Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis

Project Title Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis
Date Posted
Friday, February 15, 2019
Project ID
cder_mpl2p_wp009
Status
In progress
Deliverables
Sentinel Analytic Package: Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis
Related Links
Gastrointestinal Bleed Algorithm Defined in "Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis"
Intracranial Hemorrhage Algorithm Defined in "Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis"
Ischemic Stroke Algorithm Defined in "Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis"
Description

This analysis investigates the risk of stroke, gastrointestinal bleeding, and intracranial hemorrhage for patients with non-valvular atrial fibrillation treated with apixaban compared to warfarin in the Sentinel Distributed Database.

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.

Medical Product
apixaban
Health Outcome
gastrointestinal (GI) bleed
intracranial hemorrhage
stroke
Population / Cohort
Individuals 21 years of age and older
Time Period
December 28, 2012 - January 22, 2019
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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