IVIg Product Use and Hemolysis Events

    Basic Details
    Date Posted
    Friday, June 3, 2016
    Status
    Complete
    Medical Product
    flebogamma
    Gammagard
    Gammaplex
    Gamunex
    intravenous immunoglobulin (IVIg)
    Octagam
    Privigen
    Description

    Modular program-based one-time assessment of hemolysis events following new use of IVIg products. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information.  Queries were distributed in January 2014. This report includes data from 18 Data Partners.
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2006 - December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals with no use of IVIg 28 days before or after index date
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)