{"analyses":[{"groupDescription":"Dysphagia","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1641","statisticalMethod":"Fisher Exact"},{"groupDescription":"Dry mouth","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2623","statisticalMethod":"Fisher Exact"},{"groupDescription":"Dermatitis radiation","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5378","statisticalMethod":"Fisher Exact"},{"groupDescription":"Rash acneiform","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0570","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.8","upperLimit":"12.5","value":"8.6"},{"groupId":"OG001","lowerLimit":"8.9","upperLimit":"16.8","value":"12.3"}]}],"title":"Dysphagia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"6.0","value":"3.2"},{"groupId":"OG001","lowerLimit":"0.6","upperLimit":"3.8","value":"1.5"}]}],"title":"Dry mouth (xerostomia)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"3.6","value":"1.4"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"4.8","value":"2.2"}]}],"title":"Dermatitis radiation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"1.4","value":"0.0"},{"groupId":"OG001","lowerLimit":"0.6","upperLimit":"3.8","value":"1.5"}]}],"title":"Rash acneiform"}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"268"}],"units":"Participants"}],"description":"Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events 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. Late adverse events are those occurring after days from 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 and had follow-up data at or after day 91 from start of radiation therapy","reportingStatus":"POSTED","timeFrame":"From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.","title":"Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}