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

Basic Details
Date Posted
Tuesday, May 18, 2021
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.

Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - September 30, 2015
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
All females
Data Sources
Sentinel Distributed Database (SDD)