Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Matched Analysis

Project Title Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Matched Analysis
Date Posted
Thursday, April 18, 2019
Project ID
cder_mpl2p_wp007
Status
In progress
Deliverables
Sentinel Analytic Package: Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Matched Analysis
Related Links
Severe Uterine Bleed with Surgical Management Algorithm Defined in "Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Matched Analysis"
Severe Uterine Bleed with Transfusion Management Algorithm Defined in "Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Matched Analysis"
Description

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.

The analytic package 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.

Medical Product
apixaban
dabigatran
novel oral anticoagulant (NOAC)
rivaroxaban
warfarin
Health Outcome
severe uterine bleed
Population / Cohort
All females
Time Period
October 19, 2010 - September 30, 2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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