{"description":"Deaths (all-cause) were assessed from first dose until death (survival follow-up). 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aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":106}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":106}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":106}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":106}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":106}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":106}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":106}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":106}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":106}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":106}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":106}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":106}],"term":"Keratopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":106}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":106}],"term":"Punctate keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":106}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":106}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":106}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":106}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":106}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":106}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":106}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":106}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":106}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":106}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":106}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":106}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":106}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":106}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":106}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":106}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":106}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":106}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":106}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":106}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":106}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":106}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":106}],"term":"Hypomagnesaemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Vasculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Administration site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":106}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":106}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Substance-induced psychotic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Brain stem syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":106}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Colitis microscopic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Intestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":106}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":106}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":106}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 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and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Peritonitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":106}],"term":"Severe protein calorie malnutrition"}],"timeFrame":"Up to approximately 27 months"}