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Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 64 and Younger with Atrial Fibrillation: A Propensity Score Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
apixaban
dabigatran
non-vitamin K antagonist oral anticoagulants
rivaroxaban
Health Outcome(s)
gastrointestinal bleeding
intracranial hemorrhage
major extracranial bleeding
thromboembolic stroke
Description

This analysis investigates the comparative risk of thromboembolic stroke, intracranial hemorrhage, gastrointestinal bleeding, and major extracranial bleeding outcomes among dabigatran, rivaroxaban, and apixaban users aged under 65 years with non-valvular atrial fibrillation in the Sentinel Distributed Database (SDD).

The study period included data from October 19, 2010 to February 29, 2020.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Deliverables (2)
Sentinel Analytic Package: Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 64 and Younger: A PSM Analysis Sentinel Modular Program Report: Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 64 or Younger: A PSM Analysis
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - February 29, 2020
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 21 to 64 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Thromboembolic Stroke Algorithm Defined in "Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use: A Propensity Score Matched Analysis"
Intracranial Hemorrhage Algorithm Defined in "Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use: A Propensity Score Matched Analysis"
Gastrointestinal Bleeding Algorithm Defined in "Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use: A Propensity Score Matched Analysis"
Major Extracranial Bleeding Algorithm Defined in "Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use: A Propensity Score Matched Analysis"
Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis
Sentinel Drug Assessment: Eliquis (apixaban), Pradaxa (dabigatran), and Xarelto (rivaroxaban) & Gastrointestinal Bleeding, Intracranial Hemorrhage, Major Extracranial Bleeding, and Thromboembolic Stroke