Use of Dabigatran and Intracranial Hemorrhage, Gastrointestinal Hemorrhage, Ischemic Stroke, and Acute Myocardial Infarction

Project Title Use of Dabigatran and Intracranial Hemorrhage, Gastrointestinal Hemorrhage, Ischemic Stroke, and Acute Myocardial Infarction
Date Posted
Friday, August 17, 2018
Project ID
to16_cap_mpl2r_wp005_nsdp_v02, to16_cap_mpl2r_wp007_nsdp_v02
Status
Complete
Deliverables
Related Links
Description

These reports contain evaluations of the association between dabigatran and various outcomes, with warfarin as the comparison. The outcomes of interest include intracranial hemorrhage, gastrointestinal hemorrhage, ischemic stroke, and acute myocardial infarction. The reports display data on individuals 21 years of age and older and on individuals 65 years of age and older. Additionally, each dabigatran and outcome pair was assessed with a 183-day washout period and a 365-day washout period. See the specific deliverables for what is contained in each report. These queries were distributed to Data Partners in July 2015, and they contain data between November 1, 2010 through December 31, 2013 from the Mini-Sentinel Distribtued Database.

Medical Product
dabigatran
Health Outcome
acute myocardial infarction (AMI)
gastrointestinal hemorrhage
intracranial hemorrhage
ischemic stroke
Population / Cohort
Individuals 21 years of age and older; individuals 65 years of age and older
Time Period
November 1, 2010 - December 31, 2013
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database
FDA Center
CDER