Ischemic Stroke, Intracranial Hemorrhage, and Gastrointestinal Hemorrhage Among New Users of Apixaban and Warfarin

Project Title Ischemic Stroke, Intracranial Hemorrhage, and Gastrointestinal Hemorrhage Among New Users of Apixaban and Warfarin
Date Posted
Wednesday, July 10, 2019
Project ID
cder_mpl1r_wp056
Status
Complete
Deliverables
Description

This analysis obtained counts of new users of apixaban and warfarin among patients in the Sentinel Distributed Database (SDD). This analysis also examined incidence rates of ischemic stroke, intracranial hemorrhage, and gastrointestinal hemorrhage among new users of apixaban compared to new users of warfarin with non-valvular atrial fibrillation in the SDD. Data from February 1, 2013 to August 31, 2017 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed to Data Partners on February 1, 2018.

Medical Product
apixaban
warfarin
Health Outcome
gastrointestinal hemorrhage
intracranial hemorrhage
ischemic stroke
Population / Cohort
Individuals 21 years of age or older
Time Period
February 1, 2013 - August 31, 2017
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER