Immunoglobulin and Hemolysis 3

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.

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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