TabsDetailsBasic DetailsDate Posted: Monday, November 9, 2020Status: CompleteMedical Product: apixaban, dabigatran, rivaroxaban, warfarinHealth Outcome(s): severe uterine bleedDescription: The objective of this analysis was to investigate severe uterine bleeding (SUB) among new users of oral anticoagulants (rivaroxaban, apixaban, dabigatran, and warfarin) in the Sentinel Distributed Database (SDD). This analysis includes two reports:Report 1: We included new users from October 19, 2010 to September 30, 2015. We distributed the request to 17 Data Partners on September 17, 2019.Report 2: We obtained background incidence of SUB outcomes for the previous request (Report 1) from the SDD. The study period included data from October 19, 2010 to September 30, 2015. We distributed the request to 16 Data Partners on March 11, 2020. Read More Deliverables (2)Sentinel Modular Program Report: Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis, Report 1Sentinel Modular Program Report: Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis, Report 2Additional 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: ICPE 2020: Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant UseSevere Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score AnalysisIncidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System