{"analyses":[{"ciLowerLimit":"1.29","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.29","estimateComment":"Reference level = IMRT + Cisplatin","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","paramType":"Hazard Ratio (HR)","paramValue":"1.72","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.8","upperLimit":"83.0","value":"78.4"},{"groupId":"OG001","lowerLimit":"62.4","upperLimit":"72.2","value":"67.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"406"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"An 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","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":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}