{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"}],"units":"Participants"}],"description":"To characterize safety by evaluating Grade 3-4 acute toxicities of adjuvant durvalumab with radiotherapy in intermediate-risk Head and Neck Squamous Cell Carcinoma patients receiving adjuvant durvalumab with radiotherapy. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).","groups":[{"description":"Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments\n\nDurvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles\n\nIntensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks","id":"OG000","title":"Open-label, Single-arm"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants started to study the treatment.","reportingStatus":"POSTED","timeFrame":"Up to 30 days","title":"Number of Participants With Grade 3-4 Acute Toxicities","type":"SECONDARY","unitOfMeasure":"Participants"}