Warfarin and GI Bleed, Intracerebral Hemorrhage

    Basic Details
    Date Posted
    Friday, May 3, 2013
    Medical Product
    Health Outcome(s)
    gastrointestinal hemorrhage
    intracerebral hemorrhage (ICH)
    serious bleeding

    Modular program-based one-time assessment of gastrointestinal (GIH) and/or intracerebral hemorrhage (ICH) events following new use of warfarin among patients with a pre-existing condition of atrial fibrillation in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Programs were executed in June 2012.

    If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.

    The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

    Additional Details
    FDA Center
    Time Period
    2008 - 2009
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals with pre-existing atrial fibrillation
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)