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Incidence Rate of Severe Uterine Bleeding Among New Users of Oral Anticoagulants: A Descriptive Analysis

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

The goal of this query was to investigate the incidence rate of serious uterine bleeding (SUB) among new users of oral anticoagulants (rivaroxaban, apixaban, dabigatran, and warfarin) in preparation for a risk assessment amongst warfarin and novel oral anticoagulants (NOACs) in the Sentinel Distributed Database (SDD).

The study period includes data from October 19, 2010 to September 30, 2015. We distributed this request to 16 Data Partners on October 11, 2017.

Deliverables (1)
Sentinel Modular Program Report: Incidence Rate of Severe Uterine Bleeding Among New Users of Oral Anticoagulants: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - September 30, 2015
Analysis Type
Descriptive
Population / Cohort
All females
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis
Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis
Sentinel Drug Assessment: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Severe Uterine Bleed