Anti-D, Dexamethasone, Prednisone, Romiplostim and Hemolysis

    Basic Details
    Date Posted
    Tuesday, June 10, 2014
    Status
    Complete
    Medical Product
    anti-D
    dexamethasone
    prednisone
    romiplostim
    Health Outcome(s)
    hemolysis
    Description

    Modular program-based one-time assessment of anti-D, dexamethasone, prednisone, and romiplostim and subsequent new diagnoses of hemolysis among patients with a pre-existing condition of idiopathic thrombocytopenic purpura (ITP).  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. The queries were distributed in October 2013.  This report includes 18 Data Partners in October 2013.

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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2006-December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Pre-existing idiopathic thrombocytopenic purpura
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)