{"description":"Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title \"No Intervention\" (Arm/Group Description: \"Arm 2\") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title \"Experimental\" (Arm/Group Description: \"Arm 1\") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.","eventGroups":[{"description":"Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.\n\nObservation only for recurrence or development of an SMN","id":"EG000","otherNumAffected":0,"otherNumAtRisk":104,"seriousNumAffected":0,"seriousNumAtRisk":104,"title":"Arm 2 (Observation)"},{"description":"Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes \\& etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 \\& 6).\n\nAfter completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy.\n\nAfter surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.\n\nPatients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, \\& 16.\n\ncon","id":"EG001","otherNumAffected":78,"otherNumAtRisk":182,"seriousNumAffected":0,"seriousNumAtRisk":182,"title":"Arm I (Chemotherapy)"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":3,"numAtRisk":182}],"term":"Abdominal pain"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Acute kidney injury"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Alanine aminotransferase increased"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":10,"numAtRisk":182}],"term":"Anemia"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Catheter related infection"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Constipation"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Dehydration"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Encephalopathy"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":9,"numAtRisk":182}],"term":"Febrile neutropenia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":3,"numAtRisk":182}],"term":"Fever"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Gastrointestinal disorders - Other, specify"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Hearing impaired"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Hyperkalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":2,"numAtRisk":182}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Hypomagnesemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Hyponatremia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":6,"numAtRisk":182}],"term":"Hypophosphatemia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":0,"numAtRisk":182}],"term":"Ileus"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":10,"numAtRisk":182}],"term":"Infections and infestations - Other, specify"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":2,"numAtRisk":182}],"term":"Lymphocyte count decreased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":5,"numAtRisk":182}],"term":"Nausea"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":58,"numAtRisk":182}],"term":"Neutrophil count decreased"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Non-cardiac chest pain"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":7,"numAtRisk":182}],"term":"Platelet count decreased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Small intestinal obstruction"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Syncope"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":0,"numAtRisk":182}],"term":"Urinary tract infection"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":4,"numAtRisk":182}],"term":"Vomiting"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":17,"numAtRisk":182}],"term":"White blood cell decreased"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104},{"groupId":"EG001","numAffected":1,"numAtRisk":182}],"term":"Wound infection"}]}