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Same Day Seizures following Gadolinium Based Contrast Agents: A Self-Controlled Risk Interval Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    gadolinium-based contrast agent (GBCA)
    Health Outcome(s)
    seizure
    Description

    This request contains the estimated number of individuals with a magnetic resonance imaging (MRI) procedure, and among them, the number who had a seizure that occurred during specified risk and control windows. Gadolinium-based contrast agents (GBCA) define contrast in this request.

    • Report 1 contains estimated numbers of individuals with MRI procedures. The study period includes data from January 1, 2008 to September 30, 2015.
    • Report 2 contains baseline characteristics of individuals with MRI procedures. The study period includes data from January 1, 2008 to July 31, 2015.

    We distributed this request to 13 Sentinel Data Partners on November 23, 2016.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2008 - September 30, 2015
    Analysis Type
    Custom Code
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)