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IVIg Exposure and Renal Failure

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    intravenous immunoglobulin (IVIg)
    Health Outcome(s)
    acute kidney failure
    acute renal failure
    Description

    Modular program-based one-time assessment of IVIg and subsequent diagnosis of acute renal failure and transfusion procedures among patients with and without a new hemolysis diagnosis after exposure to IVIg. 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 6.0; click here for more information.  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
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)