Dronedarone and Electrocardiograms

    Basic Details
    Date Posted
    Monday, August 15, 2016
    Status
    Complete
    Medical Product
    dronedarone
    Health Outcome(s)
    electrocardiogram
    Description

    Modular program-based one-time assessment of the number of electrocardiograms following new exposure to dronedarone among individuals 18 and older. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of June 13, 2012 to March 3, 2015. Modular programs are adaptable standardized programs. Results were generated using Modular Program 6; click here for more information. Queries were distributed in May 2015. This report includes data from 15 Data Partners. 
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    June 13, 2012 - March 30, 2015
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals 18 years of age and older
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)