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Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion

    Basic Details
    Date Posted
    Wednesday, August 29, 2018
    Status
    Complete
    Medical Product
    amiodarone
    sofosbuvir
    Health Outcome(s)
    bradycardia
    pacemaker insertion
    Description

    This report contains the estimated rates of bradycardia and/or pacemaker insertion following use of sofosbuvir and amiodarone. Data from December 6, 2013 to July 15, 2015 from 15 health plans contributing to the Mini-Sentinel Distributed Database (MSDD) were included in this report. This request was distributed to Data Partners on July 29, 2015. 

    Additional Details
    FDA Center
    CDER
    Time Period
    December 6, 2013 - July 15, 2015
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All Individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)