRR Ratio of observed (N12) to expected (E12) reports
adjusted for the larger of the disproportionality scores
for Item1 and Item2:
N12/(E12*max(ERAM1,ERAM2))
INTEB Signal score that indicates the strength of the interaction
between Item1 and Item2. This value is a shrunken
INTRR value.
INT05 Lower 5% confidence limit for INTEB.
INT95 Upper 95% confidence limit for INTEB.
Data mining results for logistic regression runs

The following columns are available for inclusion in the results table for a logistic
regression run.
By default, a limited set of columns is included in each of these tables. To include more
columns in the results table, click Columns above the table and, optionally, check
Show All Columns.
Note:
Hover over a column heading to display a description of the column.
Results Table
The following columns are available for inclusion in the results table for a logistic
regression run. For information on the columns available for an MGPS run, see Data
mining results for MGPS runs or Logistic regression computations.
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Column Description
<predictor variable> Logistic regression runs include a drug
variable (the predictor) and an event variable
(the response). The results table includes
a column with the name of each variable
selected for the run; for example, Single
Ingredient and PT.
<response variable> Logistic regression runs can also include
covariate variables as predictors. If the run
includes covariates, click View Covariates to
review results for each covariate-event pair.
combination of items. You can click the value
of N to display a menu from which you can drill
down to view or download case information or
run reports.
Note:
On the
Covariates table,
the value of N is
not hyperlinked.
E The expected number of cases with the

combination, computed as:
(Observed # cases with predictor/Total #
cases ) x (Observed # cases with response/
Total # cases) x Total # cases
When E < .001, displays in scientific notation.
RR Relative Ratio. Observed number of cases
with the combination divided by the expected
number of cases with the combination.
(The same as N/E.) This is a sampling
estimate of the true Relative Ratio (that would
be observed if the database were much
larger, but drawn from the same conceptual
population of reports) for the particular
combination of predictor and response and
ignoring the LR adjustments for covariates and
other drugs.
LROR Logistic Regression Odds Ratio. Estimated
odds ratio relating occurrence of response to
occurrence of predictor, adjusting for other
predictors.
LR05 Lower 5% confidence limit for the logistic
regression odds ratio.
LR95 Upper 95% confidence limit for the logistic
regression odds ratio.
The interval from LR05 to LR95 is the 90%
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Column Description
JOB_ID The identifier assigned by the listener to the
sub-job in the run.
ID Identifies the unique row number assigned as
Oracle loads data from the run's output files.
ROW_NUM Identifies the row number assigned in one of
the run's output files. The value in this column
does not have to be unique in the results table
for a given run.
Covariates Table
For logistic regression runs that include computations for covariates, such as gender,
age group, or report receipt year, you can view a results table for each covariate-event
combination. The rows in this table reflect the scores calculated for each event and
each possible value for the covariates of the run, with the exception of the value
that occurs most frequently. (The value that occurs most frequently for each covariate
is used as the standard for the odds ratio calculated for each of the other values.)
For example, if you use Seriousness as a covariate and Seriousness has the unique
values YES and NO, with NO occurring most frequently, this table only includes rows
for YES in combination with each event.
Note:
Only the event values specified as results criteria apply to the table of
covariate results.
In addition to the columns shown in the results table, the following additional columns
are available in the table of covariate results:
Column Description
P_ITEM The name of the selected covariate variable, such as
Gender or Seriousness.
ITEM The value of the covariate, such as M, F, or U for a
covariate of Gender, or YES or NO for a covariate of
Seriousness.
Interactions Table
For logistic regression runs that include the computation of interactions, you can
view a results table of scores calculated for each predictor+predictor+response
(drug+drug+event, drug+covariate+event, or covariate+covariate+event).
Only the drug(s) and event(s) that you selected as criteria are included in the table of
interaction results. To include only scores that exceed a minimum threshold value in
this table, click the Columns and Rows link above the table and use the Limit to field
to select a statistic and supply that minimum number. By default, this limit is set to N >
0.0: to include rows in this table for reports in which the Item1 value and Item2 value
did not occur with the event value, you must change this limit to a negative number
such as N > -1.0.
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If your user preference, Include SQL WHERE Clause for Advanced Results
Selection, is checked, you can also specify a SQL WHERE clause. For example, to
view only rows that have a certain drug name as a value for either the first or second
predictor, enter a SQL WHERE clause of ITEM1='<drug name>' OR ITEM2='<drug
name>'.
The following columns are available in the table of interaction results:
Column Description
P_ITEM1 For the value that appears in the ITEM1 column, either
provides the name of the covariate variable or the
configuration prefix for drug (D).
ITEM1 The value of the first predictor in the interaction. This
value can be a covariate (if the run included one or more
covariates) or a drug.
P_ITEM2 For the value that appears in the ITEM2 column,
provides the configuration prefix for drug (D) or the
name of the covariate variable.
ITEM2 The value of the second predictor in the interaction. This
value can be a drug or a covariate (if the run included
multiple covariates).
<response variable name> Event (response) variable selected for the run, such as
PT.
N Observed number of cases with the combination of all
three values (ITEM1, ITEM2, response). You can click
the value of N to display a menu from which you can
drill down to view or download case information or run
reports.
N_TOT Observed number of cases in the data that have both
ITEM1 and ITEM2.
To specify a SQL WHERE clause that includes this
column, use the underlying column name of INTSS.
E The predicted value of N based on LR without
interactions: the sum, over all N_TOT reports that have
both ITEM1 and ITEM2, of the predicted probability of
the response using the LR prediction formula.
When E < .001, the value displays in scientific notation.
INT_LOF Empirical Bayes shrinkage estimate of additional
interaction due to lack of fit to the LR model, based on
the ratio N/E.
column, use the underlying column name of EXCESS2.
INT_REGR Predicted ratio of probability of the response given both
ITEMs, divided by probability given worst ITEM, if LR
model is correct.
column, use the underlying column name of EXCESS.
INT_TOT Total interaction, computed as INT_REGR * INT_LOF.
column, use the underlying column name of LROR.
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Column Description
INT05 Lower 5% confidence limit for INT_TOT.
column, use the underlying column name of LR05.
INT95 Upper 95% confidence limit for INT_TOT.
column, use the underlying column name of LR95.
LROR1 Logistic regression odds ratio relating the response
event to ITEM1.
column, use the underlying column name of PRR_A.
LROR2 Logistic regression odds ratio relating the response
event to ITEM2.
column, use the underlying column name of PRR_B.
JOB_ID The identifier assigned by the listener to the sub-job in
the run.
ID Identifies the unique row number assigned as Oracle
loads data from the output files of the run.
ROW_NUM Identifies the row number assigned in one of the output
files of the run. The value in this column may not be
unique in the results table for a given run.
Find and select a data mining run

You can use various run characteristics to easily locate a run.
Mining Results.
3. On the Select Criteria page, click Browse.
4. From the drop-down lists in the 1. Choose Characteristics section, specify the
characteristics of the runs to select. Select -- to include all runs.
Run Characteristic Description

Database Group Database group containing the data
configuration that was used for the run.
Data As Of Run As Of date. If blank, the run is not for
timestamped data and has no As Of date.
Event Variable Event variable used by the run.
Drug Variable Drug variable used by the run.
Concomitant Drugs Select Exclude for runs based on a data
configuration that is set up to exclude
concomitant drugs. Select Include for runs
based on a data configuration that is set up
to include concomitant drugs, such as an
AERS (S + C) configuration.
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Run Characteristic Description

Dimension For an MGPS run, the highest dimension
specified for the run when the run was
created.
For an LR run, select 2 for runs that did not
compute interactions and 3 for runs that did
compute interactions.
DB Restriction If a database restriction was used for the
run, select Yes. If no database restriction
was used for the run, select No.
Subset Variable Subset variable used for the MGPS run. A
run can have only one subset variable. If
blank, no subset variable was used for the
run.
Subset Type If cumulative subsetting was used for
the MGPS run, select Cumulative. If non-
cumulative (discrete) subsetting was used
for the run, select Non-cumulative. If no
subsetting was used for the run, the drop-
down list is blank.
Strata Variables Stratification variable used for the MGPS
run. The same run can have multiple
stratification variables. If blank, no
stratification variable was used for the run.
Min Count For an MGPS run, the minimum count
specified for the run.
For an LR run, the minimum number of
times a drug must occur in combination with
a specified event to be included in the run.
run.
Project Name of the project for which the run was
created.
Run Type MGPS for an MGPS run; LR for a logistic
regression run.
For example, to work with an MGPS run that uses Gender for stratification, choose
MGPS as the run type and Gender as the stratification variable. Only runs that
have both those characteristics appear in the table.
Note:
If there are no existing runs with a certain characteristic, you cannot
choose that characteristic. For example, if there are no logistic
regression runs, LR is not available for Run Type.
5. In the 2. Select Run section:
• To view a description of a run, click the Row Action ( ), and then click View
Run Details.
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• To choose a run, click the Row Action menu ( ), and then click Select.
6. Click Reset if you want to reset all criteria to -- (All).
7. To change the way columns display in this table, or for information on finding text,
printing, or downloading, see About tables.
Precision of displayed values in data mining results

This topic covers the precision with which various computed numeric columns in the
data mining results table appear. There are three types of computed numeric columns
to consider: relative reporting ratio measures, expected values, and probability values.
Note:
The full precision of numeric values is present in the underlying database.
Relative reporting ratio measures

• Numeric values with an absolute value > 10 have one digit to the right of the
decimal point.
• Numeric values between 1 and 10 have two digits to the right of the decimal point.
• Numeric values less than 1 appear as 0.xxx with three digits after the decimal.
• Scientific notation is not used.
• MGPS columns of this type: EB05, EB95, EBGM, ER05, ER95, ERAM, INTSS,
PRR, ROR05, ROR95, ROR, RR, EBMAX, RR_IND, EB05_IND, EB95_IND,
EBGM_IND, EBGMDIF_IND, E2D_DIV_E_IND, E2D_DIV_F_IND.
• Logistic regression columns of this type: RR, LROR, LR05, LR95 in the tables
for Results and Covariates, INT_REGR, INT_LOF, INT_TOT, INT05, INT95 in the
Interactions table
Expected values
• Numeric values with an absolute value > 10 have one digit to the right of the
decimal point.
• Numeric values between 1 and 10 have two digits to the right of the decimal point.
• Numeric values between .01 and 1 appear as 0.xxx with three digits after the
decimal.
• Numeric values less than .01 are expressed as scientific notation with four
significant figures.
• Columns of this type: E, F, EXCESS, EXCESS2, PRR_CHISQ, E_IND,
EXCESS_IND, EXCESS2_IND, E2D_IND.
Probability values
• Numeric values between .001 and 1 are displayed as 0.xxxx with four digits after
the decimal.
• Numeric values less than .001 are expressed as scientific notation with four
significant figures.
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• (In the event that a value is 1 or greater, it will display with two digits to the right of
the decimal point.)
• Columns of this type: P_VALUE, Q.
Create a case series from a results table

If a results table has 20 or fewer rows, you can create a new case series containing
the case IDs of cases represented. You can also add the case IDs to an existing case
series that was created from results of the same data mining run.
If you create a case series from the results of a data mining run for timestamped data,
the case series has the same As Of date as the data mining run.
Mining Results.
click Close.
select variables.
4. Click View Results Table.
5. On the Results Table page, click Add to Case Series.
• If there are more than 20 rows in the results table, an error message appears.
Click Continue and change your selection criteria to restrict results to 20 or
fewer rows.
• If there are existing case series created from results of the same data mining
run, the Add Cases from Selected Results page appears.
• Click Select for a case series. The cases are added to the selected case
series.
• If there are no existing case series created from result of the same run, you
click New Case Series, and the Create Case Series page appears.
7. In the Name field, type a name for the case series. The name does not need to be
The name of the run appears by default in the Description field as the description
of the case series. Edit the description as necessary.
• To add the case series to an existing project, click Add to existing project
and select the project from the drop-down list.
• To add the case series to a new project, click Add to new project named and
type the name of the project.
9. Click Create.
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View results graphs

• View a data mining graph
• Work with results graphs
• Set graph cutpoints and palette choices
• Graphs for 2D results
View a data mining graph

Mining Results.
click Close.
select variables.
Specify at least one drug term or one event term. For graphs to be available, you
can specify no more than 200 drug terms or 200 event terms.
• The limit of 200 is based on terms that are actually in the results.
• The limit of 200 is the number of terms remaining after applying restrictions on
the Select Criteria page. For example, if you specify 300 PTs and EBGM > 5,
and there are fewer than 200 drug-event combinations for which EBGM > 5,
graphs are available.
• You can display a sector map only if you specify no more than 5 drugs (that
are actually in the results). The limit of 5 applies regardless of restrictions on
the Select Criteria page.
• For MGPS runs, if you select the terms at a higher level in the hierarchy than
the level at which data mining was performed (for example, you specify an
HLGT and data mining was performed on PTs), typically the run includes more
than 200 PTs.
4. Click Choose Graph.
5. From the Associations selected for graphing, select the graph to generate:
• Review a drug and its associations with other items (drugs or events)—
These graphs focus on a particular drug or drugs that you specified on the
Select Criteria page. For example, suppose that you are interested in all the
events associated with DrugA. You select DrugA on the Select Criteria page
and then choose a graph to review results for the events associated with
DrugA.
• Review an event and its associations with other items (drugs or events)
—These graphs focus on a particular event or events that you specified on
the Select Criteria page. For example, suppose that you are interested in all
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the drugs associated with Event1. You select Event1 on the Select Criteria
page and then choose a graph to review results for the drugs associated with
Event1.
Note:
If you are viewing results of a three-dimensional run and you specify 2 as
the dimension (on the Select Criteria page ), you can view graphs for the
two-dimensional combinations in the results.
6. If you want to modify the graph key (for all graphs), click Set Graph Cutpoint
and Palette Choices, make your choices, and click Save to return to the Choose
Graph page.
7. Choose a graph type and click its link.
8. Specify graph display options and click Display. For information about setting
display options, see the descriptions of each graph:
• Bar graphs
• Confidence interval graphs
• Nested confidence interval graphs
• Discrete map graphs
• Cumulative map graphs
• Hierarchy graphs
• Overlap graphs
• Sector maps
The graphs appear on the right side of the page or in a popup window.
Work with results graphs

Mining Results.
2. On the Select Criteria page, choose the run. Your Default Run user preference
determines which run is selected by default.
3. To view all available runs, click Browse.
4. To see the details of the run, click View Run Details, examine the details, then
click Close.
select variables.
7. From the Associations selected for graphing, select the graph to generate and
select options from the list below.
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Option Check to
Popup Display each graph in an individual window.
If you have popup blocking software installed
on your PC, it may prevent these windows
from opening. You may want to disable your
popup blocking software.
Key Display a color key below the graph to show
which value each graph element (such as a
bar or region of the graph) represents. You
can modify the graph key as needed.
Notes Display notes about the graph.
• For some graphs, information about
what a graph component (such as
a bar, cell, or region) represents,
or statistics for the component, that
appears when you point to that
component.
• A menu that allows you to drill down
when you click a graph component.
• Print link.
• Copy to Clipboard link (with Internet
Explorer, only).
• Save to Topic link (if Topics has been
configured to offer this feature).
• For some graphs, links to download
graph data.
8. Click Display.
Set graph cutpoints and palette choices

The graph cutpoints define the ranges of values associated with different colors in
the graph. The graph palette is the spectrum of colors used for graphs based on the
results of data mining runs (including charts on the Drug Profile page) during your
current session.
You can set a default palette as your user preference, Graph color palette.
Note:
Neither cutpoints nor color settings have any effect on the sector map graph,
graphs that are based on report data, or graphs on the Oracle Empirica
Signal Review Products and Product-Event Combination pages.
Mining Results.
2. On the Select Criteria page, choose the run. Your Default Run user preference
determines which run is selected by default.
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click Close.
select variables.
5. Click Set Graph Cutpoint and Palette Choices.
6. To change the cutpoints or minimum/maximum limits for a particular score range,
enter an integer or floating point number in each of the range fields for a score
such as EBGM, ERAM, PRR, or INTSS. For example:
If you are unsure about the meaning of a score, see Data mining results for MGPS
runs or Data mining results for logistic regression runs.
7. To change the color palette, click one of the following radio buttons:
Your choices result in ranges with corresponding color gradations, as in the

following example that uses the Autumn palette:
8. Click Save.
Changes to the cutpoints and palette take effect immediately and apply to all graphs
for your current session. The next time you log in, the cutpoints are reset to defaults
and the palette is reset according to your user preference Graph color palette.
Graphs for 2D results

• View a bar graph
• Bar graphs
• View a confidence interval graph
• Confidence interval graphs
• View a discrete map graph
• Discrete map graphs
• View a cumulative map graph
• Cumulative map graphs
• View a sector map
• Sector maps
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For two-dimensional results (for example, Drug+Event), the graph types are described
in the following table. The graph types are available for MGPS runs. Some are
available for logistic regression runs.
Graph Description
Bar graph Available for MGPS and logistic regression run results. A
horizontal bar graph with one bar for each combination.
Use this graph type to plot EBGM, PRR, ROR, ERAM,
and LROR scores.
Note:
If the run includes
subsetting, the graph label
includes (for a Single
Subset).
• If looking for link name EBGM, use run type MGPS.

• If looking for link name PRR, use run type MGPS
with PRR.
• If looking for link name ROR, use run type MGPS
with ROR
• If looking for link name ERAM, use run type MGPS
with RGPS.
• If looking for link name LROR, use run type Logistic
regression.
Confidence interval bar graph Available for MGPS and logistic regression run results.
A horizontal bar graph with one bar for each
combination, showing confidence intervals based on
the EB05-EBGM-EB95, ROR05-ROR-ROR95, ER05-
ERAM-ER95, or LR05-LROR-LR95 values. Suitable for
studying scores and related confidence intervals.
Note:
If the run includes
subsetting, the graph label
Subset).
• If looking for link name EB05-EBGM-EB95, use run

type MGPS.
• If looking for link name ROR05-ROR-ROR95, use
run type MGPS with ROR.
• If looking for link name ER05-ERAM-ER95, use run
type MGPS with RGPS.
• If looking for link name LR05-LROR-LR95, use run
type Logistic regression.
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Graph Description
Discrete map graph Available for results of MGPS runs that use discrete
(non-cumulative) subsets. A map graph (discrete)
displays a colored grid showing combinations of items
(drugs or events) with a drug or event, where each
column of the grid reflects the data in a different subset.
The subsets were defined as non-cumulative (discrete)
in the data mining run.
This graph is suitable for comparing strength of
association between different subsets. For example,
to compare scores for the individual years of 1998,
1999, and 2000, or for the genders Female, Male, and
Unknown.
Link name: Map Graph showing Multiple Discrete
Subsets.
Cumulative map graph Available for results of MGPS run results that use
cumulative subsets. A map graph (cumulative) displays
a colored grid showing combinations of items (drugs or
events) with a drug or event, where each column of the
grid reflects the data in a subset. The subsets were
defined as cumulative in the data mining run.
This graph is suitable for studying the change in
association strength over time. For example, to observe
scores for 1998, 1998 through 1999, and 1998 through
2000.
Link name: Map Graph showing Cumulative Subsets.
Sector map graph Available for MGPS runs that include PT as an item
variable and for which you have selected drugs to view
results. A sector map graph for data mining results is a
visual presentation of data for a particular drug across
all System Organ Classes (SOCs). Sector map graphs
are available if you select up to five drugs on the Specify
Criteria page. The application ignores event selections
for the sector map graph.
Link name: Sector Map for Specified Drugs(s) and All
Events.
Note:
If the run includes
subsetting, the link name
Subset).
View a bar graph

Mining Runs.
2. Choose one of the following: To open the Select Criteria page either:
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• Click the Row Action menu ( ) for the run, and then click View Results.
• Hover on the Data Analysis icon ( ), in the left navigation pane then click
Data Mining Results.
The Select Criteria page appears
3. From the Run name drop-down list, select the run you want to view. (Your user
preference, Default Run, determines which run, if any, is selected by default.) You
can also click Browse next to the Run name field to find and select a run.
4. Type at least one drug or event.
6. Select a bar graph.
7. On the Bar Graph page, specify restrictions, these are applied in addition to any
restrictions that you specified on the Select Criteria page:
Restriction Description
N at least Display only combinations with an observed
count (N) of at least the specified number.
At most ____ associations Display no more than the specified number
of combinations. You can display up to 200
combinations. If combinations are excluded
because of this limit, a message appears
below the graph.
<score> at least Display only combinations with a score
(EBGM, ERAM, PRR, ROR, or LROR) of at
least the specified number.
<score> at least Display only combinations with a lower
confidence limit (EB05, ER05, ROR05,
LR05) of at least the specified number.
Subset Available only if you selected All on the
Select Criteria page. The available subsets
are all those selected during run creation.
Bar graphs show data for only one subset.
To view data for all subsets in a single
graph, click View as a Map Graph Showing
Discrete Subsets or View as a Map Graph
Showing Cumulative Subsets below the
graph.
8. Specify the following display options:
Display Option Description

Bar length controlled by: Indicate whether you want bars to show in
descending order by:
• N (observed count).
• The score (EBGM, ERAM, LROR, PRR,
or ROR).
• The lower confidence interval score
(EB05, ER05, LR05, ROR05).
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Bar color controlled by: Indicate whether bar color should be
controlled by:
• EBGM, ERAM, LROR, PRR, or ROR,
as defined by the graph key.
• EB05, ER05, LR05, or ROR05, as
defined by the graph key.
• A single color for all graph bars.
Order by bar length Check to show the bars of the graph in
descending order based on bar length.
Order by item Check to show the bars of the graph in
alphabetical order.
9. Click Display.
The bar graph appears.
10. You can point to a bar of the graph to display statistics for the combination
represented by the bar.
11. Click a bar in the graph to display a menu. If you are displaying multiple graphs on
the same page, do not click any graph until all the graphs appear.
a. To display the cases underlying the bar, click View Cases to drill down to a list
of cases for the bar.
b. To create a case series from the cases comprising the bar, click Create Case
Series.
c. To transfer to a different case series, click Transfer to Case Series.
d. To download the cases from the bar, click Download Cases.
e. To download case details of the bar, click Download Case Details.
f. To run a report about the bar, click Reports.
g. To save the graph as an attachment to a topic, click Save to Topic. (This
option is available if Links is checked and the topics feature has been set up.)
The graph is attached in a PDF file.
See Work with results graphs for information about links below the graph.
Bar graphs
Bar graphs provide a straightforward way to display the items most closely associated
with a specified drug or event, showing the strength of association by plotting each
computed statistical score as the length of a horizontal bar.
A bar graph is available for two-dimensional results of MGPS data mining runs or
logistic regression runs. You can choose a bar graph to display the following scores:
• EBGM, EB05, or N for an MGPS data mining run.
• ERAM, ER05, or N if computed for an MGPS data mining run.
• PRR, if computed for an MGPS data mining run.
• ROR, ROR05, or N, if computed for an MGPS data mining run.
• LROR, LR05, or N for a logistic regression run.
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The graph key indicates the statistical ranges that determine the bar colors. On the
Choose Graph page, you can modify the graph key (specifically, the cutpoints and
colors).
If the Notes check box is checked when you display the graph, a Notes section
provides information about the selection criteria and display options used for the
graph.
The following example is a two-dimensional data mining run, with the drug Aprindine
selected:
View a confidence interval graph

Mining Runs.
2. Perform one of the following:
The Select Criteria page appears.
3. From the Run name drop-down list, select the two-dimensional MGPS or Logistic
Regression run to view. (Your user preference, Default Run, determines which
run, if any, is selected by default.) You can also click Browse next to the Run
name field to find and select a run.
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6. Select a confidence interval graph.
7. On the Confidence Interval Graph page, specify restrictions, which will be applied
in addition to any restrictions that you specified on the Select Criteria page:
below the graph.
(EBGM, ERAM, PRR, ROR, or LROR) of at
confidence limit (EB05, ER05, ROR05,
LR05) of at least the specified number.
Bar graphs show data for only one subset.
To view data for all subsets in a single
graph, click View as a Map Graph Showing
Discrete Subsets or View as a Map Graph
Showing Cumulative Subsets below the
graph.

Bar color controlled by: Check to specify how to control bar color:
• EBGM, ERAM, LROR, or ROR, as
• EB05, ER05, LR05, or ROR05, as
• A different color for each bar in the
graph.
Order by bar length Check to show the bars of the graph in
descending order based on bar length.
Order by item Check to show the bars of the graph in
alphabetical order.
Show N at end of confidence interval Display the value of N at the end of each
confidence interval bar.
9. Click Display.
The confidence interval graph appears.
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Series.
Confidence interval graphs

Confidence interval graphs are similar to bar graphs but also include a confidence
interval or error bar superimposed on each bar to show the 5% and 95% confidence
limits. A confidence interval graph is available for two-dimensional MGPS results and
logistic regression results.
You can choose a confidence interval graph to display the following scores:
• EB05-EBGM-EB95 for an MGPS data mining run.
• ER05-ERAM-ER95 for RGPS computations, if computed in an MGPS data mining
run.
• ROR05-ROR-ROR95 for Reporting Odds Ratio computations, if computed in an
MGPS data mining run.
• LR05-LROR-LR95 for a logistic regression run.
The graph key shows the statistical ranges that determine the bar colors. You can
modify the graph key (specifically, the cutpoints and colors) on the Choose Graph
page.
If the Notes check box is selected when you display the graph, a Notes section
appears, and provides information on the selection criteria and display options used
for the graph.
The following example is for a two-dimensional data mining run, with the Anion gap
abnormal event selected:
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View a discrete map graph

Mining Runs.
• Hover on the Data Analysis icon ( ), in the left navigation page then click
3. From the Run name drop-down list, select the two-dimensional MGPS run that
uses non-cumulative subsets that you want to view. (Your user preference, Default
Run, determines which run, if any, is selected by default.) You can also click
Browse next to the Run name field to find and select a run.
6. Select a discrete map graph.
7. On the Discrete Map Graph page, specify restrictions, which will be applied in
addition to any restrictions that you specified on the Select Criteria page:
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below the graph.
EBGM at least Display only combinations with an EBGM
score of at least the specified number.
EB05 at least Display only combinations with an EB05

Select by and show value of In each cell of the grid, display the numeric
value of N (observed), EBGM, or EB05.
Cells with no occurrences are empty.
Color by Indicates whether the cell color should be
controlled by:
• EBGM, according to the graph cutpoints
and palette.
• EB05, according to the graph cutpoints
and palette.
• No color.
Order by high value in any subset Depending on your selection for Select
by and show value of, orders the
combinations in the graph in descending
order of N, EBGM, or EB05 across all
subsets.
For example, if the graph contains values of
EBGM and has at most six combinations,
order by the high value in any subset.
The application orders combinations in
descending order of EBGM according to the
table that follows this table.
Order by item Sort combinations in the graph in ascending
order of item name across all subsets.
The following table shows how the application orders combinations in descending
order of EBGM.
Combination Subset1 Subset2 Subset3

DrugA-EventA EBGM=2.0 EBGM=3.8 EBGM=1.4
DrugA-EventB EBGM=3.1 EBGM=1.1 NA
DrugA-EventC EBGM=1.5 EBGM=2.6 EBGM=2.8
DrugA-EventD EBGM=2.7 NA EBGM=2.4
DrugA-EventE EBGM=0.5 EBGM=2.5 EBGM=0.8
DrugA-EventF NA EBGM=1.1 EBGM=2.1
9. Click Display.
The discrete map graph appears.
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10. You can point to a cell of the graph to display statistics for the combination
represented by the cell. Long drug or event terms may end in an ellipsis in the
label on the graph itself; in this case, you can point to the cell to see the full terms.
Series.
Discrete map graphs

Discrete map graphs provide a way to compare strength of associations between
specified drugs and events across multiple discrete (non-cumulative) subsets.
A discrete map graph is available for two-dimensional MGPS results of data mining
runs that use non-cumulative subsets. See Subset variables for more information.
Note:
Map graphs show data for multiple subsets. To view data for only a specified
subset, click View as a Bar Graph Showing a Single Subset or View as a
Single-Subset Bar Graph with Confidence Intervals.
The graph key indicates the statistical ranges that determine the cell colors. You can
page.
provides information on the selection criteria and display options used for the graph.
The following example is for a two-dimensional data mining run, with the Tachycardia
event selected:
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View a cumulative map graph

Mining Runs.
3. From the Run name drop-down list, select the two-dimensional MGPS runs with
cumulative subsets run that you want to view. (Your user preference, Default Run,
determines which run, if any, is selected by default.) You can also click Browse
next to the Run name field to find and select a run.
6. Select a cumulative map graph.
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7. On the Map Graph (Cumulative) page, specify restrictions, which will be applied
in addition to any restrictions that you specified on the Select Criteria page:
N at least ____ Display only combinations with an observed
EBGM at least ____ Display only combinations with an EBGM
EB05 at least ____ Display only combinations with an EB05
value of at least the specified number.
below the graph.

Show value of In each cell of the grid, display the numeric value of N (observed), EBGM, or EB05.
You can also select Leave blank to display a grid without labels. Cells with no
occurrences are empty.
Color by Check to specify how to color graph cells:
• EBGM, according to the graph cutpoints and palette.
• EB05, according to the graph cutpoints and palette.
• No color.
Order by first occurrence of Indicates how to order drug-event combinations in the graph, based on descending
order of N, EBGM, or EB05 values. The application applies this ordering to
combinations for the first subset. If the maximum number of combinations is not
reached, the application applies the ordering to combinations for the second subset,
and so on, until the maximum number of combinations is reached. (The maximum
number of combinations is determined by the At most __ associations option.)
For example, the graph shows values of EBGM and has at most six combinations.
You order by the first occurrence of EBGM > 2. The combinations in descending
order of EBGM are illustrated in the table that follows this table.
Application orders combinations in descending order of EBGM
Combination Subset1 Subset2 Subset3

DrugA-EventA EBGM=2.0 EBGM=3.8 EBGM=1.4
DrugA-EventB EBGM=3.1 EBGM=1.1 NA
DrugA-EventC EBGM=1.5 EBGM=2.6 EBGM=2.8
DrugA-EventD EBGM=2.7 NA EBGM=2.4
DrugA-EventE EBGM=0.5 EBGM=2.5 EBGM=0.8
DrugA-EventF NA EBGM=1.1 EBGM=2.1
9. Click Display.
The cumulative map graph appears.
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Series.
Cumulative map graphs

Cumulative map graphs provide a way to compare strength of associations between
specific drugs and events across multiple subsets, which are typically based on
a continuous variable, such as Year. A cumulative map graph is available for two-
dimensional MGPS results of data mining runs that use cumulative subsets.
For more information on subset variables, see Subset variables.
Note:
Map graphs show data for multiple subsets, starting with the first subset for
which results exist. To view data for a specific subset, click View as a Bar
Graph Showing a Single Subset or View as a Single-Subset Bar Graph
with Confidence Intervals.
The graph key shows the statistical ranges that determine the cell colors. You can
page.
provides information on the selection criteria and display options used for the graph.
The following example is for a two-dimensional data mining run, with the Tachycardia
event selected:
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View a sector map

Mining Runs.
2. Perform one of the following: To open the Select Criteria page either:
3. From the Run name drop-down list, select the two-dimensional MGPS run you
want to view. (Your user preference, Default run determines which run, if any, is
selected by default.) You can also click Browse next to the Run name field to Find
and select a data mining run.
4. Type at least one, but no more than five, drug names.
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6. Select a sector map graph.
7. On the Sector Map page, specify the following display options:
Column Description
Color controlled by Name of the statistic whose values will be
ranked and used for coloring the sector map
tiles. Available values are those computed
by the data mining run and include EBGM,
EB05, ERAM, ER05, Chi-statistic (signed),
and PRR.
Term box size controlled by The factor that controls the size of PT tiles:
• Relative importance of term —Bases
the size of PT tiles on an algorithm that
determines the relative public health
impact of PTs. Using a recent version
of AERS data, the application computes
the public health impact for a PT as:
(number of times the PT occurs in
serious cases) * (proportion of cases
with that PT that are serious-or-fatal).
A higher Public Health Impact score
corresponds to a larger tile in the sector
map. Because size is based on the
number of cases of the PT alone (not
the number of cases that have the PT
and a particular drug), the tile size is
stable over sector maps for different
drugs.
Note:
For PTs that are new
in the MedDRA version
associated with the AERS
data used to assess
public health impact, the
application cannot determine
the tile size. The application
represents these PTs as
small tiles.
• All terms have equal size —All PT

tiles have the same size.
Display maximum intensity at signal score of Displays all tiles for which scores are above
__ this value at the maximum-intensity color, as
shown in the color key below the graph.
Use gray-scale instead of colors Use shades of gray instead of colors in the
graph.
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Column Description
Show low scores in green for color graph Check to show low scores in varying shades
of green. Clear to show low scores in black.
Note:
This setting has no effect if you
display the sector map in gray-
scale.
Omit rare terms used fewer than __ times in Number indicating how many times a PT
AERS must be in the AERS database (the same
one used for Relative importance of term)
for that PT to be shown in the sector map.
Note:
The notes for a sector map
indicate any rare terms that
are omitted because of this
restriction.
Group by HLT Within a SOC tile, group in the same

rectangular area the tiles for PTs that are
in the same HLT. If you also group by HLGT,
the tiles for PTs are grouped by HLT within
each HLGT.
Group by HLGT Within a SOC tile, group in the same
rectangular area the tiles for PTs that are in
the same HLGT.
List __ top scores Number indicating how many (up to 1000)
terms with the top scores are ranked and
listed below the sector map. The score is the
statistic selected for Color controlled by.
If multiple terms have the same score, the
application counts each term separately. For
example, you enter 20 as the limit. If the
20th row has a score that other terms after
that also have, the application shows those
additional terms as well.
Show top score indexes If checked, the application numbers tiles in
the sector map to show their rank, up to the
number of scores specified in List __ top
scores. For this option to take effect, there
must also be a value specified for List __ top
scores.
8. Click Display.
9. If you point to a PT tile, the MedDRA PT, HLT, HLGT, and SOC appear. The
following information for the combination of the drug and the term that the tile
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• N—Observed number of cases with drug-event combination.

RR; the so-called shrinkage estimate.
• EB05—A 5% probability value that the true Relative Ratio lies below it.
Note:
The ERAM and ER05 are available only if the data mining run was
set up to compute RGPS.

computations.
statistic is expressed as a negative number, indicating that the drug-event
Note:
The PRR and Chi-statistic are available only if the data mining run
was set up to compute PRR.
from the menu.
11. If you click a tile for which N is at least 1, you can then drill down to a list of cases
for the tile or view statistics for the tile.
12. To save the graph as an attachment to a topic, click Save to Topic. (This option is
available if Links is checked and the topics feature has been set up.) The graph is
attached in a PDF file.
See Work with results graphs for information about links below the graph. For best
results, print the sector map graph in landscape mode.
Sector maps
A sector map for data mining results is a visual presentation of data for a particular
drug across all System Organ Classes (SOCs). A large tile represents each System
Organ Class (SOC) in the sector map. Smaller tiles within each SOC tile represent
Preferred Terms (PTs).
A sector map graph is available for two-dimensional results of MGPS data mining
runs.
The application ranks PTs in descending order of values of the statistic (EBGM, EB05,
Chi-statistic, or PRR) that you choose. A color key indicates relative ranking. You can
also list the ranked PTs below the sector map.
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Note:
The primary path of a PT determines where it appears in the sector map. If a
PT is not in the event hierarchy associated with the configuration, it appears
in a SOC tile named Unknown.
The list of ranked PTs below the sector map includes the following information:
Field Description
Rank Ranking of the term (combined with the drug) according
to values of the statistic you have configured the sector
map to use (via the Color controlled by option).
SOC SOC containing the term.
Term (PT) Specific PT.
EBGM. EB05, Chi-statistic, or PRR Value of the statistic you have configured the sector map
to use (via the Color controlled by option).
If Notes is checked when you display the graph, a Notes section provides information
about the selection criteria and display options used for the graph.
The following example is for a two-dimensional data mining run, with the drug Abacavir
selected on the Select Criteria page:
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• View a hierarchy graph
• Hierarchy graphs
• View an overlap graph
• Overlap graphs
• View a nested confidence interval graph
• Nested confidence interval graphs
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For three-dimensional results (for example, Drug+Drug+Event), the available graph
types are described in the following table. These graph types are available for MGPS
runs only.
Graph Description
Hierarchy graph Columns of colored cells, where the rows
represent 2-way and 3-way combinations. This
graph is suitable for studying multiple-item
combinations such as drug interactions or
syndromes.
The hierarchy graph uses INTSS values.
The independence model hierarchy graph,
which uses EBGMDIF_IND values, is for
compatibility with releases prior to WebVDME
5.0.
Link name: Hierarchy Graph showing
Interaction . . .
Overlap graph A table of colored cells, where the rows
represent 2-way and 3-way combinations.
Same content as hierarchy graph, but
formatted differently.
The overlap graph uses INTSS values.
The independence model overlap graph,
which uses EBGMDIF_IND values, is for
compatibility with releases prior to WebVDME
5.0.
Link name: Overlap Graph showing
Interaction . . .
Nested confidence interval graph Sets of confidence intervals. In each set,
the first confidence interval is for the
3D combination for the specified pattern.
Subsequent confidence intervals in the set are
for 2D combinations. Uses INTSS values.
Link name: Nested Confidence Interval Graph
showing Interaction . . .
View a hierarchy graph

Mining Runs.
3. From the Run name drop-down list, select the three-dimensional run you want to
view. (Your user preference, Default Run, determines which run, if any, is selected
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by default.) You can also click Browse next to the Run name field to find and
select a run.
6. Select a hierarchy graph.
7. On the Hierarchy Graph page, specify restrictions, which will be applied in addition
to any restrictions that you specified on the Select Criteria page.
below the graph.

Show value of Select N or EBGM/INTSS as the statistic to
show in cells. You can also leave cells blank.
For 3D run results, the EBGM score applies
to the two-way combinations, which appear
in the cells in the left column. The INTSS
score applies to the three-way combinations,
which appear in the right column.
Note:
If the data mining run results
do not include items of the
same type (an option during run
creation), statistics do not appear
for items of the same type (such
as a drug+drug or event+event
combination.

• EBGM/INTSS
• No color
9. Click Display.
The hierarchy graph appears.
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Series.
Hierarchy graphs
Hierarchy graphs highlight situations in which there are interaction effects (such as
drug interactions or event syndromes), where the score for an interaction or syndrome
is not predicted by the scores of its components.
The score for an interaction is INTSS, which is calculated as the EB05 score for the
combined drugs or events divided by the highest EB95 score found for an individual
component drug or event. The graph is built within the context provided by the drug
or event specified on the Select Criteria page. A hierarchy graph is available for three-
dimensional results of MGPS data mining runs.
The key below the graph shows the statistical ranges that determine the cell colors.
The ranges are for EBGM and INTSS values. On the Choose Graph page, you can
modify the graph key (that is, the cutpoints and colors).
The following example is for a three-dimensional data mining run, with the drug Tilidine
selected. The scores for the two-way interactions between that drug and a single event
appear in the left column. The scores for three-way interactions, between the drug and
two events, appear in the right column.
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View an overlap graph

Mining Runs.
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3. From the Run name drop-down list, select the three-dimensional run you want to
view. (Your user preference, Default Run, determines which run, if any, is selected
by default.) You can also click Browse next to the Run name field to find and
select a run.
6. Select an overlap graph.
7. On the Overlap Graph page, specify restrictions, which will be applied in addition
to any restrictions that you specified on the Select Criteria page.
below the graph.

Show value of Select N or EBGM/INTSS as the statistic to
show in cells. You can also leave cells blank.
For 3D run results, the EBGM score applies
to the two-way combinations, which appear
in the cells in the left column. The INTSS
score applies to the three-way combinations,
which appear in the remainder of the graph
(in the right column).
Note:
If the data mining run results
do not include items of the
same type (an option during run
creation), statistics do not appear
for items of the same type (such
as a drug+drug or event+event
combinations.

• EBGM/INTSS
• No color
9. Click Display.
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The overlap graph appears.

Series.
Overlap graphs
Overlap graphs highlight situations in which there are interaction effects (such as drug
interactions or event syndromes), where the score for an interaction or syndrome is
not predicted simply by the scores of its components.
The score for the interaction or syndrome is shown as INTSS, which is computed
as the EB05 score for the combined drugs or events divided by the highest EB95
score found for the component drugs or events. The graph is built within the context
provided by the drug or event specified on the Select Criteria page. An overlap graph
is available for three- dimensional results of MGPS data mining runs.
The key below the graph shows the statistical ranges that determine the cell colors.
The ranges are for EBGM and INTSS values. On the Choose Graph page, you can
modify the graph key (that is, the cutpoints and colors).
The following example is for a three-dimensional data mining run, with the event
Flushing selected on the Select Criteria page. The scores for the two-way interactions
between that event and a single drug appear in the cells in the first column and the
first row of the graph. The scores for three-way interactions between the event and two
drugs appear in the remainder of the graph (in the center and in the rest of the bottom
row and right column).
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View a nested confidence interval graph

Mining Runs.
3. From the Run name drop-down list, select the three-dimensional MGPS run.
(Your user preference, Default Run, determines which run, if any, is selected by
default.) You can also click Browse next to the Run name field to find and select a
run.
6. Select a nested confidence interval graph.
7. On the Nested Confidence Interval Graph page, specify restrictions, which will
be applied in addition to any restrictions that you specified on the Select Criteria
page.
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At most ____ combinations Display no more than the specified number
of combinations. You can display graphs for
up to 200 combinations. If combinations are
excluded because of this limit, a message
appears below the graph.

Order by The application sorts the combinations by
the value of the score that you select.
For example, if you select INTSS, the 3D
combination with the highest INTSS value
appears first.
Axis Type Select either Linear or Log (logarithmic).
When you use a logarithmic axis, the
confidence intervals for the lower-level
combinations appear more clearly.
Highlight confidence intervals where INTSS Enter the INTSS value above which
> confidence interval bars are highlighted.
Show N at end of confidence interval Check to display the value of N at the end of
each bar.
Use gray-scale instead of colors Check to use shades of gray instead of
colors in the graph.
9. Click Display.
The nested confidence interval graph appears.
represented by the bar. Long drug or event terms may end in an ellipsis in the
label on the graph itself; in this case, you can point to the bar to see the full terms.
Series.
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Nested confidence interval graphs

To help you investigate possible drug interactions or multi-event syndromes, the
nested confidence interval graph displays sets of confidence intervals.
In each set, the first confidence interval is for the 3D combination for the specified
pattern (such as Drug+Drug+Event). Subsequent confidence intervals in the set are for
the 2D combinations (such as Drug+Event.)
In each confidence interval bar, the EB05 value is at the left end, the EBGM value is
the dot on the bar, and the EB95 value is at the right end. The application highlights a
confidence interval bar if its INTSS value is greater than the limit that you specify as a
display option. For more information about INTSS, see interaction scores.
To conserve space in labeling, the drug or event name indicated above the graph is
referred to by the label Drug or Event in the graph. In the example below, Drug means
Aminoglutethimide.
The key below the graph indicates INTSS values represented by the confidence
interval bars. Settings you make to cutpoints and palette choices do not affect this
graph type.
The following example shows a nested confidence interval graph for a three-
dimensional data mining run, with the drug Aminoglutethimide selected. The
confidence interval for the 3D combination of that drug and two events appears first,
followed by confidence intervals for the specified drug and each of the component
events.
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Drill down through data

• Add a drilldown map table
• Drilldown options
• View a list of cases from the Data Mining Results page
• View case details
• Case ID links
• Create a case series from drill-down information
Add a drilldown map table

3. Click the Row Action menu ( ) for a configuration, and then click Edit.
4. In the right-most column of the configuration, click Edit.
5. Next to the Drilldown Map field, click Select/Edit Table.
6. Click Create New Table.
7. In the Enter name of new drilldown table field, type a name for the new table.
Table names cannot include:
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• Spaces
• ?, \, or "
It is recommended that you use a name that distinguishes the table from
other drilldown map tables and indicates the table’s purpose, such as
DRILLDOWN_MAP.
8. Click Create Table.
The new table appears as the selected drilldown table. The first column of the
drilldown map table shows the information type.
9. Edit the drilldown map table as necessary.
Note:
The same drilldown map table may be used by more than one data
configuration in the Oracle account. Before editing a drilldown map table,
make sure you want the changes to apply to all data configurations that
refer to the drilldown map table.
a. Select the Type you want to edit and click Edit. (If you want to clear values for
the type, click Clear.)
b. In the Table field, click Select to open the Select Table and Column dialog
box and select an available table and column for the drilldown table to
reference.
The application populates the Table field and Report ID Column field with your
selection. The column should be compatible with the column for case IDs in
the source data used in data mining.
c. In the Section Title field, type a label for the section of the drilldown map
table.
The label appears on the Case Details page as the section heading.
d. In the Worksheet label field, type a label for the application to apply to the
table worksheet.
This label appears on the worksheet tabs when Case Details are downloaded
to Excel.
e. In the Display Columns section, select and label each column to include.
f. From the first Column drop-down list, select a variable.
g. In the corresponding Label column, type a label (column heading) to apply to
the variable in the drilldown table.
In the drilldown information, variables appear in the order in which you specify
them.
h. If you want the drilldown information to show only distinct values for the
variables, check Distinct.
i. Click Save.
10. When you have finished specifying all types of information that you need, click OK.
The Select/Edit Drilldown Table dialog box appears with the Table, Report ID Field,
and Display Columns columns filled in.
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Drilldown information types

The following table lists the types of information that you can include in the drilldown
map table and the corresponding label in the drilldown display. The LIST type
determines contents of the Cases page (first-level drilldown), and its first variable
must represent the case ID. All other types determine contents of the Case Details
page (second-level drilldown). Typically, the CASE, DRUG, and EVENT types, at a
minimum, are included on the Case Details page.
Type Description
CASE Case Information
DRUG Reported Drugs/Vaccines
EVENT Reported Events/Symptoms
OUTCOME Reported Outcomes
SOURCE Reported Sources
BATCH_LOT Batches/Lots
DEVICE Devices
DEVICE_CODE_DEV Facility Device Codes
DEVICE_CODE_PAT Facility Patient Codes
DEVICE_MANU_CONCLUDE Manufacturer Conclusion Codes
DEVICE_MANU_METHOD Manufacturer Method Codes
DEVICE_MANU_RESULT Manufacturer Result Codes
DIAGNOSTIC Diagnostic Procedures Performed
DRUG_HISTORY Patient Drug History
DRUG_IND Indications
DRUG_REACT Drug-Reaction Information
LINKED_CASES Linked Cases
LITERATURE Literature References
MEDICAL_CONDITION Medical Conditions
MEDICAL_HISTORY Medical History
PATIENT_REGISTRY Patient Registry Information
PREGNANCY Pregnancy Information
PREGNANCY_OUTCOME Pregnancy Outcome
REPORTER Reporter Information
CAUSE_OF_DEATH Cause of Death
PARENT Parent
PARENT_DRUG_HISTORY Parent Drug History
PARENT_MEDICAL_HISTORY Parent Medical History
AES_ADDL_HISTORY Chronological History
AES_ADDL_INFO Additional Information
AES_CEV_DRUG Drug-event Information
AES_CODES_DEV Device Codes
AES_DEVICE_CODE Device Problems
AES_DISEASE Diseases
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Type Description
AES_DOSE Dosing Regimens
AES_EVAL Case Evaluation Information
AES_EXPOSED_DEVICE Devices
AES_LAB Associated Lab Results
AES_REPORTER Reporter Information
NARRATIVE Narrative
For example, medical history or laboratory
data for the case. See Narrative text for details
about setting up narrative text.)
Drilldown options
You can drill down on the count (N) of cases from tables and graphs to access useful
options and further information.
The type of data presented during drilldown is from the source database tables, and is
determined by the drilldown map table associated with the data configuration.
• On Oracle Empirica Signal tables, the count (N) of cases is a link that you can
click to display a menu with drill-down options.
• In graphs, you can click an element (such as a bar or cell) of the graph to display
the menu.
You can select the following options for the cases that make up the count or are
represented by the graph element:
Options Click to
View Cases View a list of cases.
Create Case Series Create a case series.
For timestamped data, the As Of date of the case series
will be that of the object you are viewing.
Transfer to Case Series Transfer the list of cases to an existing case series.
Download Cases Download the list of cases.
Download Case Details Download case details for the cases to an Excel
spreadsheet or a Word Rich Text Format File. You can
download case details only if the appropriate site option
has been set. (When viewing a particular case, you can
also download case details for that one case.)
Reports View a report for the cases. You can run only one report
definition at the same time. Report definitions appear
only if they are compatible with the data configuration for
the object that you are viewing.
View a list of cases from the Data Mining Results page

Mining Results.
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2. From the Run name drop-down list, select the run you want to view. Your Default
Run user preference determines which run is selected by default.
3. Specify selection criteria, and then click View Results Table.
4. Click the drug's Row Action menu ( ) and select View Cases.
5. Click Close or perform any of these additional activities on the cases shown:
• To see the details of a case, click the Case Number.
• To create a case series containing the case IDs, click Create Case Series.
For timestamped data, the As Of date of the case series is that of the object
you were viewing when you drilled down.
• To transfer the list of cases to an existing case series, click Transfer to Case
Series.
• To download case details for all cases in the list to an Excel spreadsheet or a
Word Rich Text Format File, click Download Case Details. You can download
case details only if the appropriate site option has been set. (When viewing a
particular case, you can also download case details for that one case.)
• To view a report for the cases, click Reports. Report definitions appear only
if they are compatible with the data configuration for the object that you were
viewing.
• To save the list of cases as an attachment to a topic, click the Save to Topic
link (available if the Topics feature has been set up).
Note:
Oracle Empirica Signal retrieves the data that appears on the Cases page
from the source data. Therefore, it does not include custom terms or values
created by data transformations.
View case details

When a case ID, such as an ISR number, appears as a link anywhere in Oracle
Empirica Signal, you can click the link to drill down to case details. This includes
information about the case, presented as a set of tables showing source data for the
case.
At a minimum, the following information appears:
• Case Information (demographic information).
• Reported Drugs/Vaccines.
• Reported Events/Symptoms.
There might also be additional information about reported outcomes, case report
sources, narrative text, and so on. If specified by the data configuration, a description
of source data appears below the case details. For example: Source Data: AERS data
as of 4th quarter 2004 from NTIS Public Release loaded on 2005-04-18.
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Note:
Oracle Empirica Signal retrieves the data that appears as case details
from the source data. Therefore, custom terms or values created by data
transformations do not appear.
From Signal Review:
1. In the left navigation pane, click the Signal Review icon ( )

4. In a product-event combination table, click a total of cases in a column that
appears in bold. The bold denotes that the number is a link that, when clicked,
displays a menu.
5. Click View Cases.
6. Click a case ID; for example, an ISR number.
7. Perform additional actions in the Case Details window:
• To print case details, click Print
• To download case details to an Excel spreadsheet or a Word Rich Text Format
File, click Download.
• To save the case details as an attachment to a topic, click Save to Topic
(available topics feature has been set up).
From Data Mining Results:
Mining Results.
2. From the Run name drop-down list, select the run. Your Default Run user
preference determines which run is selected by default.
4. Click the Row Action menu ( ) or click the link in the N column and then click
View Cases.
5. Click a case ID; for example, an ISR number.
6. Perform additional actions in the Case Details window:
• To print case details, click Print.
• To download case details to an Excel spreadsheet or a Word Rich Text Format
File, click Download.
• To save the case details as an attachment to a topic, click Save to Topic
(available if the topics feature has been set up).
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Case ID links
When a case ID appears as a link anywhere in the application, you can click the link
to drill down to case details. Once you have clicked a case ID link, the color of the link
changes. This color change:
• Applies to only your username and across your Oracle Empirica Signal sessions.
• Lasts for the number of days that you have set as your user preference, Days to
retain visited status for case ID links.
• Applies across all activities within the application.
• Applies to data associated with all data configurations in the same database group
(an attribute of a configuration).
For example, two data mining runs are based on data configurations in the same
database group. When viewing results for one run, you drill down to a list of cases and
then click the case ID, 1435. The color of case ID 1435 changes, indicating that you
have visited the case ID. You log out, log back in, and view a case series that includes
case ID 1435 and is based on the second data configuration. Case ID 1435 appears in
the changed color, indicating that you have visited it.
Note:
• The user preference, Days to retain visited status for case ID links,
applies to case ID links that you visit after you set the preference.
• The visited status is reset each time you visit a case ID link. For
example, suppose that your user preference is set to 5. On Day 2,
you click a case ID link. The link visited status is retained for 5 days
beginning with Day 2. You visit the case ID link again on Day 3. The link
visited status now is retained for 5 days beginning with Day 3. Then you
change the user preference to 10. On Day 9, you view a list of cases
that includes the case ID. The case ID link is the original color again
because 6 days have passed since Day 3. When you click the link, the
user preference is reset, so the visited status is retained for 10 days (the
new preference setting) from Day 9.
• If you do not want case ID links to change color when they are visited,
you can set your user preference to retain the visited status of case IDs
to 0 days.
• If the data is associated with a data configuration that is not in a
database group, the color of visited case ID links never changes.
To remove the visited status of all your case ID links at any time, click Settings and
then click Remove Visited Status of Case ID Links.
Create a case series from drill-down information

On pages and in reports that display a list of cases identified by case ID, you can save
the list of cases for future use. The named and saved list of cases is referred to as a
case series.
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You can also transfer cases to an existing case series.
Mining Results.
2. From the Run name drop-down list, select the run you want to view. Your Default
Run user preference determines which run is selected by default.
4. Click the drug's Row Action menu ( ) whose cases you want to view and select
View Cases.
5. Click Create Case Series.
6. In the Name field, type a name for the new case series. The name does not need
to be unique, although Oracle recommends that you use a unique name.
7. In the Description field, enter a description of the case series. A default
description, which you can modify, might appear.
8. To add the case series to a project, click Add to existing project and select the
project from the drop-down list of projects associated with objects that you created
or that are published to you.
9. To create a new project and assign the case series to it, click Add to a new
project named and type a project name.
10. Click Create.
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6
Query the safety database
• View existing queries
• Queries and the query library
• Create, edit, and run a query
• Manage your queries
View existing queries

The Queries page provides information about existing queries and enables you to
define new queries. For the selected project and data configuration, the Queries page
lists queries that you have created or that are published to you. If you have the
Administer Users permission, the page also lists unpublished queries created by any
1. In the left navigation pane, hover on the Data Analysis icon ( ), then click
Queries.
2. Filter the list of your queries and queries published to you as necessary.
• From the Project drop-down list, select the project for which you want to view
queries or -- to include all projects.
• From the Configuration drop-down list, select the data configuration for which
you want to view queries or -- to include all configurations.
• From the Origin drop-down list, select the origin of the queries you want to
view; select -- to include all types.
What you can do next
• To view, print, or download the table, or to change the way data displays in the
table, see About tables.
• To print, download, or delete multiple queries, click Select Rows. Select the check
box for one or more rows or click the Select All link to check all rows (or Clear All
to uncheck all rows). Then click Print, Download, or Delete.
• To create a query using the built-in Query Wizard, click the Create Using Query
Wizard link.
• Click a query's Row Action menu ( ), to do the following:

– To run the query, click Run and select a data configuration.
– To run the query and create a case series from the query results, click Create
Case Series. You select a data configuration, review variables and values,
and optionally change the name, description, and project assignment before
saving the case series.
– To view the query logic, click View. This option shows the variables and values
that make up the query, as well as the logic.
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Queries and the query library
– To run the query and then run a report against cases found by the query, click
Report and select a data configuration. After you run the query, the Report
Definitions page appears.
For queries you created, click a query's Row Action menu ( ) to do the following:
• To copy a query, click Copy. Then provide a name for the copy and save it.
• To edit the query, click Edit. You can click Back to select a different data
configuration.
• To rename the query, click Rename. You can also change its description or assign
it to a different project.
• To publish a query, click Publish, select the login group(s), then click Back. (If you
have the Administer Users permission, you can publish configurations created by
any user in your login group.)
– To publish multiple queries, click the Select Rows link, select the radio buttons
of the queries, then click the Publish link.
– If you are a superuser, you can publish to multiple login groups, including
select login groups. If you publish to —All– and later add a new login group,
the object is published automatically to the new login group.
• To run the query and then run a report against cases found by the query, click
Report and select a data configuration. After you run the query, the Report
• To delete a query, click Delete. At the message asking if you want to delete the
query, click OK. The query is deleted and no longer appears on the Queries page.
Note:
Editing or deleting a query has no effect on any case series, database
restrictions, custom terms, or interactive reports that were created using the
query.
Queries and the query library

A query is the specification of criteria based on variables and values in the source
data. When you run a query, Oracle Empirica Signal retrieves cases that match the
specified criteria. To create or edit a query, use the Query Wizard to guide you through
the steps of selecting variables, selecting values, and specifying query logic.
For variables in a query, values do not need to be predefined. Users can supply values
at the time they run the query. For example, you can set up a query to look for cases
that include both of two products, where the two products are specified at the time you
run the query.
A query is a dynamic object that is re-applied each time you run the query. If data has
changed since the last time you ran the query, the query results can differ. In contrast,
a case series is a saved list of cases.
When creating database restrictions, custom terms, query-based case series, or
interactive reports, you can create new queries or use existing queries. The list of
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Create, edit, and run a query
existing queries is the Query Library. To use an existing query, you select it from the
Query Library. For example, there is an existing query that finds females under age
65. To perform a data mining run based only on females under age 65, you define a
database restriction based on that query.
When using an existing query in the process of defining another object, you work with
a copy of the query. Modifying the copy does not affect the query in the Query Library.
Likewise, changes to the query in the library do not affect the copies of the query
associated with any existing objects.
Note:
Because queries run on source data (not data mining results), they do not
include custom terms or values created by data transformations.

• Step 1: Create and edit a query
• Step 2 (Optional): Specify query logic
• Step 3: Preview the query
• Step 4: Save the query
• Step 5: Run a query
• Step 6: Work with the cases retrieved by the query
Step 1: Create and edit a query

When you create or edit a query, the Define Query page appears. On the Define Query
page, you specify conditions and link them with operators.
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For information about operators, see Specifying query logic.
Queries.
2. At the top left of the Queries page, click Create Using Query Wizard.
3. On the Select Configuration page, select a data configuration from the
Configuration drop-down list or click Browse to select from a list of data
configurations.
4. Click Next.
5. On the Define Query page, click Select Variables.
6. (Optional) If you want information about the variable shown, click Show Variables.
7. From the All Variables in All Tables list, select one or multiple variables on which
to base conditions and use the right-arrow button to move them to the Selected
Variables list.
8. Click OK.
A field for each variable you selected appears on the Define Query page. Oracle
Empirica Signal assigns a number to each variable. When you specify query logic,
you use that number to refer to the condition that is based on that variable. If you
point to the field name, a description of the field appears.
• If you are creating or editing a query from the Queries page or for an
interactive report, you can specify values for each variable in the query. When
running the query, you can change the specified values or enter values (if
none were provided in the original query).
• If you are creating or editing a query in the process of defining a database
restriction, custom term, or case series, you must specify values for each
variable or remove the variable.
– The way in which you specify values depends on the type of variable. For
more information, see Specify query values.
– Each condition that you specify must be referenced by the query logic. If
you are not going to reference a condition, you must remove the condition
from the query, by clicking the [X] in the upper right corner of the box
containing the variable.
Note:
You can include the same variable in the query multiple times. For
example, cases for which the subject's age is between 17 and 25 or
above 65. You include the AGE variable and set it to 17-25; include the
AGE variable again and set it to above 65; then connect the variables
with the OR operator.
10. Specify query logic by clicking Edit and entering a logical expression, referring
to variables by their numbers, then click OK. For more information, see How to
specify logic in a query.
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Note:
If you add or delete another query variable after this step, the query logic
is reset to a default.
11. If your user preferences include Show case count by default on preview page,
you can check Display Case Count in Query Preview. You must specify values
for all variables. Computation of the case count can be time-consuming, so we
recommend that you display counts only when necessary.
12. Click Next to preview the query.
Step 2 (Optional): Specify query logic

When you specify conditions in a query, they are connected using default operators.
You can modify the operators as needed.
Queries.
3. On the Select Configuration page, from the Configuration drop-down list, select
a data configuration or click Browse to select from a descriptive list of data.
4. Click Next.
6. From the All Variables in All Tables list, select one or multiple variables on which
to base conditions and use the right-arrow button to move them to the Selected
Variables list.
7. Click OK.
A field for each variable you selected appears on the Define Query page. Oracle
Empirica Signal assigns a number to each variable. When you specify query logic,
you use that number to refer to the condition that is based on that variable.
8. Specify values for each variable.
9. Click Edit.
10. Specify query logic by entering a logical expression, referring to variables by their
numbers. Use logical operators and set operators.
11. Type in logical operators, set operators, and parentheses as needed.
• The conditions in a query must be joined by the AND, OR, INTERSECT, UNION,
or MINUS operator. The NOT operator is available to negate a condition (for
example, 1 AND NOT 2).
• Each condition must be referenced by the query logic at least once. You can
refer to the same condition multiple times in a query. For example, you can
specify: (1 AND NOT 2) OR 2.
12. Click OK.
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Step 3: Preview the query

Queries.
configurations.
4. Click Next.
6. Follow the directions in steps 5 through 13 on Step 1: Use the Query Wizard to
create a query, then click Next.
The Preview Query page appears, providing the following information:
• The data source, which is the name of the data configuration on which the
query is based.
• The logic of the query and a description of each condition in the query.
Note:
If query values were not specified for a variable, the value for the
variable appears as ?.
The number of cases to be retrieved by the query (if you checked Display Case
Count in Query Preview on the Define Query page).
7. To preview the query results, click Preview Cases.
This option is available only if you specified values for all variables and site option
Allow Case Count on Query Preview page is enabled.
8. Click Next to save the query.
Step 4: Save the query

Queries.
configurations.
4. Click Next.
6. Follow the directions in steps 5 through 13 on Create a query, then click Next.
7. Preview the query results, then click Next.
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8. In the Name field, enter a name for the query. The name does not need to be
9. (Optional) In the Description field, enter an informative description of the query.
10. Choose one of the following options:
• To assign the query to an existing project, click Add to existing project
and select the project from the drop-down list. Only projects associated with
objects that you created or that are published to you appear in the list.
• To create a new project and assign the query to it, click Add to a new project
11. Click OK.
When you create or edit a query, the Define Query page appears. On the Define
Query page, you specify conditions and link them with operators. For information
about operators, see Specifying query logic.
Step 5: Run a query

Each time that you run a query, Oracle Empirica Signal executes the query. Even if
you do not change values for variables in the query, if the source data changed since
the last time you ran the query, the query results can differ from when you last ran the
query.
Queries.
2. Click the query's Row Action menu ( ), and then click Run.
Note:
When you run an interactive report, you also run a query.
3. From the Configuration drop-down list, select a data configuration from a list of
compatible data configurations. This is the source data against which the query
runs.
4. Click Next.
5. On the Run Query page, specify values for query variables. For more information,
see Specify query values.
If the operators in the query are all AND, all OR, all INTERSECT, or all UNION, you
do not need to specify values for every variable. If you do not specify a value for
a variable and you do not check Include Null values for the variable, then the
application ignores that variable. If all of the operators in the query are MINUS or if
you use a mixture of different operators in the query, you must specify values for
every variable.
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Manage your queries
Note:
You can set up a query-based interactive report to use query values
as breakdown details. If a column or row variable has no breakdown
values because you do not supply query values when running the report,
the application drops the column or row from the report. If the resulting
report has no rows or no columns, you cannot run the report until you
supply query values.
6. Click Next.
The cases matching the query appear on the Cases page. See View query results.
Step 6: Work with the cases retrieved by the query

When you run a query, the cases Oracle Empirica Signal retrieves from the source
data appear on the Cases page. Oracle Empirica Signal lists the cases in a tabular
format. The variable representing the Report ID is the first column of the table. Other
information in the table is customizable and determined by the data configuration. The
Cases page does not include custom terms or values created by data transformations.
Queries.
2. Click the query's Row Action menu ( ), and then click Run.
3. From the Configuration drop-down list, select a data configuration and click Next.
4. On the Run Query page, specify values for query variables. For more information,
see Specify query values.
5. Click Next to display the cases that match the query.
You can do the following on the Cases page:
• To run a report against cases found by the query, click Report. The Report
Word Rich Text Format file, click Download Case Details. You can download
case details only if the appropriate site option has been set. (When viewing a
particular case, you can also download case details for that one case.)
• To save a case series from the query results, click Save As Case Series.
• To save the query results as an attachment to a topic , click Save to Topic
• View case details for a single case in the list, if the appropriate site option has
been set. Click the case ID link in the case list. The Case Details page appears.
For information about how visited case ID links change color, see Case ID links.
Manage your queries

• Create a query from an existing query
• Specify query values
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Manage your queries
• Use logical and set operators

• View query logic
• Rename a query
Create a query from an existing query

The Select Query from Library page appears if you use an existing query when
defining a custom term, database restriction, or query-based interactive report. The
queries must have been created by you or published to you. (If you have the
Administer Users permission, you can select from published or unpublished queries
created by any user in your login group.)
Once you use an existing query for a custom term, database restriction, or query-
based interactive report, subsequent changes to the query in the library do not affect
the custom term, database restriction or report.
1. Select Create from Existing Query.
2. From the Project drop-down list, select a specific project, or select -- to include all
projects.
3. From the Configuration drop-down list, select the data configuration , or select --
to include all configurations. Available queries are those that are compatible with
the data configuration for the data mining run (if you are creating a custom term or
database restriction) or report definition (if you are creating a report).
4. From the Origin drop-down list, select one of the following values:
• Query—The query was created and saved from the Queries page.
• Case Series—The query was created and saved during the creation of query-
based case series on the Case Series page.
• Custom Term—The query was created and saved during the creation of a
custom term for a data mining run.
• Restriction—The query was created and saved during the creation of a
database restriction for a data mining run.
• Interactive Report—The query was created and saved during the creation of
an interactive report.
5. Click the radio button of the row for the query that you want to select.
6. Click Next.
If you are defining a custom term or database restriction, the Refine Query page
appears. Optionally, you can refine the query.
Specify query values

The way in which you specify values depends on the type of variable.
• If the Select <hierarchy> Terms link appears for a variable, click it to select terms
from the hierarchy. For example, if an event variable is associated with a MedDRA
account and your user preference, Enable Adverse Event Hierarchy Browser, is
checked, you can click Select MedDRA Terms.
• To select values from a list, click Select Available Values.
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• To refer to a saved list of terms, click Select Saved List. You can specify a saved
list that uses the same data configuration as the query.
Note:
• To look up a drug name for a drug variable, click Trade/Generic Lookup. You
can find the generic name for a drug (if you only know its trade name) or vice
versa. (This link is available if the data configuration's source data included trade
name-generic name mapping.)
Matching a text string

If the options Contains, Starts with, Ends with, or Equals appear for a variable, enter
a text string and select an option to indicate the type of matching. You can also check
Ignore capitalization to retrieve matching values regardless of upper or lower case.
Specifying ranges
For numeric or date variables, specify a range by entering From and To values.
Values equal to or greater than the From value and equal to or less than the To value
are found. If you leave the From field empty, there is no lower bound. If you leave the
To field empty, there is no upper bound.
If a date variable is stored as a date field in the source data, you must enter the date in
the format MM/DD/YYYY or use the calendar icon to select a date.
If you do not specify a time, the application considers the time to be midnight of the
specified date.
Note:
If a date variable is stored as a text field in the Oracle database, you can
search for it as you would search for any text string.
Specifying report IDs

For a variable specified with the type Report ID in the data configuration, you can enter
a string of report IDs separated by commas.
Check Include Null values to include null (empty) values along with the other values
that you specify for a variable, and click Next. For more information, including how the
NOT operator works if you include null values, see Specifying query logic.
Use logical and set operators

Logical operators
Logical operators act on individual rows of source data tables. You can use the
following logical operators between conditions:
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• AND—Find cases for which both conditions occurred simultaneously.

• OR—Find cases for which either of the conditions occurred.
You can use the logical operator NOT to negate a condition. (You cannot use NOT alone
to connect conditions.)
Set operators
Set operators act on sets of cases that are retrieved by the conditions on each side of
the set operator. You can use the following set operators between conditions:
• INTERSECT—Find cases that are in both sets.
• UNION—Find cases that are in either set.
• MINUS—Find cases that are in the set to the left of the operator, and subtract from
that list the cases that are in the set to the right of the operator.
Sometimes it is possible to specify the same query using either logical operators or set
operators. It is preferable to use logical operators because they are more efficient.
Operator priority
When the application interprets the query expression, it applies operators in the
following order:
• NOT
• AND
• OR
• INTERSECT, UNION, MINUS (same priority)
The only restriction on how logical and set operators can interact is that logical
operators cannot act on the results of set operators. For example, the following query
is invalid: 1 AND (2 INTERSECT 3).
You can use parentheses to change the way in which a query expression is
interpreted. If you do not use parentheses explicitly, the query is interpreted as if there
are parentheses, based on the default order of operators.
For example, suppose the query is:
1 AND 2 OR 3 INTERSECT 4
With no supplied parentheses, the application reads the query as:

((1 AND 2) OR 3) INTERSECT 4
If you use parentheses, the meaning of the query is different:

1 AND (2 OR 3) INTERSECT 4
Examples
You specify the following conditions:
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In the following examples, the query logic does not always refer to all three conditions.
When you create a query within the Oracle Empirica Signal application, the query logic
must reference all conditions in the query.
Note:
A condition can refer to multiple values. For example, you can include the
DRUG variable once and select Thiamine and Niacin as one condition. The
example includes the DRUG variable twice to illustrate complex logic.
If the source data includes cases A through G with the following data:
CASE_ID DRUG DOSE

A Thiamine 25
A Niacin 15
B Thiamine 15
B Niacin 25
C Calcium 15
D Thiamine 15
E Thiamine 25
F Niacin 25
G Calcium 25
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1 AND 3
The query retrieves cases with rows in which Thiamine occurred and DOSE >= 20 for
that row:
A
E
1 OR 3
The query retrieves cases with rows in which either Thiamine occurred or DOSE >= 20
for any DRUG:
A
B
C
D
E
F
G
If you use OR between variables from different tables, only cases that are in each of
those tables are retrieved. For example, if a query specifies that Death Date from
the DEMO table is within a specified range OR Outcome from the OUTCOME table is
Died OR PT from the REACTION table is Death, the application retrieves only cases
that meet the criteria and are in all three tables. You can use set operators instead
of logical operators. For example, replace OR with UNION in the query to find DEMO
table cases with Death Date within the range plus OUTCOME table cases where the
Outcome is Died plus REACTION table cases where the PT is Death.
1 AND 2
No cases are retrieved because no one row for a case can have both Thiamine and
Niacin for a DRUG.
You can use the set operator INTERSECT if you want to find cases with both Thiamine
and Niacin. See the 1 INTERSECT 2 example.
1 AND 2 OR 3
The query retrieves cases with rows in which Thiamine occurred and, for that row,
Niacin occurred (not possible, because a row can have only one DRUG), or DOSE >=
20 for any DRUG:
A
B
E
F
G
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1 AND 2 OR 3
The query retrieves cases with rows in which Thiamine occurred and, for the same
row, either Niacin occurred (not possible, since a row can have only one DRUG) or
DOSE >= 20:
A
E
1 AND NOT 3
The query retrieves cases with rows in which Thiamine occurred and DOSE is not >=
20 for that row:
B
D
NOT 1 AND 3
The query retrieves cases with rows in which Thiamine did not occur and DOSE >=
20:
B
F
G
NOT (1 AND 3)
The query retrieves cases with rows in which Thiamine with DOSE => 20 did not
occur:
A
B
C
D
F
G
NOT 1 AND NOT 3

The query retrieves cases with rows in which Thiamine did not occur and, for the
DRUG that occurred, DOSE is not >= 20:
A
C
1 INTERSECT 2
The query finds the intersection of the two sets:
A
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1 INTERSECT 3
The query finds the intersection of the two sets:
A
B
E
Note that for case B, there is no occurrence of Thiamine where DOSE >= 20, but case
B was in the set created by Condition 3 as well as the set created by condition 1, so
the query retrieves it.
1 UNION 2
The query finds the union of the two sets:
A
B
D
E
F
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3 MINUS 1
The query finds the cases that remain when cases in set 1 are removed from set 3:
F
G
1 INTERSECT 2 AND 3
The query finds the following case:
B
1 UNION 2 AND 3
The query finds the following cases:
A
B
D
E
F
Null values
If you check Include Null values for a condition, the condition finds cases with rows
for which the condition is true or the variable referenced by the condition is null. If
you precede the condition with NOT, the condition finds cases with rows for which the
condition is not true or the variable referenced by the condition is not null.
For example, suppose that the source data has four null values for DOSE (indicated
by dashes (-) in the following table):
CASE_ID DRUG DOSE

A Thiamine -
A Niacin 15
B Thiamine -
B Niacin 25
C Calcium -
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CASE_ID DRUG DOSE

D Thiamine 15
E Thiamine 25
F Niacin -
G Calcium 25
If you specify the condition DOSE >= 20 and check Include Null values, the
application finds the following cases:
A
B
C
E
F
G
When you specify that values for a query should include nulls and then you precede
the condition with the NOT operator, the query retrieves cases with rows for which the
condition is not true and the variable used in the condition is not null.
If you specify NOT 3 (meaning not condition 3, which is DOSE >= 20) and you have
checked Include Null values, the following cases are found:
A
D
View query logic

To view a query from the Queries page:
Queries.
2. Click the query's Row Action menu ( ), and then click View
The query logic for the selected query appears.
3. Click OK.
To view the query used by a case series:

1. In the left navigation pane, hover on the Data Analysis icon ( ), then click Case
Series.
The query logic for the case series appear in the Description column.
2. Click OK.
Rename a query
You can rename only those queries that you created.
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Queries.
2. Click the query's Row Action menu ( ), and then click Rename.
3. In the Name field, type a query name. The name does not need to be unique,
although we recommend that you use a unique name.
4. In the Description field, optionally modify the description of the query.
5. Choose one of the following options:
• To assign the query to an existing project, click Add to existing project
• To create a new project and assign the query to it, click Add to a new project
6. Click Save.
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7
Create and manage case series
• About case series
• Case Series page
• Create and manage case series
• Work with case series
• Case series background processing
About case series

A case series is a list of the case identifiers for cases of interest that you selected
and saved; for example, a list of all cases that involved a particular class of products
administered to patients of a particular demographic profile.
From a case series, you can access the details of each case. You also use case series
to determine the cases against which to run a report.
You can create a case series from the Case Series feature under the DATA ANALYSIS
section in the left navigation pane. You can also create case series from various pages
that list case IDs or counts of case IDs (for example, run results, drill-down information,
or certain reports).
You can also manually add or transfer additional cases to the case series.
Typically, a case series is a static list of cases; however, if you edit and re-execute the
query portion of a query-based case series, the application drops any cases that you
manually added or transferred to the case series if they do not meet the query criteria.
Query-based case series

You can use the Query Wizard to define a query that retrieves case IDs from source
data on the basis of specified criteria. For example, you can query for cases in which
the patient is a female between age 18 and 65 who has experienced events in the
Respiratory SOC (System Organ Class) and has taken DrugA.
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Case Series page
Use a query-based case series to retrieve and view source data as needed in your
review and analysis of data. For example, you can retrieve cases that meet specified
criteria, and then run a report against that case series.
Using the Query Wizard, you select variables from the source data, and then select
values for each variable. You can use logical operators (AND, OR, and NOT) or set
operators (INTERSECT, UNION, and MINUS) between the variables to construct a
logical expression. The query retrieves a list of cases. The case series consists of
case IDs of those cases. If the query retrieves a case multiple times, its case ID
appears once in the case series.
You can add the query portion of a case series to the Query Library (the Queries
page). The query in the Query Library is completely separate from the query that is
part of the case series. For example, if you modify the query in the Query Library, the
modification does not affect the case series. If you modify the query portion of a case
series, the modification does not affect the query in the library.
Case Series page

On the Case Series page, you can view information about existing case series that
you have created or that have been published to you. And you can define new case
series if you have the Create Queries/Case Series permission.
General activities
The following links and filters appear the top of the page and affect the entire page:
• Create Using Query Wizard
• Create Empty Case Series
• PRR Calculator
• Columns
• Print
• Download
• Select Rows
• Filter by project
• Filter by configuration
The following links appear the top of the page when the page is in the Select Rows
mode. The links affect the multiple cases:
• Print
• Download
• Delete
• Combine Case Series
• Select All
• Clear All
• Back
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Case Series page
Row-specific activities
The following menu options can be available from the Row menu, located in the
left-most column of the table, and affect an individual row in the table:
• Cancel
• View Cases
• View Query
• Edit Query
• Rename a case series
• Report
• Publish
• Add Query to Library
• Copy
• Delete
To add the query portion of the case series to the Query Library, click Add Query to
Library. You must have access to the data configuration on which the case series is
based. If the query is added to the Query Library (the Queries page), that query is
separate from the case series. Subsequent modification or deletion of the query in the
library has no effect on the case series.
To copy a case series, click Copy. You must have access to the configuration on
which the case series is based. You can copy any case series that you created or that
has been published to your login group. If you have the Administer Users permission,
you can copy a case series published to any login group.
To cancel a Running or In Queue case series background processing job, click
Cancel. The Cancel option is available only when a background processing job exists
for the case series.
If you click the Row Action menu ( ) for a case series that you created, you can do
the following:
• To edit the query portion of a case series that was created with the Query Wizard,
click Edit Query. You can click Back to select a different data configuration.
If the Cases Added column shows Yes, then cases have been transferred or
added manually to the case series. If you re-execute the case series, those cases
will no longer be part of the case series.
Note:
Your edits to the query portion of the case series have no effect on
the query in the Query Library (the Queries page). Likewise, editing or
deleting the query in the library has no effect on the case series.
• To rename a case series, click Rename. You can also change its description or
assign it to a different project
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Case Series page
Field descriptions—Case Series page

The Case Series page provides the following information about each case series:
Column Description
Name Name of the case series.
Description Description of the case series.
Project Name of the project to which the case series is
assigned.
Configuration Name of the data configuration associated with
the case series.
# of Cases Number of cases in the case series.
Created By Name of the user who created the case series.
Created Date and time on which the case series was
created.
Modified Date and time when the case series was last
modified.
Modified By Name of the user who last modified the case
series.
Status The current status of the background
processing job.
As Of Applies if the configuration supports
timestamped data. The As Of date associated
with the case series. If you created the case
series when drilling down, this is the As Of
date associated with what you were viewing
before you drilled down.
Note:
A date and time
appear in this
column even if
the configuration
does not support
timestamped
data. In this
case, the date
and time is
approximately
the same as the
date and time in
the Created
column.
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Column Description
Associated Run Name of the data mining run that generated
the results from which the case series was
created. If the run associated with a case
series is deleted, the application retains the
case series but it is no longer associated with
the run.
If the case series was not created from run
results, this column is empty.
Cases Added One of the following values:
• Yes—For a query-based case series,
cases have been manually added to
or transferred to the case series since
the query portion of the case series
was last executed (by clicking the Row
Action menu ( ), and then clicking

Edit Query.) If you re-execute the query
portion of the case series in this way, the
manually added or transferred cases are
dropped from the case series.
• No—For a query-based case series,
cases have not been manually added to
or transferred to the case series since
the query portion of the case series
was last executed (by clicking the Row
Action menu ( ), and then clicking Edit

Query.)
• NA—Not Applicable because the case
series is not based on a query.
ID Identifier the application assigned when the
case series was created. Each case series ID
is unique and is not re-used if the case series
is deleted.

• Create a query-based case series
• Create an empty case series
• Transfer cases to a case series
• Manually add cases to a case series
• Save a case series
• Publish a case series
Create a query-based case series

You can create a query and include the cases found by the query in the case series.
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To create or edit a query-based case series, use the Query Wizard, which guides
you through the process of selecting variables, selecting values, and specifying query
logic.
Note:
If you edit and re-execute the query portion of a query-based case series
to which cases have been transferred or added manually, Oracle Empirica
Signal drops those cases from the case series if they do not meet the query
criteria.
Series.
2. Click Create Using Query Wizard.
3. From the Configuration drop-down list, select a data configuration. You can click
Browse to select from a list of data configurations.
4. Click Next to define the query conditions.
5. Click Select Variables.
6. Select variables from the left-hand list and move them to the Selected Variables
list on the right.
7. From the Table drop-down list, select All Tables or a specific table.
8. In the Match field, enter a variable to find.
9. Click OK.
10. Build the query on the Define Query page by selecting the values to include.
11. Click Next.
12. Review the data source and query logic. To preview the query results, click
Preview Cases. This option is available only if you specified values for all
variables and your user preference Show case count by default on preview
page is enabled.
13. Click Close, then Next.
14. Save the query by specifying a name for the query. The name does not need to be
15. In the Description field, leave the description or add a description of the query.
• To assign the case series to an existing project, click Add to existing project
• To create a new project and assign the case series to it, click Add to a new
project named and enter a project name.
17. Click OK.
Oracle Empirica Signal submits the case series to the background processing job
queue. For larger datasets, the Background Processing indicator appears next to
your username at the top of the page.
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Note:
The Background Processing indicator may not appear if you create a
case series from a small data set that processes quickly.
Create an empty case series

One way to create a case series is to create an empty case series and then manually
add (type in or paste in) a list of case IDs, or transfer cases to the empty case series.
Series.
2. Click Create Empty Case Series.
3. From the Select a configuration drop-down list, select a configuration. You can
click Browse to select from a list of data configurations.
4. Click Next.
If you selected a data configuration that supports timestamped data, the Select As
Of page appears so that you can specify an As Of data.
5. In the Name field, enter a name for the case series. The name does not need to
be unique, although we recommend that you use a unique name.
6. In the Description field, enter an informative description of the case series.
7. To assign the case series to an existing project, choose one of the following:
• Click Add to existing project and select the project from the drop-down list.
Only projects associated with objects that you created or that are published to
you appear in the list.
8. Click Save.
9. View the empty case series and manually add cases to the case series or transfer
cases to the empty case series.
Transfer cases to a case series

On pages and in reports that display a list of cases, you can transfer cases to an
existing case series.
You can also create a new case series containing the cases.
For timestamped data, when cases are transferred to a case series, Oracle Empirica
Signal uses the As Of date associated with the target case series to determine
whether the cases are legitimate to add. For example, if the As Of date of the case
series is 06/15/2019 and the case ID 1554 did not exist until 07/21/2019, if you try
to add case ID 1554 to the case series, it is not added because it did not exist on
06/25/2019.
Series.
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2. From the Run name drop-down list, select the run you want to view.
4. Click the Row Action menu ( ) for a product, and then click Transfer to Case
Series. Alternatively, click a count (N) of cases in a table or click the element of a
graph, and then click Transfer to Case Series from the Row Action menu.
5. Click the row for the case series that you want to select, and then click OK.
Oracle Empirica Signal adds the case IDs to the case series if they were not
already in it. A message states how many cases were added to the case series.
Note:
It is possible, but not recommended, to transfer cases that do not meet
query criteria to a query-based case series. If the query is executed
again, the transferred cases are dropped if they do not meet the query
criteria.
Manually add cases to a case series

You can add cases manually from source data to an empty case series or to a case
series that already includes cases that you created or has been published to your login
group.
If you have the Administer Users permission, you can add cases manually to a
published or unpublished case series created by any user in your login group.
For timestamped data, when cases are added manually to a case series, the
application uses the As Of date associated with the target case series to determine
whether the cases are legitimate to add. For example, the As Of date of the case
series is 06/25/2019 and case ID 1554 did not exist until 07/21/2019. If you try to add
case ID 1554 to the case series, the application does not add it, because the case did
not exist on 06/25/2019.
Series.
2. Click the Row Action menu ( ) for the case series to which you want to add
cases, and then click View Cases.
3. Click Manually Enter IDs.
4. Type or paste in a list of case IDs. Each case must be on a separate line or
separated from the next case ID by a comma.
5. Click Append.
Oracle Empirica Signal searches the source data for the specified case IDs and
refreshes the case series list with the number of case IDs that you manually
entered, the number of case IDs added to the case series, and the total number of
case now included in the case series. If a manually added case ID does not exist
in the source data, the application does not add that case ID to the case series.
6. Click Close.
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Note:
It is possible, but not recommended, to add cases that do not meet query
criteria to a query-based case series. If you execute the query again, Oracle
Empirica Signal does not include the added cases because they do not meet
the query criteria.
Save a case series

1. Create or edit a query. For more information, see Create a query-based case
series or Create an empty case series.
2. On the Save Case Series page, in the Name field, enter a name for the case
series. The name does not need to be unique, although we recommend that you
use a unique name.
3. In the Description field, enter an informative description of the case series.
4. To assign the case series to a project perform one of the following:
• To assign a case series to an existing project, click Add to existing project
project named and enter a project name
5. Click OK.
A message tells you that the case series is being saved. If you click Cancel at this
point or navigate to another page, the application does not create the case series.
Publish a case series

Publication of a case series is a way to make it available to other users. By default, the
publication level of every newly created object is Private.
Note:
Series.
2. Click a case series' Row Action menu ( ) and click Publish.

3. From the Publish to Login Groups drop-down list, select the login groups who
may use this case series.
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4. Click Back.

• View existing case series
• View cases in a case series
• Rename a case series
• Copy a case series
• Combine case series
View existing case series

The Case Series page provides information about existing case series and enables
you to define new case series.
For the selected project and data configuration, the Case Series page lists case series
that you have created or that have been published to you. If you have the Administer
Users permission, the page also lists unpublished case series created by any users in
your login group
Series.
2. (Optional) Filter the list as necessary.
• From the Project drop-down list, select the project for which you want to view
case series or -- to include all projects.
• From the Configuration drop-down list, select the data configuration for which
you want to view case series or -- to include all configurations.
The selected case series appear. See About case series for information about the
case series.
Case series actions

• Use the links at the top of the page to customize the columns, print the table, and
download the data.
• To print, download, combine, or delete multiple case series, click Select Rows.
You can then check the rows for the case series on which you want to act. You
can also click Select All to check all rows (or click Clear All to uncheck all rows).
From the menu, click the action that you want to perform on the selected rows.
For more information see About tables.
• To create a case series by defining a query, click Create Using Query Wizard.
• To create an empty case series to which you manually add case IDs, click Create
Empty Case Series.
• To compute Proportional Reporting Ratios (PRR) for a set of previously defined
case series, click PRR Calculator.
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Row Action menu options
Click a case series' Row Action menu ( ) to do the following:

• To view a case series, click View Cases.
• To view a query, click View Query.
• To edit a query, click Edit Query.
• To rename a case series, click Rename. You can also change its description or
assign it to a different project.
• To view existing report definitions, which you can run on the case series, click
Report.
• To publish a case series, click Publish. You can publish any case series that you
created. If you have the Administer Users permission, you can publish a case
series created by any user in your login group.
• To add a query to the library, click Add Query to Library.
• To copy a case series, click Copy. You must have access to the configuration on
which the case series is based. You can copy any case series that you created
or that has been published to your login group. If you have the Administer Users
permission, you can copy a case series published to any login group.
• To delete a case series, click Delete. You can delete any case series that you
created. When a message asks if you want to delete the case series, click OK.
The case series is deleted and no longer appears on your Case Series page.
Note:
Before deleting a query-based case series, you can save the query portion of
the case series with the Add Query to Library option.
View cases in a case series

Series.
3. Click the case series' Row Action menu ( ), and then click View Cases.
Note:
Because Oracle Empirica Signal retrieves the data from the source
data, it does not include custom terms or values created by data
transformations.
The case list appears as a table. The variable representing the case ID is the
first column of the table. The data configurations associated with the case series
determines the additional columns that appear. If site option All Case Comment/
Review/Exclusion is enabled, additional columns indicate whether the case has
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been reviewed or excluded, and whether comments have been added by a

reviewer.
4. Perform additional actions on cases:
• To view case details, click the case ID in the first column.
• To add cases manually, click Manually Enter IDs and enter case IDs,
separated by lines or commas, in the text box, and click Append.
• To see the reports that can be run on the case series, click Report.
Word Rich Text Format File, click Download Case Details. (When viewing a
particular case, you can also download case details for that one case.) Oracle
Empirica Signal does not include cases that are marked as excluded and that
are hidden at the time of the download.
• To save the list of cases as an attachment to a topic, click Save to Topic
(available if the topics feature has been set up). The application does not
include cases that are marked as excluded and that are hidden at the time you
save the list as an attachment.
• If any cases have been marked as excluded as part of reviewer input, you can
click Hide Excluded. Excluded cases are not visible on the Cases page. If you
click Show Excluded, such cases are visible.
Rename a case series

You can rename only those case series that you created.
Series.
3. Click the case series' Row Action menu ( ), and then click Rename.
4. In the Name field, type a new name for the case series. The name does not need
to be unique, although we recommend that you use a unique name.
5. In the Description field, leave the description or modify the description of the case
series.
• To assign the case series to an existing project click Add to existing project
7. Click OK.
Note:
When you rename a case series, the case series name attached to any
existing report outputs is not changed.
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Chapter 7
Copy a case series

One way to create a new case series is to use an existing case series as the basis
for a new one. If you copy a query-based case series, you can then edit the copy to
create the new case series.
When you copy a query-based case series, Oracle Empirica Signal uses the query
that was in effect at the time of the original case series for the copy. Any indication
of cases as Reviewed or Excluded, and any attached comments, are included in the
copy of a case series.
Note:
The copy of a case series includes any cases that were transferred or added
manually to the case series. If you re-execute the query portion of the copy
of a query-based case series, however, Oracle Empirica Signal drops those
cases from the case series if they do not meet the query criteria.
Series.
2. Click the Row Action menu ( ) for a case series, and then click Copy.
3. From the Select a configuration drop-down list, select a data configuration. By
default, the application uses the data configuration associated with the original
case series (and you must have permissions to use that configuration). If you are
copying a query-based case series, this page does not appear.
Note:
If you select a different data configuration, case IDs that match in both
data configurations are copied, but may represent different cases if the
source data for the two data configurations differs.
4. Click Next.
5. In the Name field, enter a name for the new case series. The name does not need
to be unique, although Oracle recommends that you use a unique name.
6. In the Description field, optionally leave or edit the description of the case series.
8. Click Save.
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Chapter 7
A message tells you that the case series has been copied and shows the names
of the original case series (Source), the copy of the case series (Destination), and
the number of cases in the two lists:
9. Click Continue.
Note:
The application does not copy the original publication level to the new
case series. You must publish the new case series if you want others to
see it.
Combine case series

If you have the Create Queries/Case Series permission, you can combine two or more
case series when you have two or more complex query-based case series.
Oracle Empirica Signal copies all cases in the selected case series into a new case
series, but retains the original case series selected. Oracle Empirica Signal sets the
Reviewed and Excluded statuses for all cases to null in the new case series.
Note:
To combine case series, the status of the case series that you select must
be Completed, and the cases must have the same data configuration. For
timestamped data, the application prompts you to select an As Of date.
Series.
2. Click Select Rows to enter row selection mode.
3. Select the checkboxes next to the case series that you want to combine. You must
select at least two case series.
4. Click Combine Case Series.
5. If the case series contains timestamped data, specify an As Of date.
6. In the Name field, enter a name for the new case series. The name does not need
to be unique, although we recommend that you use a unique name.
7. In the Description field, enter an informative description of the combined case
series.
9. Click Create.
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Chapter 7
Case series background processing

• What is background processing for case series?
• How does the background processing job queue for case series work?
• Background processing job status for case series
• Cancel a background processing job for a case series
What is background processing for case series?

Background processing allows processes, such as case series creation, to run without
user intervention and interruption, so that you can perform other tasks simultaneously.
Uninterrupted background processing also allows you to exit the application without
affecting job processing or completion. Background processing is a standard feature
and occurs automatically. You do not need to enable background processing.
One background processing job exists per task when you perform any of the following:
• Create a case series using the Query Wizard.
• Create a case series from an existing query.
• Edit and save a query-based case series.
How does the background processing job queue for case series work?
A background processing job queue is a temporary container that the application
creates on demand when one or more sequential jobs are awaiting background
processing. Jobs in the queue run one at a time in the order in which the application
added them to the queue. The job queue is specific to your user account, and contains
only jobs that you created. You cannot view another user's job queue, even if you are a
superuser.
Your queue can hold an unlimited number of jobs. The application adds jobs to
your queue when you perform specific case series tasks, as described in What is
background processing?. The application can add jobs while a job is running without
interrupting that job.
When a background processing job is running, you can view the job queue and the
current status of the jobs in your queue by hovering the Background Processing
indicator ( ). The Background Processing indicator appears next to your username at
the top of the page, and remains visible until there are no unprocessed jobs remaining.
You can also view the current job status for background processing jobs for individual
case series on the Case Series page. If Completed appears in the Status column,
background processing is complete.
You can cancel Running or In Queue jobs in your background processing queue from
individual case series on the Case Series page. If you are a superuser, you can also
cancel other users' jobs from these pages.
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Chapter 7
Background processing job status for case series

Case series background processing jobs can have one of the following statuses:
• In Queue—Job is awaiting processing.
• Running—Job is currently processing.
• Cancelled—Superuser or the user who submitted the job cancelled it.
• Error Occurred—Job did not finish processing. You may see this status if, for
example, the database fails during processing.
• Completed—Job finished processing successfully.
Note:
• You can cancel In Queue or Running jobs, if necessary, from the Case
Series page.
• You cannot restart Error Occurred jobs. To complete the job processing,
edit and then save the case series.
Cancel a background processing job for a case series

The Cancel action menu command is available for In Queue or Running case series
or report outputs in your background processing queue.
You can cancel these jobs at any time from the Case Series page, depending on the
job type you submitted. You cannot cancel jobs when hovering your mouse over the
Background Processing indicator.
If you are a superuser, you can:
• Cancel jobs that you submitted.
• Cancel jobs that other users submitted.
Series.
2. Locate the case series for which you submitted a background processing job. The
status in the Status column must be In Queue or Running. If you are a superuser,
you can locate the case series that another user submitted.
If necessary, hover your mouse over the Background Processing indicator, located
next to your username at the top of the page, to obtain the case series name from
your job queue. You can sort case series by status to locate In Queue or Running
jobs.
3. Click the Row Action menu ( ) next to the case series, and click Cancel.
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8
Manage report definitions and output
• About reports
• Report structure
• View existing report definitions
• Built-in reports
• Create report definitions
• Create and run interactive reports
• Work with report outputs
• Work with report graphs
About reports
Oracle Empirica Signal supports line listings and summary reports that reflect the data
found in a set of safety reports. The set of safety reports can be from:
• Case series
• Hyperlinked N in bold (such as the count of a particular product-event combination
found in run results)
• Element of a graph, such as a bar in a bar graph
• Query results
• Interactive report
Using Oracle Empirica Signal's reporting feature you can:
• Run built-in reports that are delivered with the product. You can use these reports
as is, or copy and modify them.
• Retrieve source data and present it in a tabular format.
• View graphs of report data.
• Determine which variables to use to define rows and columns of the report.
• Define break-down variables, such as counts of PTs for males and counts of PTs
for females within each age group, at multiple levels.
• Indicate how to aggregate multiple values for variables in the report.
• Create various types of reports, from line listings to summary reports that show
statistics for cross-tabulations of variables.
• Use the drill-down feature to view case details for a report that includes case IDs
or counts.
• Create a report definition. A report definition is the specification of the format of
a report and restrictions on the data that the report displays. You must have the
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Report structure
appropriate permissions to create a report definition and publish it for other users
to view.
Note:
Because reports run on source data (not data mining results), they do not
include custom terms or values created by data transformations.
Report structure
A report is a tabular display of source data, according to the specifications of a report
definition. Because data that appears in a report is source data, the report does not
contain custom terms or values created by data transformations.
A report includes one row for each variable (or combination of variables) that you
specify as a row variable in the report definition. For each row, the report includes
columns that you identify as column variables in the report definition. Each column is
called an analysis variable.
The report definition may include multiple levels of column variables, as in the
following example. A variable that groups values for another variable is called a
breakdown variable. Any row variable can be a breakdown variable, and the column
variable at the top of the report can also be a breakdown variable.
View existing report definitions

A report definition specifies:
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Built-in reports
• Which variables from the source data appear as columns in the report, and how
they are broken down based on other variables.
• Which variable or combination of variables provide unique keys for the report.
There is one row in the report for each unique key value (or key value
combination).
• How to aggregate multiple values in individual cells.
• The subset of rows that appear in the report, based on conditions specified by a
SQL WHERE clause.
For the selected project and data configuration, the Report Definitions page lists report
definitions that you created or that are published to you. If you have the Administer
Users permission, the page also lists unpublished report definitions that were created
by any user in your login group.
The Report Definitions page lists reports based on data configurations that are
compatible with the data configuration used by the selected case series.
Display the Report Definitions page
1. In the left navigation pane, hover on the Data Analysis icon ( ), then click Report
Definitions.
2. At the top of the Report Definitions page, to the right of Case Series, click
Browse.
3. On the Select Case Series page, filter the case series.
4. Select the case series to report on and click OK, or double-click on the case
series.
Display the Report Definitions page from the Case Series or Queries page
Click the Row Action menu ( ) for a case series or query, and click Report. On the
Cases page, click the Report link.
The names of valid report definitions appear in bold on the Report Definitions page.
A report definition is a valid (and, therefore, can be run) if it includes at least one row
variable and one column variable, and no error messages appear for the variables.
Filter the report definitions as necessary
1. From the Project drop-down list, select the project for which you want to view
report definitions or -- to include all projects.
2. From the Configuration drop-down list, select the data configuration for which you
want to view report definitions or -- to include all configurations.
The selected report definitions appears. See the Report Definitions page for
information about the information shown.
Built-in reports
The Oracle Empirica Signal application includes a set of built-in report definitions that
you can run from the Report Definitions page. You can also copy them and modify the
copies as needed. Only a superuser can edit the original built-in reports.
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Built-in reports
Note:
The built-in reports are available only if a data stub has been set up as
described in AERS (1q03: S) Configuration Installation Instructions (located
in the Data_Stub folder on the installation CD).
Examples of the built-in reports follow. Each heading shows the report name and
description.
Age Group: Gender [N] – Summary: Counts by Age Group by Gender
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Built-in reports
Drugs and Events – Detail: ISR, Gender, Age (years), Generic Drugs, Events
Outcome [%] – Summary: Percentages by Outcome
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Built-in reports
Report Type: SOC [N] – Summary: Counts by Report Type by SOC
Route of Administrations [N,%] – Summary: Counts and Percentages by Route

of Administration
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Built-in reports
Sample Counts – Compares a variety of report counts
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Chapter 8
Built-in reports
SOC [%] – Summary: Percentages by SOC
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Chapter 8
Built-in reports
SOC/HLGT/HLT [N] – Summary: Counts by SOC, HLGT and HLT
Source [N, %] – Summary: Counts and Percentages by Source
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Chapter 8
Built-in reports
Sources and Outcomes – Detail: ISR, Gender, Age (years), Source(s), Serious?
and Outcome(s)
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Chapter 8
Create report definitions
Year: Report Type/Seriousness [N] – Summary: Counts by Year by Report Type/

Seriousness

• Create a report definition
• Step 1: Select a case series for a report
• Step 2: Name a report definition
• Step 3: Add rows and columns to a report definition
• Step 4: Specify a data source in a report
• Step 5: Specify content details
• Step 6: Preview a report
• Step 7: Run a report and work with report data
• Step 8: Save a report output
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Chapter 8
• Work with report definitions

• Specify report attributes/descriptors
• Specify variable breakdowns
• Report background processing
Create a report definition
Note:
You must select a case series before you can run, edit, copy, or delete
a report definition (this requirement does not apply to interactive report
definitions). If you run the report, it will be only for cases in the selected
case series.
Definitions.
Browse.
• Select the case series to report on and click OK, or double-click on the case
series.
• On the Case Series page or Queries page, click the Row Action menu ( )
for a case series or query, and click Report. On the Cases page, click the
Report link.
The names of valid report definitions appear in bold font on the Report
Definitions page. A report definition is valid (and, therefore, can be run) if
it includes at least one row variable and one column variable, and no error
messages appear for the variables.
5. To create a report definition, click Create Definition.
6. In the Name for Report field, type a report name. The name does not need to be
unique, although Oracle recommends that you provide a unique and meaningful
name.
7. In the Description of Report field, type a report description that differentiates the
report definition from others on the Report Definitions page.
8. Choose one of the following to assign the report definition to a project:
• To assign the report definition to an existing project, click Add to existing
project and select from a list of projects associated with objects that you
• To create a new project and assign the report definition to it, click Add to a
9. Click Save.
Field descriptions—Report Definitions page
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Chapter 8
The Report Definitions page provides the following information about each report
definition:
Field Description
Definition Name of the report definition. If bold, the report definition
is valid to run.
Description Description of the report definition.
Project Name of the project with which the report definition is
associated.
Configuration Name of the data configuration used by the case series
on which the report definition is based.
Created By Name of the user who created the report definition.
Created Date and time when the report definition was created.
The Created By and Created fields are filled in when the
Create Definition page is completed.
Modified Date and time when the report definition was last
modified.
Modified By Name of the user who last modified the report definition.
The Modified and Modified By fields are filled in each
time the report definition is saved.
ID Identifier that was assigned automatically to the
report definition when the report definition was saved.
Each report definition ID is unique (across all report
definitions, regardless of whether or not they are
interactive) and is not re-used if the report definition is
deleted.
Category Category of the report (intended only for informational
purposes).
Error messages
An error message appears if any of the following are true:
• You have not specified breakdown details for a column breakdown variable that
has more than 10 values. (If there are 10 or fewer values, the application
automatically uses the values as distinct values for the breakdown variable.)
• You have specified breakdown details for an analysis variable.
• In a SQL WHERE clause for the report definition, one of the variables referenced
by the WHERE clause has been removed from the report definition.
• You specified breakdown details as grouped values, but there is at least one group
that includes no values.
Step 1: Select a case series for a report

On the Report Definitions page, you must select a case series before you can run,
edit, copy, or delete a report definition. If you run the report, it is only for cases from the
selected case series.
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Chapter 8
Note:
Your case series selection does not affect the Report Outputs page or the
Interactive Reports page.
Once you select a case series, only report definitions based on data configurations
that are compatible with that of the cases series appear.
Report Definitions.
2. On the Report Definitions page, accept the case series shown or click Browse to
the right of Case Series to display the Case Series page.
3. (Optional) filter the case series by Project or by Configuration.
• From the Project drop-down list, select the project you want to view the report
definitions of – or set it to view all projects.
• From the Configurations drop-down list, selct the data configuration you want
to view the report definitions of – or set it to view all configurations.
series.
The Report Definitions page appears and shows the name of the selected case
series and the number of cases in it. Cases marked as excluded as part of review
input are included in the number, but a report that you run does not include those
case.
Step 2: Name a report definition

When you have clicked Create Definition on the Report Definitions page or you have
clicked Save As while editing a report definition, you must name the report definition.
Definitions.
the right of Case Series to display the Select Case Series page and select a case
series.
3. To create a report definition, click Create Definition.
unique, although Oracle recommends that you provide a unique and meaningful
name.
6. Choose one of the following to assign the report definition to a project.
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Chapter 8
7. Click Save.
Step 3: Add rows and columns to a report definition

You specify the variables and values (from source data) to define rows and columns in
the report, the labels of report columns, and the aggregation method (such as count,
percentage, mean, or actual value) to be used to show values in the report on the Edit
Report Columns page.
A report can include columns from multiple tables. The application assumes that the
tables can be linked by the case ID. As a result, only tables containing a case ID
column are suitable for use with reports.
If you are creating a report definition, a placeholder appears for the variables that
define rows and columns for the report in a tabular display:
The following instructions do not include changing the labels of row and column
variables or changing the aggregation method. These instructions use default labels,
which are the variable names, and the default aggregation method (Value).
Access Report Definitions
Definitions.
series.
3. Click a Report Definition's Row Action menu ( ), then click Edit.

The Edit Report Columns page appears. It also provides links to the Edit Report
Attributes and Edit Report Descriptors pages.
Define the first row variable
1. To define the first row variable, click {New Row Variable} to highlight it in yellow.
2. To specify the corresponding source data variable, to the right of the Data Source
field, click Select.
3. On the Edit Data Source page, specify a data source.
4. Click OK.
The selected variable appears as the row variable.
Define the first column variable
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Chapter 8
1. To define the first column variable, click {New Column Variable} to highlight it in
yellow.
2. To specify the corresponding source data variable, next to Data Source, click
Select.
4. Click OK.
Add a row variable
1. To add a row variable, click the name of an existing row to highlight it in yellow.
2. Click Insert Left or Insert Right.
4. Click OK.
Add a column variable
1. To add a column variable, click the name of an existing column variable to
highlight it in yellow.
2. Click Insert Left, Insert Right, Insert Above, or Insert Below.
4. Click OK.
Note:
For a column breakdown variable, you are required to specify breakdown
values. If there are 10 or fewer distinct values for the variable in the source
data, the application automatically uses those values as breakdown values.
You can modify them as needed. If there are more than 10 distinct values,
a message informs you that breakdown details are missing and you must
specify them.
Specify column attributes variables

1. Add rows and columns as described above.
2. To select an aggregation method for an analysis variable, highlight the variable in
the cell.
3. Next to Content Details, click Select.
4. Specify content details.
5. Click OK.
6. To select which source values for a variable will appear in the report, highlight the
variable in the cell.
7. Next to Breakdown Details, click Select.
8. Specify breakdown details.
9. Click OK.
• You can edit report attributes, edit report descriptors, or save or run the report
definition. For an interactive report definition, you can define a query.
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Chapter 8
• To view a histogram showing the distribution of values for a numeric variable,

click View Column Statistics.
• To delete a variable, highlight the variable and click Delete. At the message
asking if you are sure you want to delete the variable, click OK. You cannot
delete the last row variable or last column variable.
Tips when specifying columns and rows
• Click Save frequently to save the report, especially when building a complex report
definition.
• Click Preview to preview the report. (This feature is not available for interactive
reports.)
• Click Undo to remove the last change you made to the report definition since you
last saved the report definition. Click Redo to add back the last undone change.
You can click Undo and Redo successive times.
Step 4: Specify a data source in a report

In a report definition, the data source of a column variable or row variable is the name
of the source database variable from which data will be retrieved for the report. You
also specify the label that will identify the variable in the report.
Note:
If a row variable's underlying column has the same name as any column
in an analysis variable's table, then a SQL inner join of the same-named
columns occurs in addition to the usual join on report ID.
Definitions.
series.

4. On the Edit Report Columns page, next to Data Source, click Select.
5. On the Edit Data Source page, in the Table field, select the name of the database
table that contains the variable that you want to use, or select All Tables.
Note:
If you want to look at all cases, use the report ID (that is, the variable
of the Report ID type in the configuration) in the demographics table. It
is possible that a report has no record in the other tables. If you are not
interested in getting all report IDs, but only those that have records in the
table from which you are getting other data, use the report ID from that
table.
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Chapter 8
6. Select a variable.
7. When you highlight a variable in the list, the Label field shows the variable name
by default. You can type in a different label, which appears in the report as the
column heading for the variable.
For example, suppose that you use default labels for the ISR_drug and
Generic_Name variables. The column headings in the report look like this:
For clarity, you could modify them as follows:
8. To change the label, select the default label and change it.
9. Click OK.
10. If you chose a numeric value, you can click View Column Statistics to display a
histogram showing the distribution of values for the variable in the source data.
Step 5: Specify content details

Content details specify how to display values of an analysis variable; that is, the
aggregation method for values. For example, you may want to show an actual value, a
count of records with a value, a percentage of records with the value, and so on. You
can specify multiple aggregation methods for an analysis variable; each aggregation
method is represented in the report.
When you add an analysis variable to a report, the term Value appears by default as
the aggregation method:
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Chapter 8
Value stands for First value, which is the default aggregation method. (It is used when
no other aggregation method is selected.) When you change the aggregation method,
an abbreviation of that aggregation method appears in the table cell. For example, if
you select Count as the aggregation method, N appears in the table cell:
Note:
If the source table for a column or row can include multiple records per case,
the count and unique count for the column or row can differ.
Percentages in the columns or rows can add up to greater than 100 percent.
For example, the breakdown variable is PT severity. Adverse events data
can include multiple records per case. Suppose that each of 10 cases has
an event with the severity Mild, an event with the severity Moderate, and an
event with the severity Severe. The count of cases with each severity is 10.
The count of cases with any severity will also be 10. So the percentage
of cases with each severity will be 10/10, which is 100%. The total of
percentages for each severity would be 300%.
Definitions.
series.
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Chapter 8

4. On the Edit Report Columns page, highlight the aggregation method that appears
in the table cell below the analysis variable. You must click the aggregation
method, not the column heading. You can choose more than one aggregation
method for a variable.
5. Next to Content Details, click Select.
6. Select the desired aggregation methods and percentages. Available aggregation
methods depend on the data type of a variable.
7. Click OK.
Aggregation methods for text or date variables
For an analysis variable with a data type of text or date, check one or more of the
following check boxes. The abbreviation appears in the report column heading.
Check box Abbreviation Meaning

Count N The number of non-NULL values.
Count (Unique) N (U) The number of unique non-NULL
values.
Row % Row % Count of non-unique values for the
row and column/Count of non-unique
values for the row for all columns.
(There must be a column for All.)
Column % Column % Count of non-unique values for the
column and row/Count of non-unique
values for the column for all rows.
(There must be a row for All.)
Overall % Overall % Count of non-unique values for the
values for all columns and all rows.
(There must be a column for All and
a row for All.)
Row % (Unique) Row % (U) Count of unique values for the row
and column/Count of unique values
for the row for all columns. (There
must be a column for All.)
Column % (Unique) Col % (U) Count of unique values for the
column and row/Count of unique
Overall % (Unique) % (U) Count of unique values for the
a row for All.)
All values ALL All values, including null values,
separated by commas. Null values
are shown as blanks, so you may
see a list of values like "DrugA, ,
DrugC".
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Chapter 8

All values (excluding NULLs) All All values except null values,
separated by commas.
Unique values ALL (U) Unique values (in ascending order),
including NULL values, separated by
commas. Null values are represented
in the list by the string "null".
Unique values (excluding NULL) All (U) Unique values (in ascending order),
excluding NULL values, separated by
commas.
Unique values and counts ALL (N) Unique values (in ascending order),
including NULL values, separated by
commas; after each value is the
count of the value. Null values are
represented in the list by the string
"null".
Unique values and counts (Excluding All (N) Unique values (in ascending order),
NULL) excluding NULL values, separated
by commas; after each value is the
count of the value.
First value Value First non-NULL value from the
database (for the case series or
query being used). If you do not
specify an aggregation method, this
method is used by default.
Aggregation methods for numeric variables

For an analysis variable with a data type of number, check one or more of the following
check boxes. The abbreviation appears in the report column heading.
Note:
If a case is counted in multiple columns or rows, a count in the All column
or row is not necessarily the same as the total of counts in other columns or
rows of the report. Also, percentages in the columns or rows can add up to
greater than 100 percent.

Count N The number of non-NULL values.
Count (Unique) N (U) The number of unique non-NULL
values.
Row % Row % Count of non-unique values for the
row and column/Count of non-unique
values for the row for all columns.
(There must be a column for All.)
Column % Col % Count of non-unique values for the
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Chapter 8

Overall % % Count of non-unique values for the
a row for All.)
Row % (Unique) Row % (U) Count of unique values for the row
and column/Count of unique values
for the row for all columns. (There
must be a column for All.)
Column % (Unique) Col % (U) Count of unique values for the
Overall % (Unique) % (U) Count of unique values for the
a row for All.)
Sum Sum The sum of the values.
Mean Mean The mean of the values.
Median Median The median of the values.
Standard Deviation SD The standard deviation of the values.
1st Quartile Q1 The first quartile of the values.
3rd Quartile Q3 The third quartile of the values.
Min Min The minimum value.
Max Max The maximum value.
For example, suppose that a report includes counts like this:
If you replace the counts in the report with row, column, and overall percentages, the
report display changes to this:
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Chapter 8
Step 6: Preview a report

Definitions.
series.

4. Create or edit a report definition.
5. Click Preview to check that the report definition is set up as you want it before you
save or run the report. The Report Preview page shows data for only the first 10
cases of the selected case series or the first 10 cases found by the query.
Note:
You can preview only a valid report definition. A report definition is valid if it
includes at least one row variable and one column variable, and there are no
error messages displayed on the Edit Report Columns page.
Step 7: Run a report and work with report data

There are several ways to run a report. Choose one of the following:
• On the Report Definitions page, select a case series. Select the Row Action
menu ( ) for the report definition, and select Run.

• When editing a report definition, click Save & Run or Run.
• On the Interactive Reports page, click an interactive report's Row Action menu
( ), and then click Run.
• On the Queries page, click a query's Row Action menu ( ), and then click
Report.
• Drill down to the Cases page, and click Report.
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Chapter 8
• You can drill down on a count or graph element elsewhere in the application to run
a report definition against cases that make up the count or are represented by the
graph element.
Oracle Empirica Signal runs the report and displays the report output.
Work with report data

• If you have the Create Report Definitions permission, you can click Edit
Definition. The Edit Report columns page appears and you can modify the
definition as needed.
• To save report output so it can be viewed later, click Save Output. (This option is
not available if you are running a report definition after drilling down.) You can also
run a report definition and save its output in a single step. For more information,
see Creating a Report Output.
• To create a new case series containing cases in the report, click Create Case
Series. This option is available only if the case IDs in the first column of the report
contains links.
• To show the report data in a graph format, click Choose Graph.
• To save the report as an attachment to a topic, click Save to Topic (available if the
topics feature has been set up).
• To print the report, click Print.
• To download report data, click Download. The column names are created from
the labels in the report definition, followed by the breakdown specifications.
• To show descriptive information below the report, click Show Notes.
Manage report rows

• To specify how many rows should display at a time, enter a number in the Rows
per Page field and press the Enter key. You can display up to 999 rows on each
page.
• To go to another page, you can do the following:
– To view the next page, click .
– To view the previous page, click .

– To view a specific page, enter a number in the Page field and press the Enter
key.
• To find specific text on a page, press Ctrl+F or select Find on this page from the
(Internet Explorer) Edit menu. For efficiency, you may want to set the Rows per
Page to a large number before using the Find feature.
Sort the report

• To sort a column, click the column header. The column is sorted, and an arrow is
order, click the column header again. The previous primary sort order (if any)
becomes the secondary sort order. The previous secondary sort order (if any)
becomes the tertiary sort order.
8-24
Chapter 8
• Click Columns or Columns and Rows. (See Arrange table columns.)
Note:
In displayed reports, sorting is case-insensitive.
Bold counts (N) are links. Click the number to display a menu from which you can
drill-down. If specific case IDs appear in the report as a link, click a case ID to view
case details.
Step 8: Save a report output

If you are displaying a report that you ran from the Report Definitions page, you have
the option to save the output so that it can be viewed later without regenerating the
report.
Definitions.
2. Click the Row Action menu ( ) for the report definition, and then click Create
Output.
3. From the configuration drop-down list, select a configuration.
The report runs against source data for the selected data configuration. When you
save the report output, the application verifies that the selected data configuration
has a Drug type variable with a subtype of Generic, Trade, or Ingredient.
4. Click Next.
5. On the Run Query page, fill in the fields and click Next.
6. Fill in the fields on the Create Output page:
7. In the Name for Output field, type a name for the saved output. The name does
not need to be unique, although Oracle recommends that you provide a unique
and meaningful name.
8. In the Output Description field, enter a description of the saved output that
differentiates the report output from entries on the Report Outputs page.
9. From the Output Category drop-down list, select Ad Hoc or Standard. The
application uses the category for organizing reports and the category is not related
to report availability. You can include a column showing report categories on the
Report Definitions and Report Outputs pages.
10. Assign the report output to a project by choosing one of the following:
• To assign the report output to an existing project, click Add to existing

• To create a new project and assign the report output to it, click Add to a new
11. Click Save.
Oracle Empirica Signal saves the report output. Modification or deletion of the report
definition does not affect the saved report output.
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Chapter 8
Note:
The current sort order of a report is not saved as part of the report output.
Work with report definitions

• Select entries using a match string
• Edit a report definition
• Copy a report definition
• Rename a report definition
• Publish a built-in or interactive report definition
• Use XML to create a report definition
Select entries using a match string

Definitions.
series.

4. On the Edit Report Columns page, next to Data Source, click Select.
Note:
If you want to look at all cases, use the report ID (that is, the variable
of the Report ID type in the configuration) in the demographics table. It
is possible that a report has no record in the other tables. If you are not
interested in getting all report IDs, but only those that have records in the
table from which you are getting other data, use the report ID from that
table.
5. In the Match String field type a string and click Find.

All entries containing that string are listed; the matching does not distinguish
between cases (upper, lower, mixed). See below for tips on how to search for
entries using the Match field.
6. To list all entries again, click Show All.
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Chapter 8
Note:
When an entry is highlighted in the list, you can go to the next
occurrence of an entry starting with a character that you type. For
example, you can highlight the first entry in the list and type “H” to go
to the first entry starting with “H”.
7. To highlight an entry, click the entry in the list.

8. You can also do the following:
• Highlight multiple non-contiguous entries: hold down the Ctrl key while clicking
each entry.
• Highlight multiple contiguous entries: click an entry, hold down the Shift key,
and click another entry.
• Entries between and including those entries are highlighted.
• Remove highlighting from an entry: hold down the Ctrl key while clicking the
selected entry.
9. To move entries back and forth between the list of all entries and the list of
selected entries, double-click a highlighted entry or use the arrow keys as follows:
Button Use To
Move highlighted entries from the list of all

entries to the list of selected entries.
Move all entries from the list of all entries to

the list of selected entries.
Move highlighted entries from the list of

selected entries to the list of available
entries.
Move all entries from the list of selected

entries to the list of available entries.
If Clear is available, you can click it to clear out the list of selected entries.
10. If up and down arrows are available for the list of selected entries, you can
use them to order the selected entries. For example, when specifying breakdown
details in a report definition, you can order the selected entries as you want them
to appear in the report.
11. When you are satisfied with the selected entries, click OK. (In some contexts, the
button may instead be Save or Copy.)
Special characters
To search for the following special characters, you must precede each special
character with a backslash (\):
+
*
8-27
Chapter 8
?
.
\
(
)
[
]
Example Description
NAUSEA \+ VOMITING NAUSEA + VOMITING
$R$ ELBOW PAIN (R) ELBOW PAIN
Match string syntax

In the Match String field, you can use the following syntax:
Syntax What Is Matched Syntax Example Found by Example

^ Letter(s) at the ^V VERTIGO VOMITING
beginning of a value. Does not find
SEVERE VOMITING.
$ Letter(s) at the end of on$ AGITATION
a value. DEPRESSION
Does not find ANEMIA
IRON DEFIC.
. Any single character. D.stonia DYSTONIA
[abcdef] Any character [gq] All terms that have
included in the set. any of the letters g or
q, including:
ANGINA FREQUENT
URINATION
\b A word boundary in a \bDr ABNORMAL
term. DREAMS DRY
MOUTH
\s White space in a term. en\s PATHOGEN
RESISTANCE
SUDDEN INFANT
DEATH SYNDROM
\s \sen ABDO ENLARGE
Edit a report definition

Definitions.
Browse.
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Chapter 8
series.
You can also select a case series or query to report on from the Case Series page,
Queries page, or Cases page.
• On the Case Series page or Queries page, click the Row Action menu ( )
for a case series or query, and click Report.
• On the Cases page, click the Report link.
The names of valid report definitions appear in bold font on the Report Definitions
page. A report definition is valid (and, therefore, can be run) if it includes at least
one row variable and one column variable, and no error messages appear for the
variables.
5. To edit a report definition, click the report definition's Row Action menu ( , and
click Edit.
Note:
You cannot edit a report definition you didn't create.
6. On the Edit Report Columns page, you can edit the report columns, the report
attributes, and the report descriptors. Click the corresponding radial button.
7. Perform your edits, then click Save. If you are working on a complex report
definition, click Save periodically.
Each time you save the report definition, Oracle Empirica Signal fills in the Modified
and Modified By columns on the Report Definitions page.
Copy a report definition

If you cannot edit a report definition, you can copy it and modify the copy as needed.
Report Definitions.
series.
3. Click a Report Definition's Row Action menu ( ), then click Copy.

unique, although we recommend that you provide a unique and meaningful name.
6. Click Save.
Edit the copy of the report definition as needed. For example, if you want to assign the
report definition to a project, edit the report definition to provide a project name on the
Report Descriptors page.
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Chapter 8
Rename a report definition

You can rename only those report definitions that you created.
1. In the left navigation pane, hover on the Data Analysis icon ( ), click Report
Definitions or Interactive Reports.
2. Select the Row Action menu ( ) for the report definition, and then click
Rename.
3. In the Name for Report field, type a name. The name does not need to be unique,
although Oracle recommends that you use a unique name.
4. In the Description of Report field, enter an informative description of the report
definition.
5. Assign the report definition to a project by choosing one of the following:
6. Click Save.
Publish a built-in or interactive report definition

Publication of a report definition is a way to make built-in and interactive reports
available to other users. By default, the publication level of every newly created object
is Private.
Note:
Definitions or Interactive Reports.
2. Click a report definition's Row Action menu ( ) and click Publish. To publish
multiple report definitions, click the Select Rows link, select the radio buttons of
the definitions, then click the Publish link.
4. Click Back.
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Chapter 8
Use XML to create a report definition

Each report definition is stored internally as XML (eXtensible Markup Language).
Superusers can create definitions using XML.
1. Log into the Oracle Empirica Signal application as a superuser.
2. Obtain the XML that you want to use. You can copy the text from the XML field on
the Edit Report Descriptors page.
Note:
Copied XML for a non-interactive report can only be used to create a
non-interactive report. Copied XML for an interactive report can only be
used to create an interactive report.
3. On the Report Definitions page, click Create Definition from XML.

4. Provide the following information. The values that you specify appear on the
Report Definitions page or Interactive Reports page, where users can sort by
them.
Column Description Notes

Name Name of the report. Required.
Description Description of the report. None
Category Category containing the Required.
report. By default, this value
is Ad Hoc. Alternatively, you
can select Standard.
Creator Name of the user who Read-only.
created the report.
Data Applies to (non-interactive) Read-only.
report definitions only.
Specifies the configuration
on which the currently
selected case series is
based.
Configuration to report Applies to interactive report Required.
definitions only. Specifies
the configuration to supply
source data when the report
is run.
Status Under Development status Read-only.
indicates that the report is
not ready to be run until you
have saved it.
5. In the XML Definition field, paste in the copied XML.

6. Click Save.
If you want to assign the report definition to a project, edit the report definition to
provide a project name on the Edit Report Descriptors page.
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Chapter 8
Specify report attributes/descriptors

• Edit report attributes
• Allow report drilldown
• Specify report restrictions
• Edit report descriptors
Edit report attributes

Definitions.
series.

4. On the Edit Report Columns page, click the Report Attributes radio button.
5. To disable drilldown for column variables in the report, click Generate drill-down
Information, then change the value of the field to No.
This option is not available for an all cases summary interactive report.
Note:
When generated, drilldown information increases the amount of memory
used for report output. For large reports, this option should be set to No.
6. To specify report restrictions, click Restrict by SQL WHERE Clause.

Only cases that meet the criteria of the Where clause that you specify are included
in the report.
7. Type the SQL WHERE clause.
8. To see the columns defined for the report, click Show Columns.
Note:
To know the list of supported SQL functions, see SQL functions.
9. Click Apply.
Select another radio button to edit report columns or edit report descriptors. You can
also save or run the report definition. For an interactive report definition, you can also
define or edit a query.
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Chapter 8
Allow report drilldown

If drill-down is allowed for reports, users can drill down on report column variables that
show counts of cases, or on elements of graphs based on such reports. If the running
of a report generates an out-of-memory error, you can turn off drilldown in the report
definition and try running the report again. When drilldown is off, less memory is used
to run the report; however, the report may take longer to run.
Note:
For an all cases summary report, this option on the Edit Report Attributes
page is not available. However, on the Drug Profiles page, users are able to
drill down on charts based on the output of this type of report.
Definitions.
series.

5. On the Edit Report Attributes page, click Generate drill-down Information.
6. To allow drilldown in reports, click Yes (the default). To disallow drilldown, click No.
Note:
Even if you click No, users can drill down to case details from a case ID that
appears as a row variable in a report.
Specify report restrictions

You can restrict a report to data that meets a specified condition by using a SQL
WHERE clause. For example, you might want the report to include only males who
reside in the United States and are between 18 and 55 years old. The application
applies the report restriction, if specified, after generating the report, but before
displaying the report.
For an interactive report, the query run as part of the report determines which cases
are included in the report. A SQL restriction, on the other hand, acts on the data for
those cases. For example, suppose you want a report that shows drug counts for
only suspect drugs. If you include a suspect drug indicator as a query variable, the
report runs against all cases including suspect drugs. Some of these cases might also
have non-suspect drugs. However, you could specify a SQL restriction to include only
suspect drugs in the report.
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Chapter 8
Note:
Columns of the type CLOB are truncated in reports. Therefore, if a column
referenced in the restriction has the type CLOB (as is typical with narrative
text), the application applies the restriction to the truncated values for that
column.
Definitions.
series.

5. On the Edit Report Attributes page, click Restrict by SQL WHERE Clause.
6. Click Show columns.
The Select Table Columns dialog box appears listing the column names and types.
7. Click the name of the column to include in the WHERE clause.
• Note the column type, so that you know what syntax is valid for that column in
the WHERE clause.
• On the Restrict by SQL WHERE Clause page, the column you selected
appears in the SQL WHERE clause field in square brackets. The Select Table
Columns page remains open, so that you can select other columns.
8. In the SQL WHERE clause field, complete the SQL condition. You might, for
example, select the AGE column (placing AGE into the field), and then type “>=65”
to restrict the report to patients who are at least 65.
9. When you are satisfied with the WHERE clause, click Apply.
If the SQL syntax is valid, the Edit Report Attributes page appears, showing the
SQL WHERE clause and the number of rows that meet the criteria of the WHERE
clause, or
if there are errors in the SQL syntax, an error message appears when you try to
run the report.
Note:
To know the list of supported SQL functions, see SQL functions.
Edit report descriptors

Definitions.
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Chapter 8
series.

4. On a Report Definitions page, such as Edit Report Columns, Edit Report
Attributes, or Edit Report Descriptors, click the Report Descriptors radio button.
5. View or modify the information shown.
Column Description
Name of Report Name of the report definition.
Description of Report Description of the report definition.
Category Category of the report definition, either
Ad Hoc or Standard. The category is for
informational purposes. You can display it
as a column on the Report Definitions page,
the Interactive Reports page, or the Report
Outputs page.
Built-in This field is available for superusers only.
It is for use by Oracle when creating built-
in report definitions, which are predefined
reports supplied with the Oracle Empirica
Signal application and available if the
appropriate data configuration has been set
up during installation. For more information,
see Built-in reports.
Type Applies to interactive reports only. One of
the following values:
• Query-based —Indicates a report
definition that includes a query. Users
can provide values to the query when
the report is run.
• Summary of all cases —Indicates
a report definition that includes all
cases and can be used by a drug
profile configuration. Reports that can
be added as charts on the Drug Profiles
page are based on this type of report.
If you are a superuser, this field can also
show a customer-specific report that has
been provided by Oracle.
Project You can assign the report to an existing
project by clicking Add to existing project
and selecting the project from the drop-
down list containing projects associated
with objects that you created or that are
published to you.
To create a new project and assign the
report to it, click Add to a new project
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Chapter 8
Column Description
Status Ready or Under Development.
If the report definition can be run,
the application applies the Ready status
denoting that the report definition is valid. A
report definition is valid if it has at least one
row variable, at least one column variable,
and no error messages appear for report
variables. For a query-based report, a query
must be part of the report definition. For
an all cases summary report, the definition
must conform to certain criteria.
If the report definition is not ready to be run,
the application assigns it the status Under
Development.
Configuration Description of the source data of the report
definition.
XML This field is available for superusers only.
You can copy and paste this XML to create a
report using XML.
6. Click Save.
Specify variable breakdowns

• Define breakdown details
• Define breakdown by distinct values
• Define breakdown by individual values
• Edit individual value labels
• Define breakdown by grouped values
• Cutpoints
• Define breakdown by cutpoints
• View column statistics
• Define breakdown by query values
Define breakdown details

Breakdown details are the specification of values for a breakdown variable. If a
breakdown variable is a text or date variable, you can define breakdown details using
individual selected values, distinct values, or grouped values. If a breakdown variable
is a numeric variable, you define breakdown details using cutpoints. For an interactive
report, you can define a query whose user-supplied values are used as breakdown
details when the report is run.
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Chapter 8
Note:
If there are 10 or fewer values for a column breakdown value, the application
uses them by default as distinct values for the breakdown variable. For a row
variable, the application uses all values by default as distinct values for the
breakdown variable. You can modify these default breakdowns as needed.
Definitions.
series.

4. On the Edit Report Columns page, next to Breakdown Details, click Select.
5. Select the breakdown type by selecting the Every Distinct Value, Individual Values,
Grouped Values, or Query Values radio button.
• To define breakdown details by distinct value, see Defining breakdown by
distinct values. The report includes a column or row for every distinct (unique)
value of the variable. This option uses the values available at the time you run
the report, not at the time you define it.
• To define breakdown details by individual values, see Defining breakdown by
individual values. The report includes a column or row for every value that you
select. This option results in a static list of breakdown values that does not
automatically adjust to changing source data.
• To define breakdown details by grouped values, see Defining breakdown by
grouped values. The report includes a column or row for every group that you
define.
• To define breakdown details by query values, see Defining breakdown by
query values. This choice allows you to substitute values from the query that is
run as part of an interactive report.
• To define breakdown details for a numeric variable, see Defining breakdown
by cutpoints.
6. Click OK.
Report performance with breakdown details
The performance of a report with breakdown details can depend on whether the
analysis variable that you use comes from the same source table as the row variables.
If the analysis variable is from the same table as the row variables, the performance of
a report definition with breakdown details is much faster. This may be important when
you are working with a sizeable case series (containing 5,000 or more cases). The
speed difference is several orders of magnitude. When possible, select the analysis
variable from the same table as the row variables.
All column
For a breakdown variable, you can include a category for All values. The All column is
not based on values for other columns in the report. For example, if the report shows
counts, the All column is not a total of counts for the other columns.
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Chapter 8
In the following example, the same case may have PTs in both the Card SOC and
Other SOCs:
PT: Sex SOC: Card - Cases SOC: Other - Cases SOC: Null- Cases SOC: All - Cases
N(U) N(U) N(U) N(U)
F 5000 11000 0 12000
M 6000 13000 0 16500
The N (U) value for the All column and F row is not 5000 + 11000. The value in the All
column is:
• 4000 who have a PT in the Card SOC and a PT in other SOCs.
• + 1000 who have a PT in the Card SOC only.
• + 7000 (computed as 11000 - 4000) who have a PT in any SOCs except Card.
• = 12000.
Example
For example, you want a summary of the number of cases for each report type (direct,
expedited, and periodic). For your report definition, you set up the FDA Year as the
row variable and you specify Report Type as the column variable. You then need to
specify the value you want to show for each report type; that is, the analysis variable.
You specify CASE_ID as the analysis variable, label it as Cases, and select the Count
aggregation method.
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Chapter 8
Define breakdown by distinct values

In the Breakdown Details dialog box, if you click Every Distinct Value, the report
includes a column or row for every distinct (unique) value of the variable. This option
uses the values available at the time the report is run, not at the time you define the
report.
Definitions.
series.
8-39
Chapter 8

5. In the Breakdown Details dialog box, click Every Distinct Value.
6. To include a column or row in the report to represent all values for the variable
(including null values if Include a category for Null values is checked),
check Include a category for ALL selected values. For reports that display
percentages, the report must include a row or column for All.
Note:
If a case is counted in multiple columns or rows, a count in the All
column or row is not necessarily the same as the total of counts in other
columns or rows of the report. Also, percentages in the columns or rows
may add up to greater than 100 percent.
7. To include a column or row to represent null (missing) values for the variable,
check Include a category for Null values.
8. Click OK.
Example
In the following example, the All row shows the number of cases with any of the
Gender values for each Age Group. The All column shows the number of cases with
any Age Group for each Gender. Also, the NULL column shows the number of cases
(in this example, none) that have no Age Group for each Gender.
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Chapter 8
Note:
See Specifying Content Details for information about the behavior of the All
row when unique counts are shown for column variables.
Define breakdown by individual values

In the Breakdown Details dialog box, if you click Individual Values, the report includes
a column or row for every value that you select. This option results in a static list of
breakdown values that does not automatically adjust to changing source data.
Note:
If there are more than 20,000 available values for the breakdown variable,
you cannot use a breakdown by individual values.
Definitions.
series.

5. In the Breakdown Details dialog box, click Individual Values.
7. To include a column or row in the report to represent all selected values for the
variable (including null values if Include a category for Null values is checked),
check Include a category for ALL selected values. For reports that display
percentages, the report must include a row or column for All.
Note:
If a case is counted in multiple columns or rows, a count in the All
column or row is not necessarily the same as the total of counts in other
columns or rows of the report. Also, percentages in the columns or rows
may add up to greater than 100 percent.
8. To include a column or row for values that are not represented by any other
columns, check Include a category for all unselected values.
9. From the All Values list, select values for the variable.
• To find a value, you can type a string into the Find field, then click Find.
All values containing that string appear. The matching does not distinguish
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Chapter 8
between cases (upper, lower, mixed). To list all values again, you can click
Show All.
• To search for the following special characters, you must precede each special
character with a backslash (\): + * ? . \ ( ) [ ]
Note:
When a value is highlighted in the list, you can go to the next occurrence
of a value starting with a character that you type. For example, you can
highlight the first value in the list and type H to go to the first value
starting with H.
10. Highlight one or more values in the list of all values. You can also do the following:
• To highlight multiple non-contiguous values, hold down the Ctrl key while
clicking each value.
• To highlight multiple contiguous values, click a value, hold down the Shift
key, and click another value. Values between and including those values are
highlighted.
selected value.
• To move values back and forth between the list of all values and the list of
selected values, you can double-click a highlighted value or use the arrow
keys as follows:
Button Use To
Move highlighted values from the list of all

values to the list of selected entries.
Move all values from the list of all values

to the list of selected values.
Removes highlighted values from the list

of selected values.
Removes all values from the list of

selected values.
– If Clear is available, you can click it to clear out the list of selected values.
– If up and down arrows are available for the list of selected values, you can
use them to order the selected values as you want them to appear in the
report.
11. From the Breakdown values order field, select the breakdown values order.
• To sort the values in ascending order, click Sorted.

• To show values in the order in which they appear in the Selected Values list,
click Listed order.
12. When you are satisfied with the Selected Values list, click OK.
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Chapter 8
The Edit Report Columns page shows the selected values. Click Save to save
your report definition so far.
13. To edit value labels for breakdown values, in the Breakdown Details section, click
Edit Labels.
14. Click OK.
Example
The following example shows a report in which three different SOCs were selected:
In the following example, the All row shows the number of cases with any of the
Gender values for each SOC. The All column shows the number of cases with any
of the SOCs for each Gender. The Null column shows the number of cases (in this
example, none) with no SOC for each Gender. All SOCs that are not any of the three
selected SOCs are represented by the Other column:
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Chapter 8
Note:
See Specifying content details for information about the behavior of the All
row when unique counts are shown for column variables.
Edit individual value labels

If you define breakdown details using individual values, the default labels for values
are the exact values from the source data. You can modify the labels that appear in the
report. Editing the labels has no effect on the source data.
Note:
When you add reports as charts on the Drug Profiles page, the configuration
variable name is always used in the reports, instead of any specified labels
from the report definition (the all cases summary interactive report).
Definitions.
series.

4. On the Edit Report Columns page, next to Breakdown Details, click Edit Labels.
Each value that you have selected appears in the Value column.
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Chapter 8
5. In the Label field for any of the values, type in a different label.
6. Click OK.
The modified labels are shown on the Edit Report Columns page.
Define breakdown by grouped values

If you click Grouped Values in the Breakdown Details window, the report will include
a column or row for every group that you define. This option results in a static list of
breakdown values that does not automatically adjust to changing source data.
Note:
If there are more than 20,000 available values for the breakdown variable,
you cannot use a breakdown by grouped values.
Definitions.
series.
3. Click a Report Definition's Row Action menu, then click Edit.
5. In the Breakdown Details window, click Grouped Values.
6. Next to the Groups field, click New.
A message asks for the new group's name.
7. Enter a name for the new group, and click OK.
9. From the All Values list, select values to include in the group.
10. Create other groups and select values to be included in them. Make sure that each
group includes at least one value.
11. From the Breakdown values order field, select the breakdown values order:
13. When you are satisfied with the groups and other options, click OK.
14. The Edit Definition page shows the selected values. Click Save to save your report
definition so far.
Note:
You cannot save the report definition if all groups are empty (that is, have no
values in them). If some groups are empty, the report definition is saved and
the empty groups are ignored.
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Cutpoints
If you are defining breakdown details for a numeric variable, you must define cutpoints.
Cutpoints are consecutive, user-defined value ranges that categorize data for both
numeric and date variables. You use cutpoints to subset data, which allows you to
group specific portions of data that are of interest to your organization. You define
cutpoints for both numeric and date variables when you define breakdown details in a
report definition.
For example, suppose that you want to create a report definition that includes the
number of deaths that occurred:
• Before 2009
• During 2009
• After 2009
You could then define the following cutpoints for the Death Date variable in the
Breakdown Details dialog box:
You can define cutpoints for both row variables and column variables in report
definitions.
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Note:
You can also define cutpoints when you specify a data transformation for
a data configuration variable. For more information, see Defining variable
cutpoints.
With the numeric variable highlighted on the Edit Report Columns page, you can click
View Column Statistics to view a histogram of variable values.
Defining date cutpoints

You define cutpoints for date variables in report definition breakdown details as you
would define cutpoints for numeric variables. When you define cutpoints for dates, you
must ensure that you enter dates in the format MM/DD/YYYY. You must ensure that
you enter non-breaking and consecutive date ranges. You cannot set cutpoints with
gaps in the ranges.
In defining cutpoints, you may encounter the following cases:
• Cutpoints appear in the report output in alphabetical order by label name, rather
than chronological date order.
• The Save button may become inaccessible. To correct the situation, place the
cursor in the last available Value field, and then press Tab until you reach the
Save button.
Existing report definitions and date variables

Prior to Oracle Empirica Signal 7.3.337, you specified breakdown details for date
variables by Individual Values or by Grouped Values. Report definitions created prior
to Oracle Empirica Signal 7.3.337 continue to maintain the previous date variable
functionality. To define breakdown details by cutpoints for these reports, you must
delete the date variables, and then re-add them to the reports.
For information on deleting variables from breakdown details, see Edit report columns.
Adding additional rows

When you define cutpoints, a limited number of rows are available for date and label
entry. Should you require additional rows, do the following:
1. Click Save.
2. Click Select next to the Breakdown Details field.
The Breakdown Details dialog box reopens with additional rows available.
Define breakdown by cutpoints

If you are defining breakdown details for a numeric variable, you must define cutpoints.
To define cutpoints, you specify ranges of numbers by indicating their boundaries. This
option uses the values available at the time the report is run, not at the time you define
the report.
With the numeric variable highlighted on the Edit Report Columns page, you can click
View Column Statistics to view a histogram of variable values.
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Report Definitions.
series.

5. In the first value field (after VALUE <=), enter the maximum value for the first
category.
6. Enter a label for the value.
7. In the next row, in the Value field, enter the maximum value for the second
category. (The cutpoint values must be in ascending order.)
8. Enter a label.
9. Continue defining categories until you are ready to define the last category.
10. For the last category, enter only a label. Do not enter a value. This is the label for
all values greater than the previous cutpoint.
11. To include a column or row to represent null values for the variable, check Include
a category for NULL values.
12. To include a column or row to represent all values for the variable (including
null values if Include a category for NULL values is checked), check Include
a category for ALL selected values. For reports that display percentages, the
report must include a row or column for All.
13. When you are satisfied with the cutpoints, click Save.
The Edit Report Columns page shows the selected values. Click Save to save your
report definition so far.
View column statistics

When you are adding a column for a numeric variable to a report definition on the Edit
Data Source dialog box, or defining cutpoints for a numeric or date variable in a data
configuration on the Cutpoints for Variable dialog box, you can click View Column
Statistics to view information about the distribution of values for the variable in the
source data.
The following information is provided for numeric and date variables:
• A histogram—A graph of grouped (binned) data showing frequency distribution.
The x-axis represents values from the source data and the y-axis represents
counts of cases. A shaded rectangular block in the graph represents each bin. A
bin is a range of x-axis values. The top of each block indicates the count of cases
for the bin.
• Minimum—Minimum value.
• Maximum—Maximum value.
• Distinct Values—Number of distinct values.
• Total Values—Total number of values.
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The following additional information is provided for date variables:

• Average—Average value.
• Standard Deviation—Standard deviation of values.
• Variance—Variance of values.
When you point to a block in the histogram, the following information appears:
• The range of x-axis values for the bin.
• The cumulative count of cases with that range of values.
• The cumulative percentage of cases with that range of values.
Define breakdown by query values

When you create an interactive report definition, you define a query that will be run
when the report is run. The report is run against the cases found by the query. You
can set up a breakdown variable to use user-specified query values as the breakdown
details. For example, you can define a report that uses user-specified values for
Outcome as breakdown values.
Note:
You cannot define breakdown by query values for numeric or date variables.
Definitions.
series.

5. In the Breakdown Details dialog box, click Query Values.
check Include a category for NULL values.
7. To include a column or row in the report to represent all the values provided to the
query, including null values, check Include a category for ALL selected values.
For reports that display percentages, the report must include a row or column for
All.
Note:
If a case is counted in multiple columns, a count in the All column is
not necessarily the same as the total of counts in other columns of the
report.
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9. Click OK.
Make sure that the query for the report definition includes the breakdown variable.
Report background processing

• About background processing for reports
• About background processing job queues for reports
• About background processing job status for reports
• View background processing job status for reports
• Cancel a background processing job for a report
About background processing for reports

Background processing allows processes, such as reports, to run without user
intervention and interruption, so that you can perform other tasks simultaneously.
Uninterrupted background processing also allows you to exit the application without
affecting job processing or completion. Background processing is a standard feature
and occurs automatically. You do not need to enable background processing.
One background processing job exists per task when you perform any of the following:
• Create output from a report definition.
• Create output from an interactive report definition.
• Create and edit an interactive report definition.
Note:
Background processing does not occur for query-based interactive report
outputs.
About background processing job queues for reports

A background processing job queue is a temporary container that the application
creates on demand when one or more sequential jobs are awaiting background
processing. Jobs in the queue run one at a time in the order in which the application
added them to the queue. The job queue is specific to your user account, and contains
only jobs that you created. You cannot view another user's job queue, even if you are a
superuser.
Your queue can hold an unlimited number of jobs. The application adds jobs to your
queue when you perform specific report tasks, as described in About background
processing. The application can add jobs while a job is running without interrupting
that job.
When a background processing job is running, you can view the job queue and the
current status of the jobs in your queue by hovering the Background Processing
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indicator ( ). The Background Processing indicator appears next your username at

the top of the page, and remains visible until there are no unprocessed jobs remaining.
You can cancel Running or In Queue jobs in your background processing queue from
individual cases from individual report outputs on the Report Outputs page. If you are
a superuser, you can also cancel other users' jobs from these pages.
About background processing job status for reports

Report background processing jobs can have one of the following statuses:
• In Queue—Job is awaiting processing.
• Running—Job is currently processing.
• Cancelled—Superuser or the user who submitted the job cancelled it.
• Error Occurred—Job did not finish processing. You may see this status if, for
example, the database fails during processing.
• Completed—Job finished processing successfully.
Note:
You can cancel In Queue or Running jobs, if necessary, from the Report
Outputs page.
You cannot restart Error Occurred jobs. To complete the job processing,
create a new report output from the report definition.
View background processing job status for reports

You can view the current job status for background processing jobs:
• On the Report Outputs page, in the Status column.
• By hovering over the Background Processing indicator.
For information on background processing job status, see About background
processing job status.
Cancel a background processing job for a report

The Cancel action menu command is available for In Queue or Running case series
or report outputs in your background processing queue. You can cancel these jobs
at any time from the Report Outputs page, depending on the job type you submitted.
You cannot cancel jobs when hovering your mouse over the Background Processing
indicator.
If you are a superuser, you can:
• Cancel jobs that you submitted.
• Cancel jobs that other users submitted.
• Cancel other users' jobs on the Report Outputs page.
To cancel a report background processing job:
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Create and run interactive reports
Outputs.
2. Click Report Outputs.
3. Locate the report output for which you submitted a background processing job.
The status in the Status column is Running. If you are a superuser, you can locate
the report output that another user submitted.
4. If necessary, mouse over to the Background Processing indicator located next to
your username at the top of the page to obtain the report output name from your
job queue.
5. Click the report output's Row Action menu ( ), and click Cancel.
Oracle Empirica Signal cancels the job and sets the report output status to Cancelled.

• About interactive reports
• Interactive Reports page
• Create or edit an interactive report definition
• Run an interactive report
• Create a report definition file
• Run a report using a report definition file
• Query-based interactive reports
• Summary of all cases interactive reports
• Manage interactive reports
About interactive reports

Oracle Empirica Signal provides three types of interactive reports:
• Query-based—Reports are based on a query for which you can provide values.
The application runs the report against the cases found by the query. You can use
the query values as breakdown details in the report.
• Summary of all cases—Reports include all cases and generates a report output
that can be used as the source data for the tables and graphs in drug profiles.
• Customer-specific—Reports provided by Oracle.
Interactive report definitions

An interactive report definition specifies:
• Variables from the source data to appear as columns in the report. The definition
also specifies how data is broken down based on other variables.
• A variable or combination of variables that provide unique keys for the report. The
report has a row for each unique key value, or key value combination.
• How to aggregate multiple values in individual cells.
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• The subset of rows to appear in the report, based on conditions specified by a

SQL WHERE clause.
• Queries for query-based interactive reports.
Valid report definitions

The names of valid report definitions appear in bold. A report definition is valid if it
includes at least one row variable and one column variable, and no error messages
appear for report variables. For a query-based report, a query must be part of the
report definition. For an all cases summary report, the definition must conform to
certain criteria.
Interactive Reports page

On the Interactive Reports page, you can view interactive report definitions that you
created or were published to you for select projects and data configurations. This page
also lists all published and unpublished interactive report definitions created by users
in your login group, if you have the Administer Users permission.
General activities
The following links appear at the top of the page and affect the entire page:
• Create Definition
• Create Definition from XML
• Columns
• Print
• Download
Note:
The Create Definition from XML link is only available for users with the
superuser permission.
The following filters appear at the top of the page and affect the report definition list:
• Project
• Configuration
The following menu options are available from the Row Action menu, located in the
first column of the table, and affect an individual row in the table:
• Run
• Create Output (See Creating an all cases summary report output or Creating a
query-based report output.)
• Create Definition File
• Edit
• Rename
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• Copy
• Publish
• Delete
The Create Output Row Action menu option appears only for valid report definitions of
type Query-based or Summary of all cases.
The Copy Row Action menu option appears only if you have the Create Report
permission. This option is available for report definitions created by other users. You
cannot edit such report definitions, but you can copy and modify them.
Field descriptions—Interactive Reports page
Field Description
Definition Name of the interactive report definition.
Description Description of the interactive report definition.
Project Name of the project that the interactive report
definition is associated.
Configuration Name of the data configuration that the
interactive report definition is based on.
Created By Name of the user who created the interactive
report definition.
Created Date and time when the interactive report
definition was created.
The Created By and Created fields are filled in
when the Create Definition page is completed.
Modified Date and time the interactive report definition
was last modified.
Modified By Name of the user who last modified the
interactive report definition.
The Modified and Modified By fields are filled
in each time the report definition is saved.
ID Identifier that was assigned automatically to
the interactive report definition when it was
saved. Each report definition ID is unique
across all report definitions and is not reused if
the report definition is deleted.
Category Category of the report. The category is
intended only for informational purposes.
Type Type of report. For example, Query-based or
Summary of all Cases.
Create or edit an interactive report definition

Interactive Reports.
Output.
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4. Click Next.
• Name for Output—Name for the saved output. The name does not need
to be unique, although Oracle recommends that you provide a unique and
meaningful name.
• Output Description—Description of the saved output that differentiates the
report output from entries on the Report Outputs page.
• Output Category—Type of report output: Ad Hoc or Standard. The
application uses the category for organizing reports and the category is
not related to report availability. You can include a column showing report
categories on the Report Outputs pages.
7. Select an option for assigning the report output to a project:
• Add to existing project—Assign the report output to an existing project by
selecting from a list of projects associated with objects that you created or that
• Add to a new project named—Create a new project and assign the report
output to it.
8. Click Save.
• For a query-based interactive report, the Edit Report Query page appears. You
must define a query. (If you are editing the report definition, click the Query
option.)
• For a Summary of all Cases interactive report, the Edit Report Columns page
appears. If you are defining an all cases summary report, the report definition
is not valid until certain requirements have been met. See About All Cases
Summary reports.
The Edit Report Columns page appears. From this page, you can edit the report
columns, the report attributes, and the report descriptors.
The application also saves the interactive report definition and lists it on the
Interactive Report Definitions page filling in the Created By and Created columns,
although you cannot yet run it.
When defining breakdown details for a report variable that you included in the
query for the report, you can specify that the breakdown details will be the values
provided for the query variable when the report is run. See Defining breakdown by
query values.
9. Optionally, edit the report attributes.
10. Optionally, edit the report descriptors.
11. If you have made changes to an interactive report definition since the last time
it was saved, save the interactive report definition without running it by clicking
Save. If you are working on a complex report definition, click Save periodically.
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Note:
If you edit a report definition that you did not create, the Save button
does not appear.
• To save the interactive report definition with a different name, without running
it, click Save As. Provide a name for the new report definition.
• Save the interactive report definition and run it. For a valid report definition,
click Save & Run. A report is considered valid if it includes at least one row
variable and one column variable, and there are no error messages for the
report definition. For a query-based interactive report, a query must be part of
the report definition. For an all cases summary interactive report, the definition
must conform to certain criteria.
12. To run the report definition, for a valid report definition, click Run. A report is
considered valid if it includes at least one row variable and one column variable,
and there are no error messages for the report definition. For a query-based
interactive report, a query must be part of the report definition. For an all cases
summary interactive report, the definition must conform to certain criteria.
• If you run the report, you must select a data configuration to indicate the
source data against which the report will be run.
• To run a query-based report, you must also run the query. The report will be
run against cases that meet the query criteria.
• To run an all cases summary report, you must specify report parameters.
• Each time you save the report definition, the application fills in the Modified
and Modified By columns on the Interactive Reports page.
Run an interactive report

You can run a report definition and save its output in a single step.
• For a query-based interactive report, you must select a data configuration and run
a query. The application runs the query and the report against source data for
that data configuration. The report is run against only cases that meet the query
criteria.
• When you view a query-based report from the Interactive Reports page, you select
a data configuration against which to run a query. The source data for the report is
the set of cases in the selected data configuration that match the report's query.
2. Click the Row Action menu ( ) for the report definition, and then click Run.
4. Click Next.
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Oracle Empirica Signal runs the report and displays the report output.
Create a report definition file

If you are a superuser, you can create a report definition file from a valid All Cases
Summary report.
2. Select the Row Action menu ( ), and click Create Definition File.
3. From the Configuration drop-down list, select a data configuration to indicate the
source data on which to base the report. You can click Browse to select from a
descriptive list of data configurations.
4. In the Name for Output field, type a report name.
5. In the Output Description field, type a description.
6. Assign the report definition to a project.
Only the Add to existing project: option should be used. If the selected project,
based on its ID, exists on the instance in which the report is run, the report output
is placed in that project. If the project doesn’t exist on the instance in which the
report is run, the output can go into the Unassigned project. The Add to new
project named: has no affect.
7. Click Save.
The Input File page appears. The page displays the content that you can use in a
report definition file.
Run a report using a report definition file

If you are a superuser, you can create a report definition file from a valid All Cases
Summary report. You can copy the content of the Input File page into a text file
and save the file using the extension .in. You can then place the file in the input
folder of the application server in order to be processed by the Oracle Empirica
Signal application. The input folder is located in the path defined by temp_dir in
webvdme.properties.
The input file (report definition file) contains the following information.
Line in the Report Definition File Description

#datetime Date and time of creation of the report
definition file. The comments are preceded by
#.
ACTION=CREATE REPORT Represents the type of batch file. Reports
appear as CREATE REPORT. Data mining
runs appear as CREATE RUN.
Description Description of the report definition used with
Create Definition File.
Name Name of the report definition used with Create
Definition File.
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Owner Owner of the report definition used with Create
Definition File.
Project_id Project ID of the report definition used with
Create Definition File. The Report Batch Runs
page relies on the project ID.
Type 0
Report.classname com.lincolntechnologies.webvdme.reports.batc
h.RunAllCasesReportProc
Report.configuration Configuration on which the report runs. If the
configuration does not exist when the batch
report is run, an error message displays:
Configuration named ‘<configuration
name>' does not exist
Report.name Name of the report definition used with Create
Definition File. The same name will appear in
the Definition column of Report Output.
Note:
For consistency
in report outputs
that rely on a
report definition
coming from
another instance,
the report.name
should match the
value of
Name\="All Drug
Summary
Report" in XML.
Report.output_name Name entered on the Create Definition File

page. This name is used as Output in the
Report Output table.
Report.output_description Description entered on the Create Definition
File page. This description is used as
Description in the Report Output table.
Report.project_id ID of an existing project selected on the source
server. It can be used as a filter on the Report
Batch Runs page.
If the file is to be used on an instance other
than the one on which it was created, it is
unlikely that the ID is on the receiving server.
Omit or assign 0.
Report.reportid Report ID of the report definition used with
Create Definition File. This line should be
removed in order to force use of the XML
referenced by report.reportxml, especially if
the file is to be used on an instance other than
the one on which it was created.
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Report.reportxml XML of the report definition used with Create
Definition File.

report.Project\ Name If the specified project name exists on the
server on which report is ultimately run, the
report output is placed in that project. Else,
the report output is assigned to project with ID
matching report.project_id.
report.Alias\ Names Report Output Alias. If the Report Output Alias
exists, it is updated with Report.output_name.
If the Report Output Alias does not exist, it is
created and assigned the specified value.
Query-based interactive reports

• Define a query for an interactive report definition
• Create a query-based report output
Define a query for an interactive report definition

A query-based interactive report has a query associated with it. When the user runs
the report, the user specifies values for the variables in the query. The application then
runs the report against cases that meet the criteria of the query.
2. Click Create Definition.
3. From the Configuration drop-down list, select a data configuration to indicate the
source data on which to base the report. You can click Browse to select from a
descriptive list of data configurations.
4. In the Name field, type a report name. The name does not need to be unique,
although Oracle recommends that you provide a unique and meaningful name.
5. In the Description field, type a description that differentiates the report definition
from others on the Interactive Report Definitions page.
6. Assign the report definition to a project.
7. Click Save.
The Edit Report Query page appears. You can also display the page by clicking
Query on other pages of the interactive report definition.
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8. To create a new query, choose one of the following:

• To use the Query Wizard, click Create Using Query Wizard.
The Define Query page appears. For more information, see Defining a query.
• To create a query based on an existing query, click Create from Existing
Query.
The Select Query from Library page appears. Subsequent changes to the
query in the library do not affect the report. For more information, see Defining
a query.
The defined query appears on the Edit Report Query page in the Query field.
Note:
If you saved the query to the library and then you edit from this page,
your changes are not saved to the library. If the query includes a variable
that you want to use as a breakdown variable in the report, remember to
set up the breakdown details to use query values.
Breakdown details
If you want user-specified values from a query to be used as breakdown details for a
report column or row, you must do both of the following:
• Include the breakdown variable in the query.
• Specify Query Values for the variable's breakdown details.
If you set up a breakdown variable to use query values but you do not include
the variable in the query that is part of the report definition, the application cannot
determine the breakdown values. If a column or row variable has no breakdown
values, the application drops it when running the report. If this results in a report
without rows or columns, the report cannot be run.
If you include a breakdown variable in the query but do not set up the breakdown
variable to use query values, the application uses any values that a user specifies for
the query to select cases to include in the report, but does not use those values as
breakdown details. For example, the query is for generic name and generic name is a
breakdown variable with Every Distinct Value specified for breakdown details. If the
user specifies DrugA as the query value, the report includes only cases with DrugA,
and it includes a column for each value of generic name for those cases.
Create a query-based report output

You can run a query-based report definition and save its output in a single step.
Output.
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4. Click Next.
5. On the Run Query page, fill in the fields, and click Next.
meaningful name.
output to it.
8. Click Save.
Oracle Empirica Signal submits the report output to your background processing job
queue, and the Background Processing indicator appears next to the Preferences link.
Summary of all cases interactive reports

• About all cases summary reports
• Create an all cases summary report output
About all cases summary reports

An all cases summary report runs on all cases in a specific data configuration. You
can select report outputs from this report type in the Report Output field in a drug
profile configuration. You can also add a report chart to a drug profile layout for each
breakdown variable in the report definition.
To create this type of report, you create an interactive report, and then select the report
type, Summary of all cases. The report definition is not valid until all of the following
criteria are true:
• There is only one row variable.
• The row variable is based on a data configuration variable with the variable type
Drug and the variable subtype Generic, Ingredient, or Trade.
• To support reports for all three subtypes on the Drug Profiles page, you can create
a different All Cases Summary report for each of the three subtypes.
• Breakdown variables are based on variables for which the Oracle data type of the
underlying database column is VARCHAR2 or CHAR.
• The Every Distinct Value radio button is selected in breakdown details for the row
variable.
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• There is at least one column breakdown variable.

• Each column contains both a breakdown variable and an analysis variable.
We recommend that the breakdown variable and the analysis variable be from the
same source table. You cannot use a continuous variable as a breakdown variable.
The breakdown details for each column breakdown variable are:
• The Every Distinct Value radio button is selected.
• The Include a category for NULL values check box is selected.
• The Include a category for ALL selected values is deselected.
• The content detail for the analysis variable is specified as Count (Unique).
If the report does not meet all criteria, a message appears below the report, indicating
that the report is not valid. The exception to this is that the check for the drug variable
subtype is not performed until you run the report.
Example
The following example shows a report definition for an All Cases Summary report:
Available report charts in a drug profile include Distribution of <variable-name>, where

<variable-name> is the label of the breakdown variable from the report definition. The
label may differ from the variable name.
Report output for this report definition makes the following report charts available to
add to a drug profile layout:
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Create an all cases summary report output

You can run an all cases summary report definition and save its output in a single step.
Output.
4. Click Next.
meaningful name.
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output to it.
8. Click Save.
Manage interactive reports

• View an interactive report definition
• Delete an interactive report definition
View an interactive report definition

Note:
You do not need to select a case series to work with these reports. If a
case series is selected, it is not used for the interactive report.
2. Select the report definition's Row Action menu ( ), and click Run.
Note:
For a query-based report or an all cases summary report, you must
select a data configuration from a list of compatible data configurations.
3. For a query-based report, you must also run the query.

4. For an all cases summary report, you must specify report parameters.
Delete an interactive report definition

2. Select the report definition's Row Action menu ( ), and select Delete.
The Interactive Reports page refreshes with the updated list. Any report that
was created using the deleted report definition remains accessible on the Report
Outputs page.
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Work with report outputs

• View existing report outputs
• Rename a report output
• Work with a report output
View existing report outputs

A report output is the result of applying a report definition to the cases in a selected
case series or found by a query, and saving the result. A report output is static. If there
is a change in a report definition or the set of cases against which the report was run
to produce the output, you can run the report again and save another report output.
When you run a report, you can name and save the output. You can view the saved
output without any need to rerun the report. Once report output is saved, it remains
available until you explicitly delete it. Modification or deletion of the report definition,
or of the case series or query on which the report was based, do not affect the saved
report output.
For the selected project and data configuration, the Report Outputs page shows
report outputs that you have created or that are published to you. If you have the
Administer Users permission, the page also lists published and unpublished report
outputs created by any users in your login group.
Outputs.
report outputs or -- to include all projects.
3. From the Configuration drop-down list, select the data configuration from which
you want to view report outputs or -- to include all configurations.
Oracle Empirica Signal provides the following information about each report output:
Column Description
Output Name of the saved output.
Description Description of the saved output, if provided.
Project Name of the project associated with the report
output.
Configuration Name of the data configuration used by
the case series or query to run the report
definition.
Case Series Applies to non-interactive reports. Name of the
case series for which the report was run.
Created By Name of the user who saved the report output.
Created Date and time when the report output was
saved.
Status The current status of the background
processing job.
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Column Description
As Of As Of date of the case series or query
for which the report definition was run.
Appears only if the data configuration supports
timestamp data.
For output from an interactive report: As Of
date selected when the report was run.
Category Category of the report. The category is for
informational purposes.
Definition Name of the report definition.
ID Identifier that was assigned automatically to
the report output when the report output was
saved. Each report output ID is unique and is
not re-used if the report output is deleted.
General activities
• For information about viewing, printing, or downloading tables or changing the way
data displays in the table, see About tables.
• To print, download, delete, or publish multiple report outputs, click Select Rows
and check the report outputs on which you want to act.
• To check all rows, click Select All (or Clear All to uncheck all rows), then click the
action that you want to perform on the selected rows.
If you click the Row Action menu ( ) for a report output, you can do the following:
• To view the report output, click View.
• To rename the report output that you created, click Rename.
Note:
When you rename a report output that is the target of an alias, the
application updates the name of the alias target
• To cancel a Running or In Queue report output background processing job, click

Cancel.
– The Cancel option is available only when a background processing job exists
for the report output.
• To publish a report output that you created, click Publish.
• To delete a report output that you created, click Delete and, at the prompt asking if
you want to delete the report output, click OK.
– Before a deleting a report output, make sure that it is not referenced by
any drug profile configurations, because the application will remove these
references.
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Note:
When you delete a report output that is associated with an alias, the
target status of the alias becomes Broken.
Rename a report output

Outputs.
2. On the Report Outputs page, click the Row Action menu ( ) of a report output,
and then click Rename.
3. Modify the report name, description, category, or project. For more information,
see Save a report output.
4. Click Save.
The following information also appears but you cannot modify it:
Column Description
Configuration Name of the data configuration for which the
report definition was run.
Case Series Name of the case series for which the (non-
interactive) report was run.
Report Definition Name of the report definition that was run to
create the output.
Work with a report output

Outputs.
report outputs or -- to include all projects.
3. From the Configuration drop-down list, select the data configuration from which
you want to view report outputs or -- to include all configurations.
The selected report outputs appear.
4. To display the report output, select the Row Action menu ( ) of a report output,
and click View.
If the report includes an underlined count (N) of cases, the count is a link that you
can click to display a menu from which you can drill down. If specific case IDs
appear underlined in the report, you can click a case ID to view case details.
5. To publish the report output to other users, click a report output's Row Action
menu ( ) and then click Publish. To publish multiple report outputs, click the
Select Rows link, select the radio buttons of the definitions, then click the Publish
link.
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The selected login group is added to the Publication Level list.
7. Click Back.
Work with report data
• To choose a graph to show data in the report, click Choose Graph.
• To save the report output as an attachment to a topic, click Save to Topic
• To print the table (that is, the report), click Print.
• To download report data, click Download. The column names will be created from
the labels in the report definition, followed by the breakdown specifications.
• To show descriptive information below the report, click Show Notes.
Manage report rows
• To specify how many rows should display at a time, enter a number in the Rows
per Page field and press the Enter key. You can display up to 999 rows on each
page.
• To go to another page, you can do the following:
– To view the next page, click .
– To view the previous page, click .

– To view the specific page, enter a number in the Page field and press the
Enter key.
• To find specific text on a page, you can use the browser's Find feature. For
efficiency, you might want to set the Rows per Page to a large number before
using the Find feature.
Sort the report output
• To sort a column, click the column header. The column is sorted, and an arrow is
order, click the column header again. The previous primary sort order (if any)
becomes the secondary sort order. The previous secondary sort order (if any)
becomes the tertiary sort order.
• Click Columns or Columns and Rows. (See Arrange table columns.)
Note:
In displayed reports, sorting is case-insensitive.
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Work with report graphs

• Work with report graphs
• Report graph types
• Graph display options
• Aggregate bar graphs
• Detail bar graphs
• Box plot graphs
• Scatter plot graphs

Outputs.
2. Select the Row Action menu ( ) for a report output, and click View.
3. On the Display Output page, click Choose Graph.
Only those graph types that are appropriate for the report data appear.
4. Click the graph type.
• For information about aggregate bar graphs, see About aggregate bar graphs.
• For information about detail bar graphs, see About detail bar graphs.
• For information about box plots, see About box plots.
• For information about scatter plots, see About scatter plots.
5. Specify the options for the selected graph type.
• For information about aggregate bar graphs, see Viewing an aggregate bar
graph.
• For information about detail bar graphs, see Viewing a detail bar graph.
• For information about box plots, see Viewing a box plot.
• For information about scatter plots, see Viewing a scatter plot.
6. Click Display.
The selected graph appears.
Print a graph
1. Click Print.
2. Select print options.
3. Click Print.
Save the graph as an attachment to a topic
1. Click Save to Topic. The graph is attached as a PDF file.
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Note:
This option is available only if the Topics feature has been set up.
Copy a graph (using Internet Explorer browser only)

1. At the bottom of the graph, click Copy to Clipboard.
2. Open the document to which you want to add the graph(s), and Paste the graph
into that document.
Report graph types

When displaying a report or report output, you have the option to view a graphical
representation of the report data. On the Display Report or the Display Output page,
when you click Choose Graph, the Choose Graph page appears. Different graphs are
available depending on the types of columns in the report, as follows:
Graph Type Report Variables

Aggregate bar graph All column variables or all column variables
except one are numeric. A variable with
Variable Type Report ID does not need to be in
the report.
Link name: Bar graph (where rows are
aggregate values).
Detail bar graph The row variable in the report is a variable with
Variable Type Report ID.
Link name: Bar graph (where rows are detail
records).
Box plot The row variable in the report is a variable with
Variable Type Report ID. At least one column
variable is numeric.
Link name: Box plot (where rows are detail
records).
Scatter Plot The row variable in the report is a variable with
Variable Type Report ID. At least two column
variables are numeric.
Link name: Scatter plot (where rows are detail
records).
Note:
A numeric variable is one for which source data is numeric or a numeric
value such as count or percentage is specified as content detail.
The graph key and color palette that you set for graphs based on data mining results
does not affect the report graphs. The report graphs appear in color unless you choose
the display option, Use gray-scale instead of colors.
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Graph display options

The following display options are available for most report-based graphs:
Option Check to
graph.
Popup Display each graph in an individual window. If
you have popup blocking software installed on
your browser, it may prevent these windows
from opening. You may want to disable your
popup blocking software.
Key Display a color key below the graph to show
which value each graph element (such as a
bar or region of the graph) represents.
Notes Display notes about the graph. The notes are
the same as for the displayed report.
• Information about what a graph
component (such as a bar, cell, or
region) represents, or statistics for the
component, that appear when you point to
that component.
• A menu that allows you to drill down when
you click a graph component.
• Print and Copy to Clipboard links.
• A Save to Topic link (if Topics has been
configured).
Aggregate bar graphs

• About aggregate bar graphs
• View an aggregate bar graph
About aggregate bar graphs

In an aggregate bar graph, the row variable of the report appears on the y-axis. Each
numeric column variable in the report appears on the x-axis. A key appears below the
graph describing each bar.
For example, a report includes counts of PTs, drugs, and cases for each gender:
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Depending on the display options that you specify, the graph might look like this:
View an aggregate bar graph

For an overview of aggregate bar graphs, see About aggregate bar graphs.
Outputs.
4. Select Bar graph (where rows are aggregate values).
Option Description Notes

Labels X and Y Label the x-axis and y-axis to Required.
clarify what is represented by
the axes.
Show counts at the ends of Show case counts at the end If the report shows numeric
bars of bars in the graph. values that are not case
counts and you check this
option, the values are shown
instead of counts.
Transpose rows and columns Switch the roles of the rows
and columns in displaying
the graph.
Use gray-scale instead of Use shades of gray instead
colors of colors in the graph.
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Popup Display each graph in
an individual window. If
you have popup blocking
software installed on your
browser, it may prevent these
windows from opening. You
may want to disable your
popup blocking software. For
details, see Graph display
options.
6. Click Display.
Oracle Empirica Signal creates the graph using the specified display options.
These options apply only to this graph.
7. To see the exact values represented by a bar in the graph, point to the bar.
If you click a bar, you can drill down to cases for the bar. If you are displaying multiple
graphs on the same page, do not click any graph until all the graphs appear.
For information about copying, printing, or saving a graph as an attachment to a topic,
see Work with report graphs.
Detail bar graphs

• About detail bar graphs
• View a detail bar graph
About detail bar graphs

With a detail bar graph, you determine the row variables and column variables of
the report that appear on the y-axis, and the subject counts that appear on the
x-axis. There is a subject count for each primary variable that you select as a display
option. You can break down the case counts for the primary variable by specifying
a secondary variable. If you specify a secondary variable, a graph key indicates the
meaning of each bar.
You can also create multiple graphs, one for each value of a row or column variable
that you specify as a subset variable.
For example, a report shows gender, age group, and quarter from FDA date for each
case ID:
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Depending on the display options that you specify, the graph might look like this,
where Gender is the subset variable, Quarter from FDA date is the primary variable,
and Age Group is the secondary variable:
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View a detail bar graph

For an overview of detail bar graphs, see About detail bar graphs.
Outputs.
4. Select Bar graph (where rows are detail records).
5. From the Subset Variable (for multiple graphs) drop-down list, select a subset
variable. There creates one graph for each value of the selected variable.
6. From the Primary Variable (bar groups) drop-down list, select a primary variable
to appear on the x-axis.
7. From the Secondary Variable (bars within groups) drop-down list, select a
secondary variable (optional). Each bar in the graph represents a value of the
secondary variable, as identified by the color key below the graph.

the axes.
Show counts at the ends of Show case counts at the end NA
bars of bars in the graph.
Use gray-scale instead of Use shades of gray instead NA
Popup Display each graph in NA
an individual window. If
options.
9. Click Display.
10. To see the exact values represented by a bar in the graph, point to the bar.
If you click a bar, you can drill down to cases for the bar. If you are displaying multiple
graphs on the same page, do not click any graph until all the graphs appear.
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Box plot graphs

• About box plots
• View a box plot
About box plots

A box plot (also known as a box-and-whisker plot) is the plotting of data points against
horizontal and vertical axes to show the distribution of a continuous variable. In a box
plot:
• The box represents the middle 50% or so of the numeric values.
• A horizontal line within the rectangle represents the median of all values
(specifically, the value that is exactly in the middle of all values).
• The top end of the box represents the upper quartile (specifically, the median of
the ordered set of values that is greater than the overall median).
• The bottom end of the box represents the lower quartile (specifically, the median of
the ordered set of values that is less than the overall median).
The interquartile range, which is the difference between the upper quartile and the
lower quartile, is a measure of the spread of the distribution. The relative distances of
the upper and lower quartiles from the median describe the shape of the distribution of
data.
In the box plot:
• The whisker above the box plot extends from the upper quartile to the highest
actual value that is within the (75th percentile + 1.5 * (interquartile range)).
• The whisker below the box plot extends from the lower quartile to the lowest actual
value that is within the (25th percentile - 1.5 * (interquartile range)).
• Outliers are plotted as individual points in the graph. An outlier is considered to be
a value that falls outside of the upper or lower whisker.
Note:
Points in a box plot are jittered (displayed at small random offsets from the
center line). This ensures that if two records have the same value, a point is
likely to be displayed for each of them.
Several box plots might be shown in a single graph if you select a secondary variable.
If so, a key appears below the box plot to relate the individual box plots to the values
of the secondary variable.
For example, a report shows age and gender for each case ID:
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View a box plot

For an overview of box plots, see About box plots.
Outputs.
4. Select Box plot (where rows are detail records).
5. From the Subset Variable (for multiple graphs) drop-down list, select a subset
variable. Oracle Empirica Signal creates one graph for each value of the selected
variable.
6. From the Primary Variable (defines individual boxplots) drop-down list, select a
primary variable from a list of numeric variables in the report definition. Each point
in the box plot represents a value of the primary variable.
7. From the Secondary Variable (defined boxplot groups) drop-down list, select
a secondary variable (optional). Each box represents a value of the secondary
variable, as identified by the color key below the graph.

the axes.
Show all points as overlay Show all points on the box Points in a box plot are
plot. If cleared, only points jittered, so that if two records
outside the upper and lower have the same value, a point
whiskers are shown. is likely to be displayed for
each of them.
Use gray-scale instead of Use shades of gray instead NA
Popup Display each graph in an NA
individual popup window. If
options.
9. Click Display.
For information about copying, printing, or saving a graph as an attachment to a
topic, see Work with report graphs.
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10. If you point to a region of the graph, the following information appears:
• The region of the box (Upper Outlier, Upper Whisker, Upper Box, Lower Box,
Lower Whisker, or Lower Outlier).
• The value of the secondary variable, if any.
• The count of data points for the primary variable (and secondary variable, if
any) for that region of the box.
The count may be more than the number of cases because there may be more
than one data point for the same case. For example, a case might have multiple
adverse events, where each adverse event is a separate data point.
11. If you click a region (Upper Outlier, Upper Whisker, Upper Box, Lower Box, Lower
Whisker, or Lower Outlier) of the graph, you can drill down to cases for that region.
If you are displaying multiple graphs on the same page, do not click any graph
until all the graphs are displayed.
If a case has a value on the boundary between any regions (not including the
Upper Outlier or Lower Outlier regions), the case ID is included when you drill
down on either of the regions. Cases with values on the boundary of the Upper
Whisker or Lower Whisker are not included when you drill down on the Upper
Outlier or Lower Outlier regions.
Scatter plot graphs

• About scatter plots
• View a scatter plot
About scatter plots

A scatter plot is the plotting of data points against horizontal and vertical axes to show
the correlation between two or more continuous variables. You select a variable to
plot against the x-axis of the scatter plot, and one or two variables to plot against the
y-axis.
You can select a variable by which to subset data. For example, you can view a
different scatter plot for each adverse event.
If you want to use a color key to associate each dot on the graph with a particular
value, you can specify an inner breakdown variable. For example, to determine the
particular case ID associated with each dot, you can use the case ID as the inner
breakdown variable.
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Note:
• No data point is plotted for a record if either the X variable or the Y

variable is empty.
• If you select two y-axis variables, each of them uses a different shape,
as shown in the color key below the scatter plot.
• If the X and Y values for one record coincide with the X and Y values for
another record, the two data points are plotted in the same position. It is
not possible to distinguish whether that data point represents one record
or several records.
The color key below the scatter plot shows which value of the inner breakdown
variable each dot represents.
For example, a report shows age, count of PTs, and count of drugs for each case ID:
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View a scatter plot

For an overview of scatter plots, see About scatter plots.
Outputs.
4. Select Scatterplot.
5. From the Subset Variable drop-down list, select a subset variable.
Oracle Empirica Signal creates one scatter plot for each value of the subset
variable.
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6. Select an X variable; that is, a numeric variable to be plotted against the x-axis.
7. Select a Y variable; that is, a numeric variable to be plotted against the y-axis.
8. You can select another Y variable. Each of the two Y variables are plotted against
the y-axis. Each Y variable corresponds to a different-shaped point, as shown in
the key below the scatter plot.
9. You can also select a text variable as an inner breakdown variable. The color
key associates each point on the scatter plot with a particular value of the inner
breakdown variable.
Option Description
Labels X and Y Label the x-axis and y-axis to clarify what is
are represented by the axes.
Include linear regression lines Include a linear regression line to identify
trends in the data.
Include 45-degree line and matched axes Include a 45-degree line in the scatter plot.
This is useful if you are plotting two similar
variables and you are interested in the
differences.
graph.
Popup Display each graph in an individual window.
If you have popup blocking software installed
on your browser, it may prevent these
windows from opening. You may want to
disable your popup blocking software. For
details, see Graph display options.
11. Click Display.
12. To drill down to case information, point to the graph, click, and hold down the
mouse button while you draw a red rectangle around the data points for which you
want to drill down. When you release the mouse button, a menu appears and you
can drill down. Note that a single point in the graph may represent several data
points.
Note:
If you are displaying multiple graphs on the same page, do not try to drill
down until all the graphs are displayed.

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Set up and use drug profiles
• About drug profiles and layouts
• Drug Profile page
• Select drugs for a drug profile
• Select a drug profile layout
• Add a chart to a drug profile layout
• Print or copy charts (Drug Profile page)
• Link to an outside URL
• Define the Links menu
• Manage drug profile layouts
• Chart types and options
About drug profiles and layouts

A drug profile is the presentation of statistical and other information about one or
more drugs. A drug profile layout is a saved collection of charts, as well as their
placement and display options.
A chart can be either of the following:
• A graph based on the results of a data mining run.
• A graphical or tabular report based on source data, showing distribution of cases
by such variables as gender and age.
Charts in a drug profile layout can be for the same or different drugs. For example,
a layout might include charts for the drug that you are studying and for comparator
drugs.
Drug profile layouts are available on the Drug Profile page. If you have appropriate
permissions, you can create new drug profile layouts.
To use drug profiles, you must have the View Drug Profiles permission and you must
set a drug profile configuration as a user preference. The drug profile configuration
determines which data mining runs are the source of charts that can be added to a
drug profile layout. For information on setting up the drug profiles feature, see Set up
drug profiles.
Drug Profile page

What is a drug profile?
A drug profile is a presentation of graphs and reports related to one or more drugs.
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Select drugs for a drug profile
What can I do on the Drug Profile page?

Select a drug to add to a drug profile
Attach a layout to the drug profile
Manage your drug profile layouts
Select drugs for a drug profile

Drug names in the title bars of charts end with one of the following suffixes:
• (G) – Generic name
• (T) – Trade name
• (I) – Ingredient
The primary drug is shown in the Drug Profile title area next to the layout name. The
comparator drugs are the drugs for which other chart windows appear in the current
layout.
1. In the left navigation pane, hover on the Data Analysis icon ( ), then click Drug
Profiles.
2. In the drug profile menu bar, from the Drug menu, click Select.
There is a Primary Drug field and, if the layout includes chart windows for
different drugs, there are Comparator Drug fields.
3. Optionally, click Recent in the Drug menu and select from primary drugs for which
you viewed charts recently.
Note:
The Drug menu is available only if you are viewing a layout that has
been saved at least once.
4. From the Primary Drug or Comparator Drug drop-down lists, select the type of
drug (Generic, Trade, or Ingredient) that you want to specify. Any or all of the drug
types might be available depending on the drug profile configuration you are using.
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Select a drug profile layout
Note:
If you remove the comparator drug, charts for the drug are not displayed
although they are still part of the layout, unless you save the layout
without them.
5. In the Primary Drug field, type a drug name or click Select to select a drug from a
list.
Note:
The list of available drugs that you can select on the Drug menu is
determined by an algorithm described in Add a drug profile configuration.
6. If you want to select the drugs with which the layout was last saved by you or
another user, click Reset.
7. When you are satisfied with the drug selections, click OK.
Select a drug profile layout

Profiles.
2. In the drug profile menu bar, from the Layout menu, click Select.
Your most recent drug profile layout with your most recent primary drug appears,
unless one of the following is true:
• This drug profile layout was deleted.
• A drug profile layout has never been used.
• The Drug Profile page was accessed from the Products table on the Signal
Review page by selecting Drug Profile from the Row Action menu ( ) for a
product.
In these cases, the layout is determined by your Drug Profile Layout user
preference.
3. To select a layout, from the Layout menu, click Select.
The Select Drug Profile Layout dialog box provides the following information about
each layout:
Column Description
Name Name of the layout. Available layouts are
those that you created or that are published
to you. If you have the Administer Users
permission, available layouts are published
or unpublished layouts created by any users
in your login group.
Description Description of the layout.
Created By Name of the user who created the layout.
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Add a chart to a drug profile layout
Column Description
Created Date and time when the layout was created.
layout.
Modified Date and time when the layout was last
modified.

• Click the radio button of the layout
• To select a recent layout, hover over Layout and click Recent.
5. Click a recent layout name.
• The primary drug for the layout that you are viewing becomes the primary drug
for the selected layout. If you modify the layout, an asterisk appears in the
Drug Profile title area after the layout name.
• If the layout uses only one drug, it appears with the primary drug from the last
layout you viewed.
• If the layout uses multiple drugs, you must specify the primary and comparator
drugs. By default:
– The primary drug is from the last layout that you viewed.
– The comparator drugs are those that you used the last time you
viewed that particular layout. If you never viewed the layout before, the
comparator drugs are from the original definition of the layout.
Add a chart to a drug profile layout

Profiles.
2. In the drug profile menu bar, from the Layout menu, click Add Chart.
Note:
Unless you have the Create Drug Profiles Layouts permission, you will
not be able to save the layout with the new chart.
3. From the Drug Type drop-down list, select Generic, Ingredient, or Trade. Any or
all of these values might be available, depending on the drug profile configuration
that you are using.
• In the Drug Name field, type a drug name.
• Click Select to select a drug from a list, then click OK.
The list of available drugs depends on the chart that is currently highlighted in the
list of available charts. For a report chart, available drugs are determined by the
data configuration associated with the report output on which the chart is based.
For a data mining results graph, available drugs are from the corresponding data
mining results.
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Print or copy charts (Drug Profile page)
Note:
The set of drugs included in logistic regression results is typically smaller
than the set of drugs in MGPS results. Graphs for logistic regression
results will be available only if the selected drug was included in the
model or added explicitly during creation of the run.
5. Select a chart. The chart types that are available depend on the data mining runs
and report outputs referenced by the drug profile configuration that you are using.
Possible chart types are as follows:
Data Source Chart Types

MGPS 2D Run Sector map graph
EBGM graph
ERAM graph
EBGM confidence interval
ERAM confidence interval
ROR graph
ROR confidence interval graph
PRR graph
MGPS 3D Run Nested confidence interval graph
MGPS 2D by Year Run Cumulative map graph
LR 2D Run LROR graph
LROR confidence interval graph
Reports Distribution by <variable-name>, where
<variable-name> may be gender, outcome,
and so on.
6. Click OK.
The chart appears. If the selected drug is not in the run results or report output that
is the source for the selected chart, the chart cannot be displayed.
In some cases, a chart window appears but displays a message that the chart
cannot be displayed with your current display options. If you click Options below
the chart and modify the display options, you might be able to display the chart.
7. To select multiple charts, repeats steps 5 and 6.
8. When you have finished adding charts, from the Layout menu, click Save.
If you have modified a layout, the Save Layout As dialog box appears. Enter the
information and click OK. For more information, see Saving a drug profile layout.
Print or copy charts (Drug Profile page)

Print a chart
1. In the left navigation pane, hover over the Data Analysis icon ( ), then click
Drug Profiles.
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Link to an outside URL
2. In the drug profile menu bar, from the Layout menu, click Select.
• To print the selected chart, under the chart, click Print.
• To print all charts in the layout, from the Layout menu, click Print.
A preview of the printed chart appears in the Drug Progile dialog box and the Print
window appears.
4. Click Print.
Copy a chart
1. Display the chart.
2. Under the chart, click Copy.
3. Open the document to which you want to add the chart.
4. Paste in the chart using the Paste command for that application.
Note:
Copying is available in Internet Explorer only.
Link to an outside URL

By default, Oracle Empirica Signal links to NIH label information and FDA label
information for the drug associated with the current chart window. Your organization
can define the Links menu by changing the default links or adding other links.
Profiles.
2. In the drug profile menu bar, from the Links menu, click a URL name to open that
configured page.
A separate browser window opens and the page for the selected URL appears.
Define the Links menu

The Drug Profile page includes a Links menu that provides access to specified URLs.
By default, the menu includes links to FDA label information and NIH label information
for the drug associated with the current chart window. You can change the default links
or add other links.
1. In the Signal/WEB-INF/classes subdirectory of the server location where the
Oracle Empirica Signal application was installed, open the webvdme.properties
file.
2. Find lines starting with URLLINK. Lines for the default links are:
URLLINK.1.LINK_NAME=FDA Label Information
URLLINK.1.LINK_URL=http://www.accessdata.fda.gov/scripts/cder/
drugsatfda/
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index.cfm?
SearchType=BasicSearch&fuseaction=Search.SearchAction&searchTerm=\$DRU
G\$
URLLINK.2.LINK_NAME=NIH Label Information
URLLINK.2.LINK_URL=http://dailymed.nlm.nih.gov/dailymed/search.cfm?
startswith=\$DRUG\$
3. Modify or add links.
• For each link on the Links menu, there must be a pair of lines, one defining the
name of the menu option and one specifying the URL.
• In the URL, use the following string if you need to substitute in the drug name
associated with the current chart window: \$DRUG\$
• The number after URLLINK determines the order of options in the Links menu.
For example, to add a link to the two default links, you add two lines starting
with URLLINK.3. You can renumber links, but the numbers must start with 1,
and you cannot skip numbers.

• Manage existing drug profile layouts
• Create a new drug profile layout
• Save a drug profile layout
• Order charts in a drug profile layout
• Rename a drug profile layout
• Publish a drug profile layout
Manage existing drug profile layouts

The Drug Profile Layouts page lists layouts that you created or that are published
to you. If you have the Administer Users permission, the page also lists unpublished
layouts created by any users in your login group.
Profiles.
2. In the drug profile menu bar, from the Layout menu, click Manage Layouts.
The Drug Profile Layouts page appears and provides the following information
about each drug profile layout:
Column Description
Name Name of the layout.
Description Description of the layout.
Created By Name of the user who created the layout.
Created Date and time when the layout was created.
layout.
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Column Description
Modified Date and time when the layout was last
modified.
See About tables for information about viewing, printing, or downloading tables or
changing the way data displays in the table.
3. If you click the Row Action menu ( ) for a drug profile layout, you can do the
following:
• To view or select the layout, click View. The layout appears on the Drug Profile
page.
• To rename a layout that you created, click Rename.
• To publish a layout, click Publish.
• To delete a layout that you created, click Delete.
Create a new drug profile layout

Profiles.
2. In the drug profile menu bar, from the Layout menu, click Create.
The Drug Profile page is cleared and the Drug Profile title area shows the layout
name as Not Saved*.
Note:
The Create menu is enabled if you have the Create Drug Profile Layouts
permission.
3. From the Layout menu, click Add Chart.

4. From the Drug Type drop-down list, select Generic, Ingredient, or Trade. Any or
all of these values might be available, depending on the drug profile configuration
that you are using.
• In the Drug Name field, type a drug name.
• Click Select to select a drug from a list, and click OK.
The list of available drugs depends on the chart that is currently highlighted in the
list of available charts. For a report chart, available drugs are determined by the
data configuration associated with the report output on which the chart is based.
For a data mining results graph, available drugs are from the corresponding data
mining results.
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Note:
The set of drugs included in logistic regression results is typically smaller
than the set of drugs in MGPS results. Graphs for logistic regression
results will be available only if the selected drug was included in the
model or added explicitly during creation of the run.
6. Select a chart. The chart types that are available depend on the data mining runs
and report outputs referenced by the drug profile configuration that you are using.
Possible chart types are as follows:
Data Source Chart Types

MGPS 2D Run Sector map graph
EBGM graph
ERAM graph
EBGM confidence interval
ERAM confidence interval
ROR graph
ROR confidence interval graph
PRR graph
MGPS 3D Run Nested confidence interval graph
MGPS 2D by Year Run Cumulative map graph
LR 2D Run LROR graph
LROR confidence interval graph
Reports Distribution by <variable-name>, where
<variable-name> may be gender, outcome,
and so on.
7. Click OK.
The chart appears. If the selected drug is not in the run results or report output that
is the source for the selected chart, the chart cannot be displayed.
In some cases, a chart window appears but displays a message that the chart
cannot be displayed with your current display options. If you click Options below
the chart and modify the display options, you might be able to display the chart.
8. To select multiple charts, repeats steps 5 and 6.
9. To order the selected charts, from the Layout menu, click View.
10. Select a view option:
• Stack—Staggers the charts. Part of each chart window is visible so you can
click to bring that chart window forward.
• Tile—Show all chart windows without any overlap.
• Order—Order charts in the layout. The order affects only printing and the slide
show mode.
• Slide Show—View each chart on its own page.
11. In Slide Show mode, use the following keys:
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Key Description
Esc Exit slide show mode and return to the Drug
Profile page.
Home Go to the first chart in the layout.
Up arrow, Page Up, or left arrow Go to the previous chart in the layout.
Down arrow, Page Down, or right arrow Go to the next chart in the layout.
End Go to the last chart in the layout
Ctrl (or Shift) + Home Go to the top of the current chart.
Ctrl (or Shift) + Up arrow, Page Up, or left Scroll up in the current chart.
arrow
Ctrl (or Shift) + Down arrow, Page Down, or Scroll down in the current chart.
right arrow
Ctrl (or Shift) + End Go to the bottom of the current chart.
For additional chart ordering options, see Order charts in a drug profile layout.
• To save the updated layout, from the Layout menu, click Save.
• To add the currently displayed charts as a single PDF attachment to a topic,
from the Layout menu, click Save to Topic. The notes of each chart are
included, even if they are not currently displayed.
Save a drug profile layout

When a drug profile layout has been modified but not yet saved, an asterisk appears
the Drug Profile title area after the layout name. If the layout has never been saved,
the layout name shows as "Not Saved*".
Profiles.
2. In the drug profile menu bar, from the Layout menu, click Save. (This option is
available if you have the Create Drug Profile Layouts permission.)
If you have modified a layout and you try to navigate away without saving it, the
application prompts you to save the layout. Click OK.
3. If you have modified a layout that you created (or if you have the Administer Users
permission and you have modified a layout that someone in your login group
created), you can check Replace existing. If you check this option, you cannot
modify the layout name or description. If you want to rename a layout, use the
Rename option on the Drug Profile Layouts page.
4. In the Layout name field, type a name for the layout. Keep in mind that the layout
is not associated with a particular drug profile configuration. You might want to
avoid identifying a data source in the layout name or description.
5. Optionally, enter a description of the layout to differentiate this layout from other
layouts.
6. Click OK.
When Oracle Empirica Signal saves a layout, currently displayed chart windows are
saved as part of the layout. Even if a chart window shows a message that the chart
cannot be displayed with the current options, the chart window is saved. Additionally,
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the drugs associated with the saved charts are saved as the primary drug and
comparator drugs (if any).
Note:
Only displayed chart windows are saved as part of a layout. For example,
an existing layout includes a sector map for DrugA. You change the drug
profile configuration to point to different run results that do not include DrugA.
When you view the layout, a message tells you that the drug is not in the run
results. No chart window appears. If you save the layout again, the DrugA
sector map will not be part of the layout.
Order charts in a drug profile layout

You can specify the order in which you want to print charts or display them in slide
show mode. The order does not affect the displayed layout.
Profiles.
2. In the drug profile menu bar, from the Layout menu, click View, and then click
Order.
3. Use the arrow buttons to specify the order in which charts are displayed in slide
show mode or printed:
Arrow Description
Move the chart to become the first one.
Move the chart to befor the previous chart.
Move the chart to after the next chart.
Move the chart to become the last one.
4. To remove a chart from the layout, select it and click Remove.

5. To find a particular chart in the layout, select the chart name and click Find.
6. When you are finished reordering charts, click OK.
Rename a drug profile layout

Profiles.
3. Click the Row Action menu ( ) for the layout, and then click Rename.
4. In the Name field, type a name for the layout. Keep in mind that the layout is
not associated with a particular drug profile configuration. You may want to avoid
identifying a data source in the layout name or description.
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Chart types and options
5. Optionally, in the Description field, type a description of the layout to differentiate

layouts.
6. Click OK.
Publish a drug profile layout

1. In the left navigation pane, hover on the Data Analysis ( ), then click Drug
Profiles.
3. Click the Row Action menu ( ) for the layout, and then click Publish.
—All—. In the Publish to Login Groups drop-down list, click or Ctrl+click to
• If you publish to —All— and later add a new login group, the object is
published automatically to the new login group.
5. Click Back.

• Work with chart options
• Sector map graph (Drug Profile page)
• Bar graph (Drug Profile page)
• Confidence interval graph (Drug Profile page)
• Nested confidence interval graph (Drug Profile page)
• Cumulative map graph (Drug Profile page)
• Reports (Drug Profile page)
Work with chart options

Click an option at the bottom of a chart to perform the following actions:
• To redraw the chart as a table, bar graph, or pie chart, click Options. From the
Chart Options dialog box, select the chart type and click OK.
• To display the notes about the chart below the chart, click +Notes. To hide the
notes, click -Notes.
• To display a key below the chart, click +Key. To hide the key, click -Key.
• To print a chart, click Print. A preview of the printed chart appears in the Drug
Profile dialog box and the Internet Explorer Print dialog box opens for you to select
print options and click Print.
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Note:
If you want to print all charts in the layout, from the Layout, click Print.
• To copy a chart, click Copy. Open the document to which you want to add the
chart and use that application's Paste function.
Note:
This is available only in Internet Explorer.
• To determine the default color used for graphs. set the user preferences, Graph
Color Palette. You can modify the graph key for your current session on the
Choose Graph page for data mining run results.
• To resize the chart, click the diagonal lines in the lower right corner and drag the
right and bottom borders to the desired size.
Sector map graph (Drug Profile page)

A sector map is a visual presentation of data for a selected drug across all System
Organ Classes (SOCs). Each System Organ Class (SOC) is represented by a large
tile in the sector map. Smaller tiles within each SOC tile represent Preferred Terms
(PTs).
PTs are ranked in descending order of values of the statistic (EBGM, EB05, Chi-
statistic, or PRR) that you choose. A color key indicates relative ranking. You can also
list the ranked PTs below the sector map. (You must include the key in the graph to
display both the color key and the list of ranked PTs.)
Note:
The primary path of a PT determines where it appears in the sector map. If a
PT is not in the event hierarchy associated with the data mining run results, it
appears in a SOC tile named Unknown.
The list of ranked PTs below the sector map includes the following information:
Column Description
Rank Ranking of the term (combined with the drug) according
to values of the statistic you have configured the sector
map to use (via the Color controlled by option).
SOC SOC containing the term.
Term (PT) Specific PT.
EBGM. EB05, ERAM, ER05, Chi-statistic, or PRR Value of the statistic you have configured the sector map
to use (via the Color controlled by option).
1. To set options for the graph, click Options. Specify the following options and click
OK. The options apply to the specific chart, and are saved as part of the layout.
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Option Description
Color controlled by Name of the statistic whose values will be ranked and
used for coloring the sector map tiles. Available values
are those computed by the data mining run and may
include EBGM, EB05, Chi-statistic (signed), and PRR.
Term box size controlled by One of the following options indicating what controls the
size of PT tiles:
• Relative importance of term—Bases the size of
PT tiles on an algorithm that determines the relative
public heath impact of PTs. Using a recent version
of AERS data, the public health impact for a PT is
computed as: (number of times the PT occurs in
serious cases) * (proportion of cases with that PT
that are serious or fatal). A higher Public Health
Impact score corresponds to a larger tile in the
sector map. Because size is based on the number
of cases of the PT alone (not the number of cases
that have the PT and a particular drug), the tile size
is stable over sector maps for different drugs.
• All terms have equal size—All PT tiles have the
same size.
Note:
For PTs that are new in the MedDRA
version associated with the AERS data used
to assess public health impact, the tile
size cannot be determined. Such PTs are
represented as small tiles.
Display maximum intensity at signal score of All tiles for which scores are above this value are
displayed at the maximum-intensity color as shown in
the color key below the graph.
Use gray-scale instead of colors Use shades of gray instead of colors in the graph.
Show low scores in green for color graph Check to show low scores in varying shades of green.
Clear to show low signal scores in black.
Note:
This setting has no effect if you display the
sector map in gray-scale.
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Option Description
Omit rare terms used fewer than __ times in AERS Number indicating how many times a PT must be in
the AERS database (the same one used for Relative
importance of term) for that PT to be shown in the sector
map.
Note:
The notes for a sector map indicate any
rare terms that are omitted because of this
restriction.
Group by HLT Within a SOC tile, group in the same rectangular area
the tiles for PTs that are in the same HLT. If you also
group by HLGT, the tiles for PTs are grouped by HLT
within each HLGT.
Group by HLGT Within a SOC tile, group in the same rectangular area
the tiles for PTs that are in the same HLGT.
List __ top scores Number indicating how many (up to 1000) terms with the
top scores are ranked and listed below the sector map.
The score is the statistic selected for Color controlled by.
If multiple terms have the same score, each term is
counted separately. For example, suppose that you enter
20 as the limit. If the 20th row has a score that other
terms after that also have, those additional terms are
shown as well.
The list below the sector map appears when you display
the key.
Show top score indexes If checked, tiles in the sector map are numbered to show
their rank, up to the number of scores specified in List __
top scores. For this option to take effect, there must be a
value specified for List __ top scores".
2. If you point to a PT tile, the MedDRA PT, HLT, HLGT, and SOC appears. The
following information for the combination of the drug and the term that the tile
• N—Observed number of cases with drug-event combination.
RR; the so-called shrinkage estimate.
• ERAM—Empirical-Bayes Regression-adjusted Arithmetic Mean. This estimate
is computed as the shrunken observed-to-expected reporting ratio adjusted for
covariates and concomitant drugs.
• ER05—A value that there is approximately a 5% probability that the ERAM lies
below it.
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Note:
The ERAM and ER05 are available only if the data mining run was
set up to compute RGPS.
• PRR—Proportional Reporting Ratio.

statistic is expressed as a negative number, indicating that the drug-event
Note:
The PRR and Chi-statistic are available only if the data mining run
was set up to compute PRR.
For information about these statistics, see MGPS computations or PRR

computations.
from the menu that appears.
4. If you click a tile for which N is at least 1, you can then drill down to a list of cases
for the tile or view statistics for the tile.
Bar graph (Drug Profile page)

Bar graphs provide a straightforward way to display the items most closely associated
with a selected drug, showing the strength of association by plotting each computed
statistical score as the length of a horizontal bar.
For information about statistics in the graph, see MGPS computations, ROR
computations, PRR computations, or Logistic regression computations.
Option Description
below the graph.
(EBGM, LROR, PRR, or ROR) of at least
the specified number.
confidence limit (EB05, LR05, ROR05) of at
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Option Description
Bar length controlled by Indicate whether you want bars to show in
descending order by:
• N (observed count).
• The score (EBGM, LROR, PRR, or
ROR).
• The lower confidence interval score
(EB05, LR05, ROR05).
Bar color controlled by Indicate whether bar color should be
controlled by:
• EBGM, LROR, PRR, or ROR, as
• EB05, LR05, ROR05, as defined by the
graph key.
Order by bar length Show the bars of the graph in descending
order based on bar length.
Order by item Show the bars of the graph in alphabetical
order.
3. If you click on a bar, you can then drill down to a list of cases for the bar, create
a case series, transfer to case series, download cases, download case details, or
run reports for those cases.
Confidence interval graph (Drug Profile page)

Confidence interval graphs are similar to bar graphs but also include a confidence
interval or error bar superimposed on each bar to show the 5% and 95% confidence
limits.
For information about statistics in the graph, see MGPS computations, ROR
computations, PRR computations, or Logistic regression computations.
Option Description
below the graph.
(EBGM, LROR, or ROR) of at least the
specified number.
confidence limit (EB05, LR05, ROR05) of at
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Option Description
Bar color controlled by Indicate whether bar color should be
controlled by:
• EBGM, LROR, or ROR, as defined by
the graph key.
• EB05, LR05, ROR05, as defined by the
graph key.
• A different color for each bar in the
graph.
Order by bar length Show the bars of the graph in descending
order based on bar length.
Order by item Show the bars of the graph in ascending
alphabetical order.
Show N at end of confidence interval Display the value of N at the end of each
confidence interval bar.
Nested confidence interval graph (Drug Profile page)

To help you investigate possible drug interactions, the nested confidence interval
graph displays sets of confidence intervals. In each set, the first confidence interval
is for the three-way combination of drug, drug, and event, and subsequent confidence
intervals are for the two-way combinations. In each confidence interval bar, the EB05
value is at the left end, the EBGM value is the dot on the bar, and the EB95 value is at
the right end. A confidence interval bar is highlighted if its INTSS value is greater than
the limit that you specify as a display option. For more information about INTSS, see
interaction scores.
To conserve space in labeling, the drug indicated in the title bar of the graph window is
referred to by the label "Drug" in the graph.
The key below the graph indicates INTSS values represented by the confidence
interval bars.
Option Description
N at least Display only those drug-drug-event
combinations with an observed count (N) of
at least the specified number.
At most _____ combinations Display no more than the specified number
of drug-drug-event combinatoins. You can
display graphs for up to 200 combinations.
If combinations are excluded because of this
limit, a message appears below the graph.
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Option Description
Order by The value of the score that you select
here for the drug-drug-event combinations
is used to sort the graphs. For example,
if your select INTSS, the graph with the
highest INTSS value for the drug-drug-event
combination appears first.
Axis Type Select either Linear or Log (logarithmic).
When you use a logarithmic axis, the
confidence intervals for the two-way
combinations may appear more clearly.
Highlight confidence intervals where INTSS Enter the INTSS value above which
> confidence interval bars will be highlighted.
Show N at end of confidence interval Display the value of N at the end of each bar
graph.
2. You can point to a line in the graph to display statistics for the combination
represented by the line. Long drug or event terms may end in an ellipsis in the
label on the graph itself; in this case, you can point to the line to see the full terms.
Cumulative map graph (Drug Profile page)

Cumulative map graphs provide a way to compare strength of associations between
a selected drug and events across multiple subsets, which are typically based on a
continuous variable such as year. See Using a subset variable for more information.
The map graph on the Drug Profile page shows data for all subsets included in the
data mining run.
For information about statistics in the graph, see MGPS computations.
1. To set options for the graph, click Options.
2. Specify the following options and click OK. The options apply to the specific chart,
and are saved as part of the layout.
Option Description
EBGM at least Display only combinations with an EBGM
EB05 at least Display only combinations with an EB05
value of at least the specified number.
below the graph.
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Option Description
Show value of In each cell of the grid, display the numeric
value of N (observed), EBGM, or EB05. You
can also select Leave blank to display a grid
without labels. Cells with no occurrences are
empty.
Color by Indicate whether the cell color should be
controlled by:
• EBGM, according to the graph cutpoints
and palette.
• EB05, according to the graph cutpoints
and palette.
• No color.
Order by first occurrence of Indicates how to order drug-event
combinations in the graph, based on
descending order of N, EBGM, or
EB05 values. This ordering is applied
to combinations for the first subset. If
the maximum number of combinations
is not reached, the ordering is applied
to combinations for the second subset,
and so on until the maximum number of
combinations is reached. (The maximum
number of combinations is determined by
the At most __ associations option.)
For example, suppose that the graph
shows values of EBGM and has at most
six combinations. You order by the first
occurrence of EBGM > 2. Combinations are
ordered in descending order of EBGM as
follows:
Combinat Subset1 Subset2 Subset3

ion
DrugA- EBGM=3. EBGM=1. -
EventB 1 1
DrugA- EBGM=2. - EBGM=2.
EventD 7 4
DrugA- EBGM=2. EBGM=3. EBGM=1.
EventA 0 8 4
DrugA- EBGM=1. EBGM=2. EBMG=2.
EventC 5 6 8
DrugA- EBGM=0. EBGM=2. EBGM=0.
EventE 5 5 8
DrugA- - EBGM=1. EBGM=2.
EventF 1 1
label on the graph itself. In these cases, you can point to the cell to see the full
terms.
4. If you click on a cell, you can then drill down to a list of cases for the cell, create
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Reports (Drug Profile page)

The reports that you can add as charts to a drug profile are based on report output
generated by an all cases summary report. If the report output uses a breakdown
variable such as gender, you can add a report chart showing distribution by that
variable.
N represents a count of unique cases with at least one occurrence of the row value.
Percentages are computed as N divided by the total of N for all rows in the report
chart. The percentage values are meaningful only for demographic data, such as
gender, where there is one row value per case, so the total of N is the total of unique
cases. In this context, the percentage is for the number of cases with the row value out
of the total number of cases.
If there are multiple row values (for example, outcomes) per case, the total of N for all
rows is the number of non-unique cases. Thus, percentage values are the number of
cases with the row value out of the number of non-unique cases with any of the row
values. This is not likely to be a meaningful statistic.
1. To set options for the report chart, click Options.
2. Specify whether you want to view the report chart as a table, a bar graph, or a pie
chart, and then click OK.
3. For a table or bar graph, you can click on a cell or bar and drill down to a list of
cases, create a case series, transfer to case series, download cases, download
case details, or run reports for those cases.
Examples
In the following report chart, each case can be counted for only one row. The total of
N represents the unique number of cases, which is 57999. The percentage of unique
cases for gender F is 32107/57999, which is 55.36.
In the following report chart, each case can be counted for multiple rows. The total of
N (4776) for all rows is more than the unique number of cases (4532). Thus, the % is
not based on a count of unique cases.
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10
Settings and administration
• Specify settings
• Manage users, login groups, and work teams
• System configurations
• Administer the system
• Monitor the system
• Set up saved lists
Specify settings
When you click Settings in the left navigation pane, the Settings page appears. Your
user permissions determine the options you see on the Settings page. For most users,
this page includes only the following options:
• Change Password (available when not using single sign-on or LDAP)
• Remove Visited Status for Case ID Links
• Manage Saved Lists
• About
Settings for managing users

• Edit Users
• Edit User Profiles
• Edit Roles
• Edit Login Groups
• Edit Work Teams
Settings for monitoring the system

• View Currently Logged In Users
• View User Activity Audit Trail
• View Server Status
• View Free Space
• View Batch Report Queue
Settings for administering the system

• Set Site Options
• Send Message to All Users
• Restart Listener
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Manage users, login groups, and work teams
• Manage Run Storage

• Change User Default Runs
Settings for configuring the system

• Manage Subscription Data Releases
• Manage Configurations
• Manage Aliases
• Manage Drug Profile Configurations
• Manage Signal Configurations
• Manage Reviewer-User Mapping
• Manage Topic Workflow Configurations

• Ways to administer users
• How user permissions work
• What superusers can do
• Manage users
• Manage user profiles
• Manage user roles
• Manage login groups
• Manage work teams
• Use single sign-on
• Manage LDAP users
Ways to administer users

How you administer users depends on your installation type and authentication
method:
• Oracle-hosted installations with single sign-on—Create users in the Oracle
Health Sciences Identity and Access Management Service console and, optionally,
provision users on the Oracle Empirica Signal Users page.
Note:
By default, new users belong to the Users login group and are
provisioned with the user profile called user. The user profile called user
does not include any permissions or roles, unless you edit it.
• Self-hosted installations with single sign-on—Create users in Oracle Access

Manager or another single sign-on application, and provision users in the Oracle
Empirica Signal Users page.
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• Self-hosted installations with LDAP—Import user data from an LDAP directory,

and provision users in the Oracle Empirica Signal Users page. For more
information, see Configure Oracle Empirica Signal for use with LDAP.
• Self-hosted installations without external authentication—Create and
provision users in the Empirica Signal Users page.
You provide each user with a user name and password for the Oracle Empirica Signal
application.
Note:
For Oracle-hosted installations, you provide Oracle Empirica Signal
credentials only for superusers. Superusers log into the application directly.
In addition, you provision users with:

• Permissions—Rights to perform specific tasks in Oracle Empirica Signal. For
example, you can enable a user to create data mining runs, and prevent the user
from creating report definitions. For a list of permissions, see User permissions.
• User roles—Sets of permissions associated with a user's role. For example, you
might create a user role that includes the permissions to create data mining runs
and view data mining run results. You can assign one or more user roles to a
user. Oracle Empirica Signal includes pre-defined user roles, and you can create
custom user roles.
• Login group—Group to which a user belongs. When a user publishes an object
(for example, a query or report), the object can be used by other users in the same
login group. Each login group can have a customized Home page, with links to
customer-specific information.
Note:
Users with the Administer Users permission can use both published and
unpublished objects created by users in their login group.
• Work teams—Subsets of users in a login group. A user can be in multiple work

teams for the same login group. Work teams are used only in the context of the
topics feature and are intended to structure the level of access that different users
have to topics.
• User profiles—Sets of attributes (login group and quota), user roles, permissions,
and default user preferences that can be applied to users as a convenience in
setting up users. If you do not use a user profile, you must set the attributes, user
roles, and permissions for users individually, and individual users must set their
own preferences.
How user permissions work

The following table shows the user permissions required to perform activities in
Oracle Empirica Signal. You assign permissions to individual users, user roles, or user
profiles.
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A user can act on an object (for example, a data mining run) if:
• The user created the object.
• The object was published to the user's login group.
• The object was created by a different user in the user's login group, and the user
has the Administer User permission.
Permission Activities More information

View Raw Safety Database • Drill down to view case You grant this permission to
details. most users.
To save queries to the Query
Library, a user must also
have the Create Queries/Case
Series permission.
Download Raw Data • Download case series --
details and data for
results graphs.
View Data Mining Results • View results of data --
mining runs.
• Create, edit, and delete
saved lists.
Create Data Mining Run • Create and re-run data --
mining runs.
• Rename, cancel, and
delete data mining runs
that you create.
• View jobs for data mining
runs.
• Create queries to add
a database restriction or
custom terms to a data
mining run.
Save Intermediate Files • Save intermediate data --
files created during data
mining runs.
Delete Any Run • Cancel and delete any --
runs visible to the user.
View Topics • View topics on the Topics If the user is a member of a
page. work team, the user must also
have work team permissions.
Work team permissions
determine the level of
access that a user has to
topics. For example, work
team permissions determine
whether a user can view
topics, edit topics and topic
actions, edit attachments, and
so on.
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View Topics across Work • View all topics that are A user must also have the
Teams visible to any of the work View Topics permission.
teams in that user's login
group.
• View topics, topic actions,
and attachments without
membership in a work
team or work team
permissions.
Hide Queries/Case Series/ • Users with this permission --
Report pages cannot view the Queries,
Case Series, and Report
pages, regardless of their
other permissions.
View Drug Profiles • View drug profiles on the --
Drug Profile page.
Create Drug Profile Layouts • Create, edit, and manage A user must also have the
drug profile layouts on the View Drug Profile permission.
Drug Profile page.
Create Queries/Case Series • Transfer cases to an To create, copy, edit, rename,
existing case series. and delete queries and case
series, a user must also
have the View Raw Safety
Database permission.
Create Report Definitions • Create, copy, edit, and All users can run report
delete report definitions. definitions.
Create Report Outputs • Create, edit, copy, and All users can view report
delete report outputs. outputs.
BI Consumer • View Oracle Business The BI Consumer permission
Intelligence Enterprise in Oracle Empirica Signal
Edition Topics reports. corresponds to the
BI Consumer role in
Oracle Business Intelligence
Enterprise Edition.
You must implement the
Oracle Business Intelligence
Enterprise Edition Topics
reporting feature to enable this
permission.
BI Author • Perform activities that You must implement the
correspond to the BI Oracle Business Intelligence
Author role in Oracle Enterprise Edition Topics
Business Intelligence reporting feature to enable this
Enterprise Edition. permission.
BI Administrator • Perform activities that You must implement the
correspond to the Oracle Business Intelligence
BI Administrator role Enterprise Edition Topics
in Oracle Business reporting feature to enable this
Intelligence Enterprise permission.
Edition.
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View Signal Management • Perform all activities on Users can always manage
the Signal Review page signal views that they have
except activities that also created.
require Manage Signal
Views, Manage Signaling
Terms, or Manage
Signal Configurations
permissions.
Manage Signal Views • Manage signal views A user must also have
created by users in your the View Signal Management
login group. permission.
Manage Signaling Terms • Add, edit, and delete A user must also have
products and product- the View Signal Management
event combinations. permission.
• Assign products
and product-event
combinations to
reviewers.
For interactive signal
configurations only:
• Rename products.
• Manage designated
medical events, custom
terms, targeted medical
events, and listed events
for interactive signal
configurations.
Manage Signal Configurations • View and edit existing To assign signal configurations
signal configurations. to login groups, a user must
• For interactive also have the Administer
signal configurations Users permission.
only, refresh signal
configurations.
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Administer Users • View and edit user Users with this permission
names, user profiles, and cannot create or delete login
work teams in your login groups.
group. For some activities, users with
• For self-hosted this permission can act on
installations only, add objects (including unpublished
user names, user profiles, objects) created by users in
and work teams in your the same login group.
login group. Users with the Administer
• Update user information Users permission see the
from LDAP. following activities performed
• Send a message to users by the system, irrespective of
in the same login group. login group:
• Arrange table columns • Users: Create User or
and set the column layout Profile
as the default for your • Users: Edit User or Profile
login group.
• Users: Delete User or
• View the User Activity Profile
Audit Trail for users in the
same login group.
• View currently logged in
users in the same login
group.
Administer LDAP • Import LDAP users. --
• Refresh LDAP users.
• Change LDAP/Local
authentication.
Administer Drug Profiles • Create and manage drug A user must also have the
profile configurations. View Drug Profile Layouts
permission.
Manage Configurations • View data configurations. Manage subscription data is
• Create, import, copy, only available if the client
validate, and edit a machine has been provisioned
data configuration for for shared data.
which you have the Edit
permission.
• Delete a data
configuration that does
not have runs, case
series, saved lists, report
definitions, or report
outputs associated with it.
• Manage subscription
data.
Manage Topic Workflow • Create and manage topic A user must also have:
Configurations workflow configurations. • The View Topics
permission.
• The Administer Users
permission to assign
the configuration to a
login group or define
permissions for work
team members.
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Manage Aliases • Add, edit, and delete --
aliases.
What superusers can do

Superusers can perform any activities in the Oracle Empirica Signal application, with
the following exception:
Superusers must also have the Administer User permission to arrange the columns of
a table and define that layout as the default for a login group.
Superusers can act on objects (for example, data mining runs) created by users in
any login group. In contrast, users with the Administer Users permission who are not
superusers can act only on objects created by users in their login groups.
Only a superuser can:
• Publish an object to multiple login groups.
• Create, edit, or delete user roles.
• Create or delete login groups.
• Restart the listener process.
• Set any site options.
• View the server status.
• View free space.
• Create a report definition using XML.
• Create or edit built-in report definitions.
• Permanently delete a topic workflow configuration.
• Create a run definition file.
• Create a report definition file.
• Change default runs for users.
• View data source tables for runs.
• Delete any runs.
• Manage run storage.
• View the batch report queue.
• Delete a data configuration that has runs, case series, saved lists, report
definitions, or report outputs associated with it.
• Add saved lists in bulk mode.
Manage users
• View existing users
• Add or edit a user in a self-hosted environment
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• Add or edit a user in an Oracle-hosted environment

• Assign roles to a user
• Assign permissions to a user
• Change user passwords
• Rename a user
• About user names
• Purge users
• Change the authentication method for a user
• Delete a user
View existing users

2. In the Manage Users section, click Edit Users.
The Users page lists users who are in the same login group as you. For
information about viewing, printing, or downloading tables or changing the way
The following information is provided about each user name:
Column Description
User Name Unique name of the user account.
Name Full name (first name and last name) associated with the
user account.
Email Email address associated with the user name. This
address (or addresses, separated by commas) is the
default notification address for runs if the run creator
chooses email notification. This address is also used
when a user with the Administer Users permission with
appropriate permissions sends a message to all users,
and it is used when a message is generated by a topic
email notification rule.
Authentication One of the following values:
• Local—Standard Oracle Empirica Signal
authentication.
• SSO—Single sign-on authentication using Oracle
Access Manager or another application.
• LDAP— LDAP authentication.
For more information, see Configure Oracle Empirica
Signal for use with LDAP.
Login Group Appears only if you are a superuser. Login group
associated with the user.
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Column Description
Status Enabled if the user can log in to the application.
Disabled if the user cannot log in.
Note:
This value is determined
by the Account disabled
check box on the Edit User
page.
Quota Maximum amount of server space in megabytes (MB)

that the user is permitted to use for creating runs. Blank
for users who do not have a quota (that is, unlimited runs
permitted).
Add or edit a user in a self-hosted environment
Note:
This procedure does not apply for Oracle-hosted installations, unless you
are a superuser. For more information, see Add and edit a user in an Oracle-
hosted environment.
1. To use single sign-on for authentication in a self-hosted environment, create the

user in your single sign-on application.

4. To add a user:
a. Click Add a New User.
b. Fill in the according to the table below.
5. To edit a user:
a. Locate the user in the table.
b. Click the Row Action menu ( ) for the user, and then click Edit.
Note:
You can edit only users in your login group.
c. Fill in the according to the table below.

6. Click Save.
7. Provision newly created users with roles and permissions.
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Note:
If you selected a user profile, the user is already provisioned with roles
and permissions.
8. (Optional) If you plan to use the Topics feature of Oracle Empirica Signal, do the
following for newly created users:
a. Add the user to one or more work teams.
b. Assign work team permissions to the user.
Field descriptions
Field Description
Authentication Authentication method.
Username (Add User page only) Unique name of the user account (up to
100 characters). You can reuse deleted user
names.
Does not apply if LDAP authentication is used.
For more information, see About user names.
First Name First name of the user (up to 64 characters).
Last Name Last name of the user (up to 64 characters).
Email Email address of the user. This address (or
addresses, separated by a comma) is used:
• As the default email address if the user
chooses to be notified of data mining run
completion notification.
• When a message is generated by a topic
email notification rule.
• When you use the Send Message to All
Users link on the Settings page.
It is recommended that all users have an
associated email address.
User Profile The user profile, or set of attributes (login
group and quota), user roles, permissions, and
default user preferences that can be applied to
users.
The default is determined by the site option
Default user profile.
Quota Maximum amount of server space in
megabytes (M) that the user is permitted to
use for creating runs. If this limit is exceeded,
the user cannot submit new runs (or re-runs).
To indicate an unlimited amount of storage
space, leave this field blank. If you enter 0, the
user cannot create any runs even if the user
has appropriate permissions.
Login Group Name of the login group to which the user
belongs. Appears only if you are a superuser.
If this field does not appear, the login group for
the new user is the same as your login group.
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Field Description
Password (Local authentication only) Password for the user account (up to 64
characters). The password does not need
to be unique. Note that users can also
modify their own passwords. Follow any
recommendations by your organization related
to creating secure (hard-to-guess) passwords.
You must create passwords according to
the password restrictions set by your site
administrator.
Does not apply if LDAP or SSO authentication
is used.
Confirm Password (Local authentication only) Re-enter the password for the user account to
confirm it.
is used.
Superuser If selected, the user can perform any activity.
This check box is available only if you are
logged in as a superuser.
If you are not a superuser, the label Superuser
appears (without a check box) for any
previously created superuser.
Password never expires (Local authentication If selected, the user password never expires.
only)
Note:
If a user
password has
expired, a
message at the
top of the Edit
User page tells
you this when
you edit the user.

is used.
User must change password at next login If selected, the user is required to change the
(Local authentication only) password when next logging in. This option
is cleared automatically once the user has
changed the password.
is used.
Account locked (Local authentication only) If selected, the user cannot log in until you
clear the check box. This check box is selected
automatically for a user who tries to log in with
an incorrect password more than the number
of times allowed by the site option, Number of
Attempts Allowed.
is used.
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Field Description
Account disabled If selected, the user account is disabled.
Disabled users cannot log in, receive
notifications, or have objects such as topics
assigned to them.
Note:
When a local
user password
has expired, the
user account
becomes
disabled. To
allow the user to
log in again, you
must both assign
a new password
to the user and
re-enable the
user account.
Add or edit a user in an Oracle-hosted environment
Note:
This procedure does not apply for self-hosted installations. For more
information, see Add and edit a user in a self-hosted environment.
For Oracle-hosted installations, this is a two-step procedure:

1. Create users in the Oracle Health Sciences Identity and Access Management
Service console.
2. Manage the user's access rights on the Oracle Empirica Signal Users page.
Add the user in Oracle Health Sciences Identity and Access Management
Service
1. Log in to the Oracle Health Sciences Identity and Access Management Service
console.
2. Create the user.
For more information see the IAMS Delegated Administrator Quick Reference
Guide on the My Oracle website.
3. Assign the Signal role to the user.
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After a few minutes, the user is created in Oracle Empirica Signal, and an entry
appears in the Oracle Empirica Signal userprovision.log file on the application
server.
The user is provisioned with the default user profile specified as a site option.
4. Optionally, change the roles and permissions assigned to the user.
5. If you plan to use the Topics feature of Oracle Empirica Signal, optionally do the
following for newly created users:
Edit the user's access rights

1. Log in to the Oracle Empirica Signal application

4. Locate the user to edit in the table.
5. Click the user's Row Action menu ( ), and then click Edit.
Note:
6. Fill in the fields, and then click Save.
Field descriptions
Field Description
Authentication (read only) Indicates that the user is
authenticated with single sign-on.
Username (read only) Unique name of the user account (up
to 100 characters). You can reuse
deleted user names.
Does not apply if LDAP authentication
is used.
For more information, see About user
names.
First Name (read only) First name of the user (up to 64
characters).
Last Name (read only) Last name of the user (up to 64
characters).
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Field Description
Email (read only) Email address of the user. This
address (or addresses, separated by
a comma) is used:
• As the default email address if
the user chooses to be notified
of data mining run completion
notification.
• When a message is generated by
a topic email notification rule.
• When you use the Send
Message to All Users link on the
Settings page.
It is recommended that all users have
an associated email address.
User Profile The user profile, or set of attributes
(login group and quota), user
roles, permissions, and default user
preferences that can be applied to
users.
By default, new users are provisioned
with the user profile. The user profile
does not include any permissions or
roles.
Quota Maximum amount of server space
in megabytes (M) that the user is
permitted to use for creating runs.
If this limit is exceeded, the user
cannot submit new runs (or re-runs).
To indicate an unlimited amount of
storage space, leave this field blank.
If you enter 0, the user cannot
create any runs even if the user has
Login Group Name of the login group to which the
user belongs. Appears only if you are
a superuser.
By default, new users belong to the
Users login group
Password (disabled) Does not apply for SSO.
Confirm Password (disabled) Does not apply for SSO.
Superuser If selected, the user can perform any
activity. This check box is available
only if you are logged in as a
superuser.
If you are not a superuser, the
label Superuser appears (without a
check box) for any previously created
superuser.
Password never expires Does not apply for SSO.
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Field Description
User must change password at next Does not apply for SSO.
login
Account locked Does not apply for SSO.
Account disabled If selected, the user account is
disabled and the user cannot log in.
Assign roles to a user

A user role is the name of a set of permissions that are needed by a particular group
of users (such as data mining results reviewers). The application includes predefined
user roles, which can be modified or added to by a superuser. When you create a
user, you can assign one or more user roles to the user. (You can also explicitly assign
individual permissions to the user.)

3. Click the User's Row Action menu ( ), and then click Edit. You can edit only
users in the same login group as you.
4. Click Assign Roles.
5. Select or deselect checkboxes to assign roles to, or remove roles from, the user.
6. Click Save.
Note:
If you modify the user's roles and the user is currently running Oracle
Empirica Signal, the changes take effect the next time the user logs in to
Assign permissions to a user

You can assign additional permissions to an individual user; however, you cannot
disable permissions that have been assigned via a user role.

3. Click the user's Row Action menu ( ), and then click Edit. You can edit only
4. Click Assign Permissions.
Permissions that have been granted to the user are indicated by selected
checkboxes.
See User permissions for information about which Oracle Empirica Signal
activities are made available by each permission.
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5. Check or clear permission checkboxes to assign permissions to or remove

permissions from the user.
6. Click Save.
Note:
If you modify the user's permissions and the user is currently running
Oracle Empirica Signal, the changes take effect the next time the user
logs in to Oracle Empirica Signal.
Change user passwords
Note:
This procedure does not apply for single sign-on environments. You must
use the single sign-on application to change or reset user passwords.
If you have the Administer Users permission, you can change the passwords of other

5. In the New Password field, type a new password.
The site administrator sets the required password length and the types of
characters allowed (alphabetic, numeric, non-alphanumeric, lowercase, and
uppercase). There may be restrictions on the re-use of old passwords.
6. In the Confirm Password field, re-enter the same password.
The password expiration period, if one has been set as a site option, begins for
the new password. The next time the user logs in, the user must use the new
password.
Rename a user
Note:
Before you begin, if you work in a self-hosted environment with single sign-
on, rename the user in Oracle Access Manager (OAM) or your single sign-on
application. The user name in the single sign-on application must always
match the user name in Oracle Empirica Signal.
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When you change a user name:

• The original user name cannot be used to log into the Oracle Empirica Signal
application.
• The new user name appears throughout the application, including historical
activities in the User Activity Audit Trail.
• It is possible to create another user with the same, original user name after a
rename.
• The application converts user names to lowercase automatically upon creation
and, thus, does not allow duplicate user names that differ only in case. For
example, if you create user jkelley, and then attempt to create user JKelley, an
error occurs.
Note:
This procedure does not apply for Oracle-hosted installations unless you are
a superuser renaming a local user. You rename single sign-on users in the
Oracle Health Sciences Identity and Access Management Service console.

4. Click Rename User.
5. In the Username field, type the new user name for the user.
The name must be unique within the application, and can be up to 100 characters
long. If you are implementing single sign-on, type the single sign-on user name.
6. Click Save.
The new user name is displayed at the top of the Edit User page.
If the affected user is logged into the application, the user can continue working.
However, the user must use the new user name for future logins.
About user names

You create a unique user name for each user who logs in to Oracle Empirica Signal.
Oracle Empirica Signal converts user names to lowercase and does not allow two user
names that differ only in case. For example, if you create user jkelley and then attempt
to create user JKelley, Oracle Empirica Signal sends you a message that the user
already exists.
If you work in a self-hosted environment with single sign-on, you must give each user
the same user name in Oracle Empirica Signal and the single sign-on application. For
example, you might give a user the user names JKelley in Oracle Access Manager
and jkelley in Oracle Empirica Signal. The case of each user name can be different.
If you work in an Oracle-hosted environment, you create each user only once, in
Oracle Health Sciences Identity and Access Management Service console.
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Purge users
For Oracle-hosted installations with single sign-on, you delete a user by removing
the Signal role from the user in the Oracle Health Sciences Identity and Access
Management Service console. If objects are assigned to the deleted user, you must
also purge the user in Oracle Empirica Signal.
Note:
This procedure applies only to Oracle-hosted installations. For information
about deleting users in a self-hosted environment, see Delete a user.
When you purge a user:

• You become the owner of objects created by the user except topics or topic
actions.
• If the user is assigned to a product or product-event combination, Oracle Empirica
Signal removes the assignments.
To purge users, you must have Administer Users or superuser permissions.
1. If the user is assigned to a topic or topic action, reassign the topic or topic action.
• You must be on the user's work team and have the appropriate work team
permissions.
• You can reassign topics and topic actions in only one workflow configuration
within a login session. For example, if you reassign a topic in a topic workflow
configuration, you must log out and then log back in to reassign a topic in a
For more information, see Edit a topic.

4. Click Purge Users at the top of the page.
5. Click the user's Row Action menu ( ), and then click Purge.
Note:
If the user has one or more private topics, Oracle Empirica Signal prevents
you from purging the user and displays the name or ID of the private topic.
Contact a superuser to reassign or delete the private topic.
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Change the authentication method for a user
Note:
For Oracle-hosted installations, you change a user's authentication method
to SSO by creating the user in the Oracle Health Sciences Identity
and Access Management Service (IAMS) console. Do not perform this
procedure.
You can change the authentication method for a user to Local, SSO (single sign-on),
or LDAP.
Before you begin:
• If you plan to change a user's authentication method to SSO and you work in a
self-hosted environment, create the user in your single sign-on application.
• If you plan to change a user's authentication method to LDAP, import the user.

3. Click the user's Row Action menu ( ), and then click Edit.
4. From the Authentication drop-down list, select one of the following:
• Local
• SSO
• LDAP
5. Click Save.
Delete a user
Note:
This procedure does not apply for Oracle-hosted installations unless you are
a superuser deleting a local user. You delete single sign-on users in the
Oracle Health Sciences Identity and Access Management Serviceconsole.
For more information, see Purge users.
When you delete a user:

• You become the owner of objects created by the user except topics or topic
actions.
• The user cannot log in to the application.
• If the user is assigned to a product or product-event combination, Oracle Empirica
Signal removes the assignments.
• The deleted user's user name can be reused for a new user.
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• Objects cannot be assigned to the user.

• Comments created by the user on the Product-Event Combinations page remain
attributed to the user.
• The user's user name remains associated with the user's previous actions in the
User Activity Audit Trail. The user name is followed by (deleted).
1. If the user is assigned to a topic or topic action, reassign the topic or topic action.
Note the following about reassigning topics or topic actions:
• To reassign a topic or topic action, you must be on the user's work team and
have the appropriate work team permissions.
• If topics or topic actions assigned to the user are in different topic workflow
configurations, you can reassign topics and topic actions for only one topic
workflow configuration in a login session.
For example, if you reassign a topic in a topic workflow configuration, you must
log out and then log back in to reassign a topic in a different topic workflow
configuration.

4. Click the user's Row Action menu ( ), and then click Delete.
5. If the deleted user is logged in to Oracle Empirica Signal, the user can continue
working. However, after the user logs out, the user cannot log in again.
Note:
If the user has one or more private topics, Oracle Empirica Signal
prevents you from deleting the user and displays the name or ID of the
private topic. Contact a superuser to reassign or delete the private topic.
Manage user profiles

• View user profiles
• Add or edit a user profile
• Assign roles to a user profile
• Assign permissions to a user profile
• Assign preferences to a user profile
• Apply a user profile
View user profiles

A user profile is a set of attributes (login group and quota), user roles, permissions,
and default user preferences that can be applied to users. You can set up a user
profile and apply it as needed to new or existing users. Once you have applied a user
profile to a user, subsequent changes to the user profile do not affect that user.
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Note:
If you set user preferences by applying a user profile to users, those user
preferences are defaults that the individual users can override.

2. In the Manage Users section, click Edit User Profiles.
The User Profiles page provides the following information:
Column Description
User Profile Name Name of the user profile.
Login Group Name of the login group associated with
the user profile. Appears only if you are a
superuser.
megabytes (M) that users with the user
profile are permitted to use for creating
runs. If this limit is exceeded, users cannot
submit new runs (or re-runs). To indicate an
unlimited amount of storage space, leave
this field blank. If the quota is 0, users
cannot create any runs even if the user has
3. Click a user profile's Row Action menu ( ) to edit or delete the profile.
Add or edit a user profile
Note:
Modifications to a user profile are not automatically applied to users who with
that profile. To apply those changes to existing users, you need to re-apply
the user profile to those users.

• To add a user profile, click Add a New User Profile.
• To edit a user profile, click the User profile's Row Action menu ( ), and then
click Edit.
4. Enter or change the following information:
User Profile Fields
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Field Description
Edit User Profile: Name of the user profile. Can't be edited.
megabytes (M) that users with this user
profile are permitted to use for creating
runs. If this limit is exceeded, users cannot
submit new runs (or re-runs). To indicate
an unlimited amount of storage space,
leave this field blank. If you enter 0, users
cannot create any runs even if the user has
Login Group Name of the login group associated with
the user profile. Appears only if you are a
superuser. If this field does not appear, the
login group for the user profile is the same
as your login group.
5. Click Save.
6. Assign roles or assign permissions to the user profile or set user preferences for
the user profile.
Assign roles to a user profile

user roles, which can be modified or added to by a superuser.
user roles, which can be modified or added to by a superuser. When you create a user
profile, you can assign one or more user roles to the user profile.

3. Click the user profile's Row Action menu ( ), and then click Edit.
4. Click Assign Roles.
5. To assign roles to or remove roles from the user profile, select or de-select the
user role checkboxes
6. Click Save.
Assign permissions to a user profile

3. To edit a user profile, click the Row Action menu ( ) for a user profile, and then
click Edit.
4. Click Assign Permissions.
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5. To assign permissions to the user profile or remove permissions from the user
profile, select or de-select the permission checkboxes. See User permissions for
information about which activities are made available by each permission.
6. Click Save.
Assign preferences to a user profile
Note:
Preferences that you can assign to a user profile are dependent on your
permissions and the user preferences available to you.

3. To edit a user profile, click the Row Action menu ( ) for a user profile, and then
click Edit.
4. Click the Preferences link.
5. To assign user preferences to the user profile or remove user preferences from the
user profile, select or de-select the preference checkboxes and make selections
from the drop-down lists. See User permissions for information about which
activities are made available by each permission.
For details about each user preference, see Set your user preferences.
6. Click Save.
Apply a user profile

A user profile is a set of attributes (login group and quota), user roles, permissions,
and default user preferences that can be applied to users. (For more details, see Add
or edit a user profile.)
When you apply a user profile to an existing user, the information in the profile
replaces any previous settings for the user.
After applying a user profile to a user, you can modify settings further for the user.
(However, the changes are lost if you re-apply the profile.)
Note:
Once you have applied a user profile to a user, there is no further association
between the user profile and the user. For example, if the user profile is
subsequently modified or deleted, users to whom the profile was applied are
not affected.

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4. Click Apply User Profile (which is available only if there are existing user
profiles).
5. From the User Profiles list, click a user profile, associated with your login group,
to be associated with the user.
6. Click Save.
Note:
If you apply a user profile to a user who is currently logged in, any changes
that you make to the profile affect that user the next time the user logs in.
Manage user roles

• Predefined user roles
• View existing user roles
• Create a user role
• Edit a user role
• Delete a user role
Predefined user roles

Oracle Empirica Signal includes the following predefined user roles, which have one
or more user permissions assigned to them. When you assign a role to a user or user
profile, all of the permissions for that role are given to the user or user profile.
Note:
The following table includes only permissions that are assigned to at least
one predefined user role. For a description of every permission, see User
permissions.
Permissi Data Data Custome Report Report Signals Oracle

ons: Mining Mining r Designer Producer Reviewer Empirica
Run Run Administ Signal
Reviewer Designer rator Administ
rator
View Raw X X - X X X
Safety
Database
Download X X - - - X -
Raw Data
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rator
View Data X X - - - - -
Mining
Results
Create - X - - - - -
Data
Mining
Run
Save - X - - - - -
Intermedia
te Files
Create - X - X - - -
Drug
Profile
Layouts
Create X X - X X X -
Queries/
Case
Series
Create - - - X - - -
Report
Definitions
Create - - - X X - -
Report
Outputs
View - - - - - - X
Signal
Managem
ent
Manage - - - - - - X
Signaling
Terms
Manage - - - - - - X
Signal
Configurat
ions
Administer - - X - - - X
Users
Administer - - - - - - X
Drug
Profiles
Manage - - - - - - X
Configurat
ions
Manage - - - - - - X
Topic
Workflow
Configurat
ions
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rator
Manage - - - - - - X
Aliases
View existing user roles

A user role is a set of permissions needed by a particular type of user. The application
includes a set of predefined user roles, which you can modify or supplement.
When a user or user profile is created, one or more roles can be assigned to the user
or user profile. You can also assign permissions individually and explicitly to a user
or user profile. Individually assigned permissions are in addition to any permissions
granted by a role.

2. In the Manage Users section, click Edit Roles.
• To edit a user role, click Edit for the role.
• To delete a user role, click Delete for the role.
• To create a user role, click Create New Role.
Create a user role

3. Click Create New Role.
4. In the Enter name for a new role field, type a unique name for the user role, and
then click Save.
5. On the Edit Roles page for the new user role, select or deselect the Permissions
check boxes to assign permissions to, or remove permissions from, the user role.
For more information, see User permissions.
6. Click Save.
Edit a user role

3. For the user role you want to edit, click Edit.
4. On the Edit Roles page, check or clear the Permissions check boxes to assign
permissions to, or remove permissions from, the user role. See User permissions
for information about which Oracle Empirica Signal activities are made available
by each permission.
5. Click Save.
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If you modify permissions for an existing user role, then users currently logged
in and associated with the user role are not affected by the changes during
their current session. The changes take effect the next time they log into the
application.
Delete a user role

3. For the user role you want to delete, click Delete.
Users currently logged in with the deleted role can continue their current sessions.
However, after the users log out, their permissions no longer include permissions
granted solely through the deleted role.
Manage login groups

• View existing login groups
• Create a login group
• Edit a login group
• Delete a login group
View existing login groups

A login group is a group of users. A different logo image and Home page can be
established for each login group.
When a user or user profile is created, a login group must be associated with the user
or user profile. If you have the Administer Users permission, you can edit your own
login group, but you cannot create or delete login groups.
When a user publishes an object (such as a query or report), the object is usable by
other users in the same login group. (Users with the Administer Users permission can
use and act on published or unpublished objects created by other users in the same
login group.)
Additionally, work teams based on login groups can be defined for the purpose of
sharing topics.
Note:
For Oracle-hosted installations, a Users login group is included in Oracle
Empirica Signal by default. New users you create in the Oracle Health
Sciences Identity and Access Management Service (IAMS) console are
assigned to this login group by default.
1. Log in to Oracle Empirica Signal as a superuser.

3. In the Manage Users section, click Edit Login Groups.
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• To edit a login group, click Edit.

• To delete a login group, click Delete.
• To create a login group, click Create New Login Group.
Create a login group

1. Log in to Oracle Empirica Signal as a superuser. If you are not a superuser
but you have the Administer Users permission, the Login Group Settings page
appears for your own login group as soon as you click Edit Login Groups on the
Settings page.

4. Click Create New Login Group.
5. In the Enter name for new login group field, type a unique name for the login
group, and then click Save.
6. On the Login Group Settings page for the new login group, in the Logo Image
field, enter the name of an image file. (You cannot use a text file.) The image
file must exist in the \image subdirectory of the server location in which the
application was installed. The application scales any logo image that is not exactly
50 pixels in height to fit within the space allotted for the header. The aspect ratio is
maintained so that the width of the image is also scaled.
By default the Logo Image field specifies logo.gif (the Oracle Empirica Signal
logo). If you leave the Logo Image field blank, it is reset automatically to the
default.
7. In the Home Page field, enter the name of the file that contains the customized
page, in .html format, for the Home page. The .html file must exist in the
\customhomes subdirectory of the server location in which the application was
installed.
By default the Home Page field specifies home.inc (the default landing page). If
you leave the Home Page field blank, it is reset automatically to the default.
8. From the Signal Management Configuration drop-down list, select a signal
configuration from those published to the login group that you are editing.
The Signal Review Page is not available to users unless they are in a login group
with an assigned signal configuration and they have the View Signal Management
permission.
Note:
The same signal configuration can be assigned to multiple login groups.
9. From the Topic workflow Configuration drop-down list, select a topic workflow
configuration from those published to the login group that you are editing. This
will be the topic workflow configuration used on the Topic Management page (if
Signal Management is integrated with Topics, the workflow configuration used on
the Signal Review page is defined in the Signal Management Configuration). A
user can make a topic visible to work teams that are based on login groups to
which the topic workflow configuration is assigned.
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The Topic Management page is not available to users unless they are in a
login group with an assigned topic workflow configuration and they have the View
Topics permission (the exception is that users with the Manage Topic Workflow
Configurations permission can set a user preference as another way to make the
Topic Management page accessible).
Note:
The same topic workflow configuration can be assigned to multiple login
groups.
10. Click Save.
Edit a login group

3. Click Edit for a login group.
If you are not a superuser but you have the Administer Users permission, the
Login Group Settings page appears for your own login group as soon as you click
Edit Login Groups on the Settings page.
4. In the Logo Image field, enter the name of an image file to appear on the page
banner to the right of the Oracle Empirica Signal text (You cannot use a text file.)
The image file must exist in the \image subdirectory of the server location to
which the application was installed. The application scales any logo image to fit
within the space allotted for the header. The aspect ratio is maintained so that the
width of the image is also scaled.
By default the Logo Image field specifies logo.gif (the Oracle Empirica Signal
logo). If you leave the Logo Image field blank, it is reset automatically to the
default, and no image appears on the page banner to the right of the Oracle
Empirica Signal text.
5. In the Home Page field, enter the name of the file that contains the customized
page, in .html format, for the Home page. The .html file must exist in the
\customhomes subdirectory of the server location to which the application was
installed.
By default the Home Page field specifies home.inc. If you leave the Home Page
field blank, it is reset automatically to the default.
6. From the Signal Management Configuration drop-down list, select a signal
configuration from those published to the login group that you are editing.
Note:
The same signal configuration can be assigned to multiple login groups.
7. From the Topic workflow Configuration drop-down list, select a topic workflow
configuration from those published to the login group that you are editing. A user
can make a topic visible to work teams that are based on login groups to which the
topic workflow configuration is assigned.
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Topic Management ( ) is not available to users unless they are in a login

group with an assigned topic workflow configuration and they have the View
Topics permission (The exception is that users with the Manage Topic Workflow
Configurations permission can set a user preference as another way to make the
Topics page accessible).
Note:
The same topic workflow configuration can be assigned to multiple login
groups.
8. Click Save.
If you modified settings for an existing login group, then users currently logged in
who are associated with the login group are not affected by the changes during
their current session. The changes take effect the next time they log in.
Delete a login group

1. Log into the application as a superuser.
If the login group includes usernames (even if they are disabled), you cannot
delete the login group unless you first delete those usernames.

4. For the login group, click Delete.
Manage work teams

• About work teams
• Work team permissions
• View existing work teams
• Add or edit a work team
• Assign permissions to work team members
About work teams

A work team is a subset of the users who belong to a single login group. Work teams
are used only in the context of the topics feature, and are intended to structure the
level of access that different users have to topics. Work teams have properties that
control the availability of the work team for selection in the Visible to work team and
Assigned to fields of the topic and action.
When adding or editing a topic, users can make the topic visible to a work team
or teams. Users can either specify a single work team for a topic or zero, one, or
more work teams (as defined by the topic workflow configuration that is in use). Only
members of the specified work team(s) can see or act on the topic, and then only in
the ways permitted by their assigned work team permissions. (A topic that is not made
visible to any work team can only be viewed and acted on by its creator. For work on
these topics, work team permissions are not needed.)
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Note:
When assigning work team permissions, note that only users with the
View Topics user permission can access the Topics page and work with
associated topics on the Signal Review page. Work team permissions grant
different levels of access to the topics on those pages, but not to the topics
feature itself.
You can define multiple work teams within the same login group. For example,
different work teams can represent various therapeutic areas. A user can be a member
of one, several, or none of the login group's work teams.
Users with the Administer Users user permission can add and delete work teams, and
edit work teams to specify members and assign work team permissions to them. (One
of the work team permissions, Administer Work Team, can be used to give designated
members editing access only to a work team.)
Note:
Work team deletion is prevented if the work team has ever been used by
Oracle Empirica Topics for visibility or by a topic or action for assignment. If
a work team is referenced in a template, you cannot delete the work team
unless the template is deleted.
Work team permissions
Note:
To use the topics feature and access the Topics page or work with
associated topics on the Signal Review page, users must be given the View
Topics user permission. Work team permissions give users different levels of
access to the topics that appear on those tabs.
Permissions that can be assigned to work teams

The following permissions can be assigned to the members of a work team. Each
permission is independent of the others. For a member to edit a topic, both the View
Topics/Actions/Attachments permission and the Edit Topics/Actions permission must
be granted to that member. For a member to edit a topic attachment, the View Topics/
Actions/Attachments permission and the Add/Edit/Delete Attachments in Open Topics/
Actions permission must be granted.
It is possible for one person to be a member of different work teams and have different
work team permissions in each one. If a user has access to a topic that is visible to
multiple work teams through membership in more than one of those work teams, the
least restrictive permissions assigned to the user apply.
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Permission Activity
View Topics/Actions/Attachments View topics, actions, and attachments to both topics and
actions, and create .pdf or compressed .zip files of topic
information.
Note:
All work team members
should be given this
permission to allow topic
review.
Edit Topics/Actions Add and edit topics and actions, including adding
comments (if enabled by the topic workflow
configuration).
Note:
This permission does not
grant view access to
topics or actions. Typically,
members also are given
the View Topics/Actions/
Attachments work team
permission.
Add/Edit/Delete Attachments in Open Topics/Actions Add, edit, and delete attachments to topics and actions,
including adding comments (if enabled by the topic
workflow configuration).
Grants access to attachments to topics and actions that
are in a non-final state, such as Assigned.
Edit Attachments in Closed Topics/Actions Edit topic or action attachments when the topic is in a
final state, such as Closed, and edit action attachments
when the action is in a final state.
Note:
allow members to add
comments to attachments.
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Permission Activity
Reopen Topics/Actions Reopen topics or actions by changing the state from
a final state, such as Closed, to a non-final state,
such as Assigned. No other edits are permitted by this
permission.
Note:
For the Reopen option to
be available for a topic
or action, in the topic
workflow configuration at
least one state also must
be defined as a Next
possible state for the final
state.
Delete Topics/Actions Delete topics and actions.
Note:
grant delete access to
attachments.
Administer Work Team See the Administer Work Team permission section
below.
Note:
Work team permissions apply only in the context of working with topics
and, as a result, are effective only for members who also have the View
Topics user permission. Only members with the View Topics user permission
can access the Topics page, where they can add topics and make them
visible to a work team (or teams) to initiate collaborative participation. Users
who are members of the visible to work team(s) can then view and act on
topics as granted by their assigned work team permissions. View topics user
permission is also required to work with associated topics on the Signal
Review page.
Administer Work Team permission

An additional, managerial work team permission is available: Administer Work Team.
This work team permission grants members access to a limited subset of the activities
that can be performed with the Administer Users user permission. From the Settings
page, select Edit Work Teams. From the Edit Work Teams page, members with this
permission can:
• Edit work teams to add new members.
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• Assign work team permissions to members.

• Specify the values that apply to a given work team for fields with constrained
values (see Constrain field values by work team).
Default work team permissions

You can assign work team permissions individually to members, or you can define a
set of default work team permissions and assign that set to the members of a work
team. When a work team is added, each permission is designated as being in the
default set for that work team or not, as follows:
Permission Default
View Topics/Actions/Attachments Yes
Add/Edit/Delete Attachments in Open Topics/ No
Actions
Edit Attachments in Closed Topics/Actions No
Reopen Topics/Actions No
Delete Topics/Actions No
Administer Work Team No
You can change this set of default permissions so that members are given additional
permissions by default. When you add a member to a work team, the permissions
in the default set are assigned to that new member automatically. You can edit each
member's assigned permissions as needed.
If you make changes to the default set after it has been assigned to members, the
permissions granted to those members by default are updated automatically to match
the new default set.
View existing work teams

2. In the Manage Users section, click Edit Work Teams.
The Edit Work Teams page provides the following information about each work
team:
Field Description
Name Name of the work team.
Description Description of the work team.
Login Group Name of the work team's login group.
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Field Description
All Users Yes, if the work team is set up to include
all users in the login group automatically.
When a new user is added to the login
group, he or she is also added to the work
team and given the default set of work team
permissions.
No, if users in the login group are selected
individually for inclusion in the work team,
and are listed in the Users column. New
users must be added to the work team
manually.
Users Blank, if all users in the login group are in
the work team. Otherwise, lists the name of
each work team member.
Topic Visibility Whether or not the topic is visible to the
work team.
Topic/Action Assignment Whether or not topics and actions can be
Created By Name of the user who created the work
team.
created.
team.
modified.
ID Identifier that was assigned automatically
when the work team was created. Each
work team ID is unique and is not re-used
if the work team is deleted.
The table might also include columns for custom fields added by your
organization.
3. Perform the following optional activity: add a new work team. Click Add Work
Team. Only users with the Administer Users user permission can add work teams.
For more information, see Add or edit a work team.
4. If you click the Row Action menu ( ) for a work team, you can do the following:
• To edit a work team, including adding new members, click Edit.
• To assign work team permissions to members, click Assign Work Team
Permissions.
• To delete a work team, click Delete. Only users with the Administer Users user
permission can delete a work team, and a work team cannot be deleted if any
topics have been made visible to it.
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Note:
Work team deletion is prevented if the work team has ever been
used by Oracle Empirica Topics for visibility or by a topic or action for
assignment. If a work team is referenced in a template, you cannot
delete the work team unless the template is deleted.
For information about viewing, printing, or downloading tables or changing the way
Add or edit a work team

3. To add a new work team, click Add Work Team. Only users with the Administer
Users user permission can add work teams.
To edit a work team, click the Row Action menu ( ) for the work team, and then
click Edit.
4. In the Name and Description fields, enter or change the name and description of
the work team.
5. If you are a superuser, from the Login group drop-down list, select the login group
from which you want to add users to the work team. If you are not a superuser, this
field does not appear and you add users from your own login group to the work
team.
6. Select the Allow topic visibility check box to make the work team available in
the Visible to work team field and Browse work team pages when creating and
editing topics/topic templates.
7. Select the Allow assignment of topics and actions check box to make the work
team available for selection in the Assign to topic and action fields.
8. Do one of the following:
• To add all users in the login group to the work team, click the Add all users
radio button. As new users are added to the login group, they are added to the
work team and given the default set of work team permissions automatically.
• To add users in the login group to the work team individually, click the Select
users radio button. Click Select Users to individually select users. As new
users are added to the login group, you must add them to this work team
manually.
9. Optionally, supply values in any custom fields present for work teams. Custom
fields for work teams are defined in a topic workflow configuration, and a
superuser must enable these fields for use by setting site option , Topic workflow
configuration for work team custom fields.
10. When you click OK, your changes are saved and you can assign work team
permissions to the members of the work team.
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Assign permissions to work team members

3. Click the Row Action menu ( ) for the work team, and then click Assign Work
Team Permissions.
By default, each new work team member is assigned the default set of
permissions and the check box in the Use Default column is checked.
4. To assign permissions individually, clear the Use Default check box, and then
check or clear the check boxes in the row with the user's name.
Note:
You must assign at least one work team permission to each member or
the default set of permissions will be assigned.
For more information on the access level granted by each permission, see Work
team permissions.
5. Click Save.
If you modified permissions for a user who is currently logged into the application,
the user is not affected by the changes during the current session. The changes
take effect the next time the user logs in.
Use single sign-on

• About single sign-on
• Configure single sign-on in a self-hosted environment
About single sign-on

Single sign-on (SSO) is an authentication method that enables users to log in to the
Oracle Empirica Signal application and other applications using a single user name
and password combination. Users can log in to an SSO environment and access all
the applications in the environment without reentering their credentials.
SSO simplifies user administration across applications by enabling you to manage
fewer user accounts. Users do not need to remember multiple user names and
passwords.
Oracle-hosted installations are configured for SSO with Oracle Health Sciences
Identity and Access Management Service. Oracle provides you with a URL to access
the IAMS console.
For self-hosted installations, you must do the following to use SSO:
• Install and configure an SSO application, such as Oracle Access Manager.
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• Install and configure the WebGate agent on the Oracle Empirica Signal application
server.
Contact Oracle for assistance.
For more information, see Configure single sign-on in a self-hosted environment.
Configure single sign-on in a self-hosted environment

Adding Oracle Empirica Signal to a single sign-on (SSO) self-hosted environment
requires you to perform configuration tasks outside of the application before
you enable SSO for Oracle Empirica Signal users. Your application environment
determines the configuration responsibilities:
Single Sign-On configuration checklist
# Task Responsibility Source for

Instructions
1 Install and configure Customer Contact Oracle for
an SSO application assistance.
such as Oracle
Access Manager
2 Configure a WebGate Oracle Contact Oracle for
agent on the SSO assistance.
server.
3 Install and configure Oracle Contact Oracle for
WebGate on the assistance.
Oracle Empirica
Signal application
server.
4 Uncomment single Customer Oracle Health
sign-on properties in Sciences Empirica
the Signal Installation
webvdme.propert Guide.
ies file.
5 Specify the URL for Customer Oracle Health
a custom logout page Sciences Empirica
(optional). Signal Installation
Guide.
6 Change the Oracle Customer Oracle Health
Empirica Signal Sciences Empirica
application session SignalInstallation
timeout to be longer Guide.
than the SSO session
timeout.
7 Configure the Oracle Customer Oracle Health
application server for Signal Installation
native logins. Guide.
8 Restart the Oracle Customer Oracle Health
service. Signal Installation
Guide.
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# Task Responsibility Source for

Instructions
9 Validate SSO by Customer Oracle Health
logging in with your Sciences Empirica
SSO user name and Signal Installation
password. Guide.
10 Create SSO users in Customer Oracle Access
the SSO application. Manager
documentation.
11 Rename existing Customer Rename a user
Oracle Empirica Add or edit a user
Signal user names to
match their associated
SSO user names, or
create new users as
necessary.
12 Select SSO in the Customer Add or edit a user
Authentication drop- Add or editing a user
down list for users and profile
user profiles.
Manage LDAP users

• Configure Oracle Empirica Signal for use with LDAP in a self-hosted environment
• LDAP properties
• Import LDAP users
• Change a user to LDAP authentication
• Refresh LDAP users
Configure Oracle Empirica Signal for use with LDAP in a self-hosted

environment
Note:
This procedure does not apply for Oracle-hosted installations.
LDAP (Lightweight Directory Access Protocol) is an internet protocol used to look

up information stored in a directory on a server. The Oracle Empirica Signal
application provides a way for you to update user information using LDAP. Thus, user
information can be maintained in an LDAP directory and imported into the application.
User authentication is performed by LDAP instead of by the standard means of
authentication in Oracle Empirica Signal.
When user information is stored in an LDAP directory, users can be identified by a
unique user attribute that remains constant despite potential user name changes in the
LDAP directory.
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Note:
The Oracle Empirica Signal application does not update information in the
LDAP directory.
You can configure Oracle Empirica Signal to use LDAP by editing a properties file
template for Active Directory, Sun One Directory, or Oracle Internet Directory. For more
information, see your LDAP documentation.
1. Log in to Oracle Empirica Signal as a superuser.

3. In the Administer System section, click Set Site Options.
4. Deselect Enable LDAP, and then click Save.
5. Navigate to <INSTALL_DIR /Signal/WEB-INF/classes.
Note:
The Oracle Empirica Signal application does not update information in
the LDAP directory.
6. Copy the properties file that corresponds to your directory type to the same
location, and then rename the file ldap.properties:
• template_ldap_ad_kerberosAuth.properties—Active Directory using
kerberos for authentication.
• template_ldap_ad_ldapAuth.properties—Active Directory using ldap
for authentication.
• template_ldap_sunone_ldapAuth.properties—Sun One Directory.
• template_ldap_oid_ldapAuth.properties—Oracle Internet Directory.
Note:
After the ldap.properties file is created, redeploy the application server
using WebLogic Server Administration Console.
7. Open the ldap.properties file in a text editor.

8. Replace all placeholders (for example, <HOSTNAME>) with the relevant values.
For more information on LDAP Properties, see LDAP Properties.
9. Save your changes.
10. On the Settings page, click Set Site Options.
11. Select Enable LDAP, and then click Save.
12. On the Settings page, click Edit Users.
13. Click Import LDAP Users and search for users to verify the LDAP configuration.
For more information, see Import LDAP Users.
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LDAP properties
For reference, you can use the following properties to configure the Oracle Empirica
Signal application for use with LDAP. Some properties apply only to certain directory
types. You configure these properties in the appropriate ldap properties file. For more
information, see Configure Oracle Empirica Signal for use with LDAP.
Property Description
auth.mode Authentication method. Specify kerberos or
ldap.
auth.jndi.java.naming.factory.initial Implementation class for JNDI LDAP provider
used during LDAP user authentication. Specify
com.sun.jndi.ldap.LdapCtxFactory.
auth.kerberos.host Hostname for the Kerberos Key Distribution
Center (KDC) used during Kerberos-based
user authentication.
auth.kerberos.port Port for the Kerberos Key Distribution Center
(KDC) used during Kerberos-based user
authentication.
auth.kerberos.domain Domain used during Kerberos-based user
authentication.
auth.jndi.java.naming.security.protocol Security protocol used during LDAP-based
Specify one of the following:
• none - LDAP
• ssl - LDAPS
auth.jndi.java.naming.provider.url Hostname and port used during LDAP-based
auth.jndi.java.naming.security.authentication Authentication mode used during LDAP-based
user authentication. Specify simple.
search.jndi.java.naming.factory.initial Implementation class for JNDI LDAP provider
used during user search and import. Specify
com.sun.jndi.ldap.LdapCtxFactory.
search.jndi.java.naming.security.protocol Security protocol used during LDAP user
search and import. Specify one of the
following:
• none - LDAP
• ssl - LDAPS
search.jndi.java.naming.provider.url Hostname and the port used during LDAP
user search and import. When importing users
or changing a user to LDAP authentication, all
searches begin in the specified root.
search.jndi.java.naming.security.authentication Authentication mode used during LDAP user
search and import. Specify one of the
following:
• none - Anonymous connections.
• simple - Search as a specific user.
search.jndi.java.naming.security.principal Stores LDAP user name that resides in the
LdapCredentials key. For more information,
see Oracle Health Sciences Empirica Signal
Installation Guide.
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search.jndi.java.naming.security.credentials Stores LDAP password that resides in the
LdapCredentials key. For more information,
see Oracle Health Sciences Empirica Signal
Installation Guide.
search.jndi.java.naming.referral Indicates whether the LDAP provider follows
referrals during a user search and import.
Specify follow.
search.controls.timelimit Maximum number of seconds that a query of
the LDAP server can take before the LDAP
connection times out.
search.controls.countlimit Maximum number of users that can be
received from the LDAP server before the
LDAP connection times out.
search.root LDAP search root used during LDAP user
search and import.
search.syncroot LDAP search root used during LDAP refresh/
sync of users. Generally should be the same
as search.root.
search.nameAttribute LDAP attribute which is searched upon in the
Import LDAP User page.
search.emailAttribute LDAP attribute used to populate a Signal
user's email address during an import/sync
operation.
search.usernameAttribute LDAP attribute used to populate a Signal
user's user name during an import/sync
operation.
Oracle Empirica Signal ensures that the user
name in Oracle Empirica Signal matches the
user name in the directory during an import or
refresh operation.
search.firstNameAttribute LDAP attribute used to populate an Oracle
Empirica Signal user's first name during an
import/sync operation.
search.lastNameAttribute LDAP attribute used to populate an Oracle
Empirica Signal user's last name during an
import/sync operation.
search.kerberosIdAttribute LDAP attribute used to identify an Oracle
Empirica Signal user during Kerberos
authentication.
search.syncIdAttribute LDAP attribute used to identify an Oracle
Empirica Signal user during a refresh/sync
operation.
Typically, this is an attribute that is not subject
to change, such as an employee ID.
search.searchQuery LDAP search query used when the user
specifies a search string on the Import LDAP
User page.
search.searchQueryNF LDAP search query used when the user
leaves the search string blank on the Import
LDAP User page.
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search.syncQuery LDAP sync query used when refreshing users.
Import LDAP users
Note:
1. Log in to Oracle Empirica Signal as a user with the permissions Administer Users
and Administer LDAP.
Note:
Make sure that at least one user profile exists.

4. Click Import LDAP Users. This option is available only if an LDAP configuration
has been set up.
5. From the User Profile drop-down list, select the user profile to apply to the LDAP
users you import.
Available user profiles are those associated with your login group.
6. From the Domain drop-down list, select the domain from which you want to import
LDAP users. The Available LDAP Users list shows users (up to 400) in that
domain.
7. In the Name field, enter a text string, and then click Find to filter the list of
available LDAP users (optional).
8. To move users from the Available LDAP Users list to the Selected LDAP Users
list, use the arrow buttons. The double-arrow buttons move all users from one list
to the other list.
9. Click Import.
Only selected users who do not have a user name in the Oracle Empirica Signal
application are imported. The import operation does not refresh existing Oracle
Empirica Signal users. See Refresh LDAP users. A message ells you if an LDAP
user that you have selected for import already exists in the application.
10. Optionally, change the roles and permissions assigned to the user.
11. If you plan to use the Topics feature of Oracle Empirica Signal, do the following for
imported users:
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Change a user to LDAP authentication
Note:
Note:
Make sure that at least one user profile exists.

4. Click the Row Action menu ( ) for the user you want to edit, and then click Edit.
Note:
5. In the Authentication drop-down list, select LDAP.

6. Click Import LDAP Users. This option is available only if an LDAP configuration
has been set up.
7. In the Name field, enter a text string, and then click Find to filter the list of
available LDAP users (optional).
8. Select a user in the Available LDAP Users list, and then click OK.
For more information, see Import LDAP users.
Refresh LDAP users

User information in Oracle Empirica Signal is refreshed with user information from the
LDAP directory if:
• The Oracle Empirica Signal user is an LDAP user.
• There is LDAP information for the user in the LDAP directory, and that information
has changed since the last refresh of LDAP users.
User names can change as a result of refreshing LDAP users. Every place that the
user name or other information appears in the application, including the User Activity
Audit Trail, is updated with information from the LDAP directory.
• The refresh operation does not add new users from the LDAP server. See Import
LDAP users.
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System configurations
• For users who are LDAP users, do not make changes to user information in
Oracle Empirica Signal. If you do so, the changes will be lost when you next
refresh LDAP users.
Note:

4. Click Refresh LDAP Users. This option is available only if an LDAP configuration
has been set up.
Messages tell you whether or not information for each Oracle Empirica Signal user
who is an LDAP user is refreshed.
• Select a data configuration
• Manage configurations
• Manage subscription data releases
• Manage aliases
• Manage drug profile configurations
• Manage signal configurations
• Manage reviewer-user mapping
• Manage topic workflow configurations
• Transform data
Select a data configuration

A data configuration is a group of variables representing items (database table
columns) in the source data. In several places in the Oracle Empirica Signal
application, such as when creating a data mining run or query, you must select a
data configuration to indicate which source data is used. You can select the data
configuration from a list of data configurations to which you have access. If you do
not know the name of the data configuration, you can browse a descriptive list of
data configurations and select one. When you select a data configuration, it remains
selected until you select a different one.
Lists of available configurations typically show only compatible configurations. See
Data configuration and object compatibility for more information.
1. Next to the Configuration field, click Browse.
The Select Configuration dialog box appears and provides the following
information about each data configuration to which you have access:
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Column Description
ID Internal identifier of the data configuration.
Name Name of the data configuration.
Description Description of the data configuration.
Account Name of the Oracle account in which the
data configuration resides.
See About tables for information about viewing, printing, or downloading tables or
changing the way data displays in the table.
2. Click the row for the data configuration that you want to select.
3. Click OK.
Note:
Some data configurations are set up to support timestamped data. If you
select this type of data configuration during certain activities, you must
specify an As of date. See Specify an As Of date.
Example
Suppose that the source data contains all the items shown in the following example.
The data configuration specifies GENERIC_NM and PREFERRED_TERM as the
items to be available in a data mining run. If the data configuration renames
GENERIC_NM and PREFERRED_TERM to Drug and PT, when you create a run,
you select Drug and PT as the items to study. The run results show you scores for
combinations of Drug and PT values.
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Manage configurations
• About data configurations
• View existing data configurations
• Data configuration example
• Add a data configuration
• Modify a data configuration
About data configurations

• A data configuration identifies and sets up variables from the source data for use
in the Oracle Empirica Signal application. The configuration determines the drug
variables (such as generic name or trade name) and the event variables (such
as PT) that are available for such activities as data mining or querying. It also
determines:
• The variables that are available for subsetting or stratification for a data mining
run.
• Whether and how source data is transformed (for example, extraction of the year
portion of a date variable) for use in data mining runs.
• The hierarchy of terms, such as MedDRA, that is available for browsing terms.
• Whether data is timestamped.
• The case information that is available when users drill down to a list of cases or
case details.
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You can create data configurations to exert varying degrees of control over user
choices. A configuration can tightly control the variables that are available during
activities such as creating data mining runs. A configuration can also make more
variables available or leave the choice of variables up to the run creator.
For example, suppose that source data includes both the trade name and generic
name for drugs. You can create one data configuration that makes only trade names
available, and another data configuration that makes only generic names available.
You can also create a single configuration that makes both trade names and generic
names available, and then let the run creator determine which one to use.
You work with configurations on the Manage Configurations page. A configuration
becomes available for use during activities, such as data mining, only when you have
validated it and granted permissions to it.
You can create a configuration by:
• Importing it.
• Setting it up from scratch.
• Copying and modifying an existing data configuration.
Regardless of how you create the data configuration, you generally perform the
following tasks in sequence:
Data configuration tables

During Oracle Empirica Signal installation, a master configuration table for all source
databases is created in another Oracle account. The application populates this master
configuration table automatically as you add, copy, or import data configurations.
When you create a data configuration, an Oracle table, referred to as a data
configuration table, is created automatically. This configuration table resides in the
same Oracle account as the source data. Multiple data configurations and data
configuration tables might exist for an Oracle account.
A superuser can view the data configuration table for a current run and the master
data configuration table for the account from the Data Sources page.
View existing data configurations

The Manage Configurations page shows a list of the data configurations that have
been added to any of the source databases. It lists configurations that you created or
for which you have the Edit permission. The Is Valid column tells you whether or not a
data configuration has been validated.
1. Log in to Oracle Empirica Signal as a user with the Manage Configurations
permission.

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The Manage Configurations page provides the following information about each data
configuration:
Column Description
Name Name of the configuration.
Desc Description of the configuration.
Database Group Name of the database group to which the configuration
is assigned. Results reviewers can use the database
group when finding and selecting a data mining run.
The application also uses the database group when
determining color changes for case ID links that are
visited by users.
Owner Name of the user who created the configuration.
Account Name of the Oracle account in which the configuration
resides.
Table Name of the Oracle table representing the configuration.
Drilldown Map Name of the drilldown map table, which specifies the
source of case details that display when a user drills
down.
Source Desc Name of the source description table, which provides
information about the source data.
Is Valid Yes, if the configuration has been validated.
No, if the configuration requires validation.
Type The type of configurations created locally is Local. The
type of configurations imported from Subscription Data
Releases is Managed.
Data configuration options

• To add a data configuration, click Add Configuration.
• To import data configurations, click Import Configurations.
• To validate data configurations, click Validate Configurations.
• To print, download, or publish multiple data configurations, click Select Rows.
You can then check the rows for the configurations on which you want to act. You
can also click Select All to check all rows (or click Clear All to uncheck all rows).
Then click the action that you want to perform on the selected rows.
If you click the Row Action menu ( ) for a data configuration, you can click Edit to
view or edit the data configuration.
Data configuration example

This example shows two data configurations for the same source database. The
database includes both tables and views. A view may not include all the data in the
table on which it is based. For example, the DRUG table includes all reported drugs for
each case, while the DRUG_S view on that table includes only drugs with a suspect
indicator value of YES. The data mining runs and queries that are based on these
distinct configurations are different, as both the data selected for each configuration,
and the way the data can be used in the application, are different. Providing a variety
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of configurations can be useful for the comparative analyses conducted by Oracle

Empirica Signal users.
Add a data configuration

• Add a data configuration
• Connect to an Oracle account
• Specify a drilldown map table
• Select an Oracle table or column
• Source description table
• Narrative text
• Unique values table
• Specify hierarchy versions for timestamped data
• Drug and event hierarchies
• Import a data configuration
• Validate a data configuration
• Publish a data configuration
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Add a data configuration

When you add a data configuration, you specify information about the data
configuration as a whole and you add data configuration variables. Another option
is to copy an existing data configuration and edit it as needed.
The only required attributes of a data configuration are its name, drill-down map,
and configuration table name. You might want to create the data configuration with
only those attributes, add variables to the data configuration, and then edit the data
configuration to specify additional attributes. Also note that some data configuration
attributes, such as permissions to the data configuration, must be specified during
editing (not during creation).

3. Click Add Configuration.
4. If you have not already done so during your current Oracle Empirica Signal
session, you must connect to the Oracle account that will contain the
configuration.
a. From the list of accounts, click the account in which you want to add the new
configuration.
b. In the Oracle account field, leave the existing value or enter a different value,
and then click OK.
When the system has connected, the Add Configuration page appears.
5. In the Name and Description fields, enter a unique name and a description for the
configuration.
During Oracle Empirica Signal activities, users select a configuration to use. The
name and description are important and should provide information about the
source data. For example, an AERS configuration might be named 2012Q4:
AERS+SRS (S+C)", indicating the year and quarter, the fact that SRS data is
included, and the fact that both suspect (S) and concomitant (C) drugs are
included.
Note:
If a data configuration was deleted by reference only, it is still in the
database and you cannot create anew configuration with the same
name.
6. Next to the Drilldown Map field, click Select/Edit Table to specify a drill-down
map table. Select the table from the Select Drilldown Table drop-down list and
click OK. If you do not specify a drilldown map table, the configuration will not pass
validation.
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Note:
If the source data is timestamped, then for each table referenced by the
drilldown map table, there must be at least one variable with the same
name.
7. Next to the Source Description Table field, click Select Table to select a table
that has been set up as a source description table in the Oracle account to which
you are connected. For timestamped data, you should always specify a source
description table. If the data is not timestamped, the source description table is
optional. In the Select Table dialog box, click a table and click Save.
8. To make the configuration unavailable for data mining runs, check Hide from Data
Mining. The configuration can then be used for other activities, such as querying
and reporting, but not for data mining. For example, you should not use for data
mining a configuration pointing to source data from which duplicates have not
been removed.
9. To identify the configuration as including cases with suspect and concomitant
drugs, check Database includes Concomitant Drugs. If the configuration
includes suspect drugs only, clear this check box.
10. If the source data includes timestamped data, allowing for the recreation of data as
of a particular point in time, check Database is Timestamped.
• If you have not checked Database is Timestamped, provide the name of a

Drug Hierarchy Account, an Event Hierarchy Account, or both by selecting
them from the drop-down lists.
• If you have checked Database is Timestamped, click Select/Edit Table to
define hierarchy accounts for specified time periods.
If you want to associate drug variables or event variables in the configuration with
a dictionary that defines a hierarchy of terms, see Drug and event hierarchies.
a. Select the drug hierarchy value from the Drug Hierarchy Account field.
By default, the value selected is None.
b. Select the event hierarchy value from the Event Hierarchy Account field.
By default, the value selected is None.
12. In the Configuration Table Name field, enter the unique name of the table to hold
the new configuration in the Oracle account to which you are connected. The table
name cannot start with a number, and cannot be edited.
13. Click Save.
14. Prior to validating the configuration in the Modify Configuration page, you must
add variables. To add configuration variables to the configuration, click Add New
Variable.
Connect to an Oracle account

When you add or import data or topic workflow configurations, the Oracle Empirica
Signal application must connect to an Oracle account.
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3. Click Add Configuration.
• To add a configuration, click the name of an existing Oracle account. For data
configurations, click Choose a Different Account and provide the name of an
Oracle account.
When the system has connected, the Modify Configuration page appears.
• To import a configuration, click the name of an Oracle account. For data
configurations, click Import Configurations from a Different Account and
provide the name of an Oracle account.
Specify a drilldown map table

During many activities, such as viewing data mining results, users can click case ID
links to drill down to a list of cases (first-level drilldown), and can then drill down
further to view case details (second-level drilldown). The type of data presented during
drilldown is from the source database tables, and is determined by the drilldown map
table associated with the data configuration.
Drilldown information comes from the source data. Users do not see values for a
variable that includes a data transformation defined in the configuration, or any values
that are missing from the source data.
Note:
Drilling down to view case details is possible only if the appropriate site
option has been set and the user has the appropriate permission.

4. In the right-most column of the configuration, click Edit.
5. Next to the Drilldown Map field, click Select/Edit Table.
6. From the Select Drilldown table drop-down list, select a drilldown map table and
click OK. Available drilldown map tables are those in the Oracle account to which
you are connected.
Select an Oracle table or column

1. If the activity you are performing requires you to specify a table, click the table
name, and then click Save.
2. If you need to select a table and column, click a table name.
The Available Columns list shows columns in that table.
3. Click a column name, and then click Save.
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Source description table

A source description table (or view) describes the source data that is used in the
Oracle Empirica Signal application. Information from this table appears when users do
the following:
• View case details.
• View a results table on the Data Mining Results page.
• Display notes when viewing source tables from the Data Sources page.
Additionally, this table defines information needed for timestamped data. You must
specify a source description table for a data configuration that supports timestamped
data.
A source description table is created and populated outside of the Oracle Empirica
Signal application using standard Oracle tools or any application that enables working
with Oracle tables. The table must be in the Oracle account containing the source
database tables. A data configuration in the Oracle Empirica Signal application then
refers to the table. An existing data configuration can be edited to add a source
description table to it.
Content of the source description table

For the table name, it is recommended that the name distinguishes the table from
other source description tables and indicates the table's purpose. A source description
table must include one row with the following columns. All columns must be included,
even if they are not used.
Column Data Type Description

ID NUMBER(1) Unique identifier of the row.
(There will be only one row.)
DESCRIPTION VARCHAR2(30) Description of the source data.
LOADDATE DATE Date and time when the
source data was loaded.
SOURCE VARCHAR2(30) Source of the safety data.
DRUGDICTIONARY VARCHAR2(30) Reserved for future use.
DRUGDICTIONARYVER VARCHAR2(30) Reserved for future use.
EVENTDICTIONARY VARCHAR2(30) Reserved for future use.
EVENTDICTIONARYVER VARCHAR2(30) Reserved for future use.
ASOFDATE DATE Supports use of timestamped
data.
EARLIEST_ASOFDATE DATE Supports use of timestamped
data.
For example, suppose the DESCRIPTION is TEST_AERS_2019, the LOADDATE is

02-Jan-2020, and the SOURCE is NTIS. The description of the source database
appears in the application as:
Source Data: TEST_AERS_2019 from NTIS on 02-Jan-2020
You can view the source description table on the Data Sources page.
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Timestamped data
To support timestamped data, the application must know the range of dates that are
valid for users to enter when prompted for an As Of date. The following two columns of
the source description table define the range:
• ASOFDATE—Latest date for which there is consistent source data.
• EARLIEST_ASOFDATE—Earliest date for which there is consistent source data.
The values of these columns are determined during the data preparation process.
On Oracle Empirica Signal pages where users specify an As Of date, the default date
that appears is the ASOFDATE from the source description table. Users can change
the displayed date to another date that is earlier than or equal to the ASOFDATE and
later than or equal to the EARLIEST_ASOFDATE.
Narrative text
If the source data contains narrative text, you can include the narrative on the Case
Details page. There are several ways that narrative text may be set up in the source
data.
Assume that there are three categories of narrative text (CAT_A, CAT_B, and CAT_C)
and two report IDs (10, 11). The simplest way that narrative text may be stored is for
each category of narrative text to have its own column in the source database table,
with one row per report ID. This approach is used in the following example:
REPORT_ID CAT_A CAT_B CAT_C

10 This is category A This is category B This is category C
narrative text for case narrative text for case narrative text for case
10. 10. 10.
11 This is category A This is category B This is category C
narrative text for case narrative text for case narrative text for case
11. 11. 11.
For the NARRATIVE type in the drilldown map table, you would specify CAT_A,
CAT_B, and CAT_C as display columns.
Concatenation of narrative text

If the narrative text for a column is too long to fit into a single column of data type
VARCHAR2, it may be split up between columns that have the same root name and a
two-digit sequence number.
REPORT_ID CAT_A01 CAT_A02 CAT_A03 CAT_B CAT_C

10 This is It is too long to So it is split This is This is
category A fit into one between three category B category C
narrative text column of the columns. narrative text narrative text
for case 10. database for case 10. for case 10.
table.
11 This is - - This is This is
category A category B category C
narrative text narrative text narrative text
for case 11. for case 11. for case 11.
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For the NARRATIVE type in the drilldown map table, you would specify CAT_A,
CAT_B, and CAT_C as display columns. Oracle Empirica Signal would concatenate
the values in the CAT_A01, CAT_A02, and CAT_A03 columns because their root
name is the same (CAT_A). Values are concatenated in the order of the columns'
two-digit sequence numbers.
Narrative text spanning multiple rows

In the source data, there may be a column that stores the category and another
column that stores the narrative text. If there are multiple rows per report ID, you must
use the option "NARRATIVE spans multiple rows" in the drilldown map table for the
NARRATIVE type.
REPORT_ID NARRATIVE_CATEGORY NARRATIVE_TEXT

10 CAT_A This is category A narrative
text for case 10.
10 CAT_B This is category B narrative
text for case 10.
10 CAT_C This is category C narrative
text for case 10.
11 CAT_A This is category A narrative
text for case 11.
11 CAT_B This is category B narrative
text for case 11.
11 CAT_C This is category C narrative
text for case 11.
For narrative data stored this way, the Oracle data type of the column storing the
narrative text is typically CLOB (character large object), so there is no restriction on
narrative length. For the NARRATIVE type in the drilldown map table, you would
specify NARRATIVE_CATEGORY and NARRATIVE_TEXT as display columns and
you would check NARRATIVE spans multiple rows.
Unique values table

A unique values table (UVT) contains all unique values that exist in the source data for
a specific configuration variable. When displaying all values for a variable, the Oracle
Empirica Signal application references the unique values table for that variable. (The
exception to this is on the Select Criteria page for results of a data mining run, where
users select from a list of values in the data mining results.)
When you define data configuration variables, if a variable's selection type is Distinct
Value List, Select from Drug Hierarchy, or Select from Event Hierarchy, you can
also specify a unique values table. If you do not specify a UVT for a variable, the
application creates the corresponding UVT automatically when you validate the data
configuration. If the source data is updated, as in a timestamped data configuration,
you must also update the unique values tables or delete them for the individual
variables so that they will be re-created (and updated) automatically during validation.
A unique values table name starts with UVT by default. The table must have an
ITEM_VALUE column, which contains one row for each unique value. The column type
of the ITEM_VALUE column must match the column type of the corresponding column
in the source database table.
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If text values for a variable are mapped, the unique values table contains source data
values, not the mapped values.
Note:
In a timestamped database there are no start dates and end dates
associated with the unique values table, so all unique values that ever
existed are in the unique values tables.
A superuser can view the unique values tables on the Data Sources page.
Specify hierarchy versions for timestamped data

during which only one hierarchy version was used to code the source data.
For example, suppose that the source data includes the following rows:
Case ID Start Stop

100 01-01-2004 06-01-2004
200 06-01-2004 01-01-2005
300 01-01-2005 NA
Additionally suppose that different versions of MedDRA were used to code the source
data:
• MedDRA Version 6.1 was used until June 1, 2004.
• MedDRA Version 7.0 was used between June 1, 2004 and January 1, 2005.
• MedDRA Version 7.1 was used on January 1, 2005.
In Oracle Empirica Signal, you must specify the version of MedDRA used to code the
source data for each time period as described below.

3. Click the Row Action menu ( ) for the configuration, and select Edit.
4. In the top table, click Edit in the far right column for the data configuration.
5. On the Edit Configuration Details page, in the Event Hierarchy Version Table
field, click Select/Edit Table.
6. To specify only one hierarchy version for all of the source data, type the Oracle
database account name for the hierarchy version in the first row of the Hierarchy
Account column, for example:
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7. To specify different hierarchy versions:

a. In the first row of the Date column, type the last date of the earliest time period
in the source data.
The date must be in the mm/dd/yyyy format
Note:
Each date includes a time stamp of 12:00:00 a.m. For example,
if you specify that MedDRA Version 6.1 was used until (<=)
06/01/2004 and MedDRA 7.0 was used thereafter, then MedDRA 7.0
is applied to source data coded at 12:00:01 a.m. on June 1, 2004.
b. In the first row of the Hierarchy Account column, type the Oracle database
account name for the hierarchy version.
c. Fill in one row for each time period in the source data, for example:
If you need additional rows, you can select Add additional empty rows upon
saving and click Save.
For the last time period, type only the Oracle database account name for the
hierarchy version.
8. Click Save.
Drug and event hierarchies

A hierarchy determines how adverse event terms and drug terms are organized in
the source data. For example, the FOI FDA Adverse Event Reporting System (AERS)
database uses the Medical Dictionary for Regulatory Activities (MedDRA) classification
system. Other databases might use the Coding Symbols for a Thesaurus of Adverse
Events (COSTART) or the WHO Anatomical Therapeutic Chemical (ATC) classification
systems.
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Hierarchy terms are stored in an Oracle database account called the hierarchy
account. You associate each variable in a data configuration with a hierarchy level
in the hierarchy account. For example, if the source data contains MedDRA terms, you
associate each variable in the data configuration with a MedDRA hierarchy level such
as PT, HLT, HLGT, or SOC in the hierarchy account.
during which only one hierarchy version was used.
When you set up hierarchy information, users can:
• Select the Enable Drug Hierarchy Browser user preference.
• Select the Include drug/event hierarchies' primary paths in run results option
in the Data Mining Parameters page.
• Display a sector map for data mining results.
Note:
You can also set up hierarchy information using hierarchy tables. Hierarchy
tables are supported for backward compatibility.
Import a data configuration

When you import data configurations from an Oracle account, you register them for
use with the Oracle Empirica Signal application. When you import, all of the data
configurations in the specified Oracle account are imported or re-imported.
If a data configuration has been deleted permanently, it cannot be re-imported. If it
has had references to it removed, but has not been deleted permanently, it can be
re-imported.
A data configuration cannot be imported or re-imported if there is another data
configuration with the same name in another Oracle account.
In most cases, data configurations are created within the Oracle Empirica Signal
application. If created outside of the application, a data configuration must have the
same table structure as if it was defined within the application.

3. Click Import Configurations.
4. Select a configuration from the list, or select a different account by clicking Import
Configurations from a Different Account.
a. Identify the Oracle account.
b. Choose whether to add the configurations to an existing database group or to
a new database group.
c. Click OK.
5. Once imported, you can perform the following actions on the data configuration:
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• Edit the data configurations that you imported, as necessary. In some cases,
changes to the Oracle tables that are referenced by the configuration (such as
the drilldown map table) might be required. Existing data configurations that
are re-imported retain their permissions, so you do not need to re-assign the
permissions unless you want to change them.
• Validate the data configurations that you imported. When a configuration is
imported or re-imported, it must be revalidated before it can be used to create
new runs, queries, case series, or saved lists. Existing runs, queries, case
series, and saved lists based on a re-imported configuration might not work
correctly until the configuration is revalidated.
• If you have modified a data configuration, test it by selecting it for tasks in the
application. You have not yet assigned permissions to the data configuration,
but you can use it because you are the data configuration owner.
• Validate the data configuration again if you made changes to it. Even if
the only change was to assign permissions, you must validate the data
configuration again.
Validate a data configuration

Only data configurations that have passed a validation process are available for
use during Oracle Empirica Signal activities. You must validate or re-validate a data
configuration in the following situations:
• When it has been newly created.
• When it has been modified in any way, including changes to permissions.
• When it has been newly imported.
The validation process might generate warnings and errors. If warnings (but no errors)
are generated, you can ignore them so that the data configuration passes validation.
If errors are generated, you must correct them before the data configuration passes
validation.
You can either validate a single data configuration, after modifying it, or validate
multiple data configurations at the same time. For example, if you import multiple
configurations, you might want to validate them all at once.

3. To validate a single data configuration that you have just modified:
a. Click the Row Action menu ( ) for a configuration, and then click Edit.
b. Click Validate Now.
4. To validate multiple data configurations at the same time, on the Manage
Configurations page, click Validate Configurations. For example, if you import
multiple data configurations, you can validate them all at once. When you validate
multiple data configurations, the validation process is a background job that
continues to run even if you exit the application.
a. Check the data configurations that you want to validate. (You can also check
Check All or Check None.)
b. Click Validate.
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5. When validation is complete, click Continue.

6. If necessary, edit the configuration and revalidate it.
Validation process
During validation, Oracle Empirica Signal does the following:
• Shows errors and warnings, if any—If there are errors, you cannot save
the data configuration. Warning messages are prefaced by Warning. To ignore
warning messages, check Ignore Warnings.
• Gathers statistics for tables that contain actual case data—Statistics are
generated on the underlying data. Oracle uses the statistics to optimize the
performance of SQL commands, which the application uses for such tasks as
displaying results. Statistics are automatically generated during Oracle Empirica
Signal installation. If views (rather than tables) are referenced, statistics are
generated on the underlying table(s).
• Creates a unique values table for any variable of the selection type Distinct
Value List, Select from Drug Hierarchy, or Select from Event Hierarchy, but
does not have an associated unique values table—Although you cannot save a
new data configuration in this state, it is possible for imported data configurations
to be in this state.
• Creates Oracle column indexes for columns referenced by any variable, if
they do not already exist—If a variable references a column in a view, no index
is added.
Situations that generate error or warning messages
Situations that generate an error message or warning message include the following:
• There are no variables defined for the configuration.
• There is not a variable of the type Report ID for each source database table
referenced by the data configuration.
• The configuration has more than one variable of the type External Report ID.
• There are leading or trailing white spaces in the source data for a variable.
Manually entered values that do not also include the leading or trailing spaces
do not match the source data. For example, when entering data values in the
Query Wizard or specifying drugs or events as selection criteria for run results.
• Database is timestamped is checked for the data configuration, but each source
database table referenced by the data configuration does not have a variable of
the type Valid Start Date and a variable of the type Valid End Date. Note that
the source database table must contain columns (of the Oracle data type DATE)
representing start and end dates for the data configuration to reference them.
• There is no drilldown map table defined for the data configuration.
• The drilldown map table does not include a row for the LIST, CASE, DRUG, or
EVENT sections.
• The data configuration includes a variable of the selection type Select from
Event Hierarchy or Select from Drug Hierarchy, but no event or drug hierarchy
account is specified for the configuration.
• The data configuration includes a variable of the selection type Select from Event
Hierarchy or Select from Drug Hierarchy, but the variable type is not Event or
Drug, or no hierarchy level is set for the variable.
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• Database is timestamped is checked for the data configuration, but there is not
at least one variable for each source database table referenced by the drilldown
map table.
Publish a data configuration

After you validate a data configuration, you add permissions to login groups and users
and publish the selected data configuration to the groups and users.

3. Click Select Rows.
4. Select a row and click Publish.
• To grant permissions for the configuration to your login group, in the Group
Permissions section next to the Login Group, click No Access, Read, or
Edit.
• To grant permissions to individual users in your login group, in the Individual
Permissions section next to the user, click No Access, Read, or Edit.
– A user's permissions for a configuration are determined by settings for
both the individual user and the user's login group. For example, if the
individual user has Read access, but that user's login group has Edit
access, the user has Edit access.
– Users with Read permission for a configuration can select the
configuration for tasks such as creating a run or case series. Users with
Edit permission can edit, copy, and delete the configuration, as well as use
for tasks such as creating a run or case series.
6. Click Save.
Modify a data configuration

• View data configuration details
• Edit a data configuration
• View data configuration variables
• Add or edit a data configuration variable
• Add a mapped variable to the configuration
• Copy a data configuration
• Delete a data configuration
• Data configuration and variables information
View data configuration details

When you view a data configuration, information about the data configuration as a
whole and about variables in the data configuration appears. You can edit the data
configuration or the data configuration variables.
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3. Click the Row Action menu ( ) for the configuration, and then click Edit.
The Modify Configuration page appears, displaying information about the data
configuration as a whole and information about configuration variables.
Data configuration options

• To add a data configuration variable, click Add New Variable. For more
information, see Add a data configuration.
• To copy the data configuration, click Copy this Configuration. For more
information, see Copy a data configuration.
• To delete the data configuration, click Delete this Configuration. For more
information, see Delete a data configuration.
• To edit the data configuration, click Edit in the right-most column of data
configuration information. For more information, see Edit a data configuration.
• To edit a data configuration variable, click for the variable, and then click Edit.
For more information, see Add or edit a data configuration variable.
• To delete a data configuration variable, click for the variable, and then click
Delete. Click OK for the message confirming the deletion.
Note:
You cannot delete a data configuration variable if it is referenced by existing
data mining runs.
Edit a data configuration

When editing a data configuration, you can modify the data configuration as a whole,
or add, modify, or delete variables in the data configuration. Certain information about
data configurations can be specified only during editing and not when creating the
data configuration. This information includes fields related to third-party links from case
details, database groups, and permissions.

4. To modify the data configuration as a whole, next to the data configuration name in
the top portion of the page, click Edit.
5. Modify fields as necessary. For descriptions of fields, except those related to
third-party links, database group, and permissions, see Add a data configuration.
The type of all configurations will be Local after configuration details have been
edited and saved.
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Note:
If you modify the name of an existing data configuration, all references
to that name by existing runs, case series, and saved lists are updated
automatically.
6. Optionally, select the drug hierarchy value from the Drug Hierarchy Account
field.
See drug and event hierarchies for more information.
7. Optionally, select the event hierarchy value from the Event Hierarchy Account
field.
8. You can specify a link to appear on the Case Details page. For example, you can
provide a link to a third-party application page providing further information about
the case.
a. In the Third Party Link Text field, enter the name of the link to appear on the
Case Details page. If you do not specify a name, the link name is External
Link.
b. In the Third Party Link URL field, enter the URL for the third-party application
page. You can use the following substitution variables:
• $REPORT_ID$—Will be replaced by the value of the variable specified as
the Report ID Col for the LIST section of the drilldown map table for the
configuration.
• $EXTERNAL_REPORT_ID$—Will be replaced by the value of the
external report ID for the case. If you use this substitution variable, the
configuration must include a variable of the type, External Report ID.
For example: https://Signal/caseinfo.asp?caseid=$REPORT_ID$
9. To assign the configuration to a Database Group, you can select an existing
group from the drop-down list, or select Add to new group and enter a name
for the new group. Results reviewers can use this information when finding and
selecting a data mining run. The application also uses the database group when
determining color changes for case ID links that are visited by users.
10. Assign group permissions.
a. To grant permissions to your login group, in the Group Permissions, Login

Group section, next to the Login Group, click Read or Edit.
b. To grant permissions to individual users in your login group, in the Individual
Permissions, User section, next to the username, click Read or Edit.
Users with Read permission for a configuration can select the data
configuration for tasks such as creating a run or case series. Users with Edit
permission can edit, copy, and delete the data configuration, as well as use it
for tasks such as creating a run or case series.
A user's permissions for a data configuration are determined by settings
for both the individual user and the user's login group. For example, if the
individual user has Read access but that user's login group has Edit access,
the user has Edit access.
11. Click Save.
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12. Optionally, add or edit data configuration variables. For more information, see Add
or edit a data configuration variable.
Note:
Editing configuration variables will change the configuration type.
13. Validate the data configuration. Even if the only change was to assign
permissions, you must validate the data configuration again.
Certain attributes of a data configuration or its variables require you to log out of
the application and log back in before they take effect. For this reason, Oracle
suggests that you always log out and back in if you want to see the effect of your
changes.
View data configuration variables

For certain activities, you must select a data configuration. If you are not certain which
data configuration to use, viewing the variables in the data configurations can help you
determine which data configuration to use.
On the Select Configuration dialog box, click the Row Action menu ( for a data
configuration, and then click Show Variables.
The Configuration Variables page provides the following information about each
variable in the data configuration:
Column Description
Variable Name of the variable.
Description Description of the variable.
Variable Type Displays the variable type of the variable. For
descriptions of the variable types, see Add or
edit a data configuration variable.
Data Transform Type of data transformation, if any,
associated with the variable. See About data
transformations .
Add or edit a data configuration variable

When creating or editing a data configuration, you can add or modify configuration
variables as described below. You can also delete data configuration variables by
clicking the Row Action menu ( ) for the variable on the Modify Configuration page
and then clicking Delete.
If you edit or delete data configuration variables after the data configuration has been
used to create a data mining run or a query-based case series, you might not be able
to view results for that run or that case series properly. For example, if you use a
variable as an item variable in a data mining run, then change its variable type so that
it is no longer an item variable, Oracle Empirica Signal will not be able to display the
run results properly.
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3. Click the Row Action menu ( ) for the data configuration, then click Edit.
4. Click the Add New Variable link, or click the Row Action menu ( ) for a
configuration variable, and then click Edit.
5. In the Name field, enter the name of the variable.
Variable names display throughout the application, including when users select
criteria for viewing data mining results, defining queries, or creating report
definitions. For example, a column might be named SYMPTOM in the Oracle
table, but renamed to appear as Event in the application.
Note:
Commas and vertical bars are not permitted in the Name field.
6. In the Description field, type a description of the variable.

7. Next to the Table field, click Select Table/Column.
A data configuration can refer to one or more tables in a database, and one or
more columns in each table. For example, you might create a data configuration
that gets data from a demographics table, a drugs table, and an events table.
However, if you already created an Oracle view that combines data from those
three tables, you can refer to that view instead of to the three tables.
a. From the Available Columns list, select the column and click Save. You can
select any table in the Oracle account to which you are connected, and any
column in that table.
The Edit Variable page appears with the column you selected displayed in the
Column field.
b. In the Prefix field, enter a prefix.
A prefix is required only if the variable type is Event, Drug, or Generalized
Item. The alphabetical order of prefixes determines the column names for the
variables in the complete results table. For example, if the prefix for the drug
variable is D and the prefix for the event variable is E, the drug variable is in
the ITEM1 column and the event variable is in the ITEM2 column.
Note:
Multiple variables with the same prefix cannot be used as item
variables in the same data mining run.
8. From the Variable Type drop-down list, select a variable type.

To determine which variable type is appropriate, you might want to know the
Oracle data type of the column. Select Table/Column next to the Table field. In
the available Columns list, the data type appears in parentheses after the column
name.
The variable type can be one of the following:
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Variable Type Meaning

Other Identifies a variable that is not available
as an item variable in data mining runs. If
you want the variable to be available for
subsetting or stratification of data mining
runs, check Use as Subset Variable or
Use as Stratification Variable. The column
must have an Oracle data type of CHAR,
VARCHAR2, NUMBER, FLOAT, INTEGER,
DECIMAL, or SMALLINT.
Age Identifies the patient age. The column
must have an Oracle data type of
CHAR, VARCHAR2, NUMBER, INTEGER,
or SMALLINT.
The selection type for this type of variable
must be either Distinct Value List or
Continuous.
Drug Identifies the drug or vaccine. All variables
of this type are available as item variables in
data mining runs. The column must have an
Oracle data type of CHAR or VARCHAR2.
A prefix must be specified for this type
of variable, and its selection type must be
either Distinct Value List or Select from Drug
Hierarchy.
Event Identifies the event or symptom. All variables
of this type are available as item variables in
data mining runs. The column must have an
Oracle data type of CHAR or VARCHAR2.
either Distinct Value List or Select from
Event Hierarchy.
External Report ID For use when you want to include a
link to an external (third-party) application
from case details. (To do so, you specify
an external application URL on the Edit
Configuration Details page.) To use this
feature, there must be a mapping of Oracle
Empirica Signal case IDs to the IDs used
by the external application. A suggested
way to provide the mapping is to include
in the demographics table an additional
column, such as EXTERNAL_ID, to contain
the external ID associated with each case
ID in the demographics table. In the data
configuration, you must include a variable for
that column and assign to it the variable type
External Report ID. There can be only one
variable of the type External Report ID in the
data configuration.
If the case IDs used by the external
application are the same as the Oracle
Empirica Signal case IDs, an external report
ID is not needed to link to the external
application.
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Variable Type Meaning

Gender Identifies the patient gender. The column
must have an Oracle data type of CHAR or
VARCHAR2.
must be either Distinct Value List or Free
Text.
Generalized Item Identifies variables other than drug or event
that are available as item variables in data
mining runs. For example, if the Gender
variable's type is Generalized Item, users
can perform data mining for combinations
for Drug, Event, and Gender values. The
column must have an Oracle data type of
CHAR or VARCHAR2.
Distinct Value List.
Report ID Identifies the case ID (report ID or ISR). The
column must have an Oracle data type of
CHAR or VARCHAR2. You must include a
Report ID variable for each source database
table referenced by a configuration variable.
As a result, the configuration might have
several Report ID variables.
The selection type for a Report ID variable
must be Distinct Value List, and the variable
cannot be identified as a subset variable or
Note:
In the Query Wizard, this type of
variable allows entry of a string of
report IDs separated by commas.
Valid Start Date, Valid End Date Applies only if the data configuration
supports timestamped data (that is,
Database is Timestamped is checked for
the data configuration). Identifies the column
in the source data that contains a start date
or end date for each record.
You must include a Valid Start Date variable
and a Valid End Date variable for each
source database table referenced by a
configuration variable. As a result, a data
configuration might have several start and
end date variables.
must be Continuous.
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Note:
If the variable type is Drug, you must also specify a variable subtype
of Generic, Ingredient, or Trade. Each subtype can be used for only
one data configuration variable. The subtype makes the variable's values
available for selection on the Drug Profile page as a generic name, an
ingredient, or a trade name.
9. If you want the variable to be available for subsetting data mining runs, check Use
as subset variable. Typically, the Variable Type of a subset variable is Other. You
can define multiple variables in a data configuration as subset variables, though
only one subset variable can be selected for a given data mining run.
10. If you want the variable to be available for stratification of a data mining run,
check Use as stratification variable. Typically, the variable type of a stratification
variable is Other. Although you can define a variable with a variable type of Drug,
Event, or Generalized Item as a stratification variable, you cannot use the same
variable as both an item variable and a stratification variable in the same run.
Note:
Stratification variables that are not associated with data transformations
are available as additional covariates in logistic regression runs.
11. From the Selection Type drop-down list, choose a selection type, which
determines how users specify values for the variable when performing activities
such as creating a query.
Selection Types
Selection Type Meaning

Distinct Value List Users choose values from a list. Variables
with a variable type of Generalized Item, or
of Other (with Use as subset variable or
Use as stratification variable checked),
must use this selection type. For variables
with this selection type, you can identify
a unique values table to supply the list
of values. If you do not define a unique
values table, the application creates one
automatically when you validate the data
configuration.
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Selection Type Meaning

Select from Drug Hierarchy, Select from Use one of these selection types only if a
Event Hierarchy drug or event hierarchy account is specified
at the level of the configuration as a whole
and you want users to be able to browse for
and select terms from the hierarchy. (Users
can also select values from a list.) If you do
not specify this selection type, users need to
select hierarchy terms from an alphabetized
list instead of the hierarchy. See About drug
and event hierarchies.
Note:
If there is a hierarchy table
specified for the individual
variable, select the variable type
Distinct Value List for the variable.
Continuous Users specify a range of values by entering

From and To values.
Free Text Users type in a text string for which matches
will be found.
12. In the Hierarchy Level field, select the hierarchy level.
If the selection type of the variable is Select from Drug Hierarchy or Select from
Event Hierarchy, and a drug or event hierarchy account is specified at the level
of the data configuration, you must select a hierarchy level to tell the application
which level of the hierarchy is represented by the variable.
Note:
This field has no effect if there is a hierarchy table specified for the
individual variable.
13. If you do not want the variable to be available during creation of a query, from the
Hide from Query Wizard drop-down list, select Yes.
Note:
Regardless of this setting, a variable that uses a data transformation that
maps values, defines cutpoints, or converts dates is not selectable in the
Query Wizard.
14. In the Value Case field for variables whose Oracle data type is CHAR or
VARCHAR2, indicate the capitalization style that is used in the source data. The
application automatically converts terms that users enter in the Drug and Event
Term selection fields on the Select Criteria page to the capitalization style before a
match is attempted, as follows:
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• Exact Match—Entered values are not converted, and must match the case of
the source data exactly.
• All Upper—Values are in all upper case in the source data. Entered values
are converted to all upper case.
• All Lower—Values are in all lower case in the source data. Entered values are
converted to all lower case.
• Upper First Letter Each Word—The first letter of each word is capitalized in
the source data. Entered values are converted so that the first letter of each
word is in upper case and the rest are in lower case. For example, the entered
value, Renal failure, becomes Renal Failure.
• Upper First Letter Each Term—Values are in mixed case in the source data.
Entered values are converted so that the first letter of each term is in upper
case and the rest of the term is lower case. For example, the entered value,
Drug Hypersensitivity, becomes Drug hypersensitivity.
15. In the Unique Values Table field, identify an Oracle table or view that contains
the list of all possible values for the variable. You can specify an existing unique
values table (from the Oracle account in which the configuration resides) by typing
in its name.
a. To select from a list of tables, click Select Table.
b. From the Select Table dialog box, select the table and click Save.
If you leave this field blank, the application creates a unique values table
during configuration validation.
Note:
In a timestamped database, no start and end dates are associated
with the unique values table, so all unique values that ever existed
are in the tables.
16. To specify a hierarchy table for the variable, in the Hierarchy Table field, type the
table name, or click Select Table to choose from all tables in the Oracle account
to which you are connected. To supply a table name, click Create New Table.
The recommended way to set up event or drug hierarchies is to associate
an Oracle account of hierarchy information with the configuration (on the Edit
Configuration Details page). The ability to associate an individual variable
with a hierarchy table still exists to provide backward compatibility with data
configurations created in previous releases. For more information, see Event and
drug hierarchies.
17. In the Data Transformation field, specify a data transformation to transform
source data into other values available for selection when data mining runs are
created:
• If you do not want to transform source data for the variable, click None (the
default).
• To map text values, click Text mapping. This option applies only to variables
that are based on a CHAR or VARCHAR value in the source database.
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• To define variable cutpoints, click User-defined cutpoints. This option applies

only to variables that are based on a NUMBER or DATE value in the source
database.
• To exclude synthetic values, such as the names of Standardized MedDRA
Queries (SMQs), click Synthetic values. This option applies only to variables
that are based on a CHAR or VARCHAR value in the source database.
• To convert date values, select Date function and enter the function in the
field. To select a function from a list, click Select Function. This option applies
only to variables that are based on a DATE value in the source database.
18. Click Save.
If a warning message appears, as when there are leading or trailing white spaces
in the source data for the variable, you can fix the problem or click Ignore
Warnings, and then Continue.
19. Next, validate the data configuration. For more information, see Validate data
configurations.
Add a mapped variable to the configuration

3. Click the Row Action menu ( ) for the data configuration, and then click Edit.
4. On the Modify Configuration page, click the Add New Variable link.
8. As the Column of source data, select the drug or event variable containing values
that you want to map. The source column must be a text value.
9. In the Prefix field, enter a prefix.
10. From the Variable Type drop-down list, select Event or Drug.
11. Do not check Use as subset variable or Use as stratification variable.
12. Optionally, set up the mapped variable to use a hierarchy.
13. Set Hide From Query Wizard to Yes. (Even if this setting is set to No, the
mapped variable is not available in the Query Wizard.)
14. In the Data Transformation section, click Text mapping, and then click Upload
Table.
15. From the Upload Text Map CSV File dialog box, next to the File to Upload field,
click Browse.
16. Select the mapping file and click Open. The mapping file must be in the format
described in Map text values.
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17. Click Upload.
18. To make sure the mappings are correct, click View Current Mapping.
19. Click Save.

20. Validate the configuration.
Note:
If you map a variable in a configuration for which there are existing runs
that use the variable, users cannot drill down correctly in the run results
until the runs are re-executed.
Copy a data configuration

You can create a data configuration by copying an existing data configuration and
editing the copy as necessary.

4. Click Copy this Configuration.
5. In the Name field of the Add Configuration page, supply a unique name for the
new data configuration. (The default name is Copy of, followed by the name of the
original data configuration).
6. In the Description field, modify the supplied description as needed to describe the
new data configuration.
7. In the Configuration Table Name field, enter the unique name of the table to hold
the new data configuration in the Oracle account to which you are connected.
8. Click Save.
Note:
The type of all copied configurations will be Local.
Delete a data configuration

4. Click Delete this Configuration.
5. If you are a superuser, you have two options:
• To remove the data configuration from the application, but leave it in the
database so that it can later be re-imported, click Remove Reference Only.
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• To delete the data configuration completely, including deleting it from the

database, click Delete Permanently.
Note:
If you are not a superuser, you cannot delete the data configuration if
any objects are associated with it.
6. If any objects reference this configuration, you can transfer queries, report
definitions, and saved lists to a compatible data configuration. From the What
would you like to do with objects that reference this configuration? drop-
down list, select a configuration.
• Any queries, report definitions, and saved lists that are not compatible with the
data configuration that you select are deleted.
• To delete all queries, report definitions, and saved lists instead of transferring
them, at the bottom of the list, select Delete All Referenced Objects.
• All case series, data mining runs, and report outputs based on this
configuration are permanently deleted.
7. Before continuing, you might wish to:
• Add the query portion of query-based case series to the Query Library (from
the Case Series page).
• Make sure that the configuration is not referenced by any drug profile
configurations or signal configurations, because such references are removed.
• Attach run results, case lists or case details, and report outputs to a topic.
8. Click Delete.
Note:
When you delete a data configuration that is associated with an alias ,
the target status of the alias becomes Broken.
Data configuration and variables information

The Modify Configuration page provides information about the data configuration and
the data configuration variable.
Data configuration information

The Modify Configuration page provides the following information about the data
configuration:
Field Description
ID Unique identifier that is assigned automatically
to the configuration.
Description Description supplied for the configuration.
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Field Description
Database Group Name of the database group to which the
configuration is assigned. Results reviewers
can use the database group when finding
and selecting a data mining run. The
application also uses the database group
when determining color changes for case ID
links that are visited by users.
Owner Full name associated with the username that
created the configuration.
Table Name of the Oracle table containing the
specification of the configuration.
Drill Down Map Table Name of the drilldown map table, which
specifies the source of case details that
appear when a user drills down to view case
details.
Source Description Table Name of the source description table,
which provides information about the source
database.
Timestamped YES, if the configuration supports
timestamped data.
NO, if the configuration does not support
timestamped data.
Drug Hierarchy Account (or Drug Hierarchy Name of the Oracle account that drug
Version Table) variables with a selection type of Select from
Drug Browser in the configuration use for
hierarchical values.
For timestamped configurations, name of the
table that stores one or more valid hierarchy
accounts by date.
Event Hierarchy Account (or Event Hierarchy Name of the Oracle account that event
Version Table) variables with a selection type of Select from
Event Browser in the configuration use for
hierarchical values.
For timestamped data, name of the table that
stores one or more valid hierarchy accounts by
date.
Includes Concomitant Drugs YES, if the configuration includes suspect and
concomitant drugs.
NO, if the configuration includes suspect
drugs only. Results reviewers can use this
information to find a data mining run.
Hide From Data Mining YES, if the configuration can be used for case
series and reporting only.
NO, if the configuration can be used for data
mining, case series and reporting.
Valid YES, if the configuration has been validated
successfully.
NO, if the configuration has never been
validated or failed validation.
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Data configuration variable information

The Modify Configuration page provides the following information about each variable
in the data configuration:
Field Description
Variable Unique name of the variable as it appears to
Oracle Empirica Signal users on the Select
Configuration page. For example, a column
might be named SYMPTOM in the analysis
table, and Event in the Oracle Empirica Signal
application.
Desc Description of the variable.
Table Name of the source database table containing
the column that corresponds to the variable.
Column Name of the database table column that
corresponds to the variable.
Variable Type For possible variable types, see Add or edit a
configuration variable. If a subtype (Generic,
Trade, or Ingredient) is specified for a variable
with a variable type of Drug, it appears after
Drug in parentheses.
Selection Type For possible selection types, see Add or edit a
configuration variable.
Hierarchy Level Displays the hierarchy level, if any, specified
for event or drug variables with a selection
type of Select from Drug (or Event) Hierarchy.
Visibility DM & Q, if the variable is available for data
mining runs and query-based case series.
DM, if the variable is available for data mining
runs but not for query-based case series.
Value Case For possible value cases, see Add or edit a
configuration variable.
Hierarchy Table Name of the hierarchy table, if any, associated
with the variable.
Unique Values Table Name of the unique values table, if any,
associated with the variable.
Data Transform Name of the data transformation, if any,
associated with the variable.
Manage subscription data releases

• Manage subscription data releases
• Import a subscription data release
Manage subscription data releases

For Cloud environments, Oracle Empirica Signal supports access to the Oracle public
safety data library. After enabling the feature, users with Manage Configurations user
permission can access the Subscription Data Releases administration page to view
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available data releases, review their release notes, and import the releases of their
choice into Oracle Empirica Signal.
1. Log into the Oracle Empirica Signal application as a user with the Manage
Configurations user permission.

3. In the Configure System section, click Manage Subscription Data Releases.
4. (Optional) Filter the list of subscription data releases shown.
• From the Status drop-down list, select a status value or - - to include all
statuses.
• From the Data Offering drop-down list, select a data offering name or - - to
include all data offerings.
The Manage Subscription Data Releases table contains a row for each shared data
release you have access to and provides the following information about each release:
Column Description
Data Offering One of the following values: AERS, VAERS, VIGIBASE,
JADER.
Release Name The name of the release.
Description Basic information about the data release.
Status One of the following values: Available, Loaded, Running,
In Queue, Error Occurred, Cancelled.
Product Dictionaries If the data configuration specifies product hierarchy, the
name(s) and version(s) of the product hierarchy used by
this release.
Event Dictionaries If the data configuration specifies event hierarchy, the
name(s) and version(s) of the event hierarchy used by
this release.
Requested Date and time when the data release was requested.
Requested by Name of the user who requested the data release.
Imported Date and time when the data release was imported.
Imported Configurations Data configuration names for the imported data release.
Manage Subscription Data Releases page options

• To manage the columns in the table, click Columns. For more information, see
Arrange table columns.
• To download the table, click Download. For more information, see Download
data.
If you click a data release's Row Action menu ( ), you can do the following:
• To view a PDF version of the Release Notes about a data offering release, click
View Release Notes.
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• To retrieve a log of the details of the latest import, click View Log. You can print
the log.
• To import an available data release, click Import.
• To cancel an import while its status is In Queue or Running, click Cancel. The
status changes to Cancelled.
• If the import fails, the status changes to Error Occurred. You can perform the
import again by clicking Retry Import.
• To republish a loaded data offering and give all current login groups Read access
to the configurations associated with the data release, click Republish.
Import a subscription data release

To import a data release that is available to you, perform the following steps.

2. In the Configure System section, click Manage Subscription Data Releases.
3. Click a data offering's Row Action menu ( ), and click Import.

4. Choose whether you want to create Standard Runs and Report Outputs. You may
receive one or more choices depending on the data offering. See the Release
Notes for the particular data release for more details.
Note:
The report outputs that can be created along with the data release import
are summary reports for use by Drug Profiles.
5. Choose whether to notify All users or Selected users when the release is
available.
If you chose Selected users, choose them from a list of available users. Then
click OK.
6. Click Submit.
• Oracle Empirica Signal runs the import job in the background.
• You can track the progress of the import by hovering on the background
processing indicator ( ).
• The Status column on the Manage Subscription Data Releases table updates
to Running or In Queue.
• If an issue is encountered during the import, the Status column displays Error
Occurred.
7. When the import completes, view the objects associated with the imported data
release.
• The Status of the data release is updated to Loaded.
• The Imported column updates with the date and time of the import.
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• Configurations for the imported data release are available on the Manage
Configurations page. All the imported configurations will be of Type Managed.
• Standard runs, if requested, will be available on the Data Mining Runs page.
The runs will be published to all login groups.
• If report outputs were requested, then the jobs for the summary reports are
submitted. Once finished, the report outputs will be published to all currently
available login groups.
• If the data release specifies aliases and aliases did not already exist, then
aliases are created. Existing aliases are updated only if the data offering is for
a later date then the current alias.
• Email notifications are sent to users as requested in the import request.
Manage aliases
• Manage aliases
• Add or edit an alias
Manage aliases
If you have permission to view the target of an alias, the alias is listed on the Manage
Aliases page.
1. Log into the Oracle Empirica Signal application as a user with the Manage Aliases
permission.

3. In the Configure System section, click Manage Aliases.
4. From the Target Type drop-down list, select the target type for which you want to
view aliases, or--to include all types (optional).
Column Description
Name Name of the alias. The name must be unique among
other aliases for the same target type.
Target Type One of the following values:
• Configuration—The target is a data configuration.
• Data Mining Run—The target is a completed data
mining run (MGPS or logistic regression).
• Report Output—The target is a report output.
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Column Description
Target Name and/or identifier of the specific data configuration,
data mining run, or report output with which the alias is
associated.
Note:
If you change the name
of a data mining run,
report output, or data
configuration that is the
target of an existing
alias, this field is updated
automatically for that alias.
Target Status One of the following values:

• Valid—The alias target exists and, in the case of a
data configuration, is valid.
• Broken—The alias target has been deleted. In the
case of a data configuration, the target status also
becomes Broken if the data configuration becomes
invalid.
Created By Name of the user who created the alias.
Created Date and time when the alias was created.
Modified By Name of the user who last modified the alias.
Modified Date and time when the alias was last modified.
Manage Aliases page options

• To add an alias, click Add Alias. For more information, see Add or edit an alias.
• To edit an alias that you created, click the Row Action menu ( ) for an alias,
and then click Edit.
If you click the Row Action menu ( ) for an alias, you can do the following:
• To view an alias, click View.
• To edit an alias that you created, click Edit.
• To delete an alias that you created, click Delete. If you delete an alias that is
referenced by a drug profile configuration, that reference is removed from the
drug profile configuration.
Note:
If you have the Administer Users permission, you can edit or delete aliases
created by other users in your login group.
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Add or edit an alias

3. From the Target Type drop-down list, select the target type for which you want to
view aliases, or--to include all types (optional).
• To add a new alias, click Add Alias.
• To edit an alias, click the Row Action menu ( ) for the alias, and then click
Edit. You can edit only aliases that you have created, except that if you have
the Administer Users permission, you can edit aliases created by any user in
your login group.
5. In the Alias Name field, enter an alias name.
6. From the Target Type drop-down list, select the target type. For more information,
see Manage aliases.
7. From the Target drop-down list, select the target. For more information, see
Manage aliases.
8. Click OK.
Manage drug profile configurations

• About drug profile configurations
• Set up the Drug Profiles feature
• View existing drug profile configurations
• Add or edit a drug profile configuration
• Save a drug profile configuration
• View a drug profile configuration
• Rename a drug profile configuration
About drug profile configurations

A drug profile configuration is the specification of which data mining runs and which
report outputs are the source of charts that users can add to a drug profile layout (on
the Drug Profile page). To access the Drug Profile page, a user must set a drug profile
configuration as a user preference.
For example, a drug profile configuration specifies that for generic drugs, the MGPS
2D run is 2019Q4: Generic (S + C). In a drug profile, users who have that configuration
set as a user preference can add charts for a generic drug based on the results of the
2019Q4: Generic (S + C) run.
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Note:
Drug profile configurations are separate from drug profile layouts. Drug
profile layouts, which are saved collections of charts as well as their
placement and display options, can be used with various drug profile
configurations. For example, if you are using the layout, Generic + trade
comparators, and you change your user preference to a different drug profile
configuration, the Generic + trade comparators layout is still available.
Only report outputs from an all cases summary report can be used in a drug profile
configuration. This is a special type of interactive report that must meet certain criteria.
In the drug profile configuration, you can specify data mining runs and report outputs
for generic names, trade names, and ingredients. To specify a run or report output, you
can select either the run name or an alias that has been set up for the run or report
output.
You might want to create multiple drug profile configurations for different purposes. For
example, you can set up one drug profile configuration for AERS data and another
drug profile configuration for proprietary data. For information on setting up the drug
profiles feature, see Set up a drug profile.
Set up the Drug Profiles feature

To implement the features of the Drug Profile page for your organization, an
administrator must complete some configuration steps.
Required permissions
To set up the Drug Profiles feature, an administrator must have the following
permissions:
• View Data Mining Results
• Create Data Mining Run
• View Drug Profiles
• Create Drug Profile Layouts
• Create Report Definitions
• Administer Users
• Administer Drug Profiles
• Manage Aliases
Follow the steps below to set up the Drug Profiles feature. These steps include an
example of a single initial drug profile layout that presents source data and data mining
results from the frequently used standard AERS+SRS (S) data configuration.
Create an All Cases Summary report

For a drug profile layout to include distribution tables or graphs of source data, you
create an all cases summary report for the Generic drug subtype.
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1. In the left navigation pane, hover over the Data Analysis icon ( ), and then click
2. Click Create Definition.
3. Create an all cases summary report. See Create or edit an interactive report
defintion.
a. From the Configuration drop-down list, select the configuration.
b. In the Name and Description fields, type a name for the report and a
description.
c. Perform one of the following:
i. To add the report definition to an existing project, select it from the Add to
existing project drop-down list.
ii. To add it to a new project, specify the project name in the Add to a new
project named field.
d. From the Type drop-down list, select Summary of all Cases
This report type contains a single row variable for a drug subtype (such as
Generic) and includes columns that show the distribution of cases by such
variables as Gender, Age Group, and Report Received Year. You then run the
report on the current AERS+SRS (S) configuration. (The report collects data
across the entire configuration and can take some time to run.)
4. When the report output for the All Cases Summary report is complete, add an
alias for the report output. (This step also is optional, but recommended.)
Create an alias
To streamline the process of keeping drug profile layouts that include data mining run
results current over time, add an alias for each of those data mining runs.

3. On the Manage Aliases page, click Add Alias. For information on adding an
alias, see Add or edit an alias.
4. Add a Latest <run type> alias for each of these runs, such as Latest Generic
(S), and associate each alias with the most recent run of that type.
This step is optional, but recommended. For example, each quarterly AERS data
release includes a standard set of MGPS data mining runs that are based on
the current AERS+SRS (S) configuration. When each subsequent AERS data
release is received, you update the aliases to reference the newest available
run, which has the effect of keeping all of the drug profile configurations that use
those aliases up to date without requiring individual edits to every drug profile
configuration.
Add a drug profile configuration

For each drug subtype (Generic, Trade, or Ingredient), you specify a report output (to
supply source data) and data mining runs of different types (to supply run results).
Oracle recommends that you supply the aliases you set up for the report output
and data mining runs, rather than the actual names. See Add or edit a drug profile
configuration.
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2. In the Configure System section, click Manage Drug Profile Configurations.
3. On the Manage Drug Profile Configurations page, click Add Drug Profile
Configuration.
Note:
The report output for the All Cases Summary report you created is
available for selection in the Generic section, but not in the Trade or
Ingredient sections of the page. Later, you can create and run an all
cases summary report for each drug subtype, set up aliases, and edit
the drug profile configuration to reference them.
4. Publish the drug profile configuration. See Publish an object.
Set your user preference

1. Set your user preference, Drug Profile Configuration, to the drug profile
configuration you created as an alias. See Set user preferences.
2. Log out of the Oracle Empirica Signal application, then log back in.
The Drug Profile page should now be available to you.
Create a drug profile layout

For more information, see View a drug profile.
Profiles.
2. From the Layout menu, select Create.
3. Select at least one chart to include in the layout; for example, a graph of data
from one of the data mining runs you defined for the drug profile configuration, or
a graph or table of source data from the report output. For more information, see
Adding a chart to a drug profile layout.
4. Add more charts and arrange them as desired.
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5. Publish the drug profile layout. See Publish a drug profile layout.
6. Set your user preference, Drug Profile Layout, to the drug profile layout you
created.
Grant users View Drug Profiles permission

1. For each of the users who will use drug profiles, edit the user account to grant the
View Drug Profiles permission.
2. Optionally, grant the Create Drug Profile Layouts permission, as well. See
Adding or editing a user and User permissions.
Note:
Of the users who will use drug profiles, any who were logged in
when you granted the drug profiles permission(s) must log out of the
application and log back in.
3. The users who will use drug profiles can now set their user preferences, Drug
Profile Configuration and Drug Profile Layout, to the objects you created (alias
and drug profile layout). After the users log out and log back in, the Drug Profile
page is visible and the drug profile layout provided by default.
Refine the drug profile configuration and layout

You can now repeat steps of this process as needed to refine the drug profile
configuration and drug profile layout. For example, you might create and run an
additional all cases summary report for each of the other drug subtypes, Trade and
Ingredient, add an aliases for them, edit the drug profile configuration to include them,
and modify or add other drug profile layouts.
Refresh data for a drug profile

When a data update is available, such as when new AERS+SRS (S) data is released
each quarter, you refresh the data used by the drug profiles:
1. Rerun each all cases summary report referenced by the drug profiles
configuration on the new AERS+SRS (S) data configuration and save the output.
2. Rerun each data mining run referenced by the drug profiles configuration. (The
standard AERS+SRS (S) data mining runs may already have been rerun at
release installation.)
3. Update all aliases, for both report outputs and data mining runs, that are in use by
the drug profiles configuration. If you chose not to use aliases, update each drug
profile configuration to supply the new report output and data mining run names.
Note:
Run definition files and Report definition files can update existing aliases
automatically.
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View existing drug profile configurations

The Manage Drug Profile Configurations page lists drug profile configurations that you
created or that are published to you. If you have the Administer Users permission, the
page also lists unpublished configurations created by any user in your login group.

The Manage Drug Profile Configurations page provides the following information
about each profile configuration:
Column Description
ID Automatically assigned unique identifier of
the configuration.
Description Description of the configuration.
Created By Name of the user who created the
configuration.
Created Date and time when the configuration was
created.
Modified Date and time when the configuration was
last modified.
configuration.
View, edit, rename, publish, and delete drug profile configurations
If you click the Row Action menu ( ) for a drug profile configuration that you
created, you can also do the following:
• To view a drug profile configuration, click View.
• To edit a drug profile configuration, click Edit.
• To rename a drug profile configuration, click Rename. If any users have the
configuration set as a user preference, that setting is changed automatically to the
new name.
• To publish a drug profile configuration, click Publish, select the login group(s),
then click Back. (If you have the Administer Users permission, you can publish
configurations created by any user in your login group.)
If you are a superuser, you can publish to multiple login groups, including —All–.
In the Publish to Login Groups drop-down list, click or Ctrl+click to select login
groups. If you publish to —All– and later add a new login group, the object is
published automatically to the new login group.
• To delete a drug profile configuration, click Delete.
Add or edit a drug profile configuration

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• To add a new configuration, click Add Drug Profile Configuration.
• To edit a configuration, click the Row Action menu ( ) for the configuration,
and then click Edit.
4. If your organization uses signal management, from the Signal Management
Configuration drop-down list, select a signal configuration.
When the drug profile configuration and the specified signal configuration are both
in use by a user and that user has a drug layout set as a user preference, then the
Products table on the Signal Review page will have the Drug Profile menu option,
which points to the Drug Profile page.
Note:
Regardless of the drug type on the Signal Review page, the drug is
considered by the Drug Profile page to be a generic name. Thus, only
the generic name settings in the drug profile configuration are used.
5. For each section on the page, you can specify report outputs and runs that you
created or that are published to you. (If you have the Administer Users permission,
you can also specify unpublished report outputs and runs created by any users in
your login group.) For any report outputs and runs that you can specify, you can
also specify any existing aliases for them.
6. Click Next.
7. To save the configuration, enter or edit the name and description of the drug profile
configuration, and then save the drug profile configuration.
If you created a drug profile configuration, it appears as the bottom row of the
Manage Drug Profile Configurations page.
Reference data mining runs and aliases

The data mining runs that you reference in a drug profile configuration must have an
item variable with the subtype Generic, Trade, or Ingredient (depending on the section
of the drug profile configuration) in the data configuration.
Lists of available report outputs and data mining runs also include aliases for those
objects. If the drug profile configuration refers to an alias, the alias is resolved each
time a user goes to the Drug Profile page. This is useful if updates of data and
new data mining runs are expected, and you want charts for those new runs to be
available on the Drug Profile page.
For example, the drug profile configuration refers to an alias named, Latest 2D
Generic. The alias can be updated to point to new data mining runs, but the drug
profile configuration does not need to be updated, and users do not need to set their
user preference to a new drug profile configuration.
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Note:
Users of the Drug Profile Page can view charts for all report outputs
and data mining runs that are referenced by their current drug profile
configuration, regardless of whether or not they can view the report outputs
or runs elsewhere in the application.
When defining a drug profile configuration, consider which data configurations the
data mining runs and report outputs that you reference are based on.
Available drugs list

Another consideration is that when users select drugs when adding a chart (on the
Drug Profile page), the list of available drugs can differ depending on the type of
chart. For example, suppose that the 2D run results, but not the 3D run results,
include custom terms. When selecting drugs for an EBGM graph, but not for a nested
confidence interval graph, users are able to select custom terms (the nested interval
graph applies only to results for the 3D run). For consistency of available drugs that
can be selected for various chart types, the drug profile configuration should reference
similarly constructed data mining runs.
Users can also select drugs from the Drug menu. In constructing the list of available
drugs that can be selected from the Drug menu, the application uses the following
objects, in order of precedence:
• MGPS 2D Run
• MGPS 2D by Year Run
• Report Output
• MGPS 3D Run
• LR 2D Run
Save a drug profile configuration

• To add a new configuration, click Add Drug Profile Configuration.
• To edit a configuration, click the Rows Action menu ( ) for the

configuration, and then click Edit.
4. If your organization uses signal management, from the Signal Management
Configuration drop-down list, select a signal configuration.
5. For each section on the page, you can specify report outputs and runs that you
created or that are published to you. (If you have the Administer Users permission,
you can also specify unpublished report outputs and runs created by any users in
your login group.) For any report outputs and runs that you can specify, you can
also specify any existing aliases for them.
6. Click Next.
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7. To save the configuration, in the Name field, enter a name for the drug profile
configuration.
Note:
If you are editing an existing drug profile configuration and you change
its name, the existing configuration is renamed.
8. Optionally, in the Description field, enter a description of the drug profile

configuration.
If you created a drug profile configuration, it appears as the bottom row of the
Manage Drug Profile Configurations page.
Note:
Oracle recommends that you test the drug profile configuration before
publishing it. To do so, you can set your user preference, Drug Profile
Configuration, to the new drug profile configuration and go to the Drug Profile
page.
View a drug profile configuration

3. Click the Row Action menu ( ) for a configuration, and then click View.
The Drug Profile Configuration Description dialog box provides the following
information. Many of these fields are specific separately based on Drug
Subtype (Generic Name, Ingredient Name, Trade Name) as defined in the data
configuration variable:
Field Description
Drug Profile Configuration Name Name of the drug profile configuration.
ID Automatically assigned identifier of the drug
profile configuration.
Description Description of the drug profile configuration.
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Field Description
Signal Configuration Name and ID of the signal configuration
(if any) associated with the drug profile
configuration. When the drug profile
configuration and the specified signal
configuration are both in use by a user and
that user has a drug layout set as a user
preference, then the Products table on the
Signal Review page will have the Drug Profiles
menu option, which points to the Drug Profile
page.
Note:
Regardless of
the drug type on
the Signal
Review page, the
drug is
considered by
the Drug Profile
page to be a
generic name.
Thus, only the
generic name
settings in the
drug profile
configuration are
used.
Report Output ID Name and ID of (or alias for) an all cases

summary report, which is a specific type of
interactive report.
MGPS 2D ID Name and ID of (or alias for) a completed two-
dimensional MGPS data mining run for which
charts can be added on the Drugs page.
This can also be a run that uses cumulative
subsetting. In this case, only the subset that
is the accumulation of all the other subsets is
used.
MGPS 2D by Year ID Name and ID of (or alias for) a completed two-
dimensional MGPS data mining run that uses
cumulative subsetting by year, for which charts
can be added on the Drugs page.
MGPS 3D ID Name and ID of (or alias for) a completed
three-dimensional MGPS data mining run for
which charts can be added on the Drugs
page. Subsetted three-dimensional runs are
not available to select.
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Field Description
LR 2D ID Name and ID of (or alias for) a completed
logistic regression data mining run for which
charts can be added on the Drugs page.
The set of drugs included in logistic regression
results is typically smaller than the set of drugs
in MGPS results. On the Drugs page, graphs
for logistic regression results are available only
if the selected drug was included in the model
or added explicitly during creation of the run.
Rename a drug profile configuration

3. Click the Row Action menu ( ) for a drug profile configuration, and then click
Rename.
4. In the Name field, enter a new name for the drug profile configuration.
5. Optionally, in the Description field, modify the description of the drug profile
configuration.
Note:
If any users have the drug profile configuration set as a user preference, that
setting is changed automatically to the new name.
Manage signal configurations

• Manage signal configuration reference data
• Edit a signal configuration
• Manage Signal Configurations page
• Configure alerts
• Set up for interactive signal management and review
• Manage interactive signal configuration refreshes
• Manage signal comment types
• Assign reviewers
• Arrange or download tables
• Manage events and custom terms
• Manage signal views
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Manage signal configuration reference data

Just below your user name in the upper right corner of the Products and Product-
Event Combinations pages is the Manage Reference Data menu ( ):
These menu choices apply to the signal configuration and require permissions to
specify or change them:
• Add Product: Your organization chooses the products to monitor. For non-
interactive signal configurations, Oracle creates the list of monitored products
during preparation of the signal management data. You must have the Manage
Signaling Terms permission to add to and to edit the product list.
• Auto-Assign to Reviewers: You must have the Manage Signaling Terms
permission to automatically assign reviewers to products. You must have the Allow
Automatic Assignment of Reviewers permission to auto-assign reviewers.
• Modify Automatic Assignments: There is one reviewer per product. The Modify
Automatic Assignments page provides information about products that have been
assigned automatically to a reviewer. This page does not show assignments
that were made manually (when the drug was added or edited). You must
have the Administer Signal Management permission to modify automatic review
assignments.
• Manage Designated Medical Events: You can maintain a list of designated
medical events (DMEs). A DME is an adverse event that your organization wants
to monitor closely. DMEs are associated with particular products. You must have
the Manage Signaling Terms permission to manage DMEs.
• Manage Custom Terms: You can create custom terms to represent a pseudo-
value for a product or event. You must have the Manage Signaling Terms
permission to manage custom terms.
• Manage Views: You can rename, publish, delete, or reorganize saved views. You
must have the Manage Signal Views permission to manage Views.
Edit a signal configuration

You can edit signal configurations if you have the Manage Signal Configurations
permission.

2. In the Configure System section, click Manage Signal Configurations.
3. Click the Row Action menu ( ) for the signal configuration, and then click Edit.
If the signal configuration Type is Interactive, an Interactive Signal Configuration
Properties section appears in the Edit Signal Configuration page.
4. Edit the fields according to the table below.
5. Click Save.
Oracle Empirica Signal validates the signal configuration, and any errors are
displayed at the top of the page.
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Field descriptions—Edit Signal Configuration page

Fields marked with an asterisk (*) in the table are available only for interactive signal
configurations.
Field Description
Name Signal configuration name. This name appears
on the Signal Review page, above the product-
event combination table.
Description Description of the signal configuration.
Topic workflow configuration Name of the topic workflow configuration that
is integrated with the signal management
configuration. When this integration exists,
users can associate topics with product-event
combinations using the Submit Review dialog
box, and topics are stored in this topic
Note:
If product-event
combinations
have associated
topics, you
cannot change
the associated
topic workflow
configuration
until you remove
the associated
topics. The
Signal History
maintains a log
of all changes.
Topic Product Field Names of products in product-event

combinations associated with topics. You
can use the Topic Product Field filter when
browsing for existing topics from the Submit
Review dialog box.
Disable review period Select to disable the Review Period column
and Review Period filter on the Manage Signal
Views page.
Disable private comment Select to disable private comments for
product-event combinations.
Data configuration for all reports * Name of the data configuration or an alias
used when you perform a data mining run
against all safety reports.
Use the drop-down list to select a configuration
or alias. Use Browse to select a configuration.
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Field Description
Data configuration for 2D runs * Name of the data configuration or an alias
used to execute two-dimensional data mining
runs. Typically, this data configuration excludes
reports from studies and literature.
Data configuration for 3D runs * Name of the data configuration or an alias
used to execute three-dimensional data mining
runs. Typically, this data configuration includes
concomitant products.
Drug variable * Drug Variable used in data mining runs, for
example, Product Generic Name or Preferred
Product Name.
Event variable for 2D runs * Event Variable used in two-dimensional data
mining runs, for example, PT (Preferred Term)
or SMQs (Standardised MedDRA Queries).
Event variable for 3D runs * Event variable used in three-dimensional data
mining runs, for example, PT (Preferred Term).
Typically, this variable does not include SMQs
due to the size of the data mining results table.
For three-dimensional data mining runs, the
Drug variable is also used.
Stratification variables * Stratification variables used in data mining
runs.
Subset variable for signal history * For data mining runs, subset variable that
provides results in the View Signal History
page.
Subset variable for Nsince counts * For data mining runs, subset variable that
provides results in the Nsince column on the
Project for data mining runs * Name of the project used to store data mining
runs that are part of a refresh.
Publish data mining runs * Select to publish the data mining runs created
when a user refreshes the signal management
configuration.
By default, the runs are published to the same
login group that the signal configuration is
published to. A user can manually publish the
data mining runs to additional login groups.
Allow reviewers to manage their product's Select to enable all reviewers of a product to
reference data * configure Targeted Medical Events and Listed
Events for the product in the Products table on
the Signal Review page.
If deselected, only superusers and reviewers
with the Manage Signaling Terms user
permission can configure Targeted Medical
Events and Listed Events.
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Manage Signal Configurations page

On the Manage Signal Configurations page, you can modify, delete, and publish the
signal configurations. You must have the Manage Signal Configurations permission or
be a superuser to access this page.
General activities
• Manage Refreshes
• Columns
• Print
• Download
• Back
The following options appear in the Row Action menu ( ) for each signal
configuration:
• Edit
• Publish
• Edit Comment Types
• Edit Product fields
• Edit Alert Types
• Edit Product Columns
• Edit Product-Event Combinations Columns
For interactive signal configurations only:
• View Refresh Details
• Refresh
• Validate
Field descriptions—Manage Signal Configurations page
Field Description
Name Signal configuration name. When more than
one signal configuration is published to a user,
this name appears on the Signal Review page
next to the title.
Description Description of the signal configuration.
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Field Description
Topic Workflow Configuration Name of the topic workflow configuration that
is integrated with the signal management
configuration. When this integration exists,
users can associate topics with product-event
combinations using the Submit Review dialog
box, and topics are stored in this topic
Note:
If product-event
combinations
have associated
topics, you
cannot change
the associated
topic workflow
configuration
until you remove
the associated
topics. The
Signal History
maintains a log
of all changes.
Topic Product Field Topic field in which product names from

product-event combinations associated with
topics are stored. You can also use the Topic
filter when browsing for existing topics from the
Submit Review dialog box.
Modified By Role or name of the user who modified the
configuration.
Modified Date and time when the configuration was
modified.
Type Type of signal configuration. The value can be
Scripted or Interactive. For more information,
see About signal configurations.
Created Date and time when the configuration was
created.
Created By Role or name of the user who created the
configuration.
ID Identifier assigned automatically to the
configuration when the configuration was
created. Each configuration ID is unique and
is not re-used if the configuration is deleted.
Current Period Period used in last successful refresh; null if
scripted.
Data Refreshed Date of last successful refresh.
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Configure alerts
• Create an alert type
• Alert type conditions
• Edit alert types
• Modify the order in which alert types are displayed
• Activate and deactivate alerts
Create an alert type
Note:
You must have the Manage Signal Configurations permission or be a
superuser to access this page. A newly installed Signal Configuration needs
to be refreshed once before trying to create views/add alert types.

2. From the Configure System menu, select Manage Signal Configurations.
3. (Optional) If the ID column doesn't appear to the right of the Name column:
a. Click the Columns link above the table.
b. From the Available Columns list, select ID and click the right-arrow ( ) to
move it to the Selected Columns list.
c. In the Selected Columns list, click ID and use the up-arrow ( ) to move it
under Name.
d. Click OK.
4. Find the configuration to which you want to define an alert type, click the Row
Action menu ( ), then select Edit Alert Types.
Note:
This is also the page you will use to edit an existing alert type.
5. In the top left corner, click Add Alert Type.

6. In the Label field, type a unique and descriptive label for the alert type. This will be
used as the tab label.
7. In the Description field, describe how the alert gets populated. This will become
the hover help text for the tab.
8. To make this a tracked alert, select the Tracked alert checkbox, provide a
one-letter abbreviation, and select a color to associate with the alert type. The
abbreviation and color appears on the alert tab and cells on the Product-Event
Combinations table.
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Note:
If you don't select Tracked alert, this will be an informational alert
type. Informational alerts are not counted in the aggregate tracked alert
totals displayed in Product By cards, the Alert Reviewed column of the
Products table, the Product Summary panel, and on SOC cards.
9. Specify whether to base alert type rules on review periods or the complexity level/
periodicity.
a. If you select Review period, for each period:
i. Click the Row Action menu ( ).

ii. Select Import from View.
iii. Select the view to be used as the alert type rule. The alert type rule is
derived from the view, which means the view needs to have already been
created. Do this before accessing the Add/Edit Alert Type page.
iv. Click OK.
Oracle Empirica Signal imports the view and populates the Condition,
Selected Columns, and Sorted by columns.
Note:
If the signal configuration has Review Periods disabled, then
during refresh, when alerts are calculated, only the first Review
period rule will be considered.
b. If you select Complexity level /periodicity (recurrence at a regular interval),

create rules for each complexity level:

iii. Select the view to be used as the alert type rule.
iv. Click OK.
v. Enter a value in the Periodicity field.

Selected Columns, and Sorted by columns from the imported view.
Note:
Oracle Empirica Signal uses the product’s complexity level to
determine which alert type rule to use. The product’s birthdate
and the alert type rule’s periodicity determine if the alert rule
should be considered during refresh. For example, if the product
birthdate is February and the periodicity is three months, the
alert will be triggered in May, August, November, and February.
To be considered for complexity-based alert calculations, a
product needs both complexity and birthdate values.
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10. Click Save.
Oracle Empirica Signal imports the view and populates the Condition, Selected
Columns, and Sorted by columns. The alert type appears as the last row of the Edit
Alert Types page. The newly added alert type is deactivated by default. This means
that Active in next refresh is set to No for the alert type. The alert type must be
Activated to take effect.
Alert type conditions

Creating an alert type involves importing a view for each alert type rule. The view's
WHERE clause determines the condition associated with the alert type and the
conditions are validated when you save the alert type. One alert type can have several
rules; however, there is one rule per review period or per complexity level.
During validation, Oracle Empirica Signal checks the condition's SQL statement and
the columns identified in the condition. This controls the rows and columns displayed
in the Product-Event Combinations table when the alert type tab is selected. The list of
valid columns for the alert type condition is a subset of the list of columns allowed for a
view.
Although alert type conditions can contain other alerts, we do not recommend this
practice or guarantee the results.
Note:
If the alert type is tracked but you did not specify an abbreviation or color,
Oracle Empirica Signal uses default values.
Edit alert types

3. Find the configuration to which you want to add an alert, click the Row Action
menu ( ), and then select Edit Alert Types.
4. Find the alert type to edit, click its Row Action menu ( ), and then select Edit.
5. In the Label field, type a unique and descriptive label for the alert type.
The Column Name field cannot be edited. It is the database column name for the
alert type and derived from the original alert type label and will not change when
you modify the alert type label.
6. In the Description field, describe how the alert gets populated. This will become
the hover help text for the tab.
7. To make this a tracked alert, select the Tracked alert checkbox, provide a one-
letter abbreviation, and then select a color to associate with the alert type. The
abbreviation and color appear on the Product-Event Combinations table as the
tracked alert's icon.
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Note:
If the alert type has alerts that have not been reviewed and you
try to deselect Tracked, you receive a warning message and are
prevented from changing the alert type to untracked. You can switch an
Informational alert type to a Tracked alert type.
8. Specify whether to base alert type rules on review periods or the complexity level/
periodicity. The rules table contains a Modified column. The Modified column has
a value for rows with defined rules. The Modified column is empty for rows without
defined rules.
a. If you select Review period, for each period:

iii. Select a view from the Import View menu.
iv. Click OK.
Selected Columns, and Sorted by columns from the imported view.
Note:
If the signal configuration has Review Periods disabled, then during
refresh, when alerts are calculated, only the first Review period rule
will be considered.
b. If you select Complexity level/periodicity (recurrence at a regular interval),

for each level:

iii. Select a view from the Import View menu.
iv. Enter a value in the Periodicity field.
Selected Columns, and Sorted by columns.
Note:
Oracle Empirica Signal uses the product’s complexity level to
determine which alert type rule to use. The product’s birthdate
and the alert type rule’s periodicity determine if the alert rule
should be considered during refresh. For example, if the product
birthdate is February and the periodicity is three months, the alert
will be triggered in May, August, November, and February. To be
considered for complexity-based alert calculations, a product needs
both complexity and birthdate values.
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9. Click Save.
Oracle Empirica Signal verifies that the alert type has a unique label and at least
one defined alert rule.
If the alert type is tracked but you did not specify an abbreviation or color, Oracle
Empirica Signal uses default values.
Modify the order in which alert types are displayed

3. Find the configuration, click the Row Action menu ( ), then select Edit Alert
Types.
4. In the top left corner, click Modify Display Order.
5. To change the order in which alert types display, click an alert type and:
• Click to move the alert type up in the list.
• Click to move the alert type down in the list.

6. When the alert types are in the correct order, click OK.
7. Click OK.
When the order of the alert types is changed on the Edit Alert Types page,
the Products table, the Product-Event Combinations page, and the Tracked and
Informational alert graphs displayed in the right panel reflect the new order.
Activate and deactivate alerts

3. Find the configuration, click the Row Action menu ( ), then select Edit Alert
Types.
4. Find the alert type to activate or deactivate by looking in the Active in next
refresh column. Active alert types have the value, Yes. Inactive alert types have
the value No.
5. Click the alert type's Row Action menu ( ) and select Activate or Deactivate.
• You can only deactivate active alert types that do not have alerts needing
review.
• Changes will not appear in Signal Review until the signal configuration is
refreshed.
Set up for interactive signal management and review

• Add or edit a product to monitor
• Delete a product
• Modify the display order of product fields
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• Configure column labels and column descriptions for the product-event

combinations tables
• Edit a product field
• Add a product field value
• Delete a product field value
• Rename a product field value
• Modify the display order of a product field's defined values
• Case scoring algorithm
• Increased frequency algorithm
Add or edit a product to monitor

Your organization chooses the products to monitor. For non-interactive signal
configurations, Oracle creates the list of monitored products during preparation of the
signal management data. Additionally, users with the Manage Signaling Terms user
permission can add to and edit the list.
Note:
Product property values must be set up before you add a product. The user
who set up the alert types has defined the product property values you can
choose from when adding a product.
2. From the Manage Reference Data menu ( ), in the upper right corner, select
Add Product.
3. In the Add/Edit Product window, fill in the fields according to the table below.
• Code list values are defined on the Edit Product Fields page under
Manage Signal Configurations. The code list values determine the Category,
Complexity level, and Organization values available for selection.
• To be considered for complexity-based alert type rules, products must have
values for both Complexity level and Birthdate.
• Review period values are used for alert type rules based on review period.
4. Click Save.
Note:
Statistical information and alerts will appear after the next refresh.
Customers should contact Oracle for adding products to scripted signal
configurations.
Field descriptions—Add/Edit Product window
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Field Description
Product Unique name of the product.
For interactive signal configurations, you can
select terms from a list using the following
links:
• Select < hierarchy > Terms —Appears if
the product is associated with a hierarchy
such as the Anatomical Therapeutic
Chemical (ATC) Classification System.
For more information, see Selecting
hierarchy terms.
• Select Available Value—Displays valid
product names. For more information, see
Selecting values from a list.
Display name Name displayed in the Products and Product-
Event Combinations tables.
Category One of the categories defined for your signal
configuration.
Complexity level From None to High, or a custom level if
defined. This impacts alert calculation.
Birthdate Date the worldwide license went into effect,
in >MM/DD/YYYY format. This impacts alert
calculation.
Organization Organization associated with this product, as
defined for your signal configuration.
Review period Frequency that evaluations take place for
this product; for example, every 3 months, 6
months, or 1 year.
This field is required if an administrator set
up the Review Period feature for the signal
configuration.
Default view Name of the signal view associated with the
product.
Product group Group associated with the product.
• To select an existing group, click Select
from existing groups and select from a
list of groups.
• To add a new group, click Add new group
and type in a group name.
Note:
Products, not
reviewers,
belong to groups.
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Field Description
Reviewers (optional) Names of individual reviewers assigned to
the product. Click Add Reviewers From
List to select reviewers from a list. If the
product is marked as participating in automatic
assignment of reviewers, you can specify only
one reviewer.
If there is already a reviewer assigned to the
product, you can select no reviewer (--) to
remove the assignment.
Reviewers available for assignment are
users in login groups to which the signal
configuration is assigned.
Participates in automatic assignment Whether the product is eligible for automatic
assignment of reviewers.
This option is only available if the Allow
Automatic Assignment of Reviewers to
product site option is enabled.
Delete a product
You cannot delete a product in the following situations:
• There are notes for the product.
• There are comments for any product-event combinations that include the product.
You must have the Manage Signaling Terms user permission to delete a product.

3. Click the product's Row Action Menu ( ) and select Delete.

4. To delete the product, click OK on the confirmation message.
On the Signal Review page, alert counts will be updated if the deleted product had
unreviewed alerts.
Modify the display order of product fields

3. Select the signal configuration and, from its Row Action menu ( ), select Edit
Product Fields.
4. In the top left corner, click Modify Display Order.
5. To change the order in which fields display in the Edit Product Fields table and in
the Add/Edit Product window, click a field and:
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• Click to move the field up in the list.
• Click to move the field down in the list.

6. When the fields are in the correct order, click OK.
Configure column labels and column descriptions for the product-event combinations
tables
Signal summary columns appear on the product-event combinations table. When
Signal management is set up for your organization, you can edit the column headers
and tooltips for the product-event combinations tables.

3. Click the Row Action menu ( ) for the signal configuration, and then click Edit
Product-Event Columns.
4. Click Edit for a column.
5. Edit the fields according to the table below.
For more information, see the field descriptions below.
6. Click Save, and then click Close.
Field descriptions—Edit Product-Event Columns dialog box
Field Description
Column name Name of the column on the Product-Event
Combinations page. The name can appear
in the tooltip when you hover on the column
header if [%COLCODE] is included in the
column description.
Column description Description of a column on the Product-Event
Combinations page. The description appears
as a tooltip when you hover on the column
label.
Column label Text to appear as the column header on the
Edit a product field

Product Fields.
4. On the Edit Product Fields page, you can perform the following actions:
• To modify the display order of the fields, click the Modify Display Order link.
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• To change the columns included, click the Columns link.

• To print the product fields, click the Print link.
• To download the data, click the Download link.
• To change the number of rows shown, change the number in the Rows Per
page text box.
• To add a field value, from the Row Action menu ( ) of a selected product
field, click Define Values.
5. Click Back.
Add a product field value

Product Fields.
4. To add a field value, from the Row Action menu ( ) of a selected product field,
click Define Values.
5. Click the Add Value link, enter the value on the Add Value page, then click Save.
6. On the Define Product Fields page, you can also perform the following actions:
• To modify the display order of the fields, click the Modify Display Order link.
• To change the columns included, click the Columns link.
• To print the product field values, click the Print link.
• To download the data, click the Download link.
• To change the number of rows shown, change the number in the Rows Per
page text box.
7. Click Back.
Delete a product field value

Product Fields.
4. From the Row Action menu ( ) of the selected product field, click Define
Values.
5. From the Row Action menu ( ) of the selected product field value, click Delete.
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Note:
You cannot delete a value which is currently in use by a product.
Rename a product field value

Product Fields.
4. From the Row Action menu ( ) of the selected product field, click Define
Values.
5. From the Row Action menu ( ) of the selected product field value, click
Rename.
6. In the Value field, type the new name and click Save.
Modify the display order of a product field's defined values

Product Fields.
4. From the Row Action menu of the selected product field, click Define values.
5. In the top left, click Modify Display Order.
6. To change the order in which field’s defined values display in the Define Product
Field Values table and in the Add/Edit Product window, click a field and:
• Click to move the defined value up in the list.
• Click to move the defined value down in the list.

7. When the defined values are in the correct order, click OK.
Case scoring algorithm

For Argus signal management configurations, Oracle Empirica Signal includes a case
scoring algorithm. A case score indicates how well populated a report is for a given
product-event combination. Case scores are computed only if the SM_CASE_SCORE
table exists in the database user account referenced by the Argus signal management
configuration. For more information, see the Oracle Argus Mart Data Release Notes.
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Increased frequency algorithm

For interactive signal configurations, Oracle Empirica Signal includes an algorithm to
monitor events for increased frequency.
Reporting proportion (RP) is used as a proxy for exposure adjusted reporting rates and
is defined as the number of cases for a product-event combination divided by the total
number of cases for the product within the time period.
Increased frequency counts are based on the Data configuration for 2D runs
specified in the signal configuration. Increased frequency is computed for all product-
event combinations, and Oracle Empirica Signal sets a YES flag for the product-event
combinations that have at least three new reports in the most recent 12 months and
meet at least one of the following conditions:
• At least a five-fold increase in the RP for the most recent 12 months, compared to
the cumulative RP excluding the most recent 12 months.
• At least a two-fold increase in the RP for the most recent 12 months and for
the time period of 13 to 24 months ago, both compared to the cumulative RP
excluding the most recent 24 months.
The Product-Event Combinations and the Products tables maintain information for
increased frequency for three time periods, based on the initial reporting or received
date of each case, and follow-up reports are not considered. For example, Argus
Signal Management uses the following time periods:
• 1-12 months
• 13-24 months
• 25 or more months
Manage interactive signal configuration refreshes

• About refreshing interactive signal configurations
• View details for a signal management refresh
• View pending or implemented changes to an interactive signal configuration
• View existing refreshes for interactive signal configurations
• Refresh an interactive signal configuration using a definition file
• Refresh an interactive signal configuration from the Refresh Signal Management
page
• Cancel or delete a refresh for an interactive signal configuration
• View job details for an interactive signal configuration refresh
• View jobs for an interactive signal configuration refresh
• Validate an interactive signal configuration
About refreshing interactive signal configurations

You refresh an interactive signal configuration after you perform the following activities
(or the underlying data has been refreshed):
• Rename products.
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• Manage designated medical events.

• Manage custom terms.
• Manage targeted medical events.
• Manage listed events.
• Edit alert types.
During a refresh, Oracle Empirica Signal incorporates your changes and validates the
signal configuration. If validation errors are found, the refresh fails.
View details for a signal management refresh

Details for a signal management refresh include monitored products, renamed
products, designated medical events, targeted medical events, listed events, custom
terms, active alert types, and the signal configuration properties for the refresh.
To view details for existing refreshes, including refreshes that have already run, that
are currently running, or scheduled refreshes:

3. Click Manage Refreshes.
4. Click the refresh's Row Action menu ( ), and then click View Refresh Details.
For scheduled refreshes, a message stating details are not available appears
Note:
You can also view details for existing refreshes if you click the Row
Action menu ( ) for the refresh, then click View Jobs for Refresh,
and then View Refresh Details on the following page.
5. To see a preview of a refresh containing the information in its current form:
a. In the left navigation pane, click the Settings icon ( ).

b. In the Configure System section, click Manage Signal Configurations.
c. Click the Row Action menu ( ) for the signal configuration, and then click
View Refresh Details.
View pending or implemented changes to an interactive signal configuration

You can view pending or implemented changes to an interactive signal configuration
from the following pages:
• Manage Signal Configurations—View pending changes before you refresh the
• Manage Refreshes—View changes implemented during the refresh.
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3. To view pending changes to an interactive signal configuration, click the Row
Action menu ( ) for the signal configuration, and then click View Refresh
Details.
4. To view changes implemented to a signal configuration during the last refresh:
a. On the Manage Signal Configurations page, click Manage Refreshes.
b. Click the refresh's Row Action menu ( ), and then click View Refresh
Details.
Field descriptions
Field Description
ID Identifier assigned automatically to the refresh
when the refresh was created. IDs are unique
and are not reused.
Monitored products New and deleted monitored products in
alphabetical order.
Renamed products Renamed monitored products in alphabetical
order by current name.
Designated medical events New and deleted designated medical events in
alphabetical order.
Targeted medical events New and deleted targeted medical events for
monitored products in alphabetical order by
monitored product.
Listed events New and deleted listed events for monitored
products in alphabetical order by monitored
product.
Product custom terms New, edited, and deleted product custom
terms in alphabetical order. The query used to
define the custom term is shown.
Event custom terms New, edited, and deleted event custom terms
in alphabetical order. The query used to define
the custom term is shown.
Signal configuration properties Details of the signal configuration.
Active Alert Types: Review Period Based Details of the active alert types with review
period based alert type rules, including Label,
Tracked, Review Period, Condition.
Active Alert Types: Complexity Level Based Details of the active alert types with complexity
level based alert type rules, including Label,
Tracked, Complexity, Periodicity, Condition.
Data as of As of date for the refreshed data, if the data is
timestamped.
Date of refresh Date and time that the refresh was executed.
Created by Name of the user who created the refresh.
Created on Date and time that the refresh was created.
Date Date and time that you accessed the Refresh
Details page.
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View existing refreshes for interactive signal configurations

Refresh an interactive signal configuration using a definition file

To refresh a signal configuration without logging in to the Oracle Empirica Signal
application, you can use a definition file. The definition file enables you to refresh an
interactive signal configuration that you have refreshed previously.
The following procedure describes how to set up the definition file for the first time.
You must have the Manage Signal Configuration user permissions to create a
definition file.

3. Click Manage Refreshes at the top of the page.
4. Click the Row Action menu ( ) for the refresh to reschedule, and then click
Create Definition File.
5. Copy the contents of the Input File page into a text editor.
6. Set the runafter property.
The format for the date and time is mm/dd/yyyy hh\:mm\:ss.
7. Save the file as refreshTest.in.
8. Log in to the Oracle Empirica Signal application server.
9. Save the refreshTest.in file in the Signal\Input directory.
Refresh an interactive signal configuration from the Refresh Signal Management page
To refresh a signal configuration for the first time, you must use the Refresh Signal
Management page. However, for future refreshes, you can use a definition file.
You must have the Manage Signal Configurations and Create Data Mining Runs user
permissions to initiate a refresh.
After you refresh a signal configuration, you should not edit the signal configuration.
Note:
You cannot schedule a refresh if a refresh is in progress.

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3. Click the Row Action menu ( ) for the signal configuration, and then click
Refresh.
4. Specify when to perform the refresh:
• Run as soon as possible—The refresh is executed immediately.
• Do not run until—The refresh is executed on the date and time that you
specify.
5. To receive an email notification when the refresh is complete:
a. Select the Email me when complete check box.
b. Type one or more email addresses using a comma to separate each address.
The email addresses associated with your Oracle Empirica Signal user name
appear by default. To change these email addresses, contact your site
administrator.
6. Click Submit.
7. Click Continue.
Cancel or delete a refresh for an interactive signal configuration

• You can cancel refreshes that have not started or are in progress.
• You can delete refreshes that have a status of Complete, Error Occurred, or
Cancelled.
When you cancel or delete a refresh, the refresh no longer appears on the Signal
Management Refreshes page.

4. In the table, locate the refresh to cancel or delete.
5. Click the Row Action menu ( ) for the refresh, and then click Cancel or Delete.
Note:
If the refresh is canceled, the Signals Review page will remain as it had
appeared prior to initiating the refresh. Canceling a refresh also cancels runs
that are incomplete or not started.
View job details for an interactive signal configuration refresh

If a refresh job fails, you can use the Job Detail page to determine the cause of the
failure.

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4. Click the Row Action menu ( ) for the refresh, and then click View Jobs for
Refresh.
5. Click View Refresh Details.
View jobs for an interactive signal configuration refresh

The Jobs for Refresh page shows the progress of the jobs that make up a refresh.
Oracle Empirica Signal updates the page automatically until the refresh is successful
or an error causes the refresh to fail.
The name and owner of the refresh appear at the top of the page. If a refresh is
scheduled for the future, the scheduled date and time also appear.

2. In the Configure Systems section, click Manage Signal Configurations.
4. To view the changes implemented during the refresh, click View Refresh Details.
5. To view the details of a batch job, click the job Name.
Field descriptions
Column Description
ID Automatically assigned unique ID of the
refresh. IDs of deleted refreshes are not re-
used.
Name The name of each job that makes up the
refresh, for example:
• Sigmgt_Data_Preparation_ ID
• Sigmgt_Data_Deployment_ ID
Description The text, Part of Run , followed by the run ID.
Server The value, Any , appears if the next available
listener can perform the job. If multiple
listeners are in use, and the refresh is
submitted using a definition file, a listener can
be specified to perform each job, and the
unique ID of the listener appears.
Created Server date and time when the preparation job
was created.
Start Date Server date and time when the job was
started.
End Date Server date and time when the job ended.
Runnable The value is NO for a job until the preceding
job is complete. After the preceding job is
complete, the value is YES.
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Column Description
Status The column remains empty until the job has
completed or failed. If the job completes
successfully, the status is Completed. If the
run is canceled when the job is being
performed, the status is Canceled. An error
message appears on a red background if the
job failed.
Validate an interactive signal configuration

During validation, Oracle Empirica Signal checks the signal configuration to ensure the
following:
• Referenced data configurations exist.
• Referenced data configurations are valid.
• Referenced variables exist in each data configuration and are of the correct type.
For example, Oracle Empirica Signal checks whether event variables in the data
configuration are of type Event.
• Variables referenced in custom term queries exist in each data configuration
referenced in the signal management configuration.
• Variables referenced in database restriction queries exist in each data
configuration referenced in the signal management configuration.
You must have the Manage Signal Configurations permission to validate an interactive

3. Click the Row Action menu ( ) for the signal configuration, and then click
Validate.
4. Review the list of findings.
5. To return to the Manage Signal Configurations page, click Continue.
Manage signal comment types

• Add a signal comment type
• Edit a signal comment type
• Delete a signal comment type
• Change the sort order of a signal comment type
Add a signal comment type

Signal comment types are comments that you can apply to product-event
combinations, for example, Open Bring to Meeting.
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The application includes some signal comment types by default. If you have the
Manage Signal Configurations permission, you can add signal comment types.
Additionally, you can edit and delete comment types, and change the sort order of
comment types.

Comment Types.
4. Click Add Comment Type.
5. Fill in the fields according to the following table.
Field Descriptions—Add/Edit Comment Type dialog box
Field Description
Comment text Comment. When users perform Submit
Review, this value appears in the Comment
drop-down list.
Abbreviated comment text Shortened version of the comment. When
users select this comment in Submit Review,
this value appears in the Comment column on
the Product-Event Combinations page.
Is suppress reason? If you select Yes, the comment is available in
the Submit Review dialog box as a reason for
suppressing a product-event combination.
If this field is not set to Yes for any comments,
then Suppress product-event combination
does not appear on the Submit Review dialog
box.
Is review reason? If you select Yes, the comment is available
to select in the Comment field in the Submit
Review dialog box.
If private comments are enabled, the comment
is available to be added as a private comment.
Requires detailed comment? If you select Yes, users must enter an
additional free-text comment in the Submit
Review dialog box when selecting this
comment.
Requires associated topic? If you select Yes, users must associate a
topic with the product-event combination in the
Submit Review dialog box when selecting this
comment.
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Field Description
Review after delta threshold Enter the number of new cases after which
a signal that has been suppressed (on
the Submit Review dialog box) becomes
unsuppressed.
Note:
This feature is
only supported in
custom signal
configurations.
Edit a signal comment type

You can edit signal comment types if you have the Manage Signal Configurations
permission.

Comment Types.
4. In the table, locate the comment to edit.
5. Click Edit for the comment.
6. Modify the fields as needed.
For a description of the fields, see Add a signal comment type.
Delete a signal comment type

You can delete signal comment types if you have the Manage Signal Configurations
permission.
If you delete a comment that is applied to a product-event combination, the comment
remains visible when you view the signal history.

Comment Types.
4. In the table, locate the comment to delete.
5. Click Delete for the comment, and then click Close.
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Change the sort order of a signal comment type

Comment Types.
4. Click Change Sort Order.
5. Click a comment, and use the up and down arrows to change the position of the
comment.
Assign reviewers
• Assign a reviewer to a product-event combination
• Automatic assignment of reviewers to products
• Automatically assign reviewers to products
• Modify automatic reviewer assignments
Assign a reviewer to a product-event combination

You can assign a reviewer to a product-event combination. To assign a reviewer, you
must have the Manage Signaling Terms permission.

4. Click the product-event combination's Row Action menu ( ) and click Assign
Reviewer.
5. From the Reviewer drop-down list, select the reviewer.
published. This assignment does not overlap with the reviewer assignments to
products. For example, if User1 is assigned to the product Niacin, you can assign
User2 to the combination of the product Niacin and event Flushing.
6. Click OK.
You can add the Reviewer column to the Product-Event Combinations table to see
reviewer assignments.
Automatic assignment of reviewers to products

Reviewers whose names have been added to the signal management components
of the application are eligible for automatic assignment to products. You can either
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assign reviewers to products when adding or editing a product, or use a process that
automatically assigns selected reviewers to products for which there are new cases
since an indicated time period.
The automatic assignment process affects only products that have been set up to
participate in automatic assignment. (You must have checked Participates in auto-
assignment when adding or editing the product.) The process looks at products
for new cases since the time period you select, and allows you to distribute the
products evenly over selected reviewers. Because these products might already have
assignments (due to previous cases), the automatic assignment process can result in
re-assignments. Products for which there are no new cases (since the last period),
but that have been set up to participate in automatic assignment, have their reviewer
assignments cleared.
The following table shows how assignments of reviewers to products that have been
set up to participate in automatic assignment are affected by the automatic assignment
process:
Assignment status Have new cases Do not have new cases

Already Assigned Re-assigned if you select them. Assignments are cleared.
Retain previous assignments if you
do not select them.
Unassigned Assigned if you select them. Remain Remain unassigned.
unassigned if you do not select them.
How reviewers are distributed over products

The application does the following during the automatic assignment process:
1. Orders the products in ascending order of the number of new cases.
2. For the first product in the ordered list, assigns the first reviewer in the list of
Selected reviewers that you have chosen.
3. For the next product in the ordered list, assigns the next reviewer in the list of
Selected reviewers.
4. Continues to assign products until all products have been assigned. When the
application reaches the end of the list of Selected reviewers, the applications starts
again with the first reviewer in the list.
When a product that is already assigned to a reviewer is re-assigned, no attempt is
made to retain the currently assigned reviewer. However, it is possible for the product
to be re-assigned to the same reviewer coincidentally.
You can force a product that appears in new cases to retain its current assignment by
excluding it from the automatic assignment process.
Overriding automatic assignments

At the end of the automatic assignment process, the application displays the automatic
assignments that have been made to products and you have the opportunity to
override assignments. You can also override the automatic assignment for a product
on the Automatic Assignment page or by editing a product and changing the reviewer.
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Automatically assign reviewers to products

You must have the Manage Signaling Terms permission to automatically assign
reviewers to products. Additionally, an administrator must enable the Allow Automatic
Assignment of Reviewers to Products site option.
Note:
You must refresh signal management before you can use the automatic
assignment feature because it uses counts of new cases to evenly distribute
product reviews among reviewers.
2. From the Manage Reference Data menu ( ), on the top right, click Auto-
Assign to Reviewers.
3. Select a Signal set from the drop-down list.
4. From the Consider drugs with new cases since drop-down list, select a time
period.
Choose a signal set that represents new cases; for example, named "...Nsince" or
"...Nnew", and not one that represents a total count (named "...N").
5. Click Next.
6. From the Available reviewers list, select the reviewers, move them to the
Selected reviewers list, and click Next.
• Available reviewers for assignment are those in login groups to which the
signal configuration is published.
• An error message appears if there are no drugs that conform to the selected
time period.
7. From the Available drugs list, select the drugs, move them to the Selected drugs
list, and click Next.
Available drugs are those that are marked as allowing participation in automatic
assignment and for which there are new cases since the selected time period.
8. Click Next.
The Automatic Assignments dialog box appears, showing the reviewer
assignments that can be made. The number of new cases for each drug is also
shown.
9. Click Save.
Modify automatic reviewer assignments

The Automatic Assignments page provides information about drugs that have been
assigned automatically to a reviewer. There is one reviewer per drug. This page does
not show assignments that were made manually (when the drug was added or edited).
You can use this modification procedure to override automatic assignments.
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2. From the Manage Reference Data menu ( ), on the top right, click Modify
Automatic Assignments.
The Modify Automatic Assignments page appears and provides the following
information about each drug that currently has a reviewer (who has been assigned
automatically):
Column Description
Drug Name of the drug.
Reviewer Name of the reviewer who has been
assigned automatically to the drug.
If rows have been filtered using a SQL WHERE clause in the Column and Rows
dialog box, the text, Rows are filtered, appears above the table. Rest the cursor
on that text to see the SQL WHERE clause that is in effect. For more information,
see Filter products and product-event combinations using a SQL WHERE clause.
3. Click the Row Action menu ( ) for the drug, and then click Change.
4. Select another reviewer from the Reviewer drop-down list and click OK.
assigned.
Arrange or download tables

• Arrange table columns
• Configure column labels and column descriptions
• Download data
• Filter products and product-event combinations using a SQL WHERE clause
Arrange table columns
1. From a Signal Review page, from the Header Action menu ( ) for a table, click
Columns. On other pages, click the Columns link.
them to the Selected Columns list using the arrow buttons.
the table.
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• To move multiple columns, hold down the Ctrl key while you click the column
names, and then click the up or down arrows.
4. To replace your choices with the Oracle Empirica Signal defaults, click Reset in
the Columns dialog box. For the all tables, except Product-Event Combinations,
the table columns and sorting return to the default values. For the Product-Event
Combinations table, the Reset button in the Columns dialog resets to whatever
was selected when you opened the dialog. To reset a Product-Event Combinations
table to the default settings, from the Header Action menu ( ), click Reset View
to Default.
5. Specify the sort order.
If you sorted the table by clicking column headers, that sort order appears in the
Column Name and Sort Order fields. To specify a sort order:
columns.
b. From the Sort Order drop-down list, select Asc (ascending order: A-Z, 1-9) or
Desc (descending order: Z-A, 9-1).
If you are managing columns and you have checked the Allow SQL Where
Clause on the Signal Review page check box on the Set User Preferences
page, you can specify a SQL WHERE clause to filter rows on the Products
table. For the Product-Event combinations table, this is only available for
scripted signal configurations and added tabs.
6. For all tables, except the Product-Event Combinations table, if you have the
Administer Users permission, you have the option to make the current layout the
default for all of the users in your login group. This replaces the default table layout
supplied by the application with your current layout for any user who has not yet
arranged that table.
7. Click OK.
Oracle Empirica Signal saves your arrangement of columns and rows and uses
it as a default for the Products or Product-Event Combinations tables for the
selected signal configuration until you change the arrangement.
Note:
When you initially display the Products table or Product-Event
Combinations table, the columns shown and the sort order within the
table reflect the current selections. Any changes you make are retained
for that configuration.
Impact of multiple sorts on the Products table

1. Hover over an unsorted column header. A sort arrow appears indicating the initial
sort order.
• Dates and numbers are sorted in descending order.
• Strings are sorted in ascending order.
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• The sort arrow is displayed for primary, secondary, and tertiary sorted
columns.
2. Hover over a sorted column header and it continues to show the current sort
direction.
• The primary arrow is black. Secondary and tertiary arrows are gray.
• The tooltip for a sort arrow indicates the new sort direction such as "Sort
Interaction Descending" or "Sort Interaction Ascending."
Configure column labels and column descriptions

On the Edit Signal Configuration page, you can edit the appearance of the columns on
the Products page.

Product Columns.
4. To the right of a column row, click Edit.
5. Fill in the fields.
6. Click Save.
Field descriptions—Edit Product columns dialog box
Field Description
Column name Name of the column on the Products page.
Column label Text to appear as the column heading.
Column tooltip Description of a column. The description
appears as a tooltip when you hover over the
column label on the Products page.
Download data
When you view a table or case details, you can download the information to various
types of files.
Set a default download file type by modifying your user preferences. When
downloading, however, you can override the default by selecting another file type.
Note:
For floating-point numbers that are downloaded, the precision of the
numbers is accurate to the level of precision in the numbers, as displayed in
1. Make sure you have arranged table columns as you want them.
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2. From the Signal Review page Header Action menu ( ), click Download. On
other pages, click the Download link.
3. In the Base filename field, enter a filename. Do not include an extension. We
recommend that you use a filename that identifies the content of the download.
4. Select one of the following file types. For some types of information, only certain
file types are available.
File Type Description

Comma-separated file (.csv) Text file in which values are separated by a
comma. Can be used as input to or output
from Microsoft Excel.
Note:
Leading zeroes in values are not
retained when you download to
a .csv file.
Tab delimited file (.txt) Plain text file. Typically, the file extension .txt
is associated with a text editor, such as
Microsoft Notepad.
Excel spreadsheet (.xls) Spreadsheet file that can be opened by
Microsoft Excel. You must have Microsoft
Excel installed on your computer. If you
try to download a table of more than
65,535 rows, a message warns you that this
exceeds the capacity of Excel.
Note:
If dates are not displayed
appropriately in Excel, you might
need to change the display format
in Excel.
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File Type Description

Excel spreadsheet (.xlsx) Spreadsheet file that can be opened by
Microsoft Excel. You must have Microsoft
Excel installed on your computer. If you
try to download a table of more than
1,048,575 rows, a message warns you that
this exceeds the capacity of Excel.
When you download case details to an
Excel spreadsheet, a separate worksheet
is used for each of the different types of
data shown on the Case Details page. Each
worksheet is limited to 1,048,575 rows.
Note:
If dates are not displayed
appropriately in Excel, you might
need to change the display format
in Excel.
SAS Version 5 transport (.xpt) Industry-standard SAS transport file, as

defined for SAS Version 5 (XPORT format).
SAS data step definition (.sas) SAS data step file, which can be used
by SAS software to create a native SAS
dataset.
Portable Document Format (.pdf) File that includes formatting and layout
information, as well as the data. This option
requires the Adobe Acrobat Reader.
Note:
When you are downloading case details, only the Excel spreadsheet
(.xlsx) or Word Rich Text Format (.rtf) formats are available.
5. In the Limit to field, enter the number of rows that you want to download (instead
of downloading the entire table). For example, if you specify 1000, only the first
1,000 rows of the table download. Keep in mind that the way in which the table is
sorted determines which rows are downloaded. If you do not fill in the Limit to field,
all rows of the table download.
The number of rows per page of the displayed table has no effect on downloading.
For example, the table includes 100 rows and 25 rows appear per page. If you
download the table, all 100 rows download.
Note:
When you download case details, we recommend that you do not limit
the number of rows. The limit applies to each type of data. For example,
if you limit the download to two rows, only the first two drugs and the first
two adverse events for the case are downloaded.
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6. If you select Create a Zip archive file for download, the Oracle Empirica Signal
creates a file with the extension .zip to hold the file that contains the downloaded
table. You must have a ZIP file compression and extraction utility, such as WinZip,
installed on your computer.
The zip file also includes an id.txt file that provides the name of the user who
downloaded the table and the date and time of the download.
Note:
When you download data from a report, you can also include a
report definition file and analysis files. The report definition is an XML
representation of the report. The analysis files include an analysis
description file and an analysis script file (if defined for the report).
7. Click OK.
8. Open or Save the file.
For large case series, a message appears stating the file is being prepared. You
can leave this page and click anywhere in Oracle Empirica Signal while the file is
downloading.
Note:
When you download data mining results or reports, Oracle Empirica
Signal includes notes in the download (to all file types except .xpt
and .sas) if they appeared at the time of the download.
Filter products and product-event combinations using a SQL WHERE clause

You can set your user preference, Allow SQL WHERE Clause on the Signal Review
Page, to allow use of a SQL WHERE clause to restrict rows that appear on the
Products and Product-Event Combinations pages. For Product-Event Combinations
tables, you cannot modify the WHERE clause for Alert type tabs (either tracked or
informational).
To select table columns (variables) to include in the WHERE clause: from the Header
Action menu ( ) on the Products or Product-Event Combinations tables, click

Columns. On the Columns dialog, enter the WHERE clause in the Where Clause
text box. To copy an existing WHERE clause, click the Show Columns link.

4. From the Manage Reference Data menu ( ) on the top right, click Manage
Views.
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5. On the top left, click Columns. (This option is available only if you have the
Manage Signal Views permission.)
6. From the Available Columns list, select one or more columns and move them to
the Selected Columns list.
7. If you use a SQL WHERE clause, you must refer to the names of columns in the
underlying database table, which might not be the same as the column names that
appear on the page.
8. For the columns shown, specify the column names and sort order.
• From the Column Name drop-down list, select the name.
• From the Sort Order drop-down list, select Asc, to sort in ascending order, or
Desc, to sort in descending order.
9. To use the layout as the default for your login group, select the Use current
layout as login group default check box.
10. In the Where Clause text box, type or paste the SQL WHERE clause.
11. To include a column in the WHERE clause, click Show Columns and click the
column name from the Select Table Columns dialog box.
12. Click OK.
The text, Rows are (filtered), appears above the table of products or * (modified)
appears above the table of product-event combinations.
Manage events and custom terms

• Maintain a list of targeted medical events
• Maintain a list of listed events
• Add a designated medical event
• Add, edit, or delete a custom term
• Types of signaling terms
Maintain a list of targeted medical events

For interactive signal configurations, you can maintain a list of targeted medical events
(TMEs) for each product. A TME is an adverse event that your organization wants to
monitor closely for a particular product. For example, you might add Hepatic failure as
a TME for Product A.
• You must have the Manage Signaling Terms permission to manage TMEs.
• The Data Configuration for 2D Runs specified for the signal configuration must be
present and valid.
• The Event Variable for 2D Runs and Drug Variable for 2D Runs specified for the
signal configuration must exist in the Data Configuration for 2D Runs.
• You define TMEs at the hierarchy level specified in the Event Variable for 2D Runs
field for the signal configuration. For example, if the Event Variable for 2D Runs is
(Event) PT, you define TMEs using preferred terms.
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• You cannot add or delete a targeted medical event while a signal configuration
refresh is in progress.
• You must refresh the signal configuration for your changes to take effect.

3. Click the product's Row Action menu ( ) and select Manage Targeted Medical
Events.
4. Add a TME for the product using one of the following methods:
• Select < hierarchy > terms.
• Select available values.
• Select a saved list of values.
• Type the values.
Note:
5. (Optional) Select the Validate list when saving checkbox.

6. Click Save.
• The TMEs are saved and are applied when you refresh the signal
configuration.
• In the Product-Event Combinations page, the TME column identifies product-
event combinations that are associated with a TME.
Maintain a list of listed events

For interactive signal configurations, you can maintain a list of listed events for each
product. A listed event is an adverse event that is listed on the product label. For
example, dizziness is a listed event for Ibuprofen.
• You must have the Manage Signaling Terms permission to manage listed events.
present and valid.
• You define listed events at the hierarchy level specified in the Event Variable for
2D Runs field for the signal configuration. For example, if the Event Variable for 2D
Runs is (Event) PT, you define listed events using preferred terms.
• You cannot add or delete a listed event while a signal configuration refresh is in
progress.
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3. Click the product's Row Action menu ( ) and select Manage Listed Events.
4. To add listed events, specify the listed events for the product using one of the
following methods:
• Select <hierarchy> terms.
• Select a saved list of terms.
• Type the terms.
Note:

If you select the checkbox, Oracle Empirica Signal checks whether the terms that
you specified are in the source data. If the terms are not in the source data, an
error message appears and the invalid terms are moved to the end of the list.
6. Click Save.
• The listed events are saved and are applied when you refresh the signal
configuration.
• In the Product-Event Combinations page, the LST column identifies product-
event combinations that are associated with a listed event.
Add a designated medical event

For interactive signal configurations, you can maintain a list of designated medical
events (DMEs). A DME is an adverse event that your organization wants to monitor
closely. DMEs are not associated with particular products.
present and valid.
• You define designated medical events (DMEs) at the hierarchy level specified in
the Event Variable for 2D Runs field for the signal configuration.
• For example, if the Event Variable for 2D Runs is (Event) PT, you define DMEs
using preferred terms.
• You cannot add or delete DMEs while a signal configuration refresh is in progress.
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• You can add a maximum of 2000 values as DMEs.

• You must have the Manage Signaling Terms permission to manage DMEs.
2. From the Manage Reference Data menu ( ), on the top right, click Manage
Designated Medical Events.
3. Specify the DMEs to add using one of the following methods:
• Select <hierarchy> terms.
• Select a saved list of terms.
• Type the terms.
Note:
select rather than type values

If you select the checkbox, Oracle Empirica Signal checks whether the terms that
you specified are in the source data. If the terms are not in the source data, an
error message appears and the invalid terms are moved to the end of the list.
5. Click Save.
• The DMEs are saved and are applied when you refresh the signal
configuration.
• In the Product-Event Combinations page, the DME column identifies product-
event combinations that are associated with a DME.
Add, edit, or delete a custom term

For interactive signal configurations, you create custom terms to represent a pseudo-
value for a product or event. For example, you might create a custom event term
called Pain and include the following MedDRA hierarchy terms in the definition of Pain:
• Facial pain
• Lip pain
• Pain in jaw
• Gingival pain
The example is for an event variable. However, you can also create custom terms for
product variables.
Custom terms appear as optional values when you define a data mining run. For
more information about how custom terms are used in data mining runs, see What are
custom terms?
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• The data configurations specified for the signal configuration must be present and
valid.
• The values you use to define each custom term must be present in the data
configurations specified for the signal configuration.
• You cannot add, edit, or delete custom terms while a signal configuration refresh is
in progress.
• Custom terms must be unique within the signal configuration.
• You must have the Manage Signaling Terms permission to manage custom terms.
Add a custom term
Custom Terms.
3. On the top left, click Create Custom Term.
4. In the Name field, type a name for the custom term.
If the name includes an invalid character, Oracle Empirica Signal replaces the
character with a pound sign (#) and displays an informational message. The
following characters are invalid:
• \, /, <, :, >, |, ?, *, ”, &, and null
• Control characters
• Non-ASCII characters
5. From the Item variable drop-down list, select the variable type for the term; for
example, Drug or Event.
6. Specify a query to identify the cases for which to include the custom term.
• Create Using Query Wizard: Create a query from scratch following the steps
of the wizard.
• Create From Existing Query: Choose an existing query. You must have
created or published the query. Subsequent changes you make to the query
in the library do not affect the custom term.
7. In the Hierarchy Path field, click Select <hierarchy> term.
8. Browse the hierarchy to find the hierarchy item with which to associate the custom
term.
9. Click OK.
Edit a custom term

1. In the table, locate the custom term to edit.
2. Select the custom term's Row Action menu ( ) icon, then click Edit.
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3. Edit the fields as necessary.
Note:
We recommend that you do not change the name of the custom
term. Changing the name does not actually change the name of the
custom term. Rather, it creates a new custom term and removes the
old one in the next refresh. Prior comments, topic associations, and
unreviewed alerts associated with the prior custom term's product-event
combinations will be orphaned.
4. Click OK.
Delete a custom term

1. In the table, locate the custom term to delete.
2. Select the custom term's Row Action menu ( ) icon, then click Delete.
Types of signaling terms

For interactive signal configurations, you can manage the following types of signaling
terms:
• Designated medical event (DME)—Adverse events that your organization wants
to monitor closely. DMEs are not associated with a particular product. For more
information, see Add a designated medical event.
• Custom term—User-specified term used as a pseudo-product or pseudo-event
value in data mining. For more information, see Add, edit, or delete a custom term.
• Targeted medical event (TME)—Event associated with a product. For more
information see, Maintain a list of targeted medical events.
• Listed event—Event listed on the label of a product. For more information, see
Maintain a list of listed events.
You update DMEs and custom terms from the Manage Reference Data menu
( ), on the top right. You update TMEs and Listed events from the Products table.
Manage signal views

• Maintain signal views
• Rename a signal view
• Organize signal views
Maintain signal views

A signal view specifies the following for the Product-Event Combinations table:
• Which columns are included, and in what order.
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• The SQL WHERE clause that selects product-event combinations (shown on the
Rename Signal View page).
Typically, an organization has predefined standard views. Additional views can be
added by the user by the Save a product-event combinations as a new view option.
Users with Manage Signal Views permission are able to open Manage Signal Views
page. They can organize, publish, rename, and delete views created by the user,
views created by other users in their login group, as well as views published to their
login group.
Users without Manage Signal Views permission are able to open Manage Signal
Views page. They can rename and delete views that they created.
Views.
The Manage Signal Views page appears and provides the following information
about each signal view that you created. If you have the Manage Signal Views
permission, the page also lists views created by other users in your login group, as
well as views published to you.
Column Description
Name Name of the signal view.
Note:
If the signal configuration has the
review period feature set up, each
view name should include the
length of the review period, such
as New Cases (3 months) and
New Cases (6 months).
Description Description of the signal view.

Category The grouping for the view, such as Product
Alerts or Supplemental. The category
defines the view's location in the Add tab
menu on the Product-Event Combinations
page.
View categories are customized for the
requirements of each organization.
Modified Date and time when the signal view was last
modified.
Created By Name of the user who created the signal
view.
Created On Date and time when the signal view was
created.
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Column Description
Review Period The period of time for data in the view, such
as the last 3 months, 6 months, or 1 year.
Appears if the signal configuration has the
review period feature set up.
3. To organize signal views; that is, to specify how they will appear in the Add tab
menu on the Product-Event Combinations page:
a. From the Manage Reference Data menu ( , on the top right, click
Manage Views.
b. Click Organize Views. (This option is available only if you have the Manage
Signal Views permission.)
Rename, publish, or delete a view
If you click the Row Action menu ( ) for a signal view, you can do the following:
• To rename a view, click Rename.
• To publish a view, click Publish, select the login group(s), then click Back.
Note:
This option is available only if you have the Manage Signal Views
permission.
Prior to publication, signal views are visible only to their creators and to
superusers. If you are a superuser, you can publish to multiple login groups,
including —All–. In the Publish to Login Groups drop-down list, click or
Ctrl+click to select login groups. If you publish to —All– and later add a new
login group, the object is published automatically to the new login group.
• To delete a view, click Delete and then click OK.
Rename a signal view
Views.
3. Click the Row Action menu ( ) for a signal view, and then click Rename.
In addition to the information you can change in the steps below, the Rename
Signal View page shows the following information about the view:
• The ordered list of columns included on the Product-Event Combinations
page.
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• The sort order for the Product-Event Combinations table.

• The SQL WHERE clause, if any, that selects the product-event combinations
to appear in the Product-Event Combinations table.
4. In the View name field, enter a new view name.
5. In the Description field, enter an informative description of the view.
6. Optionally, change the Category assignment for the view.
• To add the view to an existing category, select Add to existing category and
select the view from the drop-down list.
• To add a new category, select Add to a new category named and type the
category name in the text box.
7. Optionally, change the Review period for the view by selecting it from the Review
period drop-down list. This option is available if the signal configuration has the
review period feature set up.
Note:
If you change the review period, the review period alerts will not display
as expected until the next refresh.
8. Click Save.
Organize signal views

You can define the order of view categories, and the views within each category.
Note:
The category, Unassigned, always appears last in the list of categories.
Views.
3. On the top left, click Organize Views. (This option is available only if you have the
Manage Signal Views permission.)
4. To specify the order in which categories appear, from the Category list, click a
category name, then click the up and down arrow keys to move the category to the
desired position.
5. To specify the order of the views assigned to a category, click a category, then, in
the Views list, click a view name and move it to the desired position with the up
and down arrow keys.
6. To reorder the views, click a view in the Views list, then click the up and down
arrow keys to move it to the desired position.
7. Click OK.
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Manage reviewer-user mapping

• Map reviewers to users
Map reviewers to users
Note:
Unmapped users will not be included in the Products By cards on the Signal
Review page.
You can assign reviewers to products and product-event combinations. In releases

prior to Oracle Empirica Signal 7.0, signal reviewers were added explicitly and were
separate from usernames. Beginning with the 7.0 release, usernames were used
instead and, as a result, existing signal reviewers must be mapped to usernames.
This mapping was performed during the upgrade to the 7.0 release. However, it is
possible that the mapping was not performed completely during the upgrade and must
be completed. In this case, if you have the Administer Signal Management permission,
you can map the remaining reviewers to usernames as needed.
Note:
If some, but not all, reviewers have been mapped to usernames, lists of
reviewers on the Signal Review page differentiate the reviewers with the
suffix (user) or (reviewer) after the name. Once all reviewers have been
mapped to usernames, the suffix no longer appears.
This feature is deprecated and will be removed in a future release. The
mapping must be completed.

2. In the Configure System section, click Manage Reviewer-User Mapping.
3. To list only reviewers who have not yet been mapped to usernames, select
Display Unmapped Reviewers.
4. Click the Row Action menu ( ) for the reviewer who you want to map to a
username, and then click Edit Reviewer User Mapping.
5. From the User list, select a username. The username becomes the display name
of the user.
6. Click Save.
Manage topic workflow configurations

• Topic workflow configuration design
• Definitions in the sample topic workflow configuration
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• Set up Oracle Empirica Topics

• Manage Topic Workflow Configurations page
• Add a topic workflow configuration
• Work with topic workflow configurations
• Manage fields
• Manage topic states
• Manage action states
• Manage topic templates
• Manage email notification rules
Topic workflow configuration design

A topic workflow configuration defines how the topics feature works in the application,
including the fields that store topic information and the workflow states that you can
assign to track progress. You can set up topic workflow configurations and the topic
feature to accommodate your organization's processes. Users with the Manage Topic
Workflow Configurations permission can work with topic workflow configurations.
The following list represents customizable areas of a topic workflow configurations:
• User settings
• Topic fields
• Topic field values
• Workflow states for topic states and action states
• Topic field accessibility and action field accessibility by states
• Attachment field accessibility by types
• Email notification rules
• Topic templates
These definitions affect the appearance and behavior of the user interface for using
topics.
A Sample Topic Workflow Configuration is provided with Oracle Empirica Signal. Use it
as a starting point when you design a configuration by copying and editing it. You can
also review the definitions in the Sample Topic Workflow Configuration and base your
design on them. The Sample Topic Workflow Configuration itself should not be edited.
Note:
Changes to a topic workflow configuration that is already in use are not
recommended.
In addition, you can prepare topic features by defining the access permissions to the
Oracle Empirica Signal users. For more information, see Set up the topics feature.
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Definitions in the sample topic workflow configuration

A sample topic workflow configuration is provided with Oracle Empirica Signal. To
design a new topic workflow configuration, you can copy the sample and edit it. Use
the information below as a guide when designing a new topic workflow configuration.
Basic configuration options

When you edit a topic workflow configuration you set these configuration options:
Option Definition
Name Sample Topic Workflow Configuration
Description Sample Topic Workflow Configuration
Allow topic to be visible to ( ) One and only one work team
(o) Zero, one or more work teams
Allow topic to be linked to (o) Topics in any state
( ) Topics in final state
Allow addition of comments to |x| Topics
|x| Attachments
|x| Actions
Allow sources of attachments |x| Application Data
|x| External URL
|x| External Document
|x| Note
Allow topic state closure only when all actions are | | (cleared)
completed
Allow action state closure only when attachments or | | (cleared)
comments are provided for action
Field definitions: topics

When you view existing fields, the Context column indicates whether a given field
applies to topics, attachments, actions, or possibly to several of these contexts.
The sample topic workflow configuration defines the following fields for topics:
Column Name Display Name Format Filter Field

TOPIC_NAME Topic name String No
TOPIC_DESCRIPTION Topic description String No
CURRENT_STATE_ID Current state Integer Yes
STATE_CHANGE_REASO Reason for change String No
N
ASSIGNED_TO_USER_ID Assigned to Integer Yes
SEARCH_KEYWORDS Keywords String Yes
RESOLUTION Resolution String No
RESOLUTION_DATE Resolution date Date No
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(This table presents a subset of the different attributes that can be set when you add or
edit a field.)
Field definitions: actions

The sample topic workflow configuration includes the following fields for actions:

ACTION_NAME Action name String No
ACTION_DESCRIPTION Action description String No
ACTION_STATE_ID Action state Integer Yes
ASSIGNED_TO_USER_ID Assigned to Integer Yes
PLANNED_COMPL_DATE Planned completion date Date No
ACTUAL_COMPL_DATE Actual completion date Date No
Field definitions: attachments

The sample topic workflow configuration includes the following fields for attachments:

NAME Attachment name String No
DESCRIPTION Attachment description String No
URL_ADDRESS URL address String No
FILE_NAME File name String No
Topic states
The sample topic workflow configuration defines the following workflow states for
topics:
Name Description Initial State Final State Next Possible

States
Init Initial state Yes No Assigned,
Closed,
Escalated
Assigned Actively being No No Closed,
reviewed Escalated
Escalated Warrants further No No Assigned, Closed
attention
Closed No further action No Yes Assigned
needed or
expected
Topic field accessibility

The sample topic workflow configuration defines the level of user access to topic fields
for a topic in each workflow state as follows:
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Topic Field Column Init Assigned Escalated Closed

Name
TOPIC_NAME Required Required Required Required
TOPIC_DESCRIPTIO Editable Editable Editable Editable
N
CURRENT_STATE_I Editable Editable Editable Editable
D
STATE_CHANGE_R -- (Hidden) Required Required Required
EASON
ASSIGNED_TO_USE Editable Required Required Required
R_ID
SEARCH_KEYWOR Editable Editable Editable Editable
DS
RESOLUTION -- (Hidden) -- (Hidden) -- (Hidden) Required
RESOLUTION_DATE -- (Hidden) -- (Hidden) -- (Hidden) Required
Action states
The sample topic workflow configuration defines the following workflow states for
actions:
Name Description Initial State Final State Next Possible

Action States
Init Initial state Yes No Closed
Closed Action completed No Yes
Action field accessibility

The sample topic workflow configuration defines the level of user access to action
fields for an action in each workflow state as follows:
Action Field Column Name Init Closed

ACTION_NAME Required Required
ACTION_DESCRIPTION Editable Editable
ACTION_STATE_ID Editable Editable
ASSIGNED_TO_USER_ID Editable Editable
PLANNED_COMPL_DATE Editable Editable
ACTUAL_COMPL_DATE Editable Editable
Attachment field accessibility

The sample topic workflow configuration defines the accessibility of attachment fields
for each type of attachment as follows:
Field Name External URL Oracle Empirica External Document Note

Signal Result
NAME Required Required Required Required
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Field Name External URL Oracle Empirica External Document Note

Signal Result
DESCRIPTION Editable Editable Editable Editable
URL_ADDRESS Required -- (Hidden) -- (Hidden) -- (Hidden)
FILE_NAME -- (Hidden) -- (Hidden) Required -- (Hidden)
Set up Oracle Empirica Topics

Oracle Empirica Topics is configured by an administrator who performs several tasks.
A sequential outline of those tasks is based on the sample topic workflow configuration
delivered with the application.
To perform the steps in this outline, an administrator must have been assigned the
Manage Topic Workflow Configurations and Administer Users permissions. To add the
work team fields, it is also necessary to have Superuser permission.
1. Make a copy of the Sample Topic Workflow Configuration supplied with Oracle
Empirica Signal as the basis for a new topic workflow configuration. For more
information, see Copy a topic workflow configuration.
Note:
The Sample Topic Workflow Configuration should not be edited.
2. Edit the new topic workflow configuration.

Your design can be based on the Sample Topic Workflow Configuration. For more
information, see Definitions in the sample topic workflow configuration.
3. Publish the new topic workflow configuration to your login group. For more
information, see Publish objects.
4. Edit your login group to select the new topic workflow configuration as its Topic
Workflow Configuration setting. For more information, see Edit a login group.
5. Create one or more work teams for your login group. A work team can contain all
of the users in a given login group, or a specified subset of those users. For more
information, see Add/edit a work team.
6. If you created work teams, assign work team permissions to each work team
member.
7. If your topic workflow configuration includes any fields with a context of work team,
a Superuser must set the Topic workflow configuration for work team custom
fields site option.
8. For each of the users in the login group (or work team), including yourself, edit the
user account to grant the View Topics permission. For more information, see Add
and edit a user and User permissions.
9. Log out of the application, and then log in again. The Topics page is now available
to you.
Users who were already logged in when you granted the View Topics permission
must log out of the application and log in again.
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If the topic workflow configuration defines application data results as an allowed

attachment type, the Save to Topic link also appears above tables, graphs, report
output, and other Oracle Empirica Signal objects.
Manage Topic Workflow Configurations page

On the Manage Topic Workflow Configurations page, you can list the topic workflow
configurations that you created or have been published to your login group.
General activities
• Add Workflow Configuration
• Import Workflow Configuration Account
• Import Workflow Configuration File
• Back
• Columns
• Print
• Download
The following menu options are available from the Row Action menu ( ), located in
the first column of the table, and affect an individual row in the table:
• Edit
• Copy
• Delete
• Publish
• Export
• Create PDF
• Manage Fields
• Manage Topic States
• Manage Action States
• Manage Topic Templates
• Manage Email Notification Rules
Field descriptions—Manage Topic Workflow Configurations page

In this section, you can view the information for each topic workflow configuration.
Field Description
ID Identifier assigned to the configuration. Each
topic workflow configuration ID is unique and is
not re-used if the configuration is deleted.
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Field Description
Name Name of the topic workflow configuration.
Description Description of the topic workflow configuration.
Account Name Name of the Oracle database account that
contains topic workflow configuration data.
Owner Name of the user who created the topic
Add a topic workflow configuration

• Add a topic workflow configuration
• Import a workflow configuration account
• Import a topic workflow configuration
• About importing a topic workflow configuration
Add a topic workflow configuration

Sometimes, organizations use only one topic workflow configuration. You can add a
blank topic workflow configuration that includes a minimal design for topic workflow.
Or, you can define the fields, workflow states, user access levels, e-mail notification
rules, and templates.
Alternatively, Oracle Empirica Signal provides a Sample Topic Workflow Configuration
which you can use as a starting point for a new topic workflow configuration.

2. In the Configure System section, click Manage Topic Workflow Configurations.
3. Click Add Workflow Configuration.
4. Enter a name and a description for the topic workflow configuration.
• If a topic workflow configuration was deleted by reference only, it is retained in
the database and you cannot create a new configuration with the same name.
• The description for the topic workflow configuration can be up to 1,000
characters.
5. Click Save.
6. (Recommended) Test the topic workflow configuration before you assign it to a
login group. To test, do the following:
a. Set your user preference for Topic Workflow Configuration to the new
configuration.
Note:
Only users with the Manage Topic Workflow Configurations
permission can set this preference.
b. Log out and log back in.
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c. Click the Topics page to add and edit topics that use the new configuration.
d. When you are finished, assign the topic workflow configuration to the login
group.
Import a workflow configuration account

You can import files from Oracle Empirica Signal 9.1 and previous releases.
Note:
This option is used when installing or upgrading the Oracle Empirica Signal
application. Typically, you do not need to perform this process during regular
system use.
When you import topic workflow configurations from an Oracle account, the application
does the following:
• Adds any new topic workflow configurations found in the Oracle account.
• Re-imports any topic workflow configurations found in the Oracle account that
have been deleted from the application by having references removed. Any topics
(and comments associated with them) that existed at the time of the deletion are
also restored.
Note:
If a topic workflow configuration has been deleted permanently, it cannot be
re-imported.
A confirmation dialog box displays after topic workflow configurations are imported
successfully. The import does not affect your current or existing topic workflow
configurations.

3. Click Import Workflow Configuration Account.
A confirmation dialog box appears.
4. Click OK.
a. Set your user preference for Topic Workflow Configuration to the new
configuration.
Note:
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c. Click the Topics page to add and edit topics that use the new configuration.
group.
Import a topic workflow configuration

You can import a previously exported topic workflow configuration using the Import
Workflow Configuration File link on the Manage Topic Workflow Configuration page.

3. Click Import Workflow Configuration File.
4. Click Browse to locate and select the export file on the local computer, or type a
name for the file in the File to Upload field.
5. Click Upload.
6. In the Name field, type a name for the workflow configuration.
7. Optionally, in the Description field, type a description.
8. Click Save.
About importing a topic workflow configuration

You can import a previously exported topic workflow configuration using the Import
Workflow Configuration File link on the Manage Topic Workflow Configuration page.
You can import topic workflow configurations that were exported from Topic schema
versions 1 or 1.1. The imported topic workflow configuration will have Topic schema
version 1.1.
To import the topic workflow configuration, you must have the Manage Topic Workflow
Configurations permission. During the import, you can name and describe the topic
The imported topic workflow configuration contains the following information from the
exported configuration:
• Topic schema version
• Export format version
• Exported timestamp
• Exported user information
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Note:
Fields with a work team context are not included in the export and import
of topic workflow configurations. Therefore, Topic Field Modified and Action
Field Modified email notification rules that reference fields with a work team
context are not included. Topic templates that contain populated topic or
action fields with a work team context are also not included. If these exist in
the original topic workflow configuration, they must be added to the imported
Work with topic workflow configurations

• Edit a topic workflow configuration
• Copy a topic workflow configuration
• Delete a topic workflow configuration
• Publish a workflow configuration
• Export a topic workflow configuration
• About exporting a topic workflow configuration
• Create a PDF for a topic workflow configuration
Edit a topic workflow configuration

On the Edit Workflow Configuration page, the topic workflow configuration options
determine how users can work with topics that are created using the topic workflow
configuration.
Note:
Editing a topic workflow configuration that is already in use is not
recommended.

4. Update the values in the Name and Description fields as needed.
5. To customize the topic workflow configuration, edit the fields according to the table
below.
6. Click Save.
7. Log out and log in again to see the changes in the application.
Field descriptions—Edit Workflow Configuration page
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Field Description
Allow topic to be visible to Defines the level of cross-team interaction
enabled for topics. You can choose one of the
following:
• One and only one work team—Topics
can be reviewed by, and assigned to, the
members of the work team selected in the
Visible to work team field of a specific
topic. For configurations that select this
option, it may be useful to give one or
more administrative users the View Topics
across Work Teams user permission.
• Zero, one or more work teams—Topics
can be reviewed by, and assigned to,
the members of all work teams selected
in the Visible to work team field of a
specific topic. Topics visible to zero work
teams are accessible only to the user who
created them.
Note:
For a user to
view or act on
topics that have
been made
visible to a work
team,
appropriate work
team
permissions
must be
assigned to that
user.
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Field Description
Allow topic to be linked to Defines how the topic linking feature functions.
You can choose one of the following:
• Topics in any state—Users can add a
reference link from one topic to another
topic regardless of workflow state.
• Topics in final state—Users can add a
reference link from one topic to another
topic that is in a final state.
Note:
For a user to link
two topics, both
topics must be
visible to the
user's work team
with the Edit
Topics or Edit
Topic Actions
work team
permission.
Allow addition of comments to Select one or more of these check boxes

to enable the comment feature, which allows
users to add free-text comments. You can
enable the comment feature for:
• Topics—Comments can be added and
appear in the Topic Comments section of
the Topic page.
• Attachments—Comments can be added
for attachments to a topic in the Topic
Attachments section of the Topic page
and for attachments to an action in the
Action Attachments section of the Topic
Action page.
• Actions—Comments can be added and
appear in the Action Comments section of
the Topic Action page.
Comments cannot be edited or deleted after
entry.
Note:
To add
comments, users
need the Edit
Topics/Actions
work team
permission.
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Field Description
Allow sources of attachments Select one or more of these check boxes to
enable the attachment feature, which allows
users to add supporting information to a topic
or action. You can clear a check box to prevent
attachments in that format from being added.
• Application Data—A Save to Topic link
is added to pages throughout Oracle
Empirica Signal to allow the currently
displayed object to be saved as an
attachment to a topic or action. A site
option can be set to limit the number of
rows in table displays that can be saved
with topics.
• External URL—Attachments in the form of
a URL can be added.
• External document—Files, including
documents, spreadsheets, and images,
can be added to the topic. A site option
can be set to limit the size of files saved
with topics.
• Note—Users can enter text to provide
an overall description of several other
attachments that are added
Attachments of the selected types can be
added to a topic or to individual actions, and
can be edited or deleted. Attachments to a
topic appear in the Topic Attachments section
of the Topic page and attachments to an action
appear in the Action Attachments section of
the Topic Action page.
Note:
To add
attachments,
users must have
the Add/Edit/
Delete
Attachments in
Open Topics/
Actions or the
Edit Attachments
in Closed Topics/
Actions work
team permission.
Allow topic state closure only when all actions If checked, users can assign a final workflow
are completed state to a topic only when all of that topic's
actions are in a final state.
If cleared, users can assign a final state to a
topic regardless of the workflow state of that
topic's actions.
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Field Description
Warn on action state closure if no attachments If checked, users who assign a final workflow
or comments are provided for action state to an action that does not have any
associated comments or attachments receive
a warning message.
If cleared, users can assign a final state to an
action at any time without a warning.
Copy a topic workflow configuration

Oracle Empirica Signal provides a sample configuration named Sample Topic
Workflow Configuration. You can copy this configuration and use it to create a
customized configuration.
Users need the Manage Topic Workflow Configurations permission to copy an existing
configuration and modify it.
Note:
When you copy a topic workflow configuration, the latest versions of
templates are also copied. However, any existing topics that are based on
the configuration are not copied.

3. Click the Row Action menu ( ) for a configuration, and then click Copy.
4. Type a unique name for the topic workflow configuration.
5. Optionally, modify the description of the topic workflow configuration.
6. Click Save.
a. At the top of the main page, click your user name and select Preferences,
then select the topic workflow configuration.
Note:

c. Click the Topic Management page to add and edit topics that use the new
configuration.
group.
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Delete a topic workflow configuration

3. Click the Row Action menu ( ) for a configuration, and then click Delete.
4. On the Delete Workflow configuration page, choose:
• Remove Reference only—Deletes the configuration by reference.
The configuration and any existing topics, including all comments and the
associated attachments, are no longer accessible from the application.
However, all of the data remains in the database and can be re-imported if
necessary.
• Delete permanently—Deletes the configuration from the database, along with
all topics, including all comments and attachments associated with them. You
must be a superuser to delete a topic workflow configuration permanently.
A message informs you that for 21 CFR Part 11 compliance, you must print
each topic for the topic workflow configuration and export tables from the
Oracle account. Before you print the topics, verify that the topic workflow
configuration options that allow addition of comments to topics, actions, and
attachments are all checked. This assures all comments are included, even if
these settings were changed in the topic workflow configuration over time.
Tables that store topic data and workflow configurations
The tables shown below store data for topics and topic workflow configurations. The
_x suffix represents the unique identifier in the TM_CONFIG_LOCAL table for a topic
Topic tables Topic workflow configurations tables

TM_TOPIC_x TM_CONFIG_LOCAL
TM_TOPIC_COMMENT_x TM_STATE_x
TM_ATTACHMENT_x TM_STATE_TOPICATTRIBUTE_x
TM_ATTACHMENT_CONTENT_x TM_STATE_TRANSITIONS_x
TM_ATTACHMENT_COMMENT_x TM_TOPIC_FIELD_x
TM_TOPICWORKTEAM_x TM_TOPIC_CODEVALUES_x
TM_TOPICLINKS_x TM_EMAIL_NOTIFN_RULES_x
TM_TOPIC_ACTION_x TM_ATTACH_ATTR_x
TM_ACTION_COMMENT_x TM_ATTACH_TYPE_x
TM_ACTION_ATTACHMENT_x TM_ACTIONSTATE_x
TA_ATTACH_CONTENT_x TM_ACTIONSTATE_ATTR_x
TA_ATTACH_COMMENT_x TM_ACTIONSTATETRANS_x
-- NY_REASON_CATEGORY
-- NY_RULES_x
-- NY_MESSAGE_x
-- NY_DESTINATION_x
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Topic tables Topic workflow configurations tables

-- NY_STATE_RULE_MAP_x
-- NY_ACTION_RULE_MAP_x
-- NY_FIELD_MODIFY_MAP_x
-- NY_CATEGORY_MAP_x
-- NY_REMIND_x
-- NY_HISTORY_x
-- NY_ACTION_REMIND_MAP_x
Publish a workflow configuration

Publishing the topic workflow configuration makes it available to other users. By
default, the publication level of every newly created object is Private.
Note:
Users without Administer Users permission can publish only objects they
have created. Users with the Administer Users permission can publish

3. Click the Row Action menu ( ) for a configuration, and then click Publish.
The Publish Workflow Configuration page appears and includes publication status
information such as who owns it and the publication level.
Note:
If no publication status appears, the object has been published to a
different login group than yours by a superuser.
4. If you are a superuser, you can publish an object to multiple login groups. In the
Publish to Login Groups drop-down list, click or Ctrl+click to select login groups.
If you publish to –All– and later add a new login group, the object is published
5. Click Publish.
The object is published to all of the users who are in your login group.
6. Click Back to return to the Manage Topic Workflow Configurations page.
Export a topic workflow configuration

You can export a topic workflow configuration.
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3. Click the Row Action menu ( ) for a configuration, and then click Export.
4. Follow the directions for your browser.
5. Click Save.
About exporting a topic workflow configuration

You can export a topic workflow configuration. The exported topic workflow
configuration can be imported into another application instance with the same or
greater topic schema version. This can be useful when developing the topic workflow
configuration in a test environment and then loading it into a production environment.
You must have the Manage Topic Workflow Configurations permission to export the
When you click Export, the selected topic workflow configuration is exported into
a .dat file in XML format, which you can save on your local computer. By default, the
file name is <Topic Workflow Configuration name>.dat.
The exported .dat file contains the following data:
• Topic schema version

• Topic workflow configuration metadata (such as, Name, Description, and ID)
• Fields
Fields that include work team contexts are not exported.
• Up to 5000 defined values for fields
A warning message appears if more than 5000 values have been defined for a
field. If you proceed, the first 5000 values are exported based on their display
order.
• Topic states and state information
• Topic field accessibility by state
• Action states and action state information
• Action field accessibility by state
• Attachment field accessibility by type
• Email notification rules
Recipient values that are exported can include New Assignee, Previous Assignee,
and Visible to Work Team Members. Individual usernames are not included in the
export.
The Topic Field Modified or Action Field Modified notification reasons that
reference fields that include work team contexts are not exported. These fields
can exist in the Message Subject and Message Text; however, because they will
not be exported, they will not be populated when the email is sent on the imported
side.
• Topic templates
If a topic template contains populated topic or action fields and these fields have a
work team context, then the topic template is not exported. The history of the topic
template is not exported.
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Create a PDF for a topic workflow configuration

3. Select the Row Action menu ( ) for a configuration, and then select Create
PDF.
4. Follow the directions for your browser.
5. Click Save.
Manage fields
• About fields
• Manage Fields page
• View a field
• Add a field
• Edit a field
• Delete a field
• Identify a field as a filter field
• Add a drop-down list field
• Add linked fields
• Add a multi-selection list field
• Constrain field values by work team
• Display order for fields and field values
• Modify the display order for a field
• Manage field values
• Manage field access
About fields
In a topic workflow configuration, you can define fields to store information for
topics, actions, and attachments. Every topic workflow configuration includes a set
of standard fields, and custom fields to store information related to topics that your
organization finds useful.
To define whether or not a field appears for topics or actions in a given workflow state
or for attachments of a certain type, you also specify the topic field accessibility by
state, action field accessibility by state, and attachment field accessibility by type.
Manage Fields page

On the Manage Fields page, you can view all defined fields, including fields that apply
only to certain states in the topic or action workflow, or to certain types of attachments.
You can add, modify, and delete these fields.
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General activities
• Add Field
• Modify Display Order
• Manage Accessibility
– Topic Fields by State
– Action Fields by State
– Attachment Fields by Type
• Back
• Columns
• Print
• Download
The following menu options are available from the Row Action menu ( ), located in
the left most column of the table, and affect an individual row in the table:
• Edit
• Define Values
• Delete
Field descriptions—Manage Fields page
Field Description
Name Oracle database column name for the field.
Format One of the following values:
• String—Alphanumeric text value for the
field.
• Integer—Positive integer value for the
field.
• Date—Date in mm/dd/yyyy format in the
field.
Filter • Yes if the field acts as a display filter,
appearing above tables of topic-related
data as a drop-down list populated by all
stored values. See Identifying a field as a
filter field.
• Select No for fields that are not used to
filter displayed data.
Custom/Standard One of the following values:
• Standard—A field included in all topic
workflow configurations.
• Custom—A field added to the
topic workflow configuration by your
organization.
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Field Description
Display Name Name of the field as it appears in the user
interface.
Order Position of the field within the workflow. The
number indicates the place in the workflow of
the field.
The context determines where the Oracle
Empirica Signal application uses the order:
• For a topic—In the Add Topic or Topic
General Information section of the Topic.
• For an action—In the Add Action or
Action General Information section of the
Topic Action page.
• For an attachment—On the Add
Attachment page.
You can modify the order of both standard and
custom fields.
Note:
The order
applies to all
fields with a
given context.
You can assign a
single order
value for the
field.
Context One or more of the following values:

• Topic
• Action
• Attachments
• Work teams
Field Type One of the following field type options:
• Single Value—A single value field type.
This is the default field type.
• Append-only—A multiple values field
type in which a previously selected value
cannot be removed. See Adding a multi-
selection list field.
• Multiple Values—A multiple values field
type that supports adding and removing
values.
• Append-only and constrained—An
append-only field whose values are
restricted based on work team. See
Constraining field values by work team/
• Linked—The subsidiary field in a linked
pair. See Adding linked fields.
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Field Description
Field Values Defined values for the field:
• A field with defined values appears with a
list selection control in the user interface.
See Adding a drop-down list field or
Adding a multi-selection list field.
• A field without defined values appears as
a value-entry field.
View a field
3. Click the Row Action menu ( ) for a configuration, and then click Manage
Fields.
Add a field
You can add a custom field to a topic workflow configuration. Adding a field adds a
column to an Oracle database table, so you must specify the data type (for example,
string, integer, or date). For string fields, specify the maximum length. You can also
make selections that affect how users interact with the field in the user interface,
including the field label displayed, how users select values for the field and whether
the field applies to topics, actions, or attachments, or any combination of these
contexts.

3. Click the Row Action menu for a configuration ( ), and then click Manage
Fields.
4. To add a field, click Add Field.
5. In the Column name field, type the field name to appear in the Oracle database.
The name must begin with a letter. It must be up to 30 characters in length, and
consist of uppercase letters, numbers, and the special characters $, _, and # only.
6. In the Display name field, type the field name to appear in the user interface.
The display name appears as the label for the field and as a column header.
7. From the Format drop-down list, select the format for field values.
8. In the Length field, specify the length of the field as an integer.
9. Optionally, specify a type for the field. Types affect the way the field appears in the
user interface.
10. Select a context for the field. The field can appear as and store values for topics,
actions, attachments, or work teams, or any combination of these contexts.
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11. To limit the values that can be selected for a field based on the work team
membership of the current user, select Work teams in addition to one of the other
contexts. See Constrain field values by work team.
Note:
A superuser must set the Topic workflow configuration for work team
custom fields site option to this configuration and the configuration must
be published. If your organization uses more than one topic workflow
configuration, you must define custom fields with the work team context
identically in each topic workflow configuration.
12. Select Display as filter field to display the field and its values above tables in the
user interface. See Identify a field as a filter field.
13. Click Save.
Fields appear in the user interface as value-entry fields unless you explicitly define
a valid set of values for them. For example, description fields are typically value-
entry fields that allow users the flexibility to enter any value.
You can define valid values for custom fields that have a format of string or
integer, and for certain standard fields. Fields with defined values appear in the
user interface as drop-down lists or, if you define a field as Append-only, as a
multi-selection list. See Add a drop-down list field and Add a multi-selection list
field.
Edit a field

Fields.
4. Click the Row Action menu ( ) for a field, and then click Edit.
5. Optionally, modify the following fields:
Field Description
Display name The label that appears when adding or
editing a topic or action.
Format Not editable. Type of data to be collected:
Date, String, or Integer.
Length For a string format field, the Length field is
editable. If you provide a new length that is
less than or equal to an existing value, the
page displays an error message.
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Field Description
Type The determines how users can specify
values:
• Single Value—A single value field type.
This is the default field type.
• Append-only—A multiple values field
type in which a previously selected
value cannot be removed.
• Multiple Values—A multiple values field
type that supports adding and removing
values.
• Append-only and constrained—An
append-only field restricted to the work
team context.
• Linked—The subsidiary field in a linked
pair.
Filter Make this a filterable field that appears in
the Select Filter drop-down list on the Topics
and Actions tabs.
6. Click Save.
Delete a field
Note:
This option is available for custom fields only.
• If you are not a superuser, you can delete a field only if no values are present for
that field in any existing topics or work teams. To prevent a field from appearing for
the topics feature, you can assign an access level of -- (Hidden) to the field for all
topic states, all action states, or all attachment types.
• If you are a superuser, you can delete a field for which a value is present
in an existing topic. A warning message informs you that for 21 CFR Part 11
compliance, you must print each topic for the topic workflow configuration, and
export tables from the Oracle account for the topic workflow configuration. For a
complete list of topic and topic workflow configuration tables, see Delete a Topic
Workflow Configuration.

Fields.
4. Click the Row Action menu ( ) for a field, and then click Delete.
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Note:
If the field is referenced in any Topic Field Modified or Action Field Modified
email notification rules, you must edit the notification rule before the field is
deleted. A dialog box appears with a list of the relevant notification rules.
Or, if you attempt to delete the field which is referenced in existing topic
templates, the application prompts you to first remove the field value from the
topic templates, and then delete the field.
Identify a field as a filter field

Any field in a topic workflow configuration can be identified as a filter field. A filter field
appears in the Select Filter drop-down list on the Filter bar of the Topics and Actions
tables. Using filter fields, you can limit the number of rows that appear in the Topics
and Actions tables to only those that match the value selected for this field.
Note:
• Only fields that store a limited number of values (no more than 50 but,
typically, less) should be identified as filter fields, as longer lists can
become difficult for users to navigate effectively.
• The first 30 characters of each field value are shown in the drop-down
list. Longer values are shortened to 30 characters.

Fields.
4. Add or edit the field, as necessary.
5. Check Display as filter field.
6. Click Save.
Add a drop-down list field

When you add a field to a topic workflow configuration, it appears by default in the
user interface as a value-entry field and accepts any alphanumeric value a user
enters. An alternative is to provide a limited set of possible entries for a field so that a
drop-down list appears in the user interface. For example:
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Users can select a single value from a drop-down list, and can change the selected
value for the field at any time (if permitted for a given workflow state by the topic or
action field access level). Drop-down lists structure data entry by limiting the number of
possible entries. They also assure that the values stored for a field are consistent.
Note:
An alternative is to add a field that appears with a multi-selection list control
in the user interface. There are two field types that support this: Append-only
and Multiple Values. If the field is Append Only, users can select one or more
values, but cannot remove any previously selected and saved values. If the
field if Multiple Values, users can select one or more values, and can remove
previously saved values. See Add a multi-selection list field.

Fields.
4. Click Add Field.
5. In the Column name field, enter a column name.
6. In the Display name field, enter a name to appear in the user interface.
7. From the Format drop-down list, select the format of the field: String, Integer, or
Date.
8. If you specified a String format, in the Length field, enter the maximum field
length.
9. In the Type section, select Single Value.
10. In the Context section, select the field context. The field can be used to collect
information for a topic, action, attachment, or work team.
11. Optionally, specify the field to be used for filtering by checking Display as filter
field. See Identify a field as a filter field.
12. Click Save.
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Note:
You can design a pair of drop-down list fields that are linked. Selections
available for the second field in the pair are dependent on the selection
for the first in the pair. See Adding linked fields.
13. Click the Row Action menu ( ) for the field you added, and then click Define
Values.
14. Click Add Value.
15. In the Value field, enter a value for users to select.
16. Click Save.
17. Repeat steps 14 - 17 to add all possible values for the field. Alternatively, you can
store all field values in a .csv (comma-separated value) file, and then upload it.
See Upload a table of valid values.
18. Modify the display order of the valid values as needed. Click Modify Display
Order.
a. From the Values for Dropdown list, select a value.
b. To change the order of the value in the list, use the up-arrow and down-arrow
buttons.
By default, the new field appears as a drop-down list for a topic or action that
is in any workflow state, for any type of document-style attachment, or for a
work team. The field is editable; that is, users can select a value from the list
or select " " (blank).
You can make this field required (the blank value is not offered, and users
must select one of the defined values before saving).
Add linked fields

In cases where user interaction with a pair of fields, which are related and requires a
selection of one field before presenting the values that are valid for another, you can
include a linked pair of drop-down lists in your topic workflow configuration.
In the following example, the user interface presents linked fields for selecting a
MedDRA SOC and MedDRA HLGT:
Users must select a value for the parent field, MedDRA SOC, first. The list of values
for the subsidiary field, MedDRA HLGT, is then populated with values that are valid
given that initial selection.
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• You must define valid values for both of the fields in a linked pair. Both fields
appear as drop-down lists in the user interface.
• Both of the fields in a linked pair must be custom fields that you add to the topic
• You must define two different fields as the linked pair. A field cannot be selected as
its own Link to parent field.
Add the parent field

The first field you add is the parent field.

2. In the Configure System section, click Manage Topic Workflow
Configurations.
Fields.
4. Click Add Field.
5. In the Column Name field, enter a column name.
6. In the Display name field, type a name to display in the user interface.
7. From the Format drop-down list, select either string or integer as the format.
8. For a string field, in the Length field, specify a maximum field length.
9. In the Type section, do not check any options.
11. To use the field as a filter, check Display as filter field. See Identify a field as a
filter field.
12. Click Save, and then click Back.
13. On the Manage Fields page, click the Row Action menu ( ) for the parent field,
and then click Define Values.
15. In the Value field, enter a value for users to select, and then click Save.
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17. Modify the display order of the valid values as needed. For more information, see
Modify the display order for the values.
Add the subsidiary field

On the Add field page, enter a second, subsidiary, field.
5. In the Type section, check Linked and, from the Link to parent field drop-down
list, select the field you added as the parent field.
6. In the Context section, select the same field context(s) as for the parent field.
7. Optionally, specify the field to be used for filtering by checking Display as filter
field. See Identify a field as a filter field.
8. Click Save.
Define the parent-child values
1. On the Manage Fields page, click the Row Action menu ( ) for the subsidiary
field, and then click Define Values.
2. Click Add Value.
3. On the Add Value page, supply the values for users to select. For each value that
you add, from the Link to parent value drop-down list, identify the value for the
parent field that must be selected for this value to be available.
4. Click Save.
5. Repeat step 4 to add all possible values for the field. Alternatively, you can store
all field values in a .csv (comma-separated value) file, and then upload it. See
Upload a table of valid values.
6. Modify the display order of the valid values, as needed. For more information, see
Modify the display order for the values.
By default, both new fields will be editable for a topic or action in any workflow
state, or for any type of document-style attachment. Users can select a value or
select " " (blank).
7. Alternatively, you can make one or both of these fields required (the blank value
is not offered, and users must select one of the defined values before saving).
Generally, you should apply the same access level to both of the fields in the
linked pair. See Manage topic field accessibility by state, Manage action field
accessibility by state, or Manage attachment field accessibility by type.
Add a multi-selection list field

user interface as a single value-entry field and accepts any alphanumeric value that
a user enters. Alternatives to single value-entry include Append-Only and Multiple
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Values. Both of these multi-selection list fields provide a limited set of possible values
and both appear in the user interface with a link to a multi-selection list.
Like a drop-down list field, a multi-selection list field limits the number of possible
entries that users can make and enforces consistency. Append-only fields also ensure
that any value selected at one point in time cannot be deleted or replaced. Users
cannot later edit this type of field to remove or replace a value. Multiple Values fields
do allow users to edit the field and remove or replace values.
Note:
You can further reduce the possibility of user error when entering field values
by setting up a multi-selection field, and then specifying the work team or
teams that can select each of its valid values. See Constrain field values by
work team.

Fields.
4. Click Add Field.
9. In the Type section, check Append-only or Multiple Values.
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filter field.
12. Click Save.
13. Click the Row Action menu ( ) for the field you added, and then click Define
Values.
The Define Valid Field Values page appears.
15. On the Add Value page, supply a value for users to select.
16. Click Save.
17. Repeat this step to add all possible values for the field. Alternatively, you can
store all field values in a .csv (comma-separated value) file and then upload it. See
Upload a table of valid values.
18. Click Back.
The Manage Fields page appears.
By default, the new field appears with a Select Available Values link next to it
for a topic or action that is in any workflow state, for any type of document-style
attachment, or for a work team. The field is editable: that is, users can select
values for it or leave it blank.
You can make this field required (users must select at least one value before
saving). See Manage topic field accessibility by state, Manage action field
accessibility by state, or Manage attachment field accessibility by type.
Constrain field values by work team

user interface as a value-entry field and accepts any alphanumeric value that a user
enters. A more structured alternative is to add a multi-selection list field, which allows
users to select one or more values but not to remove any previously saved value(s).
You can further limit the values that users can select for a multi-selection field by
specifying the values that the members of a work team are able to select; that is,
to constrain the field's valid values based on work team. This feature can reduce
the possibility of user error when entering data and prevent the loss of information
collected over time.
Note:
If your organization uses more than one topic workflow configuration, any
custom fields for the work team context must be defined identically in each
Add the field to a topic workflow configuration

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2. In the Configure System section, click Manage Topic Workflow

Configurations.
Fields.
4. Click Add Field.
9. In the Type section, check Append-only or Multiple Values.
10. In the Type section, check Constrained values based on work team.
11. In the Context section, select the field context. You must check at least one of
these options. The field can be used to collect information for a topic, action,
attachment, or work team.
12. In the Context section, check Work Team.
filter field.
14. Click Save.
Define the values
1. On the Manage Fields page, click the Row Action menu ( ) for the field, and
then click Define Values.
2. Click Add Value.
3. On the Add Value page, supply a value for users to select.
4. Click Save.
6. Click Back.
By default, the new field will be editable for a topic or action that is in any workflow
state or for every type of document-style attachment. You can make this field required
(users must select at least one value before saving), hidden, or visible in certain
states or for certain attachment types. See Manage topic field accessibility by state,
Manage action field accessibility by state, or Manage attachment field accessibility by
type.
Set site options

You can perform the following steps only if you are a superuser.

2. In the Administer System section, click Set Site Options.
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3. From the Topic workflow configuration for work team custom fields drop-
down list, select the topic workflow configuration that has the constrained value
field.
Custom work team fields appear when you add and edit work teams only after
your topic workflow configuration has been published and this site option has
been set.
4. Click Save.

7. Click the Row Action menu ( ) for a work team, and then click Edit.
The Edit Work Team page appears. Your new field appears as a multi-selection
list field.
8. To specify values for members of this work team to select for this field in the user
interface, next to the multi-selection list field, click Select Available Values.
9. To define the values to present to each set of users, repeat this step for each work
team.
10. Log out, then log back in.
11. To test your new field, in the left navigation pane, click the Topic Management
icon ( ), and then add or edit a topic, action, or attachment. The values available
for selection in this field reflect your membership in one or more work teams.
Display order for fields and field values

You can set the display order of the standard and custom fields in addition to the
display order of field values.
Standard fields appear in the following order:
1. Topic fields
2. Action fields
3. Attachment fields
The custom fields appear after the standard fields in the order you added them. You
can modify the default sequence:
• For a topic—On the Add Topic page or Topic General Information section of the
Topic page.
• For an action—On the Add Topic Action page or Action General Information
section of the Topic Action page.
• For a document-style attachment—On the Add Attachment page.
• For a work team—On the Edit Work Team page.
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Note:
A field can only have one display order, even if it appears in more than one
context. You can prevent a field from appearing when the topic or action is in
a given state by assigning a field access level of hidden to the field for that
state. This also applies to attachments of different types.
Modify the display order for a field

Fields.
4. To order a field, click Modify Display Order.
5. The dialog box lists every field in the currently assigned display order. For each
field, the identifying information appears as Display name [COLUMN_NAME]
(ID=#).
6. Click a field to select it.
7. Use the and keys to move the field up or down in the list.
Manage field values

• View valid values for a field
• Add and edit valid values for a field
• Upload a table of valid values
• Modify the display order for field values
View valid values for a field

To present a list of values for a field in the user interface, instead of a value-entry field,
you supply one or more valid values for that field. You can define values for:
• Standard fields with a format of string.
• Custom fields with a format of string.
• Custom fields with a format of integer.
You must define values for custom fields that have one of these types:
• Linked
Note:
You must define values for both the controlling parent field and its
subsidiary field. Typically, all values for the parent field are defined
before the values for the subsidiary field are defined.
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• Append-only
• Constrained and Append-only
• Multiple Values
• Constrained and Multiple Values
You can also specify the order in which the values appear in the list. If the field is not
required, users can select " " (blank) to leave the field empty.

2. In the Configure System section, click Manage Topic Workflow Configuration.
Fields.
4. Click the Row Action menu ( ) for a field, and then click Define Values.
The Define Valid Field Values page provides the following information:
Column Description
Value Value that is available for selection in the
topic field.
Link to Parent Value that must be selected for the parent
field for this value to be available. Applies to
the subsidiary field in a linked pair only.
Order Number indicating the display order for the
value.
Define Field Values options

• To add a value, click Add Value.
• To order values, click Modify Display Order.
• To upload a table of values, click Upload Table. You must prepare a comma-
separated value (.csv) file to use this option.
If you click the Row Action menu ( ) for a value, you can do the following:
• To edit a value, click Edit.
• To delete a value, click Delete.
If you delete or change a value that is already in use in a topic, the original value
remains in any topics that have used that value; however, the value is no longer
available for selection in that, or any other, topic.
Add and edit valid values for a field

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Fields.
• To add a value, click Add Value.
• To edit a value, click the Row Action menu ( ) for the value, and then click
Edit.
6. In the Value field, enter a value.
If the field you are adding is the subsidiary field in a linked pair, select the value
that this value is subsidiary to in the Link to the parent value field.
For example, if a MedDRA SOC field and a MedDRA HLGT field are linked, you
select an SOC value, and then a list of relevant HLGT values is made available for
selection.
7. Click Save.
8. Repeat this process as needed to define all valid values for the field. Alternatively,
you can save all values in a .csv file and upload the table of values.
Upload a table of valid values

Create the table of values
1. Determine the valid values for the field.
2. Prepare a comma-separated value (.csv) file with a single column and with a
column heading in the first row. Enter a single value of u to 100 characters in each
subsequent row.
Note:
For a field that is the subsidiary field in a linked pair, the table that you
upload should contain two columns. The first column should contain the
values for that field, and the second column should contain the values
that are valid for the controlling, parent field.
For example:
Typical format:
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Format for subsidiary linked fields only:
3. Save the file with the .csv (comma-separated value) file extension.
Upload the table of valid values

Fields.
5. Click Upload Table.
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6. In the File to upload field, enter the full path and file name of the .csv file, or click
Browse to locate the file on your computer.
7. Click Upload.
8. If necessary, you can edit the values or change the display order for the values.
Modify the display order for field values

You can specify the order in which valid field values appears in the drop-down list for
that field.

Fields.
5. Click Modify Display Order.
6. Use the and keys to move values up and down in the list.
Manage field access

• Manage topic field accessibility by state
• Manage action field accessibility by state
• Manage attachment field accessibility by type
Manage topic field accessibility by state

Once you have defined topic states and fields, you define the level of access that
users have to each field when a topic is in each of the workflow states. You specify
whether each field is required, editable (but not required), visible (but not editable), or
hidden in each state. If you make a field required for a state, a topic cannot be saved
in that state until the user provides a value for the field.
The access levels that you define are enforced when:
• A user edits a topic that is currently in that state.
• A user assigns that state to the topic. For example, suppose that the
RESOLUTION field is editable in the Reviewed state and required in the Closed
state. While the topic state is Reviewed, users can leave the RESOLUTION field
empty. However, the user who changes the topic's state to Closed is required to
provide a resolution.
• In addition, when a topic is created during the process of saving an attachment
to a topic from another page in the application (if enabled as an attachment type
for the topic workflow configuration), the TOPIC_NAME is required but no other
requirements for the Initial state are enforced until the first time that topic is edited.
Access levels apply only when a topic is edited. When a topic is viewed, all non-hidden
fields are display-only.
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Fields.
4. Click Manage Accessibility.
5. From the menu, select Topic Fields by State.
The Manage Topic Field Accessibility by State page presents a table with a
column for each topic state and a row for each topic field.
For reference, you can review the field access levels for topic workflow states
defined in the Sample Topic Workflow Configuration.
6. From the drop-down lists in the access level cells, select an access level for each
field when a topic is in that state. The access levels are:
Access Level Description

-- Hidden. Does not appear on the Topic page.
For example, you assign this access
level to the RESULOTION and
RESOLUTION_DATE fields for topics that
are in any state other than Closed.
Visible Appears on the Topic page as informational
text. Values cannot be entered or modified.
Note:
This access level should only
be assigned to fields that
store informational, rather than
process-related, data for the
topic. For example, this access
level is not recommended for the
CURRENT_STATE_ID field in any
state, since a topic's current state
should always be editable (or
required).
Editable Appears on the Topic page and entries are

allowed.
For example, you assign this access level
to the TOPIC_DESCRIPTION field for topics
that are in any state.
Required Appears on the Topic page and an entry
must be made. If you leave this field blank,
topic information cannot be saved.
For example, you assign this access level to
the STATE_CHANGE_REASON field when
topics are in any state other than Initial to
assure that a meaningful log of the changes
made to a topic kept.
7. Click Save.
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Manage action field accessibility by state

Once you have defined action states and fields, you define the level of access that
users have to each field when an action is in each of those states. You specify whether
each field is required, editable (but not required), visible (but not editable), or hidden in
each state. If you make a field required for a state, an action cannot be saved in that
state until the user provides a value for the field.
The access levels that you define are enforced when:
• A user edits an action that is in that state.
• A user assigns that state to the action.
Access levels apply only when an action is edited. When an action is viewed, all
non-hidden fields are display-only.

Fields.
5. From the menu, select Action Fields by State.
The Manage Action Field Accessibility by State page presents a table with a
column for each action state and a row for each action field.
For reference, you can review the field access levels for action workflow states
defined in the Sample Topic Workflow Configuration.
6. From the drop-down lists in the action state cells, select an access level for each
field when an action is in that state. The access levels are:

-- Hidden. Does not appear on the Topic
Action page.
the ACTUAL_COMPL_DATE field for actions
that are in the Initial state.
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Visible Appears on the Topic Action page as
informational text. Values cannot be entered
or modified.
Note:
This access level should only
be assigned to fields that
store informational, rather than
process-related, data for the
action. For example, this access
level is not recommended for the
ACTION_STATE_ID field in any
state, since an action's current
state should always be editable
(or required).
Editable Appears on the Topic Action page and

entries are allowed.
Typically, this access level is used for most
action fields in most states.
Required Appears on the Topic Action page and an
entry must be made. If you leave the field
blank, the action cannot be saved.
to the ACTUAL_COMPL_DATE field when
actions are in the Closed state.
7. Click Save.
Manage attachment field accessibility by type

Once you have edited a topic workflow configuration's options to select the types
of attachments that can be added to a topic (or action), and defined fields for
attachments, you specify the level of access that users have to each field based
on the type of attachment. You specify whether each field is hidden, visible, editable,
or required for an external document such as a URL, file, or note, or for an Oracle
Empirica Signal object. If you make a field required for an attachment type, an
attachment of that type cannot be added or edited until the user provides a value
for the field.
Note:
Specifications made for Oracle Empirica Signal objects apply only when the
attachment is edited. When an Oracle Empirica Signal object is saved as
an attachment to a topic, the Name field is required, the Description field is
optional, and all other fields are hidden.

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Fields.
5. From the menu, select Attachment Fields by Type.
The Manage Attachment Field Accessibility by Type page presents a table with a
column for attachment type and a row for each attachment field.
For reference, you can review the field access levels for attachment fields defined
in the Sample Topic Workflow Configuration.
6. From the drop-down lists in the attachment type cells, select an access level for
each field when an attachment is of that type. The access levels are:

-- Hidden. Does not appear when users add or
edit an attachment.
to the URL_ADDRESS field for every type
of attachment, except for URL, and to
the FILE_NAME field for every type of
attachment, except for external documents.
Visible Appears when users add or edit an
attachment as informational text. Values
cannot be entered or modified.
Editable Appears when users add or edit an
attachment and entries are allowed.
the DESCRIPTION field for all attachment
types.
Required Appears when users add or edit an
attachment and an entry must be made. If
the field is left blank, the attachment cannot
be saved.
For example, you might assign this access
level to the URL_ADDRESS field for
the URL attachment type, and to the
FILE_NAME field for the external document
attachment type.
7. Click Save.
Manage topic states

• About topic states
• Manage Topic States page
• View a topic state
• Add a topic state
• Edit a topic state
• Delete a topic state
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About topic states

To create a structured workflow for processing topics, each topic workflow
configuration defines the workflow states that can be assigned to a topic. For each
workflow state, the next possible state or states that can be assigned are also defined.
For example, the sample topic workflow configuration includes workflow states of Init
(Initial), Assigned, Escalated, and Closed for topics. When a topic is in the Init state, it
can move to any of the other three states. When it is in the Assigned state, the next
possible states are Escalated or Closed.
The illustration shows the workflow supported by these states.
Note:
Each topic workflow configuration also defines a separate set of workflow
states that can be assigned to the actions for a topic. See Action states for
more information. The illustration shows the workflow supported by these
states.
Manage Topic States page

On the Manage Topic State page, you can add, modify, and delete the topic states.
General activities
• Add State
• Back
• Columns
• Print
• Download
The following options are available from the Row Action menu ( ), and affect an
individual row in the table:
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• Edit
• Delete
Field descriptions—Manage Topic State page

In this section, you can view the information for each topic workflow state.
Field Description
Name Name of the topic workflow state.
Description Description of the topic workflow state.
Initial State Select Yes for a workflow state assigned
automatically to a new topic when it is added.
Select No for a state to indicate the topic is in
progress or closed.
Note:
When you add a
topic workflow
state, the Init
topic workflow
state is supplied
with the value set
to Yes. You
cannot add or
change this
setting for any
other topic
workflow state
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Field Description
Final State Select Yes for a workflow state to indicate no
further information is expected to be gathered
for a topic.
Select No for a state to indicate the topic is
new (initial state) or in progress.
Topics in a final state can be reopened if the
next defined possible state is not in the Final
State, and if the topic is visible to work teams
and the user has the Reopen Topics/Actions
Note:
You can set a
topic workflow
configuration
option to require
that all actions
be in a final state
before the topic
itself can be
moved to a final
state. See Edit
Workflow
Configuration
Options.
Next Possible States States a user can assign to a topic that is in

this state. Determines the transitions that are
possible from one state to another.
View a topic state

3. Click the Row Action menu ( ) for a configuration, and then click Manage Topic
States.
The defined topic states appear in a table and includes the name, description,
initial and final states and possible next states that users can assign.
Add a topic state

States.
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4. To add a topic workflow state, click Add State.

5. Type the Name of the topic workflow state.
6. Type the Description of the topic workflow state.
7. In the Possible next states field, specify the states that users are able to assign
to a topic in this state.
8. To select a state, click Select States.
9. To indicate that a state closes a topic when it is assigned, select This is a final
state.
To work with a topic that is in a final state and visible to any work team, you
must have the Reopen Topic work team permission, and a non-final state, such
as Reopened, must be defined as a possible next state. You can then reopen the
topic and change its current state to a non-final state before editing it further.
Note:
The topic workflow configuration may also require that all of a topic's
actions be in a final state before the topic itself can be assigned a final
state. See Edit Workflow Configuration Options.
After you define the workflow states for topics and define the fields that store
topic information, you should review the level of access assigned to each field and
state. When you add a new state, by default every topic field is editable when the
topic is in that state. You can modify the level of access for each field to hidden,
visible, editable, or required for the new state.
Edit a topic state

States.
4. Click the Row Action menu ( ) for a state, and then click Edit.
5. Modify the Name of the topic workflow state.
If you modify a state name, any topics currently in that state are updated
automatically.
Note:
You can rename the state named Init. However, it is always considered
to be the initial state for a topic and is assigned automatically to every
new topic created.
6. Modify the Description of the topic workflow state.
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7. In the Possible next states field, specify the states that users can assign to a
topic in this state.
Note:
If state transitions are changed and these transitions are referenced in
Topic State Changed email notification rules, you need to first edit the
notification rule. A list of the affected email notification rules is displayed.
8. To select a state, click Select States.

9. To indicate that a state closes a topic when it is assigned, select This is a final
state. To work with a topic that is in a final state and visible to all work teams, a
user must have the Reopen Topic work team permission, and a state other than
Final must be defined as a possible next state. This allows the user to reopen the
topic and change its current state to that non-final state before editing it further.
Note:
The topic workflow configuration may also require that all of a topic's
actions be in a final state before the topic itself can be assigned a final
state. See Edit Workflow Configuration Options.
Delete a topic state

States.
4. Click the Row Action menu ( ) for a state, and then click Delete.
You cannot delete the Init (Initial) state, and you cannot delete a state that is
currently assigned to any topic. To determine which topics are in a given state, in
the left navigation pane, click the Topic Management icon ( ), and then sort the
table using the Current state column.
Note:
When you delete a topic state, it is removed automatically as one of
the next possible states for any other state. You may need to adjust the
e-mail notification rules and the assignment of next possible states for
the remaining states.
Manage action states

• About action states
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• Manage Action States page

• View an action state
• Add an action state
• Edit an action state
• Delete an action state
About action states

To create a structured workflow for completing actions, each topic workflow
configuration defines the workflow states that can be assigned to an action. For each
workflow state, the next possible state or states that can be assigned are also defined.
For example, you can set up a topic workflow configuration so that an action passes
through the workflow states Initial, Assigned, and Closed.
Once you have defined action states and the fields that store action information, you
define the level of access that users have to each field when an action is in each of the
states. You specify whether each field is visible, editable, or required when the action
is in each state.
Note:
Each topic workflow configuration also defines a separate set of workflow
states that can be assigned to a topic as a whole. See Topic states for more
information.
Manage Action States page

On the Manage Action State page, you can add, modify, and delete the action states.
General activities
• Add Action State
• Back
• Columns
• Print
• Download
The following options are available from the Row Action menu ( ), and affect an
individual row in the table:
• Edit
• Delete
Field descriptions—Manage Action States page

In this section, you can view the information for each action state.
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Field Description
Name Name of the action state.
Description Description of the action state.
Initial State Select Yes for the workflow state assigned
automatically to a new action when it is added.
Select No for a state to indicate the action is in
progress or closed.
Final State Select Yes for a workflow state to indicate no
further information is expected to be gathered
for an action.
Select No for a state to indicate an action is
new (initial state) or in progress.
Note:
You can set a
topic workflow
configuration
option to require
an action to have
an associated
comment or
attachment
before a final
state can be
assigned to it.
See Edit
Workflow
Configuration
Options for more
information.
Next Possible Action States States that a user can assign to an action that
is in this state. Determines the transitions that
are possible from one state to another.
View an action state

Action States.
The defined action states appear in a table and includes the name, description,
initial and final states and possible next states that users can assign.
Add an action state

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Action States.
4. To add an action state, click Add Action State.
5. Enter the Name of the state.
6. Enter the Description of the state.
7. In the Possible next states field, specify the states that users are able to assign
to an action in this state.
8. To select a state, click Select Action States.
9. To indicate this state closes an action when assigned, select the This is a final
State check box.
Note:
The topic workflow configuration may also require all of a topic's actions
be in a final state before the topic itself can be assigned a final state.
See Edit Workflow Configuration Options.
Edit an action state

Action States.
4. Click the Row Action menu ( ) for an action state, and then click Edit.
5. Modify the Name of the action state.
If you modify a state name, any actions currently in that state are updated
automatically.
Note:
You can rename the state named Init. However, it is always considered
to be the initial state for an action and is automatically assigned to every
new action created.
6. Modify the Description of the action state.

7. In the Possible next states field, specify the states that users can assign to an
action that is in this state.
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Note:
If state transitions are changed and these transitions are referenced in
Action State Changed email notification rules, you need to first edit the
notification rule. A list of the affected email notification rules is displayed.
8. To select a state, click Select Action States.

9. To indicate that this state will close an action when it is assigned, select This is a
final state.
Note:
The topic workflow configuration may also require all of a topic's actions be
in a final state before the topic itself can be assigned a final state. See Edit
Workflow Configuration Options.
Delete an action state

Action States.
4. Click the Row Action menu ( ) for an action state, and then click Delete.
You cannot delete the Init (Initial) state, and you cannot delete a state that is
currently assigned to any action.
Note:
When you delete a state, it is removed automatically as one of the
possible next states for any other action states. You may need to adjust
the email notification rules and the assignment of next possible states for
the remaining action states.
Manage topic templates

• View existing topic templates
• Manage Topic Templates page
• View a specific topic template
• Topic Template page
• Add a topic template
• Make a topic template visible to a work team
• Edit a topic template
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• Copy a topic template

• Delete a topic template
• Topic template actions
View existing topic templates

Templates.
Oracle Empirica Signal lists the existing topic templates.
Manage Topic Templates page

Topic templates can serve as the starting point for creating new topics. If you have
the Manage Topic Workflow Configurations permission, you can add and manage topic
templates for a particular topic workflow configuration that is published to your login
group.
General activities
The following links and filters appear at the top of the page and affect the entire page.
• Add Topic Template
• Back
• Columns
• Print
• Download
The following menu options are available from the Row Action menu ( ), and affect
an individual row in the table:
• View
• Edit
• Copy
• Delete
Field descriptions—Manage Topic Templates page
Field Description
ID Identifier that was assigned automatically
when the topic template was created. Each
topic template ID is unique and is not re-used
if the template is deleted.
Name Name of the topic template.
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Field Description
Work Teams Work teams whose members can use the topic
template.
Description Description of the topic template.
Created By Name of the user who created the topic
template.
Created Date and time when the topic template was
created.
Modified By Name of the user who last modified the topic
template.
Modified Date and time when the topic template was
last modified.
View a specific topic template

Templates.
Oracle Empirica Signal lists the existing topic templates.
4. Click the Row Action menu ( ) for a topic template, and then click View.
Topic Template page

On the Topic Template page, you can view and edit topic template information,
including their actions and history.
To expand the sections on this page, click Show All, or click for a single section. To
hide section details, click for the section or click Hide All.
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Sections
Section Description Available actions

Topic Template General Displays the current field None
Information values that describe a topic
template:
• Includes all standard and
custom fields accessible
in the initial state, except
the following:
– Topic State
– Topic Assigned to
– Project
– Keywords
• Each field accepts text,
numeric, or provides a list
of pre-defined values that
you can select. A field
that accepts text may also
offer a Select Available
Values link so you can
select one or more values
from a list.
• A date field appears
as offsets expressed in
days. When the template
is used, the date field
in the topic is computed
based on topic creation
date plus topic template
offset.
• Arrow icons may appear
after the names of a pair
of fields to show that
they are a linked pair.
For example, if fields for
Country ( ) and State
( ) appear, the arrows
indicate that you must
select a value for the
Country field first and
then select a value for
the State field. You cannot
select a State value first:
the values available for
State depend on the
Country you select.
• The Visible to work team
field displays a comma
separated list of work
teams whose members
will be able to use the
topic template. When the
page is in edit mode, it
appears as a list.
• To save changes to the
Topic Template General
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Information section, click
Save. Saved changes
are shown as entries
in the History of
Topic Template General
Information section.
Note: The Save button affects
only the Topic Template
General Information section of
the topic template. You do not
need to click Save after you
work with Actions.
Template Actions Displays a list of each specific View
activity identified for the topic Edit
template. Actions may reflect
Delete
research activities, such as
literature searches, scheduled
meetings, or any other activity
you wish to track for the
topic template. When in edit
mode, you can click Add Topic
Template Action to add an
action, or click Row Action
menu for an action to view,
edit, or delete.
History of Topic Template Displays information on None
General Information changes that have taken place
for the topic template. A new
row is added to the table
each time you click Save in
the Topic Template General
Information section.
Field descriptions—Topic Template General Information

Depending on your organization’s workflow configuration, the following fields appear in
this section.
Field Description
Visible to work team The work team or teams whose members can
view or act on the topic template. You can
click Browse to view a descriptive list of work
teams.
Name Name of the topic template.
Description Description of the topic template.
Add a topic template

Adding a topic template is similar to adding a topic; however, the values entered are
inherited by topics created from the template.
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Templates.
4. Click Add Topic Template.
The Add Topic Template page displays all fields in the Topic Template General
Information section that are available in the Initial state, except for the following:
• Topic state
• Assigned to user
• Keywords
• Project
5. When creating a template, this field controls who will have access to the template.
To allow users to access the topic template, from the Visible to work team list,
select the work teams to which the users belong. By default, all work teams
appear in the list even if the topic workflow configuration is configured for only one
work team. When creating a new topic, only members of the selected work teams
will have access to this topic template.
The Comments, Attachments, and Links are not available in topic templates.
Actions are available after you save a topic template.
Note:
To select multiple work teams, hold down the Ctrl key and click each
work team. Deslect a work team by holding down the Ctrl key and
clicking the work team. You can click Browse to view a descriptive list of
work teams.
6. In the Name and Description fields, type a template name and a description for
the topic template.
7. For the other fields on the page, specify values for any other Topic fields to include
in the template. You can also add actions to the template.
Date fields are specified as offsets. Date offsets specified in the topic template are
inherited by topics as actual dates, offset from the time of topic creation.
8. Click Save or, if you want to add actions to the newly created topic template from
the Add Topic Template page, click Save & Edit.
You can then perform further editing.
Make a topic template visible to a work team

To allow users to use the topic template when creating a new topic, the template must
be made visible to a work team in which the users belong.

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Templates.
4. Click the Row Action menu ( ), for a topic template, and then click Edit.
The specific fields that appear on the Edit Topic Template page depend on your
5. When creating a template, this field controls who will have access to the template.
From the Visible to work team field, select the work teams to which the users
belong. By default, all work teams appear in this list even if the topic workflow
configuration is configured for only one work team.
Note:
To select multiple work teams, hold down the Ctrl key and click each
work team. Deselect a work team by holding down the Ctrl key and
clicking the work team.
You can click Browse to the right of the Visible to work team field to view a
descriptive list of work teams.
Column Description
ID Unique identifier of the topic template.
Name Name of the work team.
Description Description text about the work team.
Login Group Name of the login group. Each work team is a
subset of a login group.
All Users Yes, if all users in the login group are members
of the work team.
No, if users have been individually added to
the work team.
Users The full name and Oracle Empirica Signal
username of each member of the work team.
Blank, if all users in the login group are
Topic Visibility Whether or not the topic is visible to the work
team.
Topic/Action Assignment Whether or not topics and actions can be
Created By Name of the user who created the work team.
created.
team.
modified.
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Edit a topic template

When you edit a topic template, you can perform all the actions of managing a topic
template.

Templates.
4. Click the Row Action menu ( ) for a topic template, and then click Edit.
5. In the Topic General Information section, specify values.
6. Click Save.
7. In the Template Actions section, do any of the following:
• Click Add Template Action to add an action.
• Click the Row Action menu ( ) for an action, and then click View.
• Click the Row Action menu ( ) for an action, and then click Edit.
• Click the Row Action menu ( ) for an action, and then click Delete.
Copy a topic template

On the Manage Topic Templates page, if you have the Manage Topic Workflow
permission, you can copy an existing topic template using the Copy link in the Row
Action menu. Template topic actions are included in the copy.

Templates.
4. Click the Row Action menu ( ) for a topic template, and then click Copy.
5. In the Name field, leave the default name or type a different template name.
6. In the Description field, type a description of the topic template.
7. Click Save.
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Delete a topic template

On the Manage Topic Template page, you can delete a topic template using Delete in
the Row Action menu. When a topic template is deleted, any topics created previously
with that template are not affected.

Templates.
4. Click the Row Action menu ( ) for a topic template, and then click Delete.
Topic template actions

• View a topic template action
• Topic Template Action page
• Add a topic template action
• Edit a topic template action
View a topic template action

Templates.
4. Click the Row Action menu ( ) for a topic template, and then click View.
5. In the Template Actions section, click the Row Action menu ( ) for an action,
and then click View.
Topic Template Action page

On the Topic Template Action page, you can view and edit template action information.
The page allows you to view the history of the topic template actions. In edit
mode, you can also perform activities based on your permissions and topic workflow
configuration.
To expand the sections on this page, click Show All, or click for a single section. To
hide section details, click for the section or click Hide All.
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Sections

Template Action General Displays the current values in None
Information the standard or custom fields
that describe the template
action:
• The fields can be display-
only, editable, or required.
If a field is required, an
asterisk (*) appears next
to it and the action cannot
be saved until you provide
a value for the field.
• Each field accepts text,
numeric, and date values,
or provides a list of pre-
defined values that you
can select. If a value
is not required in the
field, you can select (a
blank value) to indicate
no value for the field.
A field that accepts text
may also offer a Select
Available Values link so
you can select one or
more values from a list.
• A date field appears as
offsets expressed in days.
When the template is
used, the date field in the
action is computed based
on the topic creation date
plus the template offset.
• Arrow icons may appear
after the names of a pair
of fields to show that
they are a linked pair.
For example, if fields for
Country ( ) and State
( ) appear, the arrows
indicate that you must
select a value for the
Country field first and
then select a value for
the State field. You cannot
select a State value first:
the values available for
State depend on the
Country you select.
• To save changes in the
Template Action General
Information section, click
Save.
Note: The Save button affects
only the Template Action
General Information section of
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the topic template. You do not
need to click Save after you
work with other sections of this
page.
History of Template Action Displays information on None
General Information changes made to the template
action. A new row is added to
the table each time you click
Save in the Template Action
General Information section.
Field descriptions—Template Action General Information

Depending on your organization’s workflow configuration, the following fields appear in
this section.
Field Description
Action name Name of the action.
Planned completion date Planned date for the completion of the action.
Actual completion date Date the action was completed.
If another user edits the same topic template action at the same time, the first one to
save the action will have their changes saved. The second user gets an error message
indicating the action has been changed since the edit session began. The General
Information section of the page becomes visible, allowing the user to print or take a
screen shot, so that the information can be reentered.
Add a topic template action

Templates.
5. In the Template Actions section, click Add Template Action.
6. Type the action name and description for the topic template action.
7. Enter values for any other fields to be included in the template action.
8. Click Save.
Edit a topic template action

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Templates.
5. In the Topic Template Action section, do any of the following:
• Click Add Template Action to add an action.
• To view a template action, click the Row Action menu ( ) for an action, and
then click View.
• To edit a template action, click the Row Action menu ( ) for an action, and
then click Edit.
• To delete a template action, click the Row Action menu ( ) for an action,
and then click Delete.
Manage email notification rules

• View existing email notification rules
• Manage Email Notification Rules page
• Add an email notification rule
• Edit an email notification rule
• Insert a field variable into email message text
• Delete an email notification rule
View existing email notification rules

Email Notification Rules.
Manage Email Notification Rules page

On the Manage Email Notification Rules page, you can add, modify, and delete email
notification rules.
General activities
• Add Email Notification Rule
• Back
• Columns
• Print
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• Download
The Notification Reason filter appears at the top of the page and affects the email
notification rules table.
• Edit
• Delete
Field descriptions—Manage Email Notification Rules page
Field Description
ID Email notification rule identifier.
Rule Name Email notification rule name.
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Field Description
Notification Reason The following activities initiate an automated
email:
• Topic Added—A new topic is created.
• Topic Deleted—A topic is deleted.
• Topic Modified—A topic is modified.
• Topic Field Modified—A topic field is
modified.
• Topic State Changed—The workflow state
of a topic changes.
• Topic Assignment Changed—A topic
assignment changes.
• Topic Assignment Changed (to User)—
New rule, only triggered when the new
assignee is a user.
• Topic Assignment Changed (to Work
Team)— New rule, only triggered when
the new assignee is a work team.
• Action Added—An action is added to a
topic.
• Action Deleted—An action is deleted.
• Action Modified—An action is modified.
• Action Field Modified—An action field is
modified.
• Action State Changed—The workflow
state of an action changes.
• Action Assignment Changed—An action
assignment changes.
• Action Assignment Changed (to User)—
New rule, only triggered when the new
assignee is a user.
• Action Assignment Changed (to Work
Team)—New rule, only triggered when the
new assignee is a work team.
• Email Reminder—Daily, at a time
specified in Site Options.
Multiple rules can be defined for each email
notification reason.
Message Subject Email subject line.
Message Text Email text.
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Field Description
Send To Message recipients:
• Visible to Work Team Members—All
members of the work team, or teams that
can view the topic.
• New Assignee—User or work team
currently assigned to the topic or action.
If the New Assignee is a work team,
notifications will be sent only to work team
members who can view the topic.
• Previous Assignee —User or work
team previously assigned to the topic. If
the Previous Assignee is a work team,
notifications will be sent only to work
team members who can currently view the
topic.
• Individual users—Enabled users in login
group, regardless of topic visibility.
Note:
Users must have
an email address
associated with
their username
to receive
emails.
Add an email notification rule

4. To create a rule, click Add Email Notification Rule.
5. Type the rule name in the Notification rule name text field.
6. From the Notification reason drop-down list, select the type of activity that
triggers the notification. For more information, see Field descriptions—Manage
Email Notification Rules page.
7. From the Send to list, select the recipient names. For more information, see Field
descriptions—Manage Email Notification Rules page.
8. Type a subject for email messages generated for the selected reason.
You can include field variable in this subject. When the message is generated, the
current values replace the field variables of the reference fields.
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Note:
You must provide a message subject to save the email notification rule.
9. Type the message text.

You can include field variables in this text. When the message is generated, the
current values replace the field variables of the referenced fields.
10. To insert a field variable, click Show Fields.
Before including fields in the message subject or message text, ensure that the
resulting emails will not contain sensitive or confidential information.
Note:
When you select a field variable, it is inserted at the position of the cursor.
Edit an email notification rule

4. Click the Row Action menu ( ) for a notification rule, and then click Edit.
For more information, see Field descriptions—Manage Email Notification Rules
page.
Note:
The Notification reason field is disabled during the edit mode and
cannot be modified.
Insert a field variable into email message text
Note:
Before including fields in the message subject or message text, ensure that
the resulting emails will not contain sensitive or confidential information.
To provide contextual information in an email message, you can include field variables
that will be replaced by current values when the message is generated. For example,
an email notification rule that includes field variables in the message text appears as
follows:
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The state for the <<topic.TOPIC_NAME>> topic has been changed to

<<topic.CURRENT_STATE_ID>>. The following reason for this change was provided:
<<topic.STATE_CHANGE_REASON>>.
When an email message is generated based on this rule, the body of the actual
message might read:
The state for the Acetaminophen and Alcohol Use topic has been changed to Closed.
The following reason for this change was provided: This is a known, labeled risk.
Note:
Action emails trigger when you click Save on the Topic Action page. Any
topic field included in an Action email message reflects the last saved
General Information value.

4. Click the Row Action menu ( ) for a notification rule, and then click Edit.
5. On the Edit Email Notification Rule page, click Show Fields.
For a topic-related email notification reason, a page lists all topic fields. For an
action-related reason, the page lists all topic fields and all action fields.
6. Highlight a field to insert a variable for it into the message text.
The field variable is inserted at the location of the cursor.
7. Click OK.
Delete an email notification rule

4. Click the Row Action menu ( ) for a notification rule, and then click Delete.
5. Reply to the confirmation message by clicking OK.
Transform data
• About data transformations
• Map text values
• Custom terms and mapped text values
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• Define variable cutpoints

• Convert dates
• Exclude synthetic values
About data transformations

A data transformation is a means of mapping text values to new values, converting
date values, or organizing numeric or date values into groups. The source data
remains unchanged, and the transformed values are available for selection when you
create data mining runs.
You specify data transformations for individual variables within a data configuration.
The results of the transformation do not affect the actual source data.
For example, suppose that the source data contains a date variable RCVD_DATE. You
want to allow run creators to select half-years as subset categories. You can use a
data transformation to convert the date values for the RCVD_DATE variable to new
half-year values, such as 2019H1 and 2019H2. A data mining run creator can then
use the half-year variable for subsetting, and select different half-year values as subset
categories. The source safety data continues to store only date values, but the run
results refer to the half-year values instead of the full-date values.
Transformation options
To transform data in a data configuration, you can do the following:
• Map text values.
• Define variable cutpoints.
• Convert date values.
When you define data transformations, it is preferable to include a new data
configuration variable for the transformed data. For example, if the RCVD_DATE
variable exists, and you want to transform its data, keep the RCVD_DATE variable
as is in the data configuration and add a new variable, such as RCVD_HALFYR, to
store the transformed data.
An additional transformation option allows you to upload a list of synthetic values that
are in the source data. For example, you could upload the names of Standardized
MedDRA Queries (SMQs) to be ignored by MGPS when estimating the shrinkage
parameters for EBGM scores. Note that custom terms are ignored automatically for
the estimation of shrinkage parameters.
Note:
The raw RR scores for combinations involving custom terms and the
excluded synthetic values are shrunk by the Bayesian formula, but they do
not participate in the determination of the formula itself.
For any one data configuration variable, you can only specify one data transformation
type. However, you can add variables that reference the same column in the source
database. You can also specify a different transformation for each of those variables.
For example, suppose that the source database has a RCVD_DATE column. You
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could create a RCVD_HALFYR variable to convert date values and a RCVD_RANGE

variable that groups received dates according to date cutpoints.
Transformation results
When you define data transformations that map text values, define variable cutpoints,
or convert date values, note that:
• Variables that transform data are not available for creating queries or defining
reports.
• Variables that map text values are available for creating saved lists. The mapped
values, however, do not match the source data. As a result, the saved list does not
pass validation. You can save and use the saved list, even though it does not pass
validation.
• Transformed variables are not available as the drug variable, event variable, or as
additional covariates in a logistic regression run.
• If included in the drilldown map table, a variable that transforms data shows the
source data, rather than the transformed data, when users drill down to a list of
cases or to view case details.
• If you define a data transformation for a variable in a data configuration, for which
there are existing runs that use the variable, users cannot drill down correctly in
the run results until the runs are re-executed.
Note:
These restrictions do not apply to a synthetic values transformation.
Map text values

Mapping text values from the source data to specified text values or to a different
hierarchy of terms involves a data transformation. For example, you can use mapping
to do the following:
• Combine multiple adverse events from the source data into a single combined
event.
• Specify that PTs from the source data should use a non-primary path for hierarchy
values assigned by the application.
• Recode drug names from the source data.
The mapped values can be selected for use in an MGPS data mining run.
Note:
See Defining custom terms for another way of mapping values to a term that
you specify for a data mining run. See Comparing custom terms and mapped
text values for information on the differences between these features.
To map text values, you use a text editor to create a file that contains the mappings
and then you upload the file to a mapped variable in the configuration. To view the
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current mappings for a variable, edit the configuration, and for the mapped variable
click View Current Mapping.
Note:
If you modify a mapping file, your changes are not applied automatically
to the mapped variable. You must edit the configuration and upload the
modified mapping file for the mapped variable.
Text mapping process

1. Determine how you want to map values. This example maps several PTs to the
term, Cognitive impairment, and specifies that the term Cognitive impairment will
use hierarchy values for the PT, Mental impairment.
2. In Microsoft Notepad or another text editor, create a mapping file and type the
following column headings on the first line of the document:
3. On the second line, type in the first old value (as it appears in the data, including
capitalization), a comma, and then the new value. The new value does not need to
exist in the source data. You must specify both an old value and new value. If you
do not specify both values, values might be omitted from run results.
4. Type in the value that uses the hierarchy that you want to use for the new value.
The hierarchy value is used only if the mapped variable is set up with a hierarchy.
An exact match (including capitalization) of the hierarchy value must exist in the
hierarchy, although it does not need to exist in the source data. If the mapped
variable is set up to use a hierarchy, you must specify a hierarchy value.
5. You must separate each term with a comma. Do not include extra spaces or any
extra carriage returns.
Note:
If a term includes a comma, enclose the term in double quotation marks
(for example, "Gastric ulcer, perforated"). If a term includes a double
quotation mark, enter a backslash before the double quotation mark
(for example, "Gastric ulcer, \"perforated\""). When you view the current
mapping on the Edit Variable page, the double quotation marks and/or
backslashes do not appear.
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6. Repeat this process for each value that you want to map. This example maps
several PTs to the same new value and hierarchy value. This is not a requirement
for the mapping file. In the same mapping file, you can map different PTs to
different new values and hierarchy values.
Note:
You can perform only one level of mapping. In the above example, if
you also map Cognitive impairment to Cognitive decline, none of the old
values are mapped to Cognitive decline.
In the last line of the above example, the old value is mapped to a new value but
continues to use the hierarchy of the old value. If the new value already exists in
the source data, the hierarchy value applies to the existing value, as well. In this
example, if Cognitive impairment is in the source data, the hierarchy for Mental
impairment is used for it.
7. Make sure that there are no extra carriage returns or spaces in the file. The
mapping does not work properly if there are extra carriage returns or spaces.
8. Save the file with the extension .csv.
Changing only the hierarchy
If you want to change only the hierarchy used for the old value, enter the same old and
new value, and then the hierarchy value:
Generating results for mapped values

When creating a data mining run, choose the new variable. (Because you did not
modify the original variable, that variable is also still available for selection.) Results
are generated for combinations including the new value, as in the following example:
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Note:
There might be more results for Insulin and the pre-mapped terms than
for Insulin and the new mapping term because cases that include multiple
pre-mapped terms are counted only once for the new mapping term.
Custom terms and mapped text values

The Oracle Empirica Signal application offers two options for grouping values, such as
a list of drugs or a list of events, together for use in a data mining run without affecting
source data. These features are:
• Custom Terms—see Define custom terms.
• Mapped Text Values—see Map text values.
While these options are similar, each has different advantages and limitations. The
differences between these features are as follows.
Options Custom Terms Mapped Text Values

MGPS runs can include: X X
Logistic regression runs can include: X --
Set up using query logic: X --
Set up once, then reusable: -- X
(Manage Configurations permission)
Set up for each run: X --
(Create Data Mining Run permission)
Can be set up for variables -- X
configured to use a hierarchy table:
Can be set up for variables X X
configured to use a hierarchy
account:
When a custom term is added to a data mining run, that custom term cannot include a
variable with mapped text values. Oracle recommends that when mapping text values,
instead of applying this data transformation directly to a configuration variable, set
up a new configuration variable based on the same table and column specifically to
incorporate the mapping. When two different variables are offered in this way, the
values of the original variable remain available for inclusion in a custom term. See
About data transformations.
Define variable cutpoints

Categorization based on cutpoints is a type of data transformation. If the source data
for the data configuration does not contain a variable that categorizes values in a way
that is needed for stratification or subsetting during a data mining run, you can create
categories by defining cutpoints for the variable. You can define categories for only a
continuous variable; that is, numeric or date variables.
For example, the source data contains Age, but not Age Group. The data miner wants
to subset data by the following groups: 18 or younger, 19-65, and over 65. You can
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define a variable based on Age, and then categorize those age values into groups by
specifying cutpoint values that indicate the range of each category.

4. To add a variable to represent the cutpoints, click the Add New Variable link. For
more information, see Add or edit a data configuration variable.
8. As the Column of source data, select the variable containing values that you want
to map. The source column must contain numeric or date values.
10. In the Data Transformation section, click User-defined cutpoints, and then click
View/Edit.
11. To assist you in determining which categories to define, you can view column
statistics about the distribution of values for the field in the entire source database.
12. In the first row, which starts with VALUE <=, in the Value column, enter the last
value in the first category.
13. In the Label column, enter a label for the first category. For a date value, use the
format, mm/dd/yyyy. For example, 12/14/2019.
14. In the next row, enter the last, or highest, value and a label for the second
category. (You must enter the cutpoint values in ascending order.)
15. Continue defining categories until you are ready to define the last category.
16. For the last category, enter only a label. There is no need to enter a value. For
example:
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17. If you need to add more categories than you can currently fit on this page, check
Add additional cutpoints upon saving. When you click Save, you can add more
categories.
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18. Optionally, enter values into the Minimum Value field and the Maximum Value
field.
The minimum and maximum apply to the source values, not the transformed
values. This option is useful if you want to exclude extreme values from inclusion
in a data mining run. The excluded values are considered missing. They are
assigned the value that the user sets for the user preference, Replace Missing
Values with.
When specifying a minimum and maximum value for a date value, use the format
mm/dd/yyyy, for example, 12/14/2019.
19. Click Save.
If you checked Add additional cutpoints upon saving, another row is added.
20. When you are finished specifying categories, clear Add additional cutpoints
upon saving, and click Save.
The cutpoints for the variable are created. If you define cutpoints for a variable in
a configuration for which there are existing runs that use the variable, users cannot
drill down correctly in the run results until the runs are re-executed.
Convert dates
A date conversion is a data transformation. For a variable that is based on a date
value in the source data, you can convert the date value to a year, a half year, or a
quarter year.

4. To add a variable to represent the converted data values, click the Add New
Variable link. For more information, see Add or edit a data configuration variable.
8. As the Column of source data, select the variable containing values that you want
to convert. The source column must contain date values.
10. In the Data Transformation section, click Date function, and then click Select
Function.
11. Select one of the following functions:
• QUARTER—Convert the date to a quarter year formatted as the four-digit

year followed by the quarter (for example, 2006Q1, 2006Q2, 2006Q3, and
2006Q4).
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• YEAR—Convert the date to a four-digit year.

• HALF—Convert the date to a half-year formatted as the four-digit year
followed by the half year (for example, 2006H1 and 2006H2).
12. Enter a minimum or maximum value (optional). The minimum and maximum apply
to the source values, not the transformed values.
This option is useful if you want to exclude extreme values from inclusion in a run.
The excluded values are considered missing. The application assigns the value
that the user sets for the user preference, Replace Missing Values with.
When specifying a minimum and maximum value, use the format mm/dd/yyyy, for
example, 12/14/2006.
13. Click Save.
Note:
If you convert a date variable in a configuration for which there are existing
runs that use the variable, users cannot drill down correctly in the run results
until the runs are re-executed.
Exclude synthetic values

When estimating shrinkage parameters for EBGM scores generated by a data mining
run, MGPS does not consider custom terms. If source data includes other synthetic
values, such as standardized MedDRA queries, you must exclude those values for the
appropriate data configuration variable. Once synthetic values have been excluded,
MGPS does not consider them when estimating shrinkage parameters for EBGM
scores.
Note:
AERS data releases provided to you by Oracle are already configured to
exclude SMQs as synthetic values.
1. In Microsoft Notepad, or another text editor, create a file containing the synthetic
values.
• The file must have only one column of up to 200 characters.
• The first row in the file must be the header, Value.
2. Make sure that there are no extra carriage returns or spaces in the file.
3. Save the file with the extension, .csv.

6. Click the Row Action menu ( ) for the data configuration, then click Edit.
7. Click the Row Action menu ( ) for a configuration variable, and then click Edit.
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Administer the system
8. In the Data Transformation section, click Synthetic values.

9. Click Upload Table.
10. Click Browse.
11. Select the file of synthetic values and click Open, and then click Upload.
12. To make sure the values are correct, in the Data Transformation section, select
Synthetic values and click View Current Values.
13. Click Close, and then click Save.
14. Validate the data configuration.
Note:
When you have excluded synthetic values, users creating a data mining run
do not need to take any additional steps to exclude them.

• Set site options
• Send a message to all users
• Manually restart the listener process
• Manage run storage
• Change user default data mining runs
Set site options

A site option is a setting that customizes an aspect of the Oracle Empirica Signal
application. Setting site options requires the superuser permission.
Note:
The site options in the Password Restrictions section are not applicable to
single sign-on or LDAP passwords. You can set password restrictions for
single sign-on users in Oracle Access Manager.

2. From the Administrator System section, select Set Site Options.
3. Edit the fields as necessary.
4. Click Save.
5. Optionally, you can do one of the following:
• To review your changes, select Review Changes.
• To continue to work on the application, select Continue.
Field descriptions—Site Options page
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Note:
Password-related options do not apply to SSO or LDAP authentication.
Field Description
Expiration Enter the number of days until user passwords expire.
This optional setting affects passwords for all users. The
expiration period is counted from when the user was
created or when the password was last changed. The
default value is 90 days.
Note:
Individual users can
be configured so their
password never expires.
Also, when a user
password has expired, the
user can create a new
password.
Expiration Warning Enter the number of days prior to password expiration

that a warning message begins to display when users
log in. This optional setting affects passwords for all
users. The default value is 15 days.
The expiration warning period is counted from when
the user is created or when the user's password is last
changed.
Minimum Length Enter the minimum length of new passwords. Passwords
can be up to 64 characters long. Existing passwords are
not affected by this value. The default value is 8.
Number of Attempts Allowed Select the number of times users can attempt to log
in with an incorrect or missing password before the
account is locked. The default value is 3. When this
limit is reached, an email message is sent to all
superusers and to all user names with the Administer
Users permission in the same login group as the locked
account.
Note:
When a user account
is locked, the Account
locked check box is
checked automatically for
the user. To unlock the
user account, edit the user
and clear the check box.
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Field Description
Number of Passwords Retained Indicate the number of unique passwords that are
retained in the history of the user. Passwords retained
in a user's history cannot be re-used.
For example, suppose that you set this field to 100. Each
time the user changes the password, the old password
is retained (up to 100) and when a new password is
selected, it cannot match any of those in the history. If
you want to allow password re-use, set this value to 0. If
you want to prevent password re-use, set this value to a
high number such as 1000. The default value is 8.
Alphabetic Enter a number in each field to define how many of each
Numeric character must be present when new passwords are set.
The default value for each character is one.
Non-alphanumeric
Lower case
Upper case
SMTP Server Enter the name of the SMTP server to use for email
notification of run completion, feedback email, and error
email. This field must be filled in correctly for these email
functions to work.
From Email Address Enter the email address from which topic
email notifications and run completion notifications
will be sent. The default value is
empiricasignalnoreply_ww@oracle.com.
Feedback Email Enter the email addresses for feedback that is sent
by Oracle Empirica Signal application users. You can
enter one address or multiple addresses separated by
commas.
Error Email Enter the email address for notification of system errors.
You can enter one address or multiple addresses
separated by commas.
Note:
System errors are also
recorded in the User
Activity Audit Trail.
Date Format, Select the date format and time format to use for server
Time Format date/times that are displayed in Oracle Empirica Signal
application.
Note:
UTC is Coordinated
Universal Time
(abbreviated as UTC).
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Field Description
Auto-Start Local Listener If Yes, the listener process starts automatically when a
batch run is submitted. This option needs to be set to
Yes unless the listener process does not run on the Web
server.
Log Level Select the type of information to be included in the
weberror.log file on the Oracle Empirica Signal server.
Max Memory Per Report Enter the maximum amount (MB) of memory that a
single report is allowed to use when executing. It is
recommended you consult with Oracle support before
changing this value. The max value is usually 768 MB.
Note:
To decrease the amount of
memory used by reports,
set the Generate drill-
down Information option
to No while editing report
attributes.
Max number of rows per table allowed in topic Maximum number (n) of rows of tabular data that can be
attachments saved as an attachment to a topic.
Only the first rows of the displayed tabular data are
saved as the attachment. A message informs you that
not all rows are being saved
Max number of bytes per file allowed in topic Maximum size (MB) of files that can be added as an
attachments attachment to a topic. If you try to add a larger file as an
attachment, an error message appears.
Time to send topic email reminder notifications Hour of the day when Email Reminders for Email
Notification Rules are sent.
Max cache size for LR index tables and data files Maximum size (MB) of Oracle index tables or files saved
during execution of a logistic regression run.
Show menu items: Signal Review Select to show the Signal Review menu item to users
with appropriate permissions.
Data Mining Runs Select to show the Data Mining Runs menu item in the
Data Analysis ( ) section of the left navigation pane to
users with appropriate permissions.
Data Mining Results Select to show the Data Mining Results menu item in the
Data Analysis ( ) section of the left navigation pane to
users with appropriate permissions.
Queries Select to show the Queries menu item in the Data
Analysis ( ) section of the left navigation pane.
Case Series Select to show the Case Series menu item in the Data
Reports Select to show the Reports menu item in the Data
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Field Description
Drug Profiles Select to show the Drug Profiles menu item in the Data
Analysis ( ) section of the left navigation pane to users
with appropriate permissions.
Allow Case Comment/Review/Exclusion Select to include the Reviewer Input section on the
Case Details page, or clear to prevent the Reviewer
Input section from appearing. This only affects the Case
Details page that you access on the Case Series page.
Allow Free Text Signal Comments Select to allow users to enter free text comments when,
on the Signal Review page, they filter a product-event
combination or add a comment when reviewing a signal
summary. Regardless of the setting of this option, users
can select from a list of predefined comments.
Allow Automatic Assignment of Reviewers to Products Select to allow users with appropriate permissions to
assign reviewers to products automatically.
Enable Interactive Rep Select to show the Interactive Reports link on the
orts Reports page.
Enable Query Wizard Select to enable use of the Query Wizard to define
queries.
Allow Case Count on Query Preview Page Select to show the Show case count by default on
preview page check box on the Set User Preferences
page.
Enable Second Level drill-down on Cases Page Select to allow users to drill down to view case details
for a particular case when they are viewing a list of
cases. This option does not apply to the Case Series
page or to a case ID hyperlink in a report; you can
always drill down to case details from these locations.
Enable Download Case Details Select to allow users to download case details.
Enable LDAP Select to enable the creating, updating, and
authentication of users via an LDAP directory.
Enable OBI EE Reporting Select to allow users to view or generate OBIEE reports.
Enable RGPS Option in MGPS Data Mining Runs Select to allow users to include RGPS computations in
data mining runs.
Note:
This option is enabled
only if R and RGPS are
installed.
Limit User Provisioning (Oracle-hosted installations only) Select to disallow the following activities by users with
the Administer Users user permission:
• Adding a new user on the Users page.
• Deleting users on the Users page.
• Editing the Authentication, Username, First Name,
Last Name, and Email fields on the Edit User page.
This option does not affect superusers.
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Field Description
Add message to Notes for Results (Table and Graphs) Enter text to display below tables or graphs of data
mining results. For example, the message might read
"These data do not, by themselves, demonstrate causal
associations; they may serve as an impetus for further
investigation."
Notes for Signal Management Interactions Graph Enter text to display at the bottom of the Interactions
page for a product-event combination on the Signal
Review page.
Product-event combination comment length Maximum length of detailed comments for product-event
combinations on the Signals Review page.
Default User Profile User profile used when provisioning IAMS users.
Topic workflow configuration for work team custom fields For organizations using the topics feature, indicates the
topic workflow configuration that implements custom
fields for work teams. The selected configuration also
must be published to the login group for the fields to
be visible when a work team is added or edited for that
login group. See Add or edit a work team and Constrain
field values by work team.
Send a message to all users

If you have the Administer Users permission, you can send an email message to all
Oracle Empirica Signal users who:
• Have an email address associated with their username.
• Are in your login group.
• Have an active user account (that is, the Account disabled check box is cleared on
the Add/Edit User page).
For example, you might want to send a message announcing an upgrade or
scheduling server maintenance.

2. In the Administer System section, click Send Message to All Users.
3. In the Subject field, enter the subject of your message.
4. In the Comments field, enter the text of your message.
5. Click Send.
The application sends the message to users, regardless of whether or not they are
currently logged in, and displays a confirmation for each message sent.
In the email message:
• The date and time of the message is the date and time at which you clicked
Send.
• The From line shows the email address associated with your username. If
there is no email address associated with your username, the From line
shows the email address associated with the Feedback Email field on the
Set Site Options page.
• The Subject line shows the text you entered in the subject line.
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6. Click Continue.
Manually restart the listener process

The Oracle Empirica Signal listener process is responsible for identifying background
work and assigning it to processes for execution. The listener process starts when the
application starts up, and updates an associated heartbeat date and time value every
2-30 seconds while the application is running.
Occasionally, the listener process terminates unexpectedly (either because it
encounters an error or because it is stopped by a system operator).
When a run is submitted, the application checks the heartbeat value to determine if the
listener process is still running. If the listener process is not running, the application
restarts it automatically, if the Auto-Start Local Listener site option is set to Yes. You
can also restart the listener process manually from within the application at any time.

2. In the Administer System section, click Restart Listener.
Note:
You can restart the listener process only if the listener is running as part of
the Oracle Empirica Signal website. If the listener is running outside of the
Oracle Empirica Signal website, clicking Restart Listener has no effect.
Manage run storage

• Manage data mining run storage
• Export data mining run data
• Import data mining run data
• Mark a data mining run as archived
• Move a data mining run with a Move script
• Create a run definition file
Manage data mining run storage

The Oracle Empirica Signal tools for managing data mining run storage are intended
for the use of an Oracle Database Administrator who is responsible for the Oracle
Empirica Signal database.
To archive a run, you export the run data and set the archived flag to Yes. To de-
archive a run, you import the run data and clear the Archived flag.

2. In the Administer System section, click Manage Run Storage.
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Click the Row Action menu ( ) for a run to do the following:

• To export the run data, click Export Run Data.
• To import the run data, click Import Run Data.
• To mark a run as archived, click Set Archived Flag. The value in the Archived
column changes to Yes.
• To clear the Archived flag, click Clear Archived Flag.
• To move the run to a different tablespace, click Create Move Script.
On the Data Mining Runs page, you can include an Archived column showing the
setting of the Archive flag. If the Archived flag for a run is set to Yes, the run
description on the Data Mining Runs page starts with Archived. If the Archived flag is
Yes for a run, you cannot view run results.
Export data mining run data

3. Click the Row Action menu ( ) for the run, and then click Export Run Data.
4. Follow instructions on the Export Run Data page, as shown in the following
example:
Import data mining run data

3. Click the Row Action menu ( ) for the run, and then click Import Run Data.
4. Follow instructions on the Import Run Data page, as shown in the following
example:
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Mark a data mining run as archived

On the Data Mining Runs page, you can include an Archived column showing the
setting of the Archive flag. You set the Archived flag on the Manage Run Storage
page.

3. To set the Archive flag to Yes, click the Row Action menu ( ) for the run, and
then click Set Archived Flag. You can now import this run data.
4. To clear the Archive flag, click the Row Action menu ( ) for a run with the
Archived value of Yes, and then click Clear Archived Flag. You can now export
this run data.
Note:
If the Archived flag for a run is set to Yes, the run description on the Data
Mining Runs page starts with Archived. If the Archived flag is Yes for a
run, you cannot view run results (except that you can view the complete
results table on the Data sources page).
Move a data mining run with a Move script

Oracle Empirica Signal provides a SQL script that you can run to transfer the tables
and indexes for a data mining run to a different tablespace. For example, you might
want to move a frequently used run to its own tablespace to improve performance, or
move a run to a different tablespace to facilitate archiving of the run at the tablespace
level.

3. Click the Row Action menu ( ) for the run, and then click Create Move Script.
The Move Run Script page now displays an SQL script.
4. Copy the SQL script and paste it into an ASCII text editor, such as Notepad.
5. Edit the script to define the destination tablespace for the run.
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6. Save the script in a text file and execute it using Oracle tools.
Create a run definition file

A run definition file is an input file that can be used to execute MGPS and logistic
regression data mining runs externally. The runs and results then appear in the Oracle
Empirica Signal application. Only the execution of the runs occurs outside of the
application. For more information about executing data mining runs externally, contact
Oracle.
1. Perform one of the following: In the left navigation pane, hover on the Data
Analysis icon ( ), then click Data Mining Runs.
• In the left navigation pane, hover on the Data Analysis icon ( ), then click
Data Mining Runs.
• In the left navigation pane, click the Settings icon ( ), select Manage signal
Configurations, then click Manage Refreshes.
2. Click the Row Action menu ( ) for the run, and then click Create Definition
File.
The definition input file appears.
Change user default data mining runs

2. In the Administer System section, click Change User Default Runs.
3. From the Change the Default Run for users with a current Default Run of
drop-down list, select the default run to replace for all users. Click Browse to find
and select a run.
4. From the to the following run drop-down list, select the name of the run to
replace the existing default run.
5. Click Replace Default Run.
6. Click Continue.
Note:
This option affects only current settings of user preferences.
Monitor the system

• View currently logged in users
• View the user activity audit trail
• About auditing
• View the server status
• View free disk space
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• View the batch report queue

• Truncate a report batch run
View currently logged in users

The Current Users page provides the information about users in your login group who
are currently logged into Oracle Empirica Signal.

2. In the Monitor System section, click View Currently Logged In Users.
The Current Users page displays the following information about the currently
logged in users:
Column Description
User Name Full name followed by the username in brackets.
Login Date Date and time when the user logged in. The date and
time format is set by the site administrator.
Session ID Automatically assigned identifier for the user's Oracle
Empirica Signal session.
IP IP address of the computer from which the user
connected to the application.
View the user activity audit trail

Administrators use the User Activity Audit Trail to view actions performed by users
in their login group. You can filter this activity by username, activity, date, or any
combination. The User Activity Audit Trail also includes the activities of deleted users.

2. From the Monitor System section, click View User Activity Audit Trail.
3. From the User drop-down list, select a user, or to view activities for all users,
select --.
Deleted users are denoted in the drop-down list with the (deleted) status
appended to their usernames.
4. In the Start Date and End Date fields, specify a time period for which to include
user activities, or before or after a specific date. Enter dates in the format MM/DD/
YYYY, or click the Calendar icon to select dates.

To include all activity for all users and activities, leave these fields blank.
5. Select the activities that you want to include in the report.
• To include or exclude specific activities, select or clear activity check boxes
(such as Login Failed).
• To include or exclude all activities listed for the category, select or clear
category check boxes (such as Authentication).
• To include all activities, click Check All.
• To clear all check boxes, click Clear All.
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Note:
To include Publish, Rename, and Copy activities, select the appropriate
Edit activity.
6. Click View User Activity.

The User Activity Audit Trail provides the following information:
Column Description
ID Unique activity identifier.
Username Username of the user who performed the
activity.
Note:
The report denotes deleted users
by appending (deleted) to the
username.
Session Unique identifier for the user's Oracle

Empirica Signal session.
IP Address IP address of the computer used to connect
to the application. In cases where the
connected user is a system user, the IP
address displays ::1 (local).
Activity Name Category and name of the activity.
Activity Date Date and time when the user activity
occurred. The date and time format is
determined by a site option, and by your
time zone preference.
Additional Information Details about the activity that was
performed. This might include the name
and unique identifier of an object where
the identifier is in parentheses, such
as CaseSeries=My Case Series(533). For
system errors, an error ID appears. The
Signal server log file contains the same
error identifier and more details about the
error.
data displays in the User Activity Audit Trail, see About tables.
About auditing
The Oracle Empirica Signal Auditing feature tracks user activity that occurs in the
application. Auditing captures detailed information about user actions, such as data
run creation, that provides you with an easily accessible, historical account of user
activity occurring in the following signal categories:
• Authentication
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• Errors
• Administration
• Login Groups
• Users
• Aliases
• Case Series, Queries
• Configurations
• Data Mining Runs
• Reports
• Saved Lists
• Subscription Data Releases (only used by Oracle Empirica Signal Cloud Service)
• View Results
• Drug Profiles
• Signals
• Signal Administration
• Signal Reviewer
• Topics
• Topic Administration
Note:
Auditing occurs automatically. You do not need to install or enable the
auditing feature.
An administrator can access audited user activity by viewing the User Activity Audit
Trail and use the information to:
• Trace actions by one or more users over time.
• Monitor configuration modifications.
• Monitor permission or authentication issues.
• Monitor administration changes.
• Troubleshoot errors.
• Identify suspicious activity or security incidents.
• Identify any violations in policies and procedures.
Using the User Activity Audit Trail, you can better enforce your company's security
policy and assist users with errors or issues.
Oracle Empirica Signal maintains audited user activity indefinitely. You cannot modify
or delete user activity through Oracle Empirica Signal.
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View the server status

Within the Oracle Empirica Signal application, two types of computer processing
occur:
• Foreground or interactive processing, such as the specification of runs.
• Background or batch processing, such as the execution of runs.
If you are running on a single-processor server, that processor must perform both
types of processing. If you are running on a multi-processor server, you can
control how the available processors are used to perform foreground or background
processing.
On the Server Status page, you to set the maximum number of processors to use for
background processing; that is, the number of concurrent runs that can be performed.
For a dedicated server, Oracle recommends that you set the maximum to one less
than the number of processors that are on the server. For a shared server, Oracle
recommends a smaller number of maximum processors.
For example, if there are three processors on a dedicated Oracle Empirica Signal
server, and you set the maximum number of processors to 2, then two runs can run at
the same time.

2. In the Monitor System section, click View Server Status.
3. In the Maximum Processors field, type the maximum number of processors for
the server listed.
4. Click Save.
5. Click Continue.
View free disk space

The option to view free disk space is intended for users who are familiar with Oracle
storage mechanisms.

2. In the Monitor System section, click View Free Space.
3. From the Tablespace drop-down list, select an Oracle tablespace.
View the batch report queue

The Report Batch Runs page provides information about reports that are run in batch
mode. It is intended for troubleshooting any problems related to batch reports in
conjunction with Oracle.

2. In the Monitor System section, click View Batch Report Queue.
From this page, you can truncate report batch runs, delete the report batch run,
and view the jobs for a run. When viewing the jobs for a report batch run, you can
also view detailed information, including log files, for the job.
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Truncate a report batch run

This feature is intended for use in conjunction with Oracle.

2. In the Monitor System section, click View Batch Report Queue.
3. In the top left corner, click Truncate.
4. In the Truncate Runs completed before field, select the date before which
completed runs should be truncated.
5. Click Truncate.
Set up saved lists

• About saved lists
• Saved Lists page
• Create or edit a saved list
• Add saved lists in bulk
• View or print a saved list
• Set permissions for a saved list
About saved lists

A saved list is a list of up to 1,000 drug or event terms that have been grouped
together and saved. Once you have created a saved list, you can refer to the
list instead of specifying the individual terms. For example, if you have saved
antipsychotic drugs in a list, you can refer to that list elsewhere when you need a
list of antipsychotic drugs.
In most places where you can select values for a drug or event variable (for example,
when selecting criteria to view data mining run results), you can create a saved list
from the values that you have selected. You can also create or edit saved lists by
clicking the Settings icon ( ) in the left navigation pane, and then clicking Manage
Saved Lists.
Saved Lists page

On the Saved Lists page, you can view saved lists that you have created or for which
you have the edit permission. The page displays saved lists created by all users in
your login group if you have the Administer Users permission.
General activities
• Create Saved List
• Add Lists In Bulk
• Back
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• Columns
• Print
• Download
The following filters appear at the top of the page and affect the rows displayed in the
table:
• Project
• Configuration
• View
• Edit
• Set Permissions
• Delete
Field descriptions—Saved List page
Field Description
Name Name of the saved list.
Description Description of the saved list.
Project Name of the project to which the saved list is
assigned.
Configuration Name of the data configuration on which the
saved list is based. If the saved list is based on
a run, the name of the data configuration used
by the run appears.
Created By Name of the user who created the saved list.
Created On Date and time the saved list was created.
# of Terms Number of terms included in the saved list.
ID Identifier the application automatically assigns
when the saved list is created. Each saved list
ID is unique and is not re-used if you delete
the saved list.
List Type Type of variable to which the saved list is
attached. Possible values are Drug, Event, and
Item.
Modified Date and time when the saved list was last
modified.
Modified By Name of the user who last modified the saved
list.
Variable Name of the variable for which the saved list
contains terms.
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Create or edit a saved list

Most dialog boxes from which you can select values for drug or event variables, such
as when browsing and selecting terms from a hierarchy, include a Save As List button
to create a saved list from the values that you have selected.
You can also create a saved list from scratch and edit a saved list.

2. Click Manage Saved Lists.
• To create a saved list, click Create Saved List.
• To edit a saved list, click the Row Action menu ( ) for a saved list, and then
click Edit.
4. In the Name field, enter the name for the list.
5. In the Description field, enter a description of the list.
6. Assign the saved list to a project.
• To assign the saved list to an existing project, click Add to existing project
and select a project from the drop-down list of projects associated with objects
that you created or that are published to you.
• To create a new project and assign the saved list to it, click Add to a new
7. From the Configuration drop-down list, select a configuration, or click Browse to
browse for a configuration.
8. From the Associated Variable drop-down list, select a variable to associate with
the saved list. The list includes variables that have a Variable Type of Drug, Event,
or Generalized Item in the data configuration.
9. Enter values for the saved list.
• Click Select Available Values. For more information, see Select values from
the list.
• Click Select ATC Terms or Select MedDRA Terms (if the selected variable
has an associated hierarchy). See Select hierarchy terms.
• Type the values (or copy them from elsewhere and paste them in). For
example, you can include custom terms that were used in a data mining run.
Note:
10. To verify that the specified values match values in the source data, check Validate
list when saving. If any of the terms do not have a matching value in the source
data, an error message appears and the unmatched values appear at the end of
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the list. If you clear Validate list when saving, you can use the saved list even if it
did not pass validation.
Note:
If you create a saved list by saving values during viewing of data mining
results, the list might include custom terms. For the custom terms, no
matches are found in the source data. However, matches are found
when the saved list is used to select drugs or events to view data mining
results that include those custom terms.
11. Click Save.
The saved list is available when you select results criteria for a run that is based on the
same data configuration or create a query using the variable with which the saved list
is associated. To make your list available to other users, set permissions for it.
Add saved lists in bulk

On the Saved Lists page, the Add Lists in Bulk option enables you to add multiple
saved lists at the same time. You can use this feature only if you are a superuser. If
you are interested in using this feature, contact Oracle.

3. Click Add Lists in Bulk.
4. On the Saved List Bulk Entry page, enter the configuration or click Browse to
select a configuration.
5. From the Variable drop-down list, select a variable.
6. In the List_Name List_Value text box, enter the contents of one or more saved
lists.
Each line must contain a List_name and List_value, separated by a tab.
7. Click Save.
Note:
The content you entered is not validated.
View or print a saved list

You can view or print the variables and terms included in a saved list. For more
information about saved lists, see About saved lists.

3. Click the Row Action menu ( ) of the saved list.
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4. To view the list, click View.

5. (Optional) To print the terms and other information for the saved list, click Print to
access the Windows Print Window.
Set permissions for a saved list

Users with the Read permission can select a saved list for use during certain activities.
Users with the Edit permission can select the saved list, as well as edit, modify
permissions for, or delete the saved list on the Saved Lists page.

3. Click the Row Action menu ( ) of the saved list, and then click Set
Permissions.
The Saved Lists Permissions dialog box has two sections. The Group Permissions
applies to your login group. The Individual Permissions section includes individual
users in your login group. Superusers see all login groups.
The permissions you can select are No Access, Read, or Edit.
4. To grant permissions to a login group, click No Access, Read, or Edit. The
selected permission applies to all members of the login group.
5. To grant permissions to individual users in your login group, in the Individual
Permissions section, click No Access, Read, or Edit next to each username.
User permissions for a saved list are determined by settings for both the individual
user and the user's login group. For example, if the individual user has Read
access but that user's login group has Edit access, the user has Edit access.
6. Click Save.
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page 218 -> Logistic regression computations >> M.

Oracle Health Sciences Empirica

Copyright © 2002, 2021, Oracle and/or its affiliates.

3 Use Oracle Empirica Topics

4 Initiate and monitor data mining runs

5 Retrieve and review data mining results

6 Query the safety database

7 Create and manage case series

8 Manage report definitions and output

9 Set up and use drug profiles

10 Settings and administration

Access to Oracle Support

Additional copyright information

Log in to Oracle Empirica Signal

To log in using your Oracle Empirica Signal username:

To log in using your single sign-on username:

Prerequisites and usage notes

Configure Google Chrome

Clear the cache in Chrome

Allow pop-ups within Oracle Empirica Signal

1. Clicking the icon ( ).

Configure Microsoft Edge

Clear the cache in Edge

Turn off the pop-up blocker

Configure Internet Explorer

Clear the cache in Internet Explorer

Allow pop-up windows only for Oracle Empirica Signal

Alternatively, turn off the pop-up blocker for all pop-ups

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Specify required Internet Explorer browser settings

1. Click the IE gear icon ( ):

Settings that apply to all browsers

The browser's Back button

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SAS System Viewer

View release notes and other documents

About the Oracle Empirica Signal application

1. Set up the database(s)

2. Define data configurations

3. Perform data mining runs

4. View the data mining run results

5. (Optional) Monitor potential safety signals

6. Query data and define and run reports

7. View drug profiles

8. (Optional) Track signals with topics

Signal detection methods

What do data mining statistics do?

Statistical association vs. causal relationship

Prioritizing with rankings or thresholds

Other factors to consider

What are the data mining statistics?

How does the method cope with statistical uncertainty?

Can the method adjust for confounding?

Why do statistics for significance matter?

Using significance scores

Comparing significance and association scores

Some pharmacovigilance groups may find it effective to prioritize investigations based