Oxicam NSAIDs, Modafinil/Armodafinil, Sulfamothoxazole and Severe Cutaneous Adverse Reaction (SCAR) Events

Project Title Oxicam NSAIDs, Modafinil/Armodafinil, Sulfamothoxazole and Severe Cutaneous Adverse Reaction (SCAR) Events
Date Posted
Friday, June 7, 2013
Project ID
MSY2_MP3t4
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of Severe Cutaneous Adverse Reaction (SCAR) events among incident users of three different drug classes and drugs, including oxicam NSAIDs, modafinil/armodafinil, and sulfamothoxazole, in the Mini-Sentinel Distributed Datebase. Two main categories of counts were generated: 1) incident counts with respect to each of the medications, and 2) frequency of SCAR events for each exposure group per 1000 person-days at risk [January 2000 – May 2011]. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Programs were executed in July 2011.

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Medical Product
modafinil
modafinil/armodafinil
oxicam
sulfamothoxazole
Health Outcome
severe cutaneous adverse reaction (SCAR)
Population / Cohort
All individuals
Time Period
2000 - 2011
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER