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

Project Title Time Until Guillain-Barré Syndrome or Bell's Palsy Diagnosis following Initiation of Checkpoint Inhibitor Treatment
Date Posted
Friday, January 24, 2020
Project ID
cder_mpl1r_wp118
Status
Complete
Deliverables
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.

Medical Product
atezolizumab
avelumab
durvalumab
ipilimumab
nivolumab
pembrolizumab
Health Outcome
Bell’s palsy
Guillain-Barré syndrome
Population / Cohort
All individuals
Time Period
March 1, 2011 - June 30, 2018
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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