{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"1.0","pValueComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"3.3","value":"1.5"},{"groupId":"OG001","lowerLimit":"0.6","upperLimit":"3.3","value":"1.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"394"}],"units":"Participants"}],"description":"Early death is defined as death due to adverse event or within 30 days of treatment completion.","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 patients who started study treatment","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":"Percentage of Participants Experiencing Early Death","type":"SECONDARY","unitOfMeasure":"percentage of participants"}