TabsDetailsBasic DetailsDate Posted: Monday, September 14, 2020Status: CompleteMedical Product: apixaban, dabigatran, rivaroxabanHealth Outcome(s): bleeding eventintracranial hemorrhagestrokeDescription: 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 Partner on December 20, 2019. Read More Deliverables (2)Sentinel Modular Program Report: Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched AnalysisSentinel Analytic Package: Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: October 19, 2010 - September 30, 2015Assessment Type: Exploratory AnalysesPopulation / Cohort: Individuals 65 years of age and olderData Sources: Sentinel Distributed Database (SDD)Related Links: Gastrointestinal Bleeding Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"Thromboembolic Stroke Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"Intracranial Hemorrhage Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"Major Extracranial Bleeding Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"ICPE 2020: Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel SystemThromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis
