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Multiple Sclerosis Relapses among Copaxone, Glatopa, Gilenya, and Glatiramer Users

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    Copaxone
    Gilenya
    glatiramer
    Glatopa
    Health Outcome(s)
    multiple sclerosis relapse
    Description

    The goals of this request were to 1) estimate the rate of multiple sclerosis (MS) relapses among Copaxone, Glatopa, Gilenya, and glatiramer users and 2) compare MS relapse algorithms in the Sentinel Distributed Database (SDD). Data from September 21, 2010 to January 31, 2018 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed on June 26, 2018.

    Additional Details
    FDA Center
    CDER
    Time Period
    September 21, 2010 - January 31, 2018
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 18 to 64 years of age
    Data Sources
    Sentinel Distributed Database (SDD)