A Protocol for Assessment of Dabigatran and Selected Safety Outcomes

    Basic Details
    Date Posted
    Friday, January 26, 2018
    Status
    Complete
    Medical Product
    dabigatran
    warfarin
    Health Outcome(s)
    intracranial hemorrhage
    ischemic stroke
    major extracranial hemorrhage
    Description

    This protocol will guide a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

    This protocol was posted for public comment from December 30, 2013 through January 13, 2014. The public comment period is now closed. Revised versions were approved for implementation by FDA on March 18, 2014, and March 27, 2015. A log of changes is included in the revised protocol (v3.0).

    Additional Details
    FDA Center
    CDER
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    Population / Cohort
    Adults with diagnosed non-valvular atrial fibrillation
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Alan S. Go MD; Division of Research, Kaiser Permanente Northern California, Oakland, CA 

    Joshua Gagne PharmD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 

    Marsha Reichman PhD; David Graham MD, MPH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD 

    Workgroup Members

    Daniel Singer MD; Medicine Division, Massachusetts General Hospital, Boston, MA

    T. Craig Cheetham PharmD, MS; Kaiser Permanente Southern California, Downey, CA

    Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Mary Ross Southworth PharmD; Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD

    Rongmei Zhang PhD; Yu-te Wu PhD; Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD

    Monika Houstoun PharmD; Katrina Mott MS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD