{"description":"SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":24,"description":"The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.","id":"EG000","otherNumAffected":24,"otherNumAtRisk":24,"seriousNumAffected":12,"seriousNumAtRisk":24,"title":"SRT501"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":24}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":24}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":24}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":24}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":24}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":24}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"CHILLS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"DISEASE PROGRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":24}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"NEUROPATHY PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":24}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"DYSGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"LETHARGY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":24}],"term":"PAIN IN EXTREMITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"MUSCLE SPASMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"MUSCULOSKELETAL CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"MUSCULOSKELETAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"JOINT SWELLING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"MUSCULAR WEAKNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"NECK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 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COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"RHINORRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":24}],"term":"ANOREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"DECREASED APPETITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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13.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"DEPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"CONFUSIONAL STATE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":24}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 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13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Sinus Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Renal impairment"}],"timeFrame":"From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)"}