{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","groupDescription":"Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \\[RTOG = Radiation Therapy Oncology Group\\]","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.05","paramType":"Hazard Ratio (HR)","paramValue":"0.76","statisticalComment":"Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.96","groupDescription":"Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.01","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalComment":"Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.4","upperLimit":"67.2","value":"57.3"},{"groupId":"OG001","lowerLimit":"56.9","upperLimit":"75","value":"65.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"106"}],"units":"Participants"}],"description":"Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.","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":"Disease-free Survival","type":"PRIMARY","unitOfMeasure":"percentage of participants"}