Anti-D, Dexamethasone, Prednisone, Romiplostim and Hemolysis

Project Title Anti-D, Dexamethasone, Prednisone, Romiplostim and Hemolysis
Date Posted
Tuesday, June 10, 2014
Project ID
MSY5_MPR04
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of anti-D, dexamethasone, prednisone, and romiplostim and subsequent new diagnoses of hemolysis among patients with a pre-existing condition of idiopathic thrombocytopenic purpura (ITP).  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. The queries were distributed in October 2013.  This report includes 18 Data Partners in October 2013.

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
anti-D
dexamethasone
prednisone
romiplostim
Health Outcome
hemolysis
Population / Cohort
Pre-existing idiopathic thrombocytopenic purpura
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