Warfarin and GI Bleed, Intracerebral Hemorrhage

Basic Details
Date Posted
Friday, May 3, 2013
Status
Complete
Medical Product
warfarin
Health Outcome(s)
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding
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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Additional Details
FDA Center
CDER
Time Period
2008 - 2009
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
All individuals with pre-existing atrial fibrillation
Data Sources
Mini-Sentinel Distributed Database (MSDD)