{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.97","estimateComment":"Reference arm = RT + Cetuximab","groupDescription":"CPS ≥ 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.11"},{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.06","estimateComment":"Reference arm = RT + Cetuximab","groupDescription":"CPS = 0","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.64"},{"groupDescription":"Interaction","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.41","pValueComment":"Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43.6","upperLimit":"76.2","value":"59.9"},{"groupId":"OG001","lowerLimit":"43.9","upperLimit":"65.6","value":"54.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"CPS ≥ 1 (PD-L1 expression)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"35.1","upperLimit":"88.0","value":"61.5"},{"groupId":"OG001","lowerLimit":"9.9","upperLimit":"50.1","value":"30.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"CPS = 0 (no PD-L1 expression)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"108"}],"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). PD-L1 expression is defined by a combined positive score (CPS) ≥ 1, assessed by masked central analysis of baseline tissue specimens. CPS = \\[(number of tumor cells positive for PD-L1) / (number of tumor cells positive for PD-L1 + number of tumor cells negative for PD-L1)\\] multiplied by 100, yielding a possible score of 0 to 100. Treatment effect hazard ratios within PD-L1 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 CPS score.","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 PD-L1 (Programmed Cell Death Ligand 1) Expression","type":"SECONDARY","unitOfMeasure":"percentage of participants"}