{"eventGroups":[{"description":"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.\n\nBeyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.","id":"EG000","otherNumAffected":34,"otherNumAtRisk":64,"seriousNumAffected":47,"seriousNumAtRisk":64,"title":"Lenalidomide, Dexamethasone, Bortezomib Combination"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":64}],"term":"Sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":64}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Without prior colostomy","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":64}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":64}],"term":"Muscle Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":64}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":64}],"term":"Peripheral Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":64}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":64}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":64}],"term":"Extremity Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":64}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":64}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":64}],"term":"Neuropathic Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"Rash/ desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"without concurrent neutropenia","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"Motor Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":64}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"neurologic- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"joint pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"aspartate transaminase disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"nonneuropatic generalized weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"alanine aminotransferase disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"alkaline phosphatase disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"cushingnoid appearance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"ocular- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"tinnitus"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":64}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"w/o prior colostomy","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"peripheral edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":64}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Pain: extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"Motor Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Pulmonary/ Upper Respiratory Event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"With concurrent grade 0-2 Neutropenia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Psychosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Without Neutropenia","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"Hypophosphatemia"}],"timeFrame":"Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment"}