{"description":"All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.","eventGroups":[{"description":"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.\n\nBendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4","id":"EG000","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":7,"seriousNumAtRisk":18,"title":"Original BBD Regimen"},{"description":"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.\n\nTreatment:\n\nBendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16\n\nMaintenance:\n\nBortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15","id":"EG001","otherNumAffected":38,"otherNumAtRisk":41,"seriousNumAffected":17,"seriousNumAtRisk":41,"title":"Modified BBD Regimen"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":18},{"groupId":"EG001","numAffected":31,"numAtRisk":41}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":18},{"groupId":"EG001","numAffected":28,"numAtRisk":41}],"term":"PERIPHERAL NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18},{"groupId":"EG001","numAffected":23,"numAtRisk":41}],"term":"ANEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18},{"groupId":"EG001","numAffected":21,"numAtRisk":41}],"term":"EDEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":18,"numAtRisk":41}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18},{"groupId":"EG001","numAffected":18,"numAtRisk":41}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18},{"groupId":"EG001","numAffected":18,"numAtRisk":41}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18},{"groupId":"EG001","numAffected":17,"numAtRisk":41}],"term":"INSOMNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":15,"numAtRisk":41}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18},{"groupId":"EG001","numAffected":15,"numAtRisk":41}],"term":"DIARRHEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18},{"groupId":"EG001","numAffected":15,"numAtRisk":41}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18},{"groupId":"EG001","numAffected":14,"numAtRisk":41}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18},{"groupId":"EG001","numAffected":13,"numAtRisk":41}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18},{"groupId":"EG001","numAffected":13,"numAtRisk":41}],"term":"ANOREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":18},{"groupId":"EG001","numAffected":13,"numAtRisk":41}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":11,"numAtRisk":41}],"term":"PAIN IN EXTREMITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":10,"numAtRisk":41}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":10,"numAtRisk":41}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":18},{"groupId":"EG001","numAffected":10,"numAtRisk":41}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":10,"numAtRisk":41}],"term":"ASTHENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":9,"numAtRisk":41}],"term":"FEVER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18},{"groupId":"EG001","numAffected":9,"numAtRisk":41}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":8,"numAtRisk":41}],"term":"NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":7,"numAtRisk":41}],"term":"PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":7,"numAtRisk":41}],"term":"ALLERGIC RHINITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"NASAL CONGESTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"DYSPNEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"DYSPEPSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"UPPER RESPIRATORY INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"DRY SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"WEIGHT LOSS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"DYSGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"DEPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":41}],"term":"TASTE ALTERATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"CATARACT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"CHEST CONGESTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"CREATININE LEVELS INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"HYPOKALEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"GASTROESOPHAGEAL REFLUX DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"ALKALINE PHOSPHATASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"ARTHRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"BRONCHIAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"BRUISING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"DYSPHAGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"HEARING IMPAIRED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"HYPERGLYCEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"NECK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"SKIN CHANGES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"THROMBOEMBOLIC EVENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"ERYTHEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"NASAL DRAINAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"PARESTHESIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"GAIT DISTURBANCE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"DEHYDRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"ATRIAL FIBRILLATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"BLURRED VISION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"FALL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"FLU LIKE SYMPTOMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"HYPOALBUMINEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"THRUSH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"CHILLS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"URINARY FREQUENCY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"ALLERGIC REACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":41}],"term":"MUCOSITIS"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Amyloidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Angina pectoris"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":41,"numEvents":2}],"term":"Cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Cardiac failure congestive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Disease progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Diverticulum"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Hypercalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Neutropenic sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":41,"numEvents":9}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Salivary duct obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Sudden death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":41,"numEvents":2}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Urosepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Vertigo"}],"timeFrame":"every 4 weeks for up to 32 weeks on the Original BBD Regimen, or up to 2 years on the Modified BBD Regimen"}