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Occurrence of Stroke, Intracranial Hemorrhage, and Bleeding Outcomes Following Direct Oral Anticoagulant Use in Patients Aged 64 or Younger with Atrial Fibrillation: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    apixaban
    dabigatran
    edoxaban
    rivaroxaban
    Health Outcome(s)
    gastrointestinal bleeding
    intracranial hemorrhage
    major extracranial bleeding
    thromboembolic stroke
    Description

    In this report, we compared risk of thromboembolic stroke, intracranial hemorrhage, major extracranial bleeding, and gastrointestinal bleeding outcomes associated with the use of dabigatran, edoxaban, rivaroxaban, and apixaban in those aged 64 years or younger with atrial fibrillation in the Sentinel Distributed Database (SDD). 

    The study period includes data from October 19, 2010 to September 30, 2019. We distributed this request to 15 Sentinel Data Partners on February 26, 2020.

    Additional Details
    FDA Center
    CDER
    Time Period
    October 19, 2010 - September 30, 2019
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 64 years of age and younger
    Data Sources
    Sentinel Distributed Database (SDD)