Exposure to Intravenous (IV) Iron Procedures and Anaphylaxis and Epinephrine Events

Basic Details
Date Posted
Friday, March 2, 2018
Status
Complete
Medical Product
intravenous (IV) iron
Health Outcome(s)
anaphylaxis
epinephrine event
Description

Mini-Sentinel's IV Iron Workgroup requested execution of Modular Program #3 (MP3) to investigate exposure to IV iron procedures and anaphylaxis and epinephrine events for individuals with and without a pre-existing condition of dialysis. This involved one run of MP3. The time window for the request is January 1, 2000 – December 31, 2012. The package was distributed to Data Partners on January 17, 2013.

Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - December 31, 2012
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
All individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)