{"description":"Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.","eventGroups":[{"description":"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy\n\nLenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.\n\nSequential Maintenance Therapy: Subjects who achieve \\>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \\> stable disease (SD) from maintenance (per discussion with physician):\n\n* 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis\n* Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle\n* Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7\n* Prednisone 60 mg /m2 po daily on","id":"EG000","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":4,"seriousNumAtRisk":18,"title":"High-risk Multiple Myeloma"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Otitis, external ear (non-infectious)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":5}],"term":"Hemoglobin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10}],"term":"anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":18,"numEvents":15}],"term":"Leukocytes (total WBC)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10}],"term":"leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":18,"numEvents":13}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Lymphocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":18,"numEvents":20}],"term":"Neutrophils / granulocytes (ANC / AGC)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":18,"numEvents":12}],"term":"Platelets"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18,"numEvents":9}],"term":"thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cardiac General - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cardiac Arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cardiac Left Ventricular Function"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Constitutional Symptoms - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Decreased Libido"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":18,"numEvents":15}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10}],"term":"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Rigors / chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Sweating (diaphoresis)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Weight gain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Dermatology / Skin - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Folliculitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cold sore - left upper lip"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Contact dermatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Excoriation bilateral dorsal aspect of feet, related to scratching"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hyperpigmentation - nailbeds"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Induration, CS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Peeling skin, intermittent, NCS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Redness-feet"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Right ankle erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Dry Skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Hair Loss / Alopecia (scalp or body)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":18,"numEvents":8}],"term":"Pruritus / itching"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":18,"numEvents":13}],"term":"Rash / desquamation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hot flashes / flushes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18,"numEvents":6}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":18,"numEvents":8}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":18,"numEvents":11}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Heartburn / dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Taste Alteration (dysgeusia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":5}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Hemorrhage / Bleeding - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Infection - Other (Cellulitis)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18,"numEvents":9}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":5}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":18,"numEvents":19}],"term":"Edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Alkaline phosphatase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"AST, SGOT (serum glutamic oxaloacetic transaminase)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Calcium, serum-low (hypocalcemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Magnesium, serum-low (hypomagnesemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18,"numEvents":7}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18,"numEvents":6}],"term":"Potassium, serum-high (hyperkalemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Decreased Neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Uric Acid, serum-high (hyperuricemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Arthritis (non-septic)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Joint-function"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":5}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Osteonecrosis (avascular necrosis)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Ataxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Parasthesias"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Mood Swings"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Cognitive disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18,"numEvents":6}],"term":"Mood Alteration - Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Mood Alteration - Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Neuropathy: motor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10}],"term":"Neuropathy: sensory"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":5}],"term":"Syncope (fainting)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Dry Eye Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Ocular / Visual - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Vision - blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Gastrointestinal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":18,"numEvents":33}],"term":"Musculoskeletal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Pain - General"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pain - Head / headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pain - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Bronchospasm, wheezing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":18,"numEvents":11}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18,"numEvents":7}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cyanosis of toes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pneumonitis / pulmonary infiltrates"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pulmonary / Upper Respiratory - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Orthopnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Renal / Genitourinary - Other (Specify, __)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Malodorous 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CS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Esophageal spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Food Aversions, CS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hiccups"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Increased thirst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Oral lesion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Bilateral facial swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Paresthesias- Intermittent"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Right Breast Pressure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Sore throat intermittent"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Sternal Discomfort"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Supraventricular and nodal arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Atrial Fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Chest Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Congestive Heart Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Ventricular Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cardiac Ischemia / infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Acute Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Bacteremia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Muscular / skeletal hypoplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"fainting","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Back Pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Musculoskeletal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Abdominal Pain","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Pain - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Deep Vein Thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Thrombosis / thrombus / embolism"}],"timeFrame":"Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness."}