{"eventGroups":[{"description":"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.\n\nMAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\ncarfilzomib: Given IV\n\ndexamethasone: Given IV or PO\n\nlaboratory biomarker analysis: Correlative studies","id":"EG000","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":2,"seriousNumAtRisk":10,"title":"Treatment (Carfilzomib, Dexamethasone)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Heart failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Ear pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Tinnitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Dental caries"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Flatulence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Upper gastrointestinal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Irritability"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Gum infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Glucose intolerance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue 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(9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Cognitive disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Nervous system disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Reproductive system and breast disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 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alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Rash acneiform"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Surgical and medical procedures - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Flushing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Heart Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (9.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Hip 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