{"description":"Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).","eventGroups":[{"description":"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).\n\nclinical observation: Patients undergo observation\n\ntherapeutic conventional surgery: Patients undergo surgery","id":"EG000","otherNumAffected":0,"otherNumAtRisk":205,"seriousNumAffected":0,"seriousNumAtRisk":205,"title":"Arm A: No Adjuvant Treatment"},{"description":"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.\n\nclinical observation: Patients undergo observation\n\ntherapeutic conventional surgery: Patients undergo surgery\n\n3-dimensional conformal radiation therapy: Patients undergo radiotherapy","id":"EG001","otherNumAffected":0,"otherNumAtRisk":17,"seriousNumAffected":1,"seriousNumAtRisk":17,"title":"Arm B: Low Risk; Adjuvant Radiotherapy"},{"description":"High risk \\[metastatic, resected, incompletely resected, or unresected disease\\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.\n\ndoxorubicin hydrochloride: Given IV\n\nclinical observation: Patients undergo observation\n\n3-dimensional conformal radiation therapy: Patients undergo radiotherapy\n\nifosfamide: Given IV","id":"EG002","otherNumAffected":2,"otherNumAtRisk":110,"seriousNumAffected":1,"seriousNumAtRisk":110,"title":"Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy"},{"description":"High risk \\[metastatic, resected, incompletely resected, or unresected disease\\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.\n\ndoxorubicin hydrochloride: Given IV\n\nclinical observation: Patients undergo observation\n\ntherapeutic conventional surgery: Patients undergo surgery\n\n3-dimensional conformal radiation therapy: Patients undergo radiotherapy\n\nifosfamide: Given IV","id":"EG003","otherNumAffected":7,"otherNumAtRisk":196,"seriousNumAffected":3,"seriousNumAtRisk":196,"title":"Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Cardiac disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Cardiac disorders - Other, specify"},{"organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Dermatitis radiation"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Diarrhea"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":110,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Encephalopathy"},{"organSystem":"General disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"General disorders and administration site conditions - Other, specify"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Hepatic infection"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Hypokalemia"},{"organSystem":"Vascular disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":110,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Hypotension"},{"organSystem":"Cardiac disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Pericardial effusion"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Seizure"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Skin ulceration"},{"organSystem":"Vascular disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Thromboembolic event"},{"organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Wound dehiscence"}],"seriousEvents":[{"organSystem":"General disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Death NOS"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Infections and infestations - Other, specify"},{"organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify"},{"organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":110,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"Treatment related secondary malignancy"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":205,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":110,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"Upper gastrointestinal hemorrhage"}]}