{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0688","pValueComment":"Two-side significance level = 0.05","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"36"}]}],"title":"< Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"57"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"11"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"119"}],"units":"Participants"}],"description":"Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Randomized and started study treatment","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up: weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.","title":"Number of Participants by Highest Grade Adverse Event Reported","type":"SECONDARY","unitOfMeasure":"Participants"}