{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"34"}],"title":"Dindo scale Grade 0"},{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"58"}],"title":"Dindo scale Grade 1-2"},{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"24"}],"title":"Dindo scale Grade 3"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}],"title":"Dindo scale Grade 4"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"title":"Dindo scale Grade 5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"119"}],"units":"Participants"}],"description":"Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.\n\nGrade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group.\n\nThe perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.","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 followed by surgery)","reportingStatus":"POSTED","timeFrame":"From the date of surgery, up to 60 days following surgery","title":"Perioperative Complications","type":"SECONDARY","unitOfMeasure":"Participants"}