{"analyses":[{"ciLowerLimit":"0.94","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.36","estimateComment":"Reference level = IMRT + Cisplatin","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.09","pValueComment":"Two-sided significance level = 0.05","paramType":"Hazard Ratio (HR)","paramValue":"1.49","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.8","upperLimit":"11.9","value":"8.6"},{"groupId":"OG001","lowerLimit":"8.6","upperLimit":"15.3","value":"11.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"406"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis 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":"Time to Distant Metastasis","type":"SECONDARY","unitOfMeasure":"percentage of participants"}