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Natalizumab, Efalizumab, and Progressive Multifocal Leukoencephalopathy (PML)

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    efalizumab
    natalizumab
    Health Outcome(s)
    progressive multifocal leukoencephalopathy (PML)
    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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    Additional Details
    FDA Center
    CDER
    Time Period
    2003 - 2011
    Analysis Type
    Mini-Sentinel
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)