Project Title | Immunoglobulin and Hemolysis 3 |
Date Posted |
Tuesday, June 10, 2014 |
Project ID |
MSY5_MPR03 |
Status |
Complete |
Deliverables | |
Description |
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. |
Medical Product |
immunoglobulin (Ig) |
Health Outcome |
hemolysis |
Time Period |
2006 - 2012 |
Assessment Type |
Exploratory Analyses |
Study Type |
Modular Program |
Data Sources |
Mini-Sentinel Distributed Database (MSDD) |
FDA Center |
CBER |