IVIg Product Use and Hemolysis Events

Project Title IVIg Product Use and Hemolysis Events
Date Posted
Friday, June 3, 2016
Project ID
to09y05_mpr_wp14_v03
Status
Complete
Deliverables
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.
 
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
Gammagard
Gammaplex
Gamunex
Octagam
Privigen
flebogamma
intravenous immunoglobulin (IVIg)
Population / Cohort
All individuals with no use of IVIg 28 days before or after index date
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
CDER
Scroll to Top