{"description":"Safety set included all participants who received at least 1 dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.","eventGroups":[{"deathsNumAffected":7,"deathsNumAtRisk":9,"description":"Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).","id":"EG000","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":3,"seriousNumAtRisk":9,"title":"1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab"},{"deathsNumAffected":6,"deathsNumAtRisk":10,"description":"Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.","id":"EG001","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":6,"seriousNumAtRisk":10,"title":"2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab"},{"deathsNumAffected":2,"deathsNumAtRisk":6,"description":"Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.","id":"EG002","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":10,"numEvents":8},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":10,"numEvents":7},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Deafness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Asthenopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Corneal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Corneal epithelial microcysts"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Corneal opacity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Corneal toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":8}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":9}],"term":"Eye irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":3}],"term":"Foreign body sensation in eyes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":10,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":6}],"term":"Keratopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":12}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Retinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":10,"numEvents":6},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":11}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Visual acuity reduced"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Vitreous floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vitreous haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Xerophthalmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hiatus hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Catheter site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hepatic steatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Furuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Perichondritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Varicella zoster virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Ocular procedural complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Subdural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":9}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Electrocardiogram PR prolongation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":4}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypervolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Iron deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vitamin B12 deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":4}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Melanocytic naevus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Skin papilloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Disturbance in attention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dizziness postural"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Facial paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hemianopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hallucination"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gynaecomastia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nasal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sinus pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Orthostatic hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Craniofacial fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood lactic acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Osteolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Confusional state"}],"timeFrame":"All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 281 weeks."}