{"analyses":[{"groupDescription":"Dysphagia","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0075","statisticalMethod":"Fisher Exact"},{"groupDescription":"Dry mouth","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2955","statisticalMethod":"Fisher Exact"},{"groupDescription":"Dermatitis radiation","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","statisticalMethod":"Fisher Exact"},{"groupDescription":"Rach acneiform","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.7","upperLimit":"17.6","value":"13.1"},{"groupId":"OG001","lowerLimit":"17.3","upperLimit":"27.0","value":"21.7"}]}],"title":"Dysphagia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"6.4","value":"3.5"},{"groupId":"OG001","lowerLimit":"0.8","upperLimit":"4.2","value":"1.8"}]}],"title":"Dry mouth (xerostomia)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.1","upperLimit":"9.9","value":"6.4"},{"groupId":"OG001","lowerLimit":"13.1","upperLimit":"21.9","value":"17.0"}]}],"title":"Dermatitis radiation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"1.3","value":"0.0"},{"groupId":"OG001","lowerLimit":"9.9","upperLimit":"17.9","value":"13.4"}]}],"title":"Rash acneiform"}],"denoms":[{"counts":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"276"}],"units":"Participants"}],"description":"Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).","id":"OG000","title":"IMRT"},{"description":"Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).\n\nCetuximab: 400 mg/m\\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.","id":"OG001","title":"IMRT Plus Cetuximab"}],"paramType":"NUMBER","populationDescription":"Randomized eligible participants who started protocol treatment","reportingStatus":"POSTED","timeFrame":"From start of radiation therapy to 90 days","title":"Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}