TabsDetailsBasic DetailsDate Posted: Thursday, January 10, 2013Status: CompleteMedical Product: efalizumab, natalizumabHealth 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.If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer. Read More Deliverables (1)Mini-Sentinel Modular Program Report: Natalizumab Efalizumab PML 1Additional InformationAdditional DetailsFDA Center: CDERTime Period: 2003 - 2011Study Type: Modular ProgramAssessment Type: Exploratory AnalysesData Sources: Mini-Sentinel Distributed Database (MSDD)
