{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","value":"4"}],"title":"CTCAE Grade 0"},{"measurements":[{"groupId":"OG001","value":"106"}],"title":"CTCAE Grade 1-2"},{"measurements":[{"groupId":"OG001","value":"15"}],"title":"CTCAE Grade 3"},{"measurements":[{"groupId":"OG001","value":"1"}],"title":"CTCAE Grade 4"},{"measurements":[{"groupId":"OG001","value":"1"}],"title":"CTCAE Grade 5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"description":"The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification:\n\n* Grade 0 No event reported\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. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken","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":"Only patients in the \"Preoperative radiotherapy followed by en-bloc surgery\" that received at least one dose of radiotherapy were considered for this secondary endpoint.","reportingStatus":"POSTED","timeFrame":"From date of randomization to the date of surgical procedure, prior to surgery","title":"Acute Toxicity Profile of Preoperative Radiotherapy.","type":"SECONDARY","unitOfMeasure":"Participants"}