CTCAE-4优质文档课件.03-vs-5.0简介.pptxVIP

BriefintroductionofCTCAE

ContentIntroductionPurposeEvolutionCTCAE4.03CTCAE4.03vs5.0

CommonTerminologyCriteriaAdverseEventsThetoolusedtodeterminetheseverityofanAEinoncologyclinicaltrials.Fundamentallyintendedtobeanagreeduponterminologyforthedesignation,reportingandgradingofAEsthatoccurinoncologyresearch.IntroductionofCTCAE

EnablerecognitionandprovideseveritygradingofAEsStandardizeAEreportingacrossgroups/sitesMonitorsafetydataProvideregulatoryreportingDefineprotocolparametersrelatedto:Eligibility,DLT/MTD/MAD,Dosemodification)PurposeofCTCAE

CTCv2.0NCI,FDA,EORTC,etc.300AEterms;22Organs化疗，放疗，外科治疗规范分级指标未对迟发性不良反应进行描述，对于外科和儿科的描述过于局TCAEv5.0NCI837terms2003CTCv1.0NCI（NationalCancerInstitute)49AEterms;13organs;18Classes仅限于药物所致的急性不良反应1988CTCAEv3.0NCI1059AEtermsShortTerms完善1-5级临床描述，新增死亡按SOC分类,增加了“心律不齐”、“心血管系统”和“生长发育”等类别迟发性不良反应评价标准；外科和儿科不良反应这是国际上第一个同时包含急性不良反应和迟发性不良反应的不良反应评级体系CTCAEv4.0/4.03NIH,NCI-CBIIT/NCI790AEtermsDeletetheShortterms2009/2010EvolutionofCTCAE

USEMedDRA(MedicalDictionaryforRegulatoryActivities)CTCAE4.03-MedDRAMedDRA系统器官分类（systemorganclass,SOC）高位组语（Highlevelgroupterms,HLGT)高位语（HighLevelterms,HLT)首选语（preferredterms,PT)低位语（Lowlevelterms,LLT)

USEMedDRA(MedicalDictionaryforRegulatoryActivities)CTCAEtermsaregroupedbyMedDRAPrimary

SOCs.EachCTCAEtermisaMedDRALLTAbriefdefinitionisprovidedtoclarifythe

meaningofeachAEtermCTCAE4.03-MedDRA

CTCAEtermsaregroupedbyMedDRAPrimary

SOCs.CTCAE4.03-MedDRA

Mildasymptomaticormild

symptomsclinicalordiagnostic

observationsonlyinterventionnotindicated

1Moderateminimal,localornoninvasiveinterventionindicatedlimitingageappropriateinstrumentalADL*2SevereSevereormedicallysignificantbutnot

immediatelylife-threateninghospitalizationorprolongation

ofhospitalizationindicatedDisablinglimitingselfcareADL**3Life-threateningLife-threateningconsequencesurge