{"description":"Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment.\n\n2 patients randomized to PAN+5AZA received only 5AZA \\& no PAN \\& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \\& were not part of the safety set but were part of the FAS for the 5AZA group","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 g/m2/day for 7 days in Week 1 of each cycle","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":5,"seriousNumAtRisk":6,"title":"Phase Ib PAN + 5-Aza 20mg"},{"deathsNumAffected":1,"deathsNumAtRisk":18,"description":"In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle","id":"EG001","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":15,"seriousNumAtRisk":18,"title":"Phase Ib PAN + 5-Aza 30mg"},{"deathsNumAffected":2,"deathsNumAtRisk":7,"description":"In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle","id":"EG002","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":6,"seriousNumAtRisk":7,"title":"Phase Ib PAN + 5-Aza 40mg"},{"deathsNumAffected":6,"deathsNumAtRisk":38,"description":"In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.\n\nIn both phases, dose of 5-Azacytidine was 75 mg/m\\^2, subcutaneously Daily for Day 1 to Day 7.","id":"EG003","otherNumAffected":38,"otherNumAtRisk":38,"seriousNumAffected":28,"seriousNumAtRisk":38,"title":"Phase IIb PAN + 5-Aza"},{"deathsNumAffected":3,"deathsNumAtRisk":42,"description":"The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.\n\nDose of 5-Azacytidine: 75 mg/m\\^2 subcutaneously daily from Day 1 to Day","id":"EG004","otherNumAffected":38,"otherNumAtRisk":42,"seriousNumAffected":28,"seriousNumAtRisk":42,"title":"Phase IIb 5-Aza"},{"deathsNumAffected":12,"deathsNumAtRisk":111,"description":"Patients in the Panobinostat + 5-Azacytidine arm and in the 5-Azacytidine arm","id":"EG005","otherNumAffected":107,"otherNumAtRisk":111,"seriousNumAffected":82,"seriousNumAtRisk":111,"title":"Phase Ib and IIb"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":8,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":12,"numAtRisk":38},{"groupId":"EG004","numAffected":14,"numAtRisk":42},{"groupId":"EG005","numAffected":40,"numAtRisk":111}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":6,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":8,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":16,"numAtRisk":38},{"groupId":"EG004","numAffected":10,"numAtRisk":42},{"groupId":"EG005","numAffected":39,"numAtRisk":111}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Splenomegaly"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":12,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":18,"numAtRisk":38},{"groupId":"EG004","numAffected":10,"numAtRisk":42},{"groupId":"EG005","numAffected":47,"numAtRisk":111}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Thrombocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":8,"numAtRisk":111}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Bundle branch block left"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hypertensive heart disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Ventricular extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Ear disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Hypoacusis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Otorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Thyroid disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blepharitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Eye irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Optic atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pupillary reflex impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":6,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":18,"numAtRisk":111}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Abdominal wall haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Abdominal wall mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Anal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Anal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Anal skin tags"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Angina bullosa haemorrhagica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":11,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":10,"numAtRisk":38},{"groupId":"EG004","numAffected":16,"numAtRisk":42},{"groupId":"EG005","numAffected":42,"numAtRisk":111}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6},{"groupId":"EG001","numAffected":15,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":22,"numAtRisk":38},{"groupId":"EG004","numAffected":9,"numAtRisk":42},{"groupId":"EG005","numAffected":54,"numAtRisk":111}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Dyschezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Epigastric discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gastroenteritis eosinophilic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gastrointestinal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gastrointestinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Gingival pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Haemorrhoidal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":5,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Intra-abdominal haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Lip swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Loose tooth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6},{"groupId":"EG001","numAffected":14,"numAtRisk":18},{"groupId":"EG002","numAffected":7,"numAtRisk":7},{"groupId":"EG003","numAffected":23,"numAtRisk":38},{"groupId":"EG004","numAffected":18,"numAtRisk":42},{"groupId":"EG005","numAffected":66,"numAtRisk":111}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Noninfective gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Parotid gland enlargement"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Retroperitoneal haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Swollen tongue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tongue coated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tooth impacted"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":8,"numAtRisk":111}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":6},{"groupId":"EG001","numAffected":9,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":16,"numAtRisk":38},{"groupId":"EG004","numAffected":12,"numAtRisk":42},{"groupId":"EG005","numAffected":46,"numAtRisk":111}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":10,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":25,"numAtRisk":111}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Catheter site discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Catheter site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Catheter site haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Catheter site phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":12,"numAtRisk":111}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Facial pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6},{"groupId":"EG001","numAffected":12,"numAtRisk":18},{"groupId":"EG002","numAffected":6,"numAtRisk":7},{"groupId":"EG003","numAffected":10,"numAtRisk":38},{"groupId":"EG004","numAffected":16,"numAtRisk":42},{"groupId":"EG005","numAffected":48,"numAtRisk":111}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Feeling cold"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Feeling hot"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Generalised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Injection site bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":5,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Injection site haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Injection site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Injection site irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":5,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Injection site pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Injection site rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":8,"numAtRisk":111}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":8,"numAtRisk":38},{"groupId":"EG004","numAffected":9,"numAtRisk":42},{"groupId":"EG005","numAffected":27,"numAtRisk":111}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Puncture site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":8,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":18,"numAtRisk":38},{"groupId":"EG004","numAffected":9,"numAtRisk":42},{"groupId":"EG005","numAffected":41,"numAtRisk":111}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Thirst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hepatomegaly"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Allergic oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Allergy to chemicals"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Anal fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Anal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Carbuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Chronic sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Enterobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Enterococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haemorrhoid infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Herpes simplex"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Human polyomavirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Infectious colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Localised infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Mucormycosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pseudomonas infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Puncture site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Allergic transfusion reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":9,"numAtRisk":111}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Post procedural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Post procedural swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Procedural hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tongue injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Transfusion reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":8,"numAtRisk":111}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":8,"numAtRisk":111}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Blood albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood bicarbonate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood creatinine decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":5,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":14,"numAtRisk":111}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood folate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood thyroid stimulating hormone decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Blood urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Breath sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":8,"numAtRisk":111}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Coagulation test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Electrocardiogram T wave abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Fibrin D dimer increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Glucose urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Left ventricular end-diastolic pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":6,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Nitrite urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":8,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Protein urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Prothrombin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Prothrombin time shortened"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Troponin T increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Urobilinogen urine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Vitamin D decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":7,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":16,"numAtRisk":111}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"White blood cells urine positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":5,"numAtRisk":7},{"groupId":"EG003","numAffected":9,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":29,"numAtRisk":111}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Fluid overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Fluid retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Gout"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hypercreatininaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Hyperlipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hypermagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":5,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":7,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":16,"numAtRisk":111}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":10,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":7,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":27,"numAtRisk":111}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":9,"numAtRisk":111}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":5,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":14,"numAtRisk":111}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":5,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":14,"numAtRisk":111}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Coccydynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Joint effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Limb discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Muscle fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":13,"numAtRisk":111}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Rotator cuff syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Spinal deformity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Spinal osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Temporomandibular joint syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Benign lung neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Lipoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Disturbance in attention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":5,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":15,"numAtRisk":111}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":12,"numAtRisk":111}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Facial paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":7},{"groupId":"EG003","numAffected":7,"numAtRisk":38},{"groupId":"EG004","numAffected":7,"numAtRisk":42},{"groupId":"EG005","numAffected":24,"numAtRisk":111}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hypotonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Normal pressure hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Partial seizures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Polyneuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Sciatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Fear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":5,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":15,"numAtRisk":111}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Personality change"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Sleep disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Anuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Bladder pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haemorrhage urinary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Renal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Scrotal erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Scrotal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Scrotal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Bronchial disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Bronchial obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Bronchostenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":7,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":23,"numAtRisk":111}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":18,"numAtRisk":111}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":5,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":19,"numAtRisk":111}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Hyperventilation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Laryngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Oropharyngeal blistering"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":5,"numAtRisk":42},{"groupId":"EG005","numAffected":14,"numAtRisk":111}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pharyngeal erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Rhonchi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tachypnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":6,"numAtRisk":111}],"term":"Dermatitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":10,"numAtRisk":111}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Exfoliative rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Koebner phenomenon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Papule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":7,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":13,"numAtRisk":111}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":9,"numAtRisk":111}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":6,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":16,"numAtRisk":111}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Skin haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Skin plaque"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Arteriosclerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":5,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":11,"numAtRisk":111}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pallor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Peripheral artery aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Peripheral artery occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Peripheral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Phlebitis superficial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Poor venous access"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Shock"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Anaemia of malignant disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":10,"numAtRisk":38},{"groupId":"EG004","numAffected":6,"numAtRisk":42},{"groupId":"EG005","numAffected":27,"numAtRisk":111}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haemolytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":7,"numAtRisk":111}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Left ventricular hypertrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Uveitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Duodenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gastroenteritis eosinophilic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Large intestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tongue haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Volvulus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":5,"numAtRisk":111}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Abscess soft tissue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Bacterial sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Breast cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Escherichia bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Escherichia infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gastrointestinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Herpes simplex"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Impetigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Oral bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Parotitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Perirectal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pharyngeal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":8,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":16,"numAtRisk":111}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pulmonary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":4,"numAtRisk":42},{"groupId":"EG005","numAffected":9,"numAtRisk":111}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":4,"numAtRisk":111}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Transfusion reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Ulna fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Electrocardiogram ST segment depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Electrocardiogram T wave inversion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Heart rate increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Troponin T increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":3,"numAtRisk":111}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Benign anorectal neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Large cell lung cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Meningioma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Prerenal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":2,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Embolism venous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":1,"numAtRisk":42},{"groupId":"EG005","numAffected":2,"numAtRisk":111}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":0,"numAtRisk":42},{"groupId":"EG005","numAffected":1,"numAtRisk":111}],"term":"Peripheral artery occlusion"}],"timeFrame":"Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks."}