{"description":"The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":17,"description":"In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.","id":"EG000","otherNumAffected":16,"otherNumAtRisk":17,"seriousNumAffected":8,"seriousNumAtRisk":17,"title":"ALCL Arm"},{"deathsNumAffected":3,"deathsNumAtRisk":9,"description":"In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.","id":"EG001","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"IMT Arm"},{"deathsNumAffected":13,"deathsNumAtRisk":18,"description":"In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.","id":"EG002","otherNumAffected":17,"otherNumAtRisk":18,"seriousNumAffected":7,"seriousNumAtRisk":18,"title":"Other Tumors"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":6,"numAtRisk":18}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Lymph node pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Lymphoid tissue hyperplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Myelosuppression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":17},{"groupId":"EG001","numAffected":4,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":18}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Palpitations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Sinus bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Gilbert's syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Ear discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Otorrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blindness unilateral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Conjunctival haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Conjunctivitis allergic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Diplopia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Eye pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Eyelid oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Lacrimation increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Photopsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":17},{"groupId":"EG001","numAffected":4,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":18}],"term":"Visual impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Vitreous floaters"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Abdominal discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Abdominal pain lower"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Abdominal tenderness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":18}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":17},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":6,"numAtRisk":18}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Enteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Gastric ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Gastrointestinal disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Gastrointestinal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Gingival bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Haemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hiatus hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17},{"groupId":"EG001","numAffected":5,"numAtRisk":9},{"groupId":"EG002","numAffected":7,"numAtRisk":18}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Odynophagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Oesophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Proctitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Toothache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":6,"numAtRisk":18}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Chest discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":18}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Generalised oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Influenza like illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":6,"numAtRisk":18}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Peripheral swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Swelling face"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Biliary dilatation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Cholangitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Cholelithiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Seasonal allergy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Eyelid folliculitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Genital herpes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hordeolum"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Infected cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Influenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Klebsiella infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Mucosal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Oesophageal candidiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Oral candidiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Oral herpes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Otitis externa"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Otitis media"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pelvic infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Respiratory tract infection viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Tonsillitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Vaginal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Viral infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Contusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Exposure during pregnancy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Head injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Ligament sprain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Limb injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Muscle strain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Paternal exposure during pregnancy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Pelvic fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Wrist fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":17},{"groupId":"EG001","numAffected":4,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":18}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Amylase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17},{"groupId":"EG001","numAffected":4,"numAtRisk":9},{"groupId":"EG002","numAffected":6,"numAtRisk":18}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood folate decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood glucose decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood phosphorus decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood testosterone decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood uric acid increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"C-reactive protein increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Globulins decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Haemoglobin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"SARS-CoV-2 test positive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Weight decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Weight increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"White blood cell count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":4,"numAtRisk":18}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hyperuricaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":18}],"term":"Hypoalbuminaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Hypocalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":18}],"term":"Hypokalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Hypophosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Hypoproteinaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Costochondritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Intervertebral disc protrusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Joint effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Muscle disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Muscle fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Muscle spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Muscular weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Pain in jaw"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Pseudarthrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Cancer pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Tumour associated fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Tumour pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Ageusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Amnesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dysaesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Memory impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Neuropathy peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Petit mal epilepsy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Taste disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Visual perseveration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Aggression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Delirium"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Depressed mood"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":18}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Libido decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Urinary incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dysmenorrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Erectile dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Intermenstrual bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Ovarian cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Vaginal discharge"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Atelectasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":4,"numAtRisk":18}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":4,"numAtRisk":18}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Dyspnoea exertional"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Haemoptysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Hiccups"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Nasal congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Oropharyngeal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Paranasal cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Pharyngeal erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Productive cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pulmonary hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Respiratory tract congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Rhinorrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Tonsillar hypertrophy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Acne"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dermatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dermatitis acneiform"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Eczema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hair disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hair growth abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hand dermatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hirsutism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hyperhidrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Mechanical urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Nail discolouration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Nail disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Onychomadesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Purpura"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Skin exfoliation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Skin lesion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Skin mass"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Skin ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Abscess drainage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Mole excision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Hot flush"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Peripheral coldness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Phlebitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Varicose vein"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Cardiac failure congestive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Myocardial ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Eyelid ptosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Visual acuity reduced"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Faecaloma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Disease progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Jaundice cholestatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Hypophagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Cerebral infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Neurogenic bladder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Interstitial lung disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":18}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":18}],"term":"Deep vein thrombosis"}],"timeFrame":"From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum duration between first and last dose: 444 weeks)"}