Details
Modular program-based one-time assessment of hemolysis events following new use of several immunoglobulin products, including Flebogamma, Gammagard liquid, Gammaplex, Gamunex, Octagam, Privigen, Lyophilized product IV, Non-lyophilized intramuscular, Non-lyophilized unspecified route, and other intravenous immunoglobulin (IVIg) products. The query was run against the Mini-Sentinel Distributed Database for the time period of January 1, 2006- December 31, 2012. Modular programs are adaptable standardized programs. Results were generated using Modular Program 6, version 6.0; click here for more information. The queries were distributed to 18 Data Partners in October 2013.
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.