Skip to main content

IVIg Product Use and Hemolysis Events

    Basic Details
    Date Posted
    Friday, June 3, 2016
    Medical Product
    intravenous immunoglobulin (IVIg)

    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.
    If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by sending an email requesting assistance to
    The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

    Additional Details
    FDA Center
    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)