{"analyses":[{"ciLowerLimit":"0.57","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.51","estimateComment":"Reference arm = RT + cetuximab","groupDescription":"p16-positive","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.20"},{"ciLowerLimit":"0.83","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.89","estimateComment":"Reference arm = RT + cetuximab","groupDescription":"p16-negative","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.55"},{"groupDescription":"Interaction","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.61","pValueComment":"Testing the interaction of treatment arm and p16 status (positive, negative)","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.6","upperLimit":"89.9","value":"74.8"},{"groupId":"OG001","lowerLimit":"57.4","upperLimit":"80.1","value":"68.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"title":"p16-positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.6","upperLimit":"68.5","value":"48.1"},{"groupId":"OG001","lowerLimit":"10.1","upperLimit":"36.3","value":"23.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"p16-negative"}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"115"}],"units":"Participants"}],"description":"Failure for progression-free survival is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Positive p16 status was defined as more than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells, confirmed by central pathology review. Treatment effect hazard ratios within p16 subgroup were estimated by Cox proportional hazards model and progression-free survival estimates were estimated by Kaplan-Meier method. Analysis was planned to occur after 69 failure events had been reported and tissue specimen analysis was complete.","dispersionType":"95% Confidence Interval","groups":[{"description":"IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\\^2 IV starts one week prior to RT, then 250 mg/m\\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"RT + Cetuximab"},{"description":"IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"RT + Durvalumab"}],"paramType":"NUMBER","populationDescription":"Randomized participants with p16 status.","reportingStatus":"POSTED","timeFrame":"From randomization to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported.","title":"Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline p16 Status","type":"SECONDARY","unitOfMeasure":"percentage of participants"}