{"analyses":[{"ciLowerLimit":"0.63","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.76","estimateComment":"Reference arm = historical control","groupDescription":"Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \\[RTOG = Radiation Therapy Oncology Group\\]","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.66","paramType":"Hazard Ratio (HR)","paramValue":"1.05","statisticalComment":"Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)","statisticalMethod":"Gray's test"},{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.87","estimateComment":"Reference arm = historical control","groupDescription":"Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.86","paramType":"Hazard Ratio (HR)","paramValue":"1.16","statisticalComment":"Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)","statisticalMethod":"Gray's test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"27.8","value":"19.8"},{"groupId":"OG001","lowerLimit":"13.4","upperLimit":"24.3","value":"18.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"106"}],"units":"Participants"}],"description":"Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).","dispersionType":"95% Confidence Interval","groups":[{"description":"Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.","id":"OG000","title":"RT + Cisplatin + Cetuximab"},{"description":"Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.","id":"OG001","title":"RT + Docetaxel + Cetuximab"}],"paramType":"NUMBER","populationDescription":"Eligible patients who started protocol treatment and did not withdraw consent.","reportingStatus":"POSTED","timeFrame":"From randomization to 2 years","title":"Local-regional Control","type":"SECONDARY","unitOfMeasure":"percentage of participants"}