Algorithms Evaluating Dabigatran Use and Acute Myocardial Infarction Compared with Warfarin

Project Title Algorithms Evaluating Dabigatran Use and Acute Myocardial Infarction Compared with Warfarin
Date Posted
Thursday, August 23, 2018
Project ID
cder_mpl2r_wp001_nsdp_v01
Status
Complete
Deliverables
Related Links
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. 

Medical Product
dabigatran
warfarin
Health Outcome
acute myocardial infarction (AMI)
Population / Cohort
All individuals 21 years of age and older
Time Period
November 1, 2010 - May 31, 2014
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER