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	Mini-Sentinel Modular Program Report: IV Iron and Anaphylaxis Report 1 Mini-Sentinel Modular Program Report: IV Iron and Epinephrine Report 2 Mini-Sentinel Modular Program Report: IV Iron and Anaphylaxis Report 3 Mini-Sentinel Modular Program Report: IV Iron and Epinephrine Report 4
Related Links	Parenteral Iron and Anaphylactoid Reactions
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

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