TabsDetailsBasic DetailsDate Posted: Thursday, February 4, 2021Status: CompleteMedical Product: apixaban, dabigatran, direct oral anticoagulant (DOAC), rivaroxaban, warfarinHealth Outcome(s): cutaneous small-vessel vasculitisDescription: This analysis investigates the risk of cutaneous small-vessel vasculitis (CSVV) associated with the use of dabigatran, rivaroxaban, apixaban, and warfarin among patients with atrial fibrillation in the Sentinel Distributed Database (SDD).The study period includes data from October 19, 2010 to February 29, 2020. We distributed this request to 16 Data Partners on September 15, 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. Read More Deliverables (2)Sentinel Analytic Package: Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched AnalysisSentinel Modular Program Report: Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: October 19, 2010 - February 29, 2020Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Individuals aged 21 to 99 yearsData Sources: Sentinel Distributed Database (SDD)Related Links: Cutaneous Small-Vessel Vasculitis Algorithm Defined in "Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use: A Propensity Score Matched Analysis"Cutaneous Small-Vessel Vasculitis following Direct Oral Anticoagulants (DOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis
