Dabigatran, Warfarin and GI Bleed, Intracerebral Hemorrhage

Project Title Dabigatran, Warfarin and GI Bleed, Intracerebral Hemorrhage
Date Posted
Friday, May 3, 2013
Project ID
MSY3_MPR31-p2
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of gastrointestinal (GIH) and/or intracerebral hemorrhage (ICH) events following new use of dabigatran or 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.

This report is similar to other modular program reports based on FDA queries concerning dabigatran, warfarin, and gastrointestinal and intracranial hemorrhages. Please refer to each report's specifications sheet for exact parameters.

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Medical Product
dabigatran
warfarin
Health Outcome
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding
Population / Cohort
All individuals with pre-existing atrial fibrillation
Time Period
2010 - 2011
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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