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

Project Title Exposure to Intravenous (IV) Iron Procedures and Anaphylaxis and Epinephrine Events
Date Posted
Friday, March 2, 2018
Project ID
msy4_mpr13_v1
Status
Complete
Deliverables
Related Links
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.

Medical Product
intravenous (IV) iron
Health Outcome
anaphylaxis
epinephrine event
Population / Cohort
All individuals
Time Period
January 1, 2000 - December 31, 2012
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER