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Warfarin and GI Bleed, Intracerebral Hemorrhage

    Basic Details
    Date Posted
    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
    Analysis Type
    Mini-Sentinel
    Population / Cohort
    All individuals with pre-existing atrial fibrillation
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)