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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.

Deliverables (1)
Sentinel Modular Program Report: Multiple Sclerosis Relapses among Copaxone, Glatopa, Gilenya, and Glatiramer Users
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)