{"eventGroups":[{"description":"Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long","id":"EG000","otherNumAffected":32,"otherNumAtRisk":32,"seriousNumAffected":10,"seriousNumAtRisk":32,"title":"Bort, Dex, and Dox With ALCAR"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"abdominal pain"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":32}],"term":"Alkaline phosphatase increased"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Alopecia"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":32}],"term":"Anemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32}],"term":"Anorexia"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"back pain"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Bloating"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":32}],"term":"Bone pain"},{"organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Blurred vision"},{"organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"Bruising"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Colitis"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Confusion"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":32}],"term":"Constipation"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Cough"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"Creatine increased"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Dehydration"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":32}],"term":"Diarrhea"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":32}],"term":"Dizziness"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Dysphagia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Dyspnea"},{"organSystem":"General disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":32}],"term":"Edema limbs"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Extrapyramidal involuntary movement"},{"organSystem":"General 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disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Hypoalbuminemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Hyponatremia"},{"organSystem":"Vascular disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Hypotension"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":32}],"term":"Infections and infestations other, specify: with or without neutropenia"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":32}],"term":"Insomnia"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"LDH"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":32}],"term":"Lymphocyte count decrease"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Metabolic changes"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Muscle pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Musculoskeletal and connective tissue disorder- other, specify: Joint pain"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":32}],"term":"Nausea"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":32}],"term":"Neuropathic pain"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":32}],"term":"Neutrophil count decreased"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"Oral pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Pain in extremity"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Peripheral motor neuropathy"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":32}],"term":"Peripheral sensory neuropathy"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":32}],"term":"Platelet count decreased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Pneumonitis"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Pruritus"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":32}],"term":"Rash maculo-papular"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Rectal hemorrhage"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Sweating"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"Taste Alteration"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32}],"term":"Upper respiratory infection"},{"organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Urinary frequency"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"Vomiting"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32}],"term":"Weight loss"},{"organSystem":"Investigations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":32}],"term":"White blood cell decreased"}],"seriousEvents":[{"organSystem":"Vascular disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Thrombosis/embolism - DVT"},{"organSystem":"General disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Fever (in the absence of neutropenia)"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"CNS Hemorrhage/bleeding"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Hemorrhage - Other, specify: GI-esophagus"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Febrile neutropenia - pneumonia"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Infection with unknown ANC"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Infection without Neutropenia"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Infection/Febrile Neutropenia"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Infection/Febrile Neutropenia - Other, specify: Normal ANC, Gr 1 or 2 neutrophils"},{"organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Muscle weakness (not due to neuropathy)"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Neurology - Other, specify: encephalopathy"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Neurology - Other, specify: vocal cord paralysis"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Seizure"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Dyspnea"}],"timeFrame":"Adverse Events were collected while subjects were receiving study treatment through 30 days post last dose of study treatment, up to 28 weeks."}