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Ischemic Stroke, Intracranial Hemorrhage, and Gastrointestinal Hemorrhage Among New Users of Apixaban and Warfarin

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    apixaban
    warfarin
    Health Outcome(s)
    gastrointestinal hemorrhage
    intracranial hemorrhage
    ischemic stroke
    Description

    This analysis obtained counts of new users of apixaban and warfarin among patients in the Sentinel Distributed Database (SDD). This analysis also examined incidence rates of ischemic stroke, intracranial hemorrhage, and gastrointestinal hemorrhage among new users of apixaban compared to new users of warfarin with non-valvular atrial fibrillation in the SDD. Data from February 1, 2013 to August 31, 2017 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed to Data Partners on February 1, 2018.

    Additional Details
    FDA Center
    CDER
    Time Period
    February 1, 2013 - August 31, 2017
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 21 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)