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

Project Title Same Day Seizures following Gadolinium Based Contrast Agents: A Self-Controlled Risk Interval Analysis
Date Posted
Friday, September 11, 2020
Project ID
cder_ahr_wp007
Status
Complete
Deliverables
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.

Medical Product
gadolinium-based contrast agent (GBCA)
Health Outcome
seizure
Population / Cohort
All individuals
Time Period
January 1, 2008 - September 30, 2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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