| 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. 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. |
| 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 |
