Immunoglobulin and Hemolysis 2

    Basic Details
    Date Posted
    Tuesday, June 10, 2014
    Status
    Complete
    Medical Product
    immunoglobulin (Ig)
    Health Outcome(s)
    hemolysis
    Description

    Modular program-based one-time assessment of hemolysis events following new use of several immunoglobulin products among patients with several pre-existing conditions, including primary immune deficiency, chronic inflammatory demyelinating polyneuropathy (CIDP), Kawasaki Disease, idiopathic thrombocytopenic purpura (ITP), Guillain-Barre syndrome (GBS), and myasthenia gravis. 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 3, version 6.0; click here for more information. The queries were distributed in October 2013.   This report includes data from 18 Data Partners.

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