TabsDetailsBasic DetailsDate Posted: Thursday, February 14, 2019Status: CompleteMedical Product: apixabanHealth Outcome(s): gastrointestinal (GI) bleedintracranial hemorrhagestrokeDescription: 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. Read More 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 1Sentinel 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 2Sentinel Analytic Package: Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: December 28, 2012 - June 30, 2018Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Individuals 21 years of age and olderData Sources: Sentinel Distributed Database (SDD)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"ICPE 2020: Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel SystemRisk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin