Warfarin and GI Bleed, Intracerebral Hemorrhage

Basic Details
Date Posted
Friday, May 3, 2013
Medical Product
Health Outcome(s)
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding

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.

If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.

The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

Additional Details
FDA Center
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)