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IVIg Product Use and Hemolysis Events

Basic Details
Date Posted
Status
Complete
Medical Product
flebogamma
Gammagard
Gammaplex
Gamunex
intravenous immunoglobulin (IVIg)
Octagam
Privigen
Description

Modular program-based one-time assessment of hemolysis events following new use of IVIg products. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information.  Queries were distributed in January 2014. This report includes data from 18 Data Partners.
 
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Deliverables (2)
Mini-Sentinel Modular Program Report: IVIg Product use and Hemolysis Events, Report 1 Mini-Sentinel Modular Program Report: IVIg Product use and Hemolysis Events, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2006 - December 31, 2012
Analysis Type
Mini-Sentinel
Population / Cohort
All individuals with no use of IVIg 28 days before or after index date
Data Sources
Mini-Sentinel Distributed Database (MSDD)