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Use of Dabigatran and Intracranial Hemorrhage, Gastrointestinal Hemorrhage, Ischemic Stroke, and Acute Myocardial Infarction

    Basic Details
    Date Posted
    Medical Product
    Health Outcome(s)
    acute myocardial infarction (AMI)
    gastrointestinal hemorrhage
    intracranial hemorrhage
    ischemic stroke

    These reports contain evaluations of the association between dabigatran and various outcomes, with warfarin as the comparison. The outcomes of interest include intracranial hemorrhage, gastrointestinal hemorrhage, ischemic stroke, and acute myocardial infarction. The reports display data on individuals 21 years of age and older and on individuals 65 years of age and older. Additionally, each dabigatran and outcome pair was assessed with a 183-day washout period and a 365-day washout period. See the specific deliverables for what is contained in each report. These queries were distributed to Data Partners in July 2015, and they contain data between November 1, 2010 through December 31, 2013 from the Mini-Sentinel Distribtued Database.

    Additional Details
    FDA Center
    Time Period
    November 1, 2010 - December 31, 2013
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 21 years of age and older; individuals 65 years of age and older
    Data Sources
    Mini-Sentinel Distributed Database