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Seizures Following Gadolinium-Based Contrast Agents Exposure: A Self-Controlled Risk Interval Analysis

    Basic Details
    Date Posted
    Medical Product
    gadolinium-based contrast agents (GBCA)
    Health Outcome(s)

    In this request, we estimated the number of individuals exposed to magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) and among them, the number who had a seizure that occurred during specified risk and control windows.

    The study period includes data from January 1, 2008 to November 30, 2016. We distributed this request to 15 Sentinel Data Partners on May 26, 2017.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    Time Period
    January 1, 2008 - November 30, 2016
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 2 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)