{"analyses":[{"ciLowerLimit":"0.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.08","estimateComment":"Stratified by EGFR and site/p16 status. Reference level = IMRT.","groupDescription":"This trial was designed to detect a hazard ratio (HR) of 0.74 with 80% statistical power and overall one-sided alpha of 0.025 (372 deaths) using a stratified log-rank test, assuming a control arm 3-year survival rate of 60.1%. The amended protocol based on ≥ 5 years potential follow-up projected 169 events, providing 55%, 66%, and 79% power to detect HRs of 0.71, 0.68, and 0.64, respectively, using the original one-sided alpha of 0.0183 the final analysis.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0747","pValueComment":"One-sided significance level = 0.0183","paramType":"Hazard Ratio (HR)","paramValue":"0.81","statisticalComment":"Stratified by EGFR and site/p16 status","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"63.1","upperLimit":"74.3","value":"68.7"},{"groupId":"OG001","lowerLimit":"71.4","upperLimit":"81.6","value":"76.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"287"},{"groupId":"OG001","value":"290"}],"units":"Participants"}],"description":"Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.","dispersionType":"95% Confidence Interval","groups":[{"description":"Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).","id":"OG000","title":"IMRT"},{"description":"Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).\n\nCetuximab: 400 mg/m\\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.","id":"OG001","title":"IMRT Plus Cetuximab"}],"paramType":"NUMBER","populationDescription":"Randomized eligible participants","reportingStatus":"POSTED","timeFrame":"From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.","title":"Percentage of Participants Alive (Overall Survival)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}