{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.46","estimateComment":"Reference level = IMRT + Cisplatin","groupDescription":"Variant","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.10"},{"ciLowerLimit":"0.79","ciPctValue":"95","ciUpperLimit":"1.53","estimateComment":"Reference level = IMRT + Cisplatin","groupDescription":"Non-variant","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.10"},{"groupDescription":"Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.9890","pValueComment":"Two-sided significance level = 0.05","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"72.0","upperLimit":"94.6","value":"83.3"},{"groupId":"OG001","lowerLimit":"66.5","upperLimit":"90.3","value":"78.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"48"}],"units":"Participants"}],"title":"Variant"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"75.6","upperLimit":"86.1","value":"80.8"},{"groupId":"OG001","lowerLimit":"72.2","upperLimit":"83.1","value":"77.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"239"}],"units":"Participants"}],"title":"Non-variant"}],"denoms":[{"counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"287"}],"units":"Participants"}],"description":"KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.","dispersionType":"95% Confidence Interval","groups":[{"description":"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.","id":"OG000","title":"IMRT + Cisplatin"},{"description":"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.","id":"OG001","title":"IMRT + Cetuximab"}],"paramType":"NUMBER","populationDescription":"Eligible participants with KRAS data","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.","title":"Overall Survival by Treatment Arm Within KRAS Variant Status Group","type":"SECONDARY","unitOfMeasure":"percentage of participants"}