{"analyses":[{"ciLowerLimit":"0.84","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.12","estimateComment":"Reference arm = radiation therapy + cetuximab","groupDescription":"Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8878","pValueComment":"One-sided significance level = 0.2","paramType":"Hazard Ratio (HR)","paramValue":"1.33","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.3","upperLimit":"76.1","value":"63.7"},{"groupId":"OG001","lowerLimit":"41.5","upperLimit":"59.8","value":"50.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"123"}],"units":"Participants"}],"description":"Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy.\n\nFailure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported.","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","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.","title":"Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary]","type":"PRIMARY","unitOfMeasure":"percentage of participants"}