{"analyses":[{"ciLowerLimit":"0.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","estimateComment":"Reference arm = historical control","groupDescription":"Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \\[RTOG = Radiation Therapy Oncology Group\\]","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.04","paramType":"Hazard Ratio (HR)","paramValue":"0.72","statisticalComment":"Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.82","estimateComment":"Reference arm = historical control","groupDescription":"Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.56","statisticalComment":"Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.5","upperLimit":"78","value":"68.8"},{"groupId":"OG001","lowerLimit":"71.4","upperLimit":"86.9","value":"79.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"106"}],"units":"Participants"}],"description":"Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) 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":"Overall Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}