{"description":"All-Cause Mortality was assessed as per ITT population. Adverse Events: Safety Analysis Set included all participants who received at least one dose of study treatment.","eventGroups":[{"deathsNumAffected":99,"deathsNumAtRisk":126,"description":"Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.","id":"EG000","otherNumAffected":118,"otherNumAtRisk":123,"seriousNumAffected":43,"seriousNumAtRisk":123,"title":"AG-120"},{"deathsNumAffected":14,"deathsNumAtRisk":61,"description":"Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.","id":"EG001","otherNumAffected":56,"otherNumAtRisk":59,"seriousNumAffected":14,"seriousNumAtRisk":59,"title":"Placebo"},{"deathsNumAffected":34,"deathsNumAtRisk":43,"description":"Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.","id":"EG002","otherNumAffected":36,"otherNumAtRisk":43,"seriousNumAffected":12,"seriousNumAtRisk":43,"title":"After Cross Over to AG-120"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":123},{"groupId":"EG001","numAffected":17,"numAtRisk":59},{"groupId":"EG002","numAffected":12,"numAtRisk":43}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":123},{"groupId":"EG001","numAffected":10,"numAtRisk":59},{"groupId":"EG002","numAffected":12,"numAtRisk":43}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":123},{"groupId":"EG001","numAffected":10,"numAtRisk":59},{"groupId":"EG002","numAffected":10,"numAtRisk":43}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":123},{"groupId":"EG001","numAffected":9,"numAtRisk":59},{"groupId":"EG002","numAffected":7,"numAtRisk":43}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":123},{"groupId":"EG001","numAffected":5,"numAtRisk":59},{"groupId":"EG002","numAffected":5,"numAtRisk":43}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":123},{"groupId":"EG001","numAffected":11,"numAtRisk":59},{"groupId":"EG002","numAffected":6,"numAtRisk":43}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":123},{"groupId":"EG001","numAffected":7,"numAtRisk":59},{"groupId":"EG002","numAffected":5,"numAtRisk":43}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":123},{"groupId":"EG001","numAffected":11,"numAtRisk":59},{"groupId":"EG002","numAffected":5,"numAtRisk":43}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":7,"numAtRisk":43}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123},{"groupId":"EG001","numAffected":6,"numAtRisk":59},{"groupId":"EG002","numAffected":9,"numAtRisk":43}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":123},{"groupId":"EG001","numAffected":11,"numAtRisk":59},{"groupId":"EG002","numAffected":5,"numAtRisk":43}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123},{"groupId":"EG001","numAffected":7,"numAtRisk":59},{"groupId":"EG002","numAffected":5,"numAtRisk":43}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":123},{"groupId":"EG001","numAffected":7,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":123},{"groupId":"EG001","numAffected":6,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":123},{"groupId":"EG001","numAffected":4,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123},{"groupId":"EG001","numAffected":10,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":123},{"groupId":"EG001","numAffected":5,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":123},{"groupId":"EG001","numAffected":6,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123},{"groupId":"EG001","numAffected":4,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":123},{"groupId":"EG001","numAffected":6,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":6,"numAtRisk":43}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":123},{"groupId":"EG001","numAffected":6,"numAtRisk":59},{"groupId":"EG002","numAffected":5,"numAtRisk":43}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123},{"groupId":"EG001","numAffected":4,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123},{"groupId":"EG001","numAffected":4,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":3,"numAtRisk":43}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":7,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":4,"numAtRisk":43}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123},{"groupId":"EG001","numAffected":4,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":2,"numAtRisk":43}],"term":"Platelet count decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Tachyarrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Intestinal pseudo-obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Oesophageal varices haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Biliary obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Cholangitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hepatic cirrhosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hepatic haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Biliary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Escherichia bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Systemic candida"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Arterial injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Multiple sclerosis relapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Thecal sac compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Nephropathy toxic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":123},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":43}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Blood loss anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":43}],"term":"Localised oedema"}],"timeFrame":"From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 years)"}