{"eventGroups":[{"description":"A single arm, open-label, single institution phase 2 clinical trial is planned.\n\nCarfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.","id":"EG000","otherNumAffected":44,"otherNumAtRisk":44,"seriousNumAffected":28,"seriousNumAtRisk":44,"title":"Carfilzomib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":44}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":44}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":44}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":44}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":44}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":44}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":44}],"term":"Peripheral edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":44}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":44}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":44}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":44}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":44}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"ALT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"AST increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"Hyperglycemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Abdominal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Blood and lymphatic system disorders - Other, spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Bronchopulmonary hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Participants expired due to progression of disease","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"Infections and infestations - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44}],"term":"Myelodysplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTC-4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44}],"term":"Upper respiratory infection"}]}