StandardizingAssessment and Reporting ofAdverse Effects in Rheumatology Clinical Trials II: the Rheumatology Common Toxicity Criteria v.2.0 THASIAWOODWORTH,DANIELE.FURST,RIEKEALTEN,CLIFTONBINGHAM,DAVIDYOCUM, VICTORSLOAN,WAYNETSUJI,RANDALLSTEVENS,JAMESFRIES,JAMESWITTER,KENTJOHNSON, MARISSALASSERE,andPETERBROOKS

Objective.TheOMERACTDrugSafetyWorkingGroupfocusesonstandardizationofassessmentand reporting of adverse events in clinical trials and longitudinal and observational studies in rheumatol- ogy.ThisgroupdevelopedtheRheumatologyCommonToxicityCriteria(RCTC)in1999,buildingon theOncologyCommonToxicityCriteria.AtOMERACT8,aworkshopgroupreviewedtheuseofthe RCTCandotherinstrumentsinrheumatologyclinicaltrialstodate,toreviseandtostimulateitsimple - mentation. Methods. TheWorkingGroupdraftedarevisionoftheRCTCafteraniterativeexaminationofitscon - tents,terms,anddefinitions.TheRCTCwerecomparedwiththeOncologyCommonToxicityCriteria (CTCv.2.0),andtheCommonTerminologyCriteriaforAdverseEvents(CTCAEv.3.0).Inadditiona pharmaceutical company focus group met to clarify the challenges of application of RCTC terms and definitions,relativetothestandardinpharmaceuticalclinicaltrials,i.e.,verbatimrecordingofadverse events followed by mapping to Medical Dictionary of Drug RegulatoryActivities (MedDRA) terms. The workshop focused on the proposed revision of RCTC to version 2.0 and on the research agenda, includingavalidationoftheRCTCinfuturetrials. Results. AtOMERACT8,breakoutgroupsamendedthecontentsofthe4currentand2newcategories ofadverseeventtermswithinthedraftRCTCv.2.0.Participantsrecognizedtheneedtostandardizethe definitionsfordiseaseflares,infection,malignancy,andcertainsyndromessuchasdrughypersensitiv - ityandinfusionreactions.Moderateconsensus(62%)wasreachedinthefinalplenarysessionthatthe amendedRCTCv.2.0shouldbepromulgatedandtestedinavailabletrialsofanti-tumornecrosisfactor agents. Conclusion. TheRCTChasfacevalidityandconstructvalidity.However,documentationofdiscrimi- nationandfeasibility(theotherelementsoftheOMERACTfilter)isneeded.Collaborationwithdrug safety working groups in rheumatology professional organizations is necessary to enable this project. (JRheumatol2007;34:1401-14)