Natalizumab, Efalizumab, and Progressive Multifocal Leukoencephalopathy (PML)

Project Title Natalizumab, Efalizumab, and Progressive Multifocal Leukoencephalopathy (PML)
Date Posted
Thursday, January 10, 2013
Project ID
MSY3_MPR16
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of the risk of progressive multifocal leukoencephalopathy (PML) associated with use of natalizumab and efalizumab in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs. Queries were executed in May 2012.

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Medical Product
efalizumab
natalizumab
Health Outcome
progressive multifocal leukoencephalopathy (PML)
Time Period
2003 - 2011
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER