Immunoglobulin and Hemolysis 1

Project Title Immunoglobulin and Hemolysis 1
Date Posted
Tuesday, June 10, 2014
Project ID
MSY4_MPR48
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of several immunoglobulin (Ig) product groups (subcutaneous Ig, other branded intravenous immunoglobulin (IVIg), other IVIg, and intramuscular Ig) and hemolysis.  The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 through December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 6, version 5.0.1; click here for more information. The query was distributed in August 2013.  These reports include data from 18 Data Partners.

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Medical Product
Gammagard
Gammaked
Gammaplex
Gamunex
Gamunex-C
Hizentra
Octagam
Privigen
flebogamma
immunoglobulin (Ig)
vivaglobin
Health Outcome
hemolysis
Time Period
January 1, 2006 - December 31, 2012
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CBER
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