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Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins

Basic Details
Date Posted
Status
Complete
Medical Product
statin
warfarin
Health Outcome(s)
gastrointestinal hemorrhage
Description

This statistical methods project is one of four workgroups that used exposure/outcome pairs with known positive associations to test Mini-Sentinel (now Sentinel) routine querying tools. Specifically, these known positive associations tested the Cohort Identification and Descriptive Analysis (CIDA) tool in combination with the Propensity Score Analysis (PSA) tool.

This known positive test case assessed the association between new use of warfarin and gastrointestinal (GI) bleeding, with statins as the comparison exposure. Data from January 1, 2012 to September 30, 2015 from 14 Data Partners contributing to the Sentinel Distributed Database (SDD) were included in this report. 

Deliverable(s) (1)
Sentinel Modular Program Report: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins
Information
Time Period
January 1, 2012 - September 30, 2015
Population / Cohort
Individuals 18 years of age or older
Data Source(s)
Sentinel Distributed Database (SDD)
Related Links
Related Link(s)
Gastrointestinal Bleeding Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins"
Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angioensin-Converting Enzyme (ACE) Inhibitors versus Beta-blockers
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins