TabsDetailsBasic DetailsDate Posted: Friday, March 2, 2018Status: CompleteMedical Product: intravenous (IV) ironHealth Outcome(s): anaphylaxisepinephrine eventDescription: 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. Read More Deliverables (4)Mini-Sentinel Modular Program Report: IV Iron and Anaphylaxis Report 1Mini-Sentinel Modular Program Report: IV Iron and Epinephrine Report 2Mini-Sentinel Modular Program Report: IV Iron and Anaphylaxis Report 3Mini-Sentinel Modular Program Report: IV Iron and Epinephrine Report 4Additional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2000 - December 31, 2012Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: All individualsData Sources: Mini-Sentinel Distributed Database (MSDD)Related Links: Parenteral Iron and Anaphylactoid Reactions
