Dronedarone and Electrocardiograms

Project Title Dronedarone and Electrocardiograms
Date Posted
Tuesday, August 16, 2016
Status
Complete
Deliverables
Related Links
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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Medical Product
dronedarone
Health Outcome
electrocardiogram
Population / Cohort
All individuals 18 years of age or older
Time Period
June 13, 2012 - March 30, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER