Anticoagulants and Bleeding Events

    Basic Details
    Date Posted
    Friday, May 20, 2016
    Status
    Complete
    Medical Product
    anticoagulant
    dabigatran
    warfarin
    Health Outcome(s)
    bleeding event
    Description

    Modular program-based one-time assessment of exposure to two anticoagulant medications and bleeding events with and without a pre-existing condition of atrial fibrillation (ICD-9-CM 427.31). The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information.  Queries were distributed in July 2013. This report includes data from 18 Data Partners.

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    Additional Details
    FDA Center
    CDER
    Time Period
    October 19, 2010 - December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)