TabsDetailsBasic DetailsDate Posted: Friday, June 7, 2013Status: CompleteMedical Product: modafinil, modafinil/armodafinil, oxicam, sulfamothoxazoleHealth Outcome(s): severe cutaneous adverse reaction (SCAR)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.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. Read More Deliverables (1)Mini-Sentinel Modular Program Report: OxicamAdditional InformationAdditional DetailsFDA Center: CDERTime Period: 2000 - 2011Study Type: Modular ProgramAssessment Type: Exploratory AnalysesPopulation / Cohort: All individualsData Sources: Mini-Sentinel Distributed Database (MSDD)