Anticoagulant Use Among Patients with Atrial Fibrillation

    Basic Details
    Date Posted
    Sunday, January 31, 2016
    Status
    Complete
    Medical Product
    anticoagulant
    dabigatran
    oral formulation of apixaban
    rivaroxaban
    warfarin
    Description

    Modular program-based one-time assessment of anticoagulant use among patients with atrial fibrillation (AF) using Modular Program 6 (MP6) version 7.1. AF patients were stratified by scores depending on the presence of various inclusion criteria (i.e., congestive heart failure, age, diabetes, hypertension, and/or stroke). Nine runs of the Sentinel Cohort Identification and Descriptive Analysis (CIDA) tool were required; click here for more information on CIDA. The time window for this request was January 1, 2006 to June 30, 2014. The package was distributed to three Data Partners in March 2015; this report contains information from three Data Partners. Please see the Specifications tab for more details on each scenario.

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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2006 and June 30, 2014
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals with atrial fibrillation (AF)
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)