{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"53"}],"title":"CTCAE Grade 0"},{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"50"}],"title":"CTCAE Grade 1-2"},{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"20"}],"title":"CTCAE Grade 3"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}],"title":"CTCAE Grade 4"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"CTCAE Grade 5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"description":"The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification:\n\n* Grade 0 no event\n* Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.\n* Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.\n* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.\n* Grade 4 Life-threatening consequences; urgent intervention indicated.\n* Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.","groups":[{"description":"En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.\n\ntherapeutic conventional surgery","id":"OG000","title":"Surgery Alone"},{"description":"3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions\n\ntherapeutic conventional surgery\n\n3-dimensional conformal radiation therapy","id":"OG001","title":"Preoperative Radiotherapy Followed by En-bloc Surgery"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)","reportingStatus":"POSTED","timeFrame":"From day 60 after surgery till end of follow-up, up to 7 years","title":"Late Complications","type":"SECONDARY","unitOfMeasure":"Participants"}