Algorithms Evaluating Dabigatran Use and Acute Myocardial Infarction Compared with Warfarin

Basic Details
Date Posted
Thursday, August 23, 2018
Status
Complete
Medical Product
dabigatran
warfarin
Health Outcome(s)
acute myocardial infarction (AMI)
Description

These reports evaluated varying methods of stockpiling and censoring algorithms in the association between dabigatran and acute myocardial infarction, with warfarin as the comparison exposure. These queries were distributed on November 13, 2015 to 8 Data Partners using the Sentinel Distributed Query Tool; this report includes results from 8 Data Partners. 

Additional Details
FDA Center
CDER
Time Period
November 1, 2010 - May 31, 2014
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
All individuals 21 years of age and older
Data Sources
Mini-Sentinel Distributed Database (MSDD)