{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"1.94","estimateComment":"Reference level = IMRT + Cisplatin","groupIds":["OG000","OG001"],"nonInferiorityComment":"The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \\<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.","nonInferiorityType":"NON_INFERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.45"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"80.6","upperLimit":"88.6","value":"84.6"},{"groupId":"OG001","lowerLimit":"73.4","upperLimit":"82.5","value":"77.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"406"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"An 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","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"percentage of participants"}