Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion

Project Title Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion
Date Posted
Wednesday, August 29, 2018
Project ID
to16_cap_mpl1r_wp034_nsdp_v01
Status
Complete
Deliverables
Related Links
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. 

Medical Product
amiodarone
sofosbuvir
Health Outcome
bradycardia
pacemaker insertion
Population / Cohort
All Individuals
Time Period
December 6, 2013 - July 15, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER