|Project Title||Dabigatran, Warfarin and GI Bleed, Intracerebral Hemorrhage|
Friday, May 3, 2013
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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intracerebral hemorrhage (ICH)
|Population / Cohort|
All individuals with pre-existing atrial fibrillation
2010 - 2011
Mini-Sentinel Distributed Database (MSDD)