Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion

Details

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.

Deliverables (1)

Mini-Sentinel Modular Program Report: Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion

Additional Information

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)