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Immunoglobulin Products and Hemolysis

    Basic Details
    Date Posted
    Medical Product
    immunoglobulin (Ig)
    Health Outcome(s)

    Report 1 is a modular program-based one-time assessment of the use of intravenous immunoglobulin products and subsequent diagnosis of hemolysis among patients with Primary Immunodeficiency, CIDP, Kawasaki Disease, ITP, Myasthenia Gravis, and Guillain-Barre Syndrome. 

    Report 2 is a modular program-based one-time assessment of the use of several immunoglobulin (Ig) products and diagnosis of hemolysis events within 2, 7, and 14 days of Ig injection. 

    The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to March 31, 2014.  Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Descriptive Analysis (CIDA) tool; click here for more information.  Queries were distributed in August 2014. This report includes data from 15 Data Partners.
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    Additional Details
    FDA Center
    Time Period
    January 1, 2006 - March 31, 2014
    Analysis Type
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)