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

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

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.

Deliverables (2)
Sentinel Modular Program Report: Seizures Following Gadolinium-Based Contrast Agents Exposure: A Self-Controlled Risk Interval Analysis Sentinel Analytic Package: Seizures Following Gadolinium-Based Contrast Agents Exposure: A Self-Controlled Risk Interval Analysis
Additional Details
FDA Center
CDER
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)
Related Links
Seizure Algorithm Defined in "Seizures Following Gadolinium-Based Contrast Agents Exposure: A Self-Controlled Risk Interval Analysis"