TabsDetailsBasic DetailsDate Posted: Wednesday, April 17, 2019Status: CompleteMedical Product: apixaban, dabigatran, novel oral anticoagulant (NOAC), rivaroxaban, warfarinHealth Outcome(s): severe uterine bleedDescription: This analysis investigates the risk of severe uterine bleed for patients treated with Novel Oral Anticoagulants (NOACs) (including Rivaroxaban, Dabigatran, Apixaban), and Warfarin in the Sentinel Distributed Database. This request includes two reports:Report 1: This request was distributed to Data Partners on October 11, 2017.Report 2: This analysis is an update to the previous request, including new indication covariates, redefined age groups, and revisions to the propensity score stratification analysis. This request was distributed to Data Partners on December 30, 2019.The analytic packages 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 (3)Sentinel Modular Program Report: Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Matched Analysis, Report 1Sentinel Modular Program Report: Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Stratified Analysis, Report 2Sentinel Analytic Packages: Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: October 19, 2010 - September 30, 2015Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: All femalesData Sources: Sentinel Distributed Database (SDD)Related Links: Severe Uterine Bleed with Surgical Management Algorithm Defined in "Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis"Severe Uterine Bleed with Transfusion Management Algorithm Defined in "Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis"ICPE 2020: Comparative Risk Assessment of Severe Abnormal Uterine Bleeding associated with Non-Vitamin K Oral AnticoagulantsIncidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis