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Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion

Basic Details
Date Posted
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. 

Deliverables (1)
Mini-Sentinel Modular Program Report: Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion
Additional Details
FDA Center
CDER
Time Period
December 6, 2013 - July 15, 2015
Analysis Type
Descriptive
Population / Cohort
All Individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Related Links
Boceprevir, Ledipasivir/Sofosbuvir, Simeprevir Sodium, Sofosbuvir, and Telaprevir Use