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Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
apixaban
dabigatran
rivaroxaban
warfarin
Health Outcome(s)
severe uterine bleed
Description

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.
Deliverables (2)
Sentinel Modular Program Report: Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis, Report 1 Sentinel Modular Program Report: Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - September 30, 2015
Analysis Type
Descriptive
Population / Cohort
Females
Data Sources
Sentinel Distributed Database (SDD)
Related Links
ICPE 2020: Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant Use
Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis
Incidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System
Sentinel Drug Assessment: Eliquis (apixaban), Pradaxa (dabigatran), and Xarelto (rivaroxaban) & Severe Uterine Bleed
Incidence Rate of Severe Uterine Bleeding Among New Users of Oral Anticoagulants: A Descriptive Analysis
Incidence of Severe Uterine Bleeding Outcomes among Oral Anticoagulant Users and Nonusers