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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.

Deliverables (2)
Sentinel Modular Program Report: Same Day Seizures following Gadolinium Based Contrast Agents: A Self-Controlled Risk Interval Analysis, Report 1 Sentinel Modular Program Report: Same Day Seizures following Gadolinium Based Contrast Agents: A Self-Controlled Risk Interval Analysis, Report 2
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)
Related Links
Sentinel Drug Study: Gadolinium-Based Contrast Agents & Seizure