Quinine Sulfate, Diltiazem and Selected Thrombotic Events

Project Title Quinine Sulfate, Diltiazem and Selected Thrombotic Events
Date Posted
Wednesday, January 8, 2014
Project ID
MSY3_MPR10
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of incident use of quinine sulfate or diltiazem and outcomes of hemolytic-uremic syndrome, immune thrombocytopenic purpura, unspecified thrombocytopenia, other secondary thrombocytopenia, and thrombotic microangiopathy. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 through December 31, 2010.  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 March/April 2012. This report includes data from 17 Data Partners.

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Medical Product
diltiazem
quinine sulfate
Health Outcome
hemolytic-uremic syndrome
immune thrombocytopenic purpura
other secondary thrombocytopenia
thrombotic microangiopathy
unspecified thrombocytopenia
Time Period
2006 - 2010
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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