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Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    apixaban
    dabigatran
    rivaroxaban
    Health Outcome(s)
    bleeding event
    intracranial hemorrhage
    stroke
    Description

    In this report we compared risk of stroke, intracranial hemorrhage, and bleeding outcomes associated with use of dabigatran, rivaroxaban, and apixaban in those aged 65 years or older in the Sentinel Distributed Database (SDD).

    The study period included data from October 19, 2010 to September 30, 2015. We distributed this request to 1 Data Partner on December 20, 2019.

    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 - September 30, 2015
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 65 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)