Immunoglobulin and Hemolysis 1

    Basic Details
    Date Posted
    Tuesday, June 10, 2014
    Status
    Complete
    Medical Product
    flebogamma
    Gammagard
    Gammaked
    Gammaplex
    Gamunex
    Gamunex-C
    Hizentra
    immunoglobulin (Ig)
    Octagam
    Privigen
    vivaglobin
    Health Outcome(s)
    hemolysis
    Description

    Modular program-based one-time assessment of several immunoglobulin (Ig) product groups (subcutaneous Ig, other branded intravenous immunoglobulin (IVIg), other IVIg, and intramuscular Ig) and hemolysis.  The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 through December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 6, version 5.0.1; click here for more information. The query was distributed in August 2013.  These reports include data from 18 Data Partners.

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    Additional Details
    FDA Center
    CBER
    Time Period
    January 1, 2006 - December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)