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Occurrence of Stroke, Intracranial Hemorrhage, and Bleeding Outcomes Following Direct Oral Anticoagulant Use in Patients with Atrial Fibrillation: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
apixaban
dabigatran
edoxaban
rivaroxaban
Health Outcome(s)
gastrointestinal bleeding
intracranial hemorrhage
major extracranial bleeding
thromboembolic stroke
Description

In this report, we compared risk of thromboembolic stroke, intracranial hemorrhage, major extracranial bleeding, and gastrointestinal bleeding outcomes associated with the use of dabigatran, edoxaban, rivaroxaban, and apixaban in those aged 64 years or younger with atrial fibrillation in the Sentinel Distributed Database (SDD). 

The study period includes data from October 19, 2010 to September 30, 2019. We distributed this request to 15 Sentinel Data Partners on February 26, 2020.

Deliverables (1)
Sentinel Modular Program Report: Occurrence of Stroke, Intracranial Hemorrhage, and Bleeding Outcomes Following Direct Oral Anticoagulant Use in Patients with Atrial Fibrillation: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - September 30, 2019
Analysis Type
Descriptive
Population / Cohort
Individuals 64 years of age and younger
Data Sources
Sentinel Distributed Database (SDD)