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Algorithms Evaluating Dabigatran Use and Acute Myocardial Infarction Compared with Warfarin

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    dabigatran
    warfarin
    Health Outcome(s)
    acute myocardial infarction (AMI)
    Description

    These reports evaluated varying methods of stockpiling and censoring algorithms in the association between dabigatran and acute myocardial infarction, with warfarin as the comparison exposure. These queries were distributed on November 13, 2015 to 8 Data Partners using the Sentinel Distributed Query Tool; this report includes results from 8 Data Partners. 

    Additional Details
    FDA Center
    CDER
    Time Period
    November 1, 2010 - May 31, 2014
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    All individuals 21 years of age and older
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)