Immunoglobulin Products and Hemolysis

Project Title Immunoglobulin Products and Hemolysis
Date Posted
Wednesday, July 6, 2016
Status
Complete
Deliverables
Description

Report 1 is a modular program-based one-time assessment of the use of intravenous immunoglobulin products and subsequent diagnosis of hemolysis among patients with Primary Immunodeficiency, CIDP, Kawasaki Disease, ITP, Myasthenia Gravis, and Guillain-Barre Syndrome. 

Report 2 is a modular program-based one-time assessment of the use of several immunoglobulin (Ig) products and diagnosis of hemolysis events within 2, 7, and 14 days of Ig injection. 

The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to March 31, 2014.  Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Descriptive Analysis (CIDA) tool; click here for more information.  Queries were distributed in August 2014. This report includes data from 15 Data Partners.
 
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Medical Product
immunoglobulin (Ig)
Health Outcome
hemolysis
Population / Cohort
All individuals
Time Period
January 1, 2006 - March 31, 2014
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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