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Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis

    Basic Details
    Date Posted
    Status
    In progress
    Medical Product
    apixaban
    dabigatran
    non-vitamin K antagonist oral anticoagulants
    rivaroxaban
    Health Outcome(s)
    gastrointestinal bleeding
    intracranial hemorrhage
    major extracranial bleeding
    thromboembolic stroke
    Description

    This analysis investigates the comparative risk of thromboembolic stroke, intracranial hemorrhage, gastrointestinal bleeding, and major extracranial bleeding outcomes among dabigatran, rivaroxaban, and apixaban users aged under 65 years with non-valvular atrial fibrillation in the Sentinel Distributed Database (SDD).

    The study period included data from October 19, 2010 to February 29, 2020.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    CDER
    Time Period
    October 19, 2010 - February 29, 2020
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 21 to 64 years of age
    Data Sources
    Sentinel Distributed Database (SDD)