Oracle Argus InsightCognos User's GuideRelease 7.0.1E28481-01March 2012

Oracle Argus Insight Cognos User's Guide, Release 7.0.1E28481-01Copyright 2010, 2012 Oracle and/or its affiliates. All rights reserved.This software and related documentation are provided under a license agreement containing restrictions onuse and disclosure and are protected by intellectual property laws. Except as expressly permitted in yourlicense agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license,transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverseengineering, disassembly, or decompilation of this software, unless required by law for interoperability, isprohibited.The information contained herein is subject to change without notice and is not warranted to be error-free. Ifyou find any errors, please report them to us in writing.If this is software or related documentation that is delivered to the U.S. Government or anyone licensing iton behalf of the U.S. Government, the following notice is applicable:U.S. GOVERNMENT RIGHTS Programs, software, databases, and related documentation and technical datadelivered to U.S. Government customers are "commercial computer software" or "commercial technical data"pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. Assuch, the use, duplication, disclosure, modification, and adaptation shall be subject to the restrictions andlicense terms set forth in the applicable Government contract, and, to the extent applicable by the terms ofthe Government contract, the additional rights set forth in FAR 52.227-19, Commercial Computer SoftwareLicense (December 2007). Oracle America, Inc., 500 Oracle Parkway, Redwood City, CA 94065.This software or hardware is developed for general use in a variety of information managementapplications. It is not developed or intended for use in any inherently dangerous applications, includingapplications that may create a risk of personal injury. If you use this software or hardware in dangerousapplications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and othermeasures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damagescaused by use of this software or hardware in dangerous applications.Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks oftheir respective owners.Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarksare used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD,Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of AdvancedMicro Devices. UNIX is a registered trademark of The Open Group.This software or hardware and documentation may provide access to or information on content, products,and services from third parties. Oracle Corporation and its affiliates are not responsible for and expresslydisclaim all warranties of any kind with respect to third-party content, products, and services. OracleCorporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to youraccess to or use of third-party content, products, or services.

ContentsPreface . ixAudience. ixDocumentation Accessibility . ixFinding Information and Patches on My Oracle Support . ixFinding Oracle Documentation. xiRelated Documents . xiiConventions . xii1 IntroductionOverview of Generating Reports in Argus Insight .Argus Insight Components .Argus Insight Process Flow .Product Compatibility and Upgrade Options .Compatibility of Argus Insight with Argus Safety .Upgrade Paths to Argus Insight 7.0.1 .Copy Configuration Utility.1-11-21-31-41-41-41-42 Getting StartedAbout Login Accounts and Access.System Administrator Account.Single Sign-On Accounts.Logging In to the Argus Insight Application .Setting Your Personal Options.Changing the Default Home Page .Changing Your Preferences for Overwrite Confirmation.Viewing Group Memberships.Entering Dates in Argus Insight Date Fields .Viewing the Database Name and Argus Insight Release.Viewing the Online Help.Logging Out.2-12-12-22-22-42-42-52-62-62-82-82-83 Creating Queries by ExampleOverview of the Query by Example Tool . 3-2About the Tabs on the QUERY BY EXAMPLE Page . 3-2Example of a QBE. 3-3iii

Using the Type-Ahead Feature in Input Fields . 3-3Starting a New QBE . 3-4Entering Your Search Criteria and Executing the QBE . 3-4Reviewing the Results of Your QBE. 3-6Reviewing and Modifying the Criteria for an Executed QBE . 3-7Saving the QBE . 3-8Reviewing the Input Fields on Each QBE Tab. 3-9General Tab . 3-9Selecting the Study Information . 3-12Patient Tab. 3-13Patient View. 3-13Parent View. 3-15Selecting a Lab Test. 3-17Using the MedDRA Browser. 3-18Products Tab . 3-20Using the Product Browser. 3-24Using the WHO Drug Browser. 3-26Using the Study Drug Lookup. 3-29Events Tab . 3-30Analysis Tab. 3-32Activities Tab . 3-34Additional Info Tab. 3-35Assigning Group-Level Permissions to a Saved QBE. 3-36Working with the Last Modified or Executed QBE . 3-37Working with Saved QBEs . 3-38Searching for a Saved QBE . 3-39Creating a New QBE. 3-39Modifying a Saved QBE . 3-40Deleting a Saved QBE. 3-40Associating a Report Group with a QBE . 3-40Executing a Saved QBE . 3-41Executing a Saved QBE on the Active Case Series. 3-41Using QBEs with Advanced Conditions . 3-42Converting a QBE to an Advanced Condition . 3-42Integrating a QBE with an Advanced Condition . 3-434 Using Filters to Create QueriesAbout Filters. 4-2Using Predefined Filters . 4-3Selecting a Predefined Filter . 4-4Creating a Value Set for the Predefined Filter . 4-5Executing a Value Set . 4-9Creating Custom Filters . 4-9Creating a Custom Filter . 4-9Creating a Value Set for a Custom Filter . 4-12Working with the Last Modified or Executed Value Set . 4-16iv

Working with Saved Filters and Value Sets .Searching Saved Filters and Value Sets .Creating a New Filter .Creating a New Value Set .Modifying a Filter or Value Set .Deleting a Filter or Value Set.Associating a Report Group with a Value Set .Executing a Value Set .Executing a Saved Value Set on the Active Case Series .Using Filters with Advanced Conditions .Converting a Value Set to an Advanced Condition.Integrating a Value Set with an Advanced 4-224-235 Using Advanced Conditions to Create QueriesCreating a New Advanced Condition . 5-2Returning to the Advanced Conditions Editor. 5-7Assigning a Category to an Advanced Condition . 5-7Using and Ordering Advanced Condition Operators . 5-10Advanced Condition Example. 5-10Sample SQL Generated . 5-11Working with the Last Modified or Saved Advanced Condition. 5-12Working with Saved Advanced Conditions. 5-13Searching Saved Advanced Conditions. 5-14Creating a New Advanced Condition. 5-14Modifying an Advanced Condition . 5-15Modifying the SQL of an Advanced Condition. 5-15Deleting an Advanced Condition . 5-16Associating a Report Group with an Advanced Condition. 5-16Executing an Advanced Condition . 5-16Executing a Saved Advanced Condition on the Active Case Series. 5-176 Working with LibrariesViewing Save Queries in the Query Library.Associating a Query in the Query Library .Deleting a Query from the Query Library.Disassociating a Report in the Query Library.Viewing All Reports Associated with a Query or Case Series .Modifying a Query or Case Series in the Associated Reports Library.Disassociating a Report in the Associated Reports Library.6-26-36-36-36-46-56-57 Working with Case SeriesWorking with the Active Case Series .Viewing the Active Case Series.Active Case Series and Active Query Names .Sorting, Searching, and Navigating .Saving the Active Case Series.7-27-27-37-37-3v

Viewing the Criteria that Generated the Active Case Series . 7-4Assigning Group-Level Access Permissions. 7-4Adding an Annotation to a Case . 7-6About Case Annotations. 7-6Annotations in the Active Case Series . 7-6Annotations in Advanced Conditions . 7-7Annotations in Report Writer . 7-8Adding a Case to a Case Series . 7-8Deleting a Case from a Case Series. 7-9Working with Case Series Saved in the Library. 7-9Opening the CASE SERIES LIBRARY Page . 7-10Searching for a Saved Case Series in the Library . 7-11Making a Case Series Active. 7-11Modifying a Case Series . 7-11Merging Case Series. 7-12Importing a Case Series from an External Source . 7-13Deleting a Case Series from the Library . 7-14Viewing the Query Criteria that Generated the Case Series. 7-14Associating a Report Group with a Case Series . 7-15Sharing Case Series with Argus Safety Web . 7-15Exporting a Case Series to Microsoft Excel . 7-15Freezing and Unfreezing Case Series Data . 7-17Before Freezing the Data in a Case Series. 7-17Access Rights . 7-17Working with Frozen Case Series. 7-17Reports and a Frozen Case Series . 7-17List Maintenance Items and Derivation Rules in a Frozen Case Series . 7-18Freezing a Case Series. 7-18Recognizing a Frozen Case Series . 7-19Freezing and Saving Case Series . 7-19Unfreezing Case Series Data. 7-19Using the Link to Argus Safety Medical Review. 7-218 Generating and Scheduling Standard ReportsAbout Standard Reports . 8-2Case Series, ETL, and Association . 8-2Browser Configuration . 8-2Report Cover Page . 8-3Page Header. 8-4Page Contents . 8-4Page Footer. 8-4Working in the STANDARD REPORTS Page . 8-5Generating Standard Reports . 8-6Producing an Event-Level Report . 8-8Scheduling and Associating Reports Against a Query or Case Series . 8-10Working in the Scheduled Reports Group Dialog Box. 8-10Viewing the Reports in a Group . 8-11vi

VIewing, Sorting, and Searching the Report Groups .Using the Command Buttons.Associating a Report Group .Creating and Scheduling a New Report Group .Working in the Reports Scheduling Dialog Box.Entering the Report Name and Description .Setting Up the Schedule .Setting Up to Run the Reports Now.Defining E-Mail Information.Browsing and Sorting the List of Available Reports .Selecting and Adding Reports to the Group.Entering Required Pre-filters and Selecting a Report Format .Saving the Schedule.Scheduling a Report without a Query.Listing of the Standard Reports.Compliance Reports.Configuration Reports.General Reports .Management Reports.Pharmacovigilance Reports -188-198-208-218-218-228-238-249 Creating Custom ReportsGeneral Report Writer Information . 9-2Creating a New Report . 9-2Using Case Series Criteria and Case Series Name in New Report . 9-5Using Case Series Criteria and Name with Other Objects. 9-6Editing Reports . 9-10Filtering Data . 9-11Sorting Data . 9-12Summarizing Data . 9-13Formatting Data in Reports . 9-14Performing Calculations . 9-15Changing the Report Layout . 9-16Creating a Chart . 9-17Grouping by Row Headings. 9-18Ungrouping a Report. 9-19Creating Crosstab Reports . 9-20Summarizing the Sections in the Report . 9-21Converting to a Crosstab Report . 9-22Creating Sections in the Report. 9-23Swapping Rows and Columns. 9-24Running the Report in Specific Formats .

Cognos User's Guide Release 7.0.1 E28481-01 March 2012. Oracle Argus Insight Cognos User's Guide, Release 7.0.1 . Entering Dates in Argus Insight Date Fields . 5-11 Worki