Cutaneous Small Vessel Vasculitis and Acute Kidney Injury Following Direct-Acting Oral Anticoagulant Use

Project Title Cutaneous Small Vessel Vasculitis and Acute Kidney Injury Following Direct-Acting Oral Anticoagulant Use
Date Posted
Monday, September 16, 2019
Project ID
cder_mpl1r_wp102
Status
Complete
Deliverables
Related Links
Description

In this report, we investigated counts of cutaneous small vessel vasculitis (CSVV) diagnoses in patients without prior autoimmune disease who had prior direct-acting oral anticoagulant (DOAC) exposure or diagnosis of atrial fibrillation. We additionally evaluated counts of acute kidney injury (AKI) diagnoses among patients with prior DOAC exposure in the Sentinel Distributed Database (SDD). We included in this report data from January 1, 2010 to June 30, 2018 from 17 Data Partners contributing to the SDD. This request was distributed on December 11, 2018.

Medical Product
direct-acting oral anticoagulant
Health Outcome
acute kidney injury
cutaneous small vessel vasculitis
Population / Cohort
Individuals 30 years of age or older
Time Period
January 1, 2010 - June 30, 2018
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER