{"description":"At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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(21.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":34}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":34}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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(21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":34}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Asteatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":34}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":34}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous 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(21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":34}],"term":"Chillblains"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Back 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connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":34}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Periodontal disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Tooth 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(21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Subdural 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(21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Malignant neoplasm of unknown primary site"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Osteonecrosis of jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Lung neoplasm malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34}],"term":"Sebaceous naevus"}],"timeFrame":"Up to approximately 33 months"}