{"eventGroups":[{"description":"Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \\<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.","id":"EG000","otherNumAffected":25,"otherNumAtRisk":25,"seriousNumAffected":12,"seriousNumAtRisk":25,"title":"Lenalidomide and Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":25}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":25}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":25}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":25}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":25}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":25}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":25}],"term":"Fibrin D dimer increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25}],"term":"Fibrin degradation products increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":25}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Hypogeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":25}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":25}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":25}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Hot flush"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Gastric cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Waldenstrom's macroglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Vertigo positional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Amyloidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Fractured sacrum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Pelvic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Diplegia 1 ( 4.0)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Orthostatic hypotension"}],"timeFrame":"Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks"}