{"description":"By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.","eventGroups":[{"description":"Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.","id":"EG000","otherNumAffected":34,"otherNumAtRisk":35,"seriousNumAffected":33,"seriousNumAtRisk":35,"title":"Combination Chemotherapy"}],"frequencyThreshold":"0","otherEvents":[{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":35}],"term":"Acidosis"},{"notes":"Grades 1-2","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Activated partial thromboplastin time prolonged"},{"notes":"Grades 1-2","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Alanine aminotransferase increased"},{"notes":"Grades 1-2","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Anemia"},{"notes":"Grades 1-2","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Aspartate aminotransferase increased"},{"notes":"Grades 1-2","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Bladder spasm"},{"notes":"Grades 1-2","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Blood bilirubin increased"},{"notes":"Grades 1-2","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Burn"},{"notes":"Grades 1-2","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Catheter related infection"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Constipation"},{"notes":"Grades 1-2","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Depression"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35}],"term":"Gastritis"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Gastrointestinal disorders - Other, specify"},{"notes":"Grades 1-2","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":35}],"term":"Hematuria"},{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Hyperglycemia"},{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypermagnesemia"},{"notes":"Grades 1-2","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypertension"},{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypoalbuminemia"},{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Hypocalcemia"},{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":35}],"term":"Hypokalemia"},{"notes":"Grades 1-2","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":35}],"term":"Hypophosphatemia"},{"notes":"Grades 1-2","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Infections and infestations - Other, specify"},{"notes":"Grades 1-2","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"INR increased"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Intra-abdominal hemorrhage"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Mucositis oral"},{"notes":"Grades 1-2","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Peripheral motor neuropathy"},{"notes":"Grades 1-2","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35}],"term":"Peripheral sensory neuropathy"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Proctitis"},{"notes":"Grades 1-2","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":35}],"term":"Proteinuria"},{"notes":"Grades 1-2","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Psychosis"},{"notes":"Grades 1-2","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Radiation recall reaction (dermatologic)"},{"notes":"Grades 1-2","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":35}],"term":"Rash maculo-papular"},{"notes":"Grades 1-2","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Thromboembolic event"},{"notes":"Grades 1-2","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Urinary frequency"},{"notes":"Grades 1-2","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Urinary tract infection"},{"notes":"Grades 1-2","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Urinary tract pain"},{"notes":"Grades 1-2","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Vomiting"}],"seriousEvents":[{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Abdominal pain"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Activated partial thromboplastin time prolonged"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Adult respiratory distress syndrome"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Alanine aminotransferase increased"},{"notes":"Grades 3-5","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":35}],"term":"Anemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35}],"term":"Anorexia"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Aspartate aminotransferase increased"},{"notes":"Grades 3-5","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Back pain"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Bladder infection"},{"notes":"Grades 3-5","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Bladder spasm"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Blood bilirubin increased"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Bronchial infection"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Catheter related infection"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Colitis"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Constipation"},{"notes":"Grades 3-5","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Cystitis noninfective"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35}],"term":"Dehydration"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35}],"term":"Diarrhea"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Dysphagia"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Dyspnea"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Electrocardiogram QT corrected interval prolonged"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Esophagitis"},{"notes":"Grades 3-5","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Fatigue"},{"notes":"Grades 3-5","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":35}],"term":"Febrile neutropenia"},{"notes":"Grades 3-5","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Fever"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Fibrinogen decreased"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Forced expiratory volume decreased"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Gastritis"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Gastrointestinal disorders - Other, specify"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"GGT increased"},{"notes":"Grades 3-5","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Hematuria"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hyperglycemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hyperkalemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypermagnesemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypernatremia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypoalbuminemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Hypocalcemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":35}],"term":"Hypokalemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Hypomagnesemia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35}],"term":"Hyponatremia"},{"notes":"Grades 3-5","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Hypophosphatemia"},{"notes":"Grades 3-5","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Hypotension"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35}],"term":"Hypoxia"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Ileus"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":35}],"term":"Infections and infestations - Other, specify"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Intra-abdominal hemorrhage"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Lung infection"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Lymphocyte count decreased"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Mucositis oral"},{"notes":"Grades 3-5","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Myocardial infarction"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}],"term":"Nausea"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":35}],"term":"Neutrophil count decreased"},{"notes":"Grades 3-5","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Pain of skin"},{"notes":"Grades 3-5","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Pericardial effusion"},{"notes":"Grades 3-5","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Perineal pain"},{"notes":"Grades 3-5","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Peripheral motor neuropathy"},{"notes":"Grades 3-5","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Peripheral sensory neuropathy"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Pharyngeal mucositis"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":35}],"term":"Platelet count decreased"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Pleural hemorrhage"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Pneumonitis"},{"notes":"Grades 3-5","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Pulmonary hypertension"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Sepsis"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Upper gastrointestinal hemorrhage"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Upper respiratory infection"},{"notes":"Grades 3-5","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Urinary retention"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}],"term":"Urinary tract infection"},{"notes":"Grades 3-5","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Vascular access complication"},{"notes":"Grades 3-5","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Vasovagal reaction"},{"notes":"Grades 3-5","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35}],"term":"Vomiting"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35}],"term":"Weight loss"},{"notes":"Grades 3-5","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":35}],"term":"White blood cell decreased"},{"notes":"Grades 3-5","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35}],"term":"Wound infection"}]}