{"description":"Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).","eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":52,"description":"INDUCTION:\n\nCycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22.\n\nCycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22.\n\nCONSOLIDATION:\n\nFour 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22.\n\nMAINTENANCE:\n\nAfter completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1.\n\nelotuzumab: Given intravenously (IV)\n\nLenalidomide: Given by IV\n\nDexamethasone: Given orally (PO) or by IV\n\nautologous stem cell transplantation","id":"EG000","otherNumAffected":52,"otherNumAtRisk":52,"seriousNumAffected":20,"seriousNumAtRisk":52,"title":"ERd Therapy"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":52,"numEvents":29}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Increased tendency to bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52,"numEvents":22}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":15}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Deafness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":7}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Ectropion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Eye irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Eye pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye 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toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":8}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Glossodynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Poor dental condition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":52,"numEvents":15}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":7}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":52,"numEvents":12}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":52,"numEvents":48}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General 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bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 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intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Unevaluable event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4}],"term":"Seasonal allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":5}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Oral 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infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":6}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":52,"numEvents":12}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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