Time Until Guillain-Barré Syndrome or Bell's Palsy Diagnosis following Initiation of Checkpoint Inhibitor Treatment

Basic Details
Date Posted
Friday, January 24, 2020
Status
Complete
Medical Product
atezolizumab
avelumab
durvalumab
ipilimumab
nivolumab
pembrolizumab
Health Outcome(s)
Bell’s palsy
Guillain-Barré syndrome
Description

In this request, we examined the number of checkpoint inhibitor users with a diagnosis of Guillain-Barré syndrome (GBS) or Bell's palsy after drug initiation in the Sentinel Distributed Database (SDD). We also examined the time to GBS or Bell's palsy diagnosis after checkpoint inhibitor initiation among users in the SDD.

We used data from March 1, 2011 to June 30, 2018 from 17 Data Partners contributing to the SDD in this report. We distributed this request to Data Partners on September 25, 2018.

Additional Details
FDA Center
CDER
Time Period
March 1, 2011 - June 30, 2018
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)