{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.8","upperLimit":"21.9","value":"17.5"},{"groupId":"OG001","lowerLimit":"11.3","upperLimit":"18.8","value":"14.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"359"},{"groupId":"OG001","value":"367"}],"units":"Participants"}],"description":"Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. \"Treatment-related\" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE","dispersionType":"95% Confidence Interval","groups":[{"description":"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.","id":"OG000","title":"IMRT + Cisplatin"},{"description":"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.","id":"OG001","title":"IMRT + Cetuximab"}],"paramType":"NUMBER","populationDescription":"Eligible patients who started study treatment and had adverse events assessment at 3 months after treatment end","reportingStatus":"POSTED","timeFrame":"From start of treatment to approximately 4.5 months (3 months after the end of treatment)","title":"Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}