Warfarin and GI Bleed, Intracerebral Hemorrhage

Project Title Warfarin and GI Bleed, Intracerebral Hemorrhage
Date Posted
Friday, May 3, 2013
Project ID
MSY3_MPR31-p3
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of gastrointestinal (GIH) and/or intracerebral hemorrhage (ICH) events following new use of warfarin among patients with a pre-existing condition of atrial fibrillation in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Programs were executed in June 2012.

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Medical Product
warfarin
Health Outcome
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding
Population / Cohort
All individuals with pre-existing atrial fibrillation
Time Period
2008 - 2009
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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