TabsDetailsBasic DetailsDate Posted: Monday, August 24, 2020Status: CompleteMedical Product: apixaban, dabigatran, rivaroxaban, warfarinHealth Outcome(s): severe uterine bleedDescription: The objective of this request was to investigate severe uterine bleeding (SUB) among new users of oral anticoagulants (rivaroxaban, apixaban, dabigatran, and warfarin) in the Sentinel Distributed Database (SDD). We included new users between October 19, 2010 and September 30, 2015 from 17 Data Partners contributing to the Sentinel Distributed Database (SDD) in this report. This request was distributed on September 17, 2019. Read More Deliverables (1)Sentinel Modular Program Report: Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: October 19, 2010 - September 30, 2015Study Type: Modular ProgramAssessment Type: Exploratory AnalysesPopulation / Cohort: FemalesData Sources: Sentinel Distributed Database (SDD)Related Links: 2020 ICPE Poster: Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant UseSevere Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis
