{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.\n\nBone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally","id":"EG000","otherNumAffected":3,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"Cohort B (Lenalidomide, Dexamethasone)"},{"deathsNumAffected":0,"deathsNumAtRisk":11,"description":"Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\n\nBone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally","id":"EG001","otherNumAffected":10,"otherNumAtRisk":11,"seriousNumAffected":2,"seriousNumAtRisk":11,"title":"Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":3}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":11,"numEvents":7}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":5}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Muscle cramp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Musculoskeletal, conn tissue - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Peripheral sensory neuropathy"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Thromboembolic event"}],"timeFrame":"1 year"}