{"analyses":[{"ciLowerLimit":"0.50","ciPctValue":"95","ciUpperLimit":"2.04","estimateComment":"Reference level = IMRT + Cisplatin","groupDescription":"Variant","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.01"},{"ciLowerLimit":"0.94","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.73","estimateComment":"Reference level = IMRT + Cisplatin","groupDescription":"Non-variant","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.27"},{"groupDescription":"Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.5556","pValueComment":"Two-sided significance level = 0.05","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"63.9","upperLimit":"89.3","value":"76.6"},{"groupId":"OG001","lowerLimit":"54.2","upperLimit":"81.2","value":"67.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"48"}],"units":"Participants"}],"title":"Variant"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"69.4","upperLimit":"80.8","value":"75.1"},{"groupId":"OG001","lowerLimit":"62.0","upperLimit":"74.1","value":"68.0"}]}],"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 progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio 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":"Progression-free Survival Within KRAS Variant Status","type":"SECONDARY","unitOfMeasure":"percentage of participants"}