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

Basic Details
Date Posted
Status
Complete
Medical Product
apixaban
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
stroke
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 study period included data from December 28, 2012 to June 30, 2018. We distributed this request to 8 Data Partners on January 22, 2019. This request includes two reports:

  • Report 1: In this report, analyses were restricted to Data Partners 1-7 of 8.
  • Report 2: In this report, analyses were restricted to Data Partner 8 of 8.

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 (3)
Sentinel Modular Program Report: Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis, Report 1 Sentinel Modular Program Report: Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis, Report 2 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
Additional Details
FDA Center
CDER
Time Period
December 28, 2012 - June 30, 2018
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 21 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Eliquis (Apixaban) & Gastrointestinal (GI) Bleed, Intracranial Hemorrhage, and Stroke
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"
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"
ICPE 2020: Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel System
Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin