IVIg Exposure and Renal Failure

Basic Details
Date Posted
Saturday, March 7, 2015
Status
Complete
Medical Product
intravenous immunoglobulin (IVIg)
Health Outcome(s)
acute kidney failure
acute renal failure
Description

Modular program-based one-time assessment of IVIg and subsequent diagnosis of acute renal failure and transfusion procedures among patients with and without a new hemolysis diagnosis after exposure to IVIg. 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 6.0; click here for more information.  Queries were distributed in October 2013. This report includes data from 18 Data Partners.

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Additional Details
FDA Center
CBER
Time Period
2006 - 2012
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
All individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)