{"eventGroups":[{"description":"Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle\n\nDexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle","id":"EG000","otherNumAffected":26,"otherNumAtRisk":26,"seriousNumAffected":11,"seriousNumAtRisk":26,"title":"Lenalidomide Plus Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":26}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":26}],"term":"DRY SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 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infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":26}],"term":"NASOPHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":26}],"term":"DYSGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":26}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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WEAKNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"MUSCLE SPASMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"DECREASED APPETITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"HYPOPHOSPHATAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"ALANINE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"ASPARTATE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"WEIGHT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":26}],"term":"INSOMNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":26}],"term":"HICCUPS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"HEPATIC FUNCTION ABNORMAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"HEAD INJURY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"ERYTHEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"ABDOMINAL PAIN UPPER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"GASTROENTERITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"HYPOAESTHESIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"DIABETES MELLITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"HYPERURICAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"HYPOALBUMINAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"HYPONATRAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"BLOOD CREATININE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"BLOOD UREA INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"CONTUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}],"term":"CATARACT"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"CARDIAC FAILURE ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"CORONARY ARTERY STENOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"INTERSTITIAL LUNG DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"PNEUMONIA ASPIRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"LOWER GASTROINTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"HEPATIC FUNCTION ABNORMAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"TUMOUR LYSIS SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"PRESYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}],"term":"TOXIC SKIN ERUPTION"}],"timeFrame":"From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks."}