Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis

Project Title Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis
Date Posted
Tuesday, September 15, 2020
Project ID
cder_mpl2p_wp017
Status
Complete
Deliverables
Related Links
Description

In this report we compared risk of stroke, intracranial hemorrhage, and bleeding outcomes associated
with use of dabigatran, rivaroxaban, and apixaban in those aged 65 years or older in the Sentinel Distributed Database (SDD).

The study period included data from October 19, 2010 to September 30, 2015. We distributed this request to 1 Data PartnerĀ on December 20, 2019.

Medical Product
apixaban
dabigatran
rivaroxaban
Health Outcome
bleeding event
intracranial hemorrhage
stroke
Population / Cohort
Individuals 65 years of age and older
Time Period
October 19, 2010 - September 30, 2015
Assessment Type
Exploratory Analyses
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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