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

    Basic Details
    Date Posted
    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
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)