TabsDetailsBasic DetailsDate Posted: Monday, September 14, 2020Status: CompleteMedical Product: allopurinol, direct oral anticoagulant (DOAC), warfarinHealth Outcome(s): cutaneous small-vessel vasculitisDescription: The purpose of this request was to calculate the number of treated patients and time to treatment among patients exposed to either direct oral anticoagulants (DOACs), warfarin, or allopurinol who had a prior diagnosis of atrial fibrillation in the Sentinel Distributed Database (SDD). The outcomes of interest were cutaneous small‐vessel vasculitis (CSVV) followed by a treatment of prednisone or prednisolone or steroid medication within 90 days.The study period included data from October 19, 2010 to December 31, 2018. We distributed this request to 17 Data Partners on February 10, 2020. Read More Deliverables (1)Sentinel Modular Program Report: Cutaneous Small-Vessel Vasculitis following Direct Oral Anticoagulants (DOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: October 19, 2010 - December 31, 2018Study Type: Modular ProgramAssessment Type: Exploratory AnalysesPopulation / Cohort: Individuals 21 years of age and olderData Sources: Sentinel Distributed Database (SDD)Related Links: 2020 ICPE Poster: Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant UseComplementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel VasculitisCutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched AnalysisDirect Oral Anticoagulants (DOACs), Warfarin, Allopurinol, or Propylthiouracil Use in Patients with Cutaneous Small-Vessel Vasculitis: A Descriptive Analysis
