Immunoglobulin and Hemolysis 2

Project Title Immunoglobulin and Hemolysis 2
Date Posted
Tuesday, June 10, 2014
Project ID
MSY5_MPR2
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of hemolysis events following new use of several immunoglobulin products among patients with several pre-existing conditions, including primary immune deficiency, chronic inflammatory demyelinating polyneuropathy (CIDP), Kawasaki Disease, idiopathic thrombocytopenic purpura (ITP), Guillain-Barre syndrome (GBS), and myasthenia gravis. 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 3, version 6.0; click here for more information. The queries were distributed in October 2013.   This report includes data from 18 Data Partners.

If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.

The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

 

Medical Product
immunoglobulin (Ig)
Health Outcome
hemolysis
Time Period
2006 - 2012
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CBER