Immunoglobulin Products and Hemolysis

    Basic Details
    Date Posted
    Wednesday, July 6, 2016
    Status
    Complete
    Medical Product
    immunoglobulin (Ig)
    Health Outcome(s)
    hemolysis
    Description

    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
    CDER
    Time Period
    January 1, 2006 - March 31, 2014
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)