{"description":"The summary tables below include all adverse events starting or worsening on or after the first dose of everolimus, and starting no later than 30 days after the date of last dose of everolimus. Adverse events starting during the placebo period were not counted.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":117,"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL","id":"EG000","otherNumAffected":110,"otherNumAtRisk":117,"seriousNumAffected":50,"seriousNumAtRisk":117,"title":"Everolimus LT Target of 3 to 7 ng/mL"},{"deathsNumAffected":2,"deathsNumAtRisk":130,"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL","id":"EG001","otherNumAffected":126,"otherNumAtRisk":130,"seriousNumAffected":49,"seriousNumAtRisk":130,"title":"Everolimus HT Target of 9 to 15 ng/mL"},{"deathsNumAffected":1,"deathsNumAtRisk":114,"description":"Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.","id":"EG002","otherNumAffected":109,"otherNumAtRisk":114,"seriousNumAffected":38,"seriousNumAtRisk":114,"title":"Everolimus Start Ext"},{"deathsNumAffected":4,"deathsNumAtRisk":361,"description":"Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.","id":"EG003","otherNumAffected":345,"otherNumAtRisk":361,"seriousNumAffected":137,"seriousNumAtRisk":361,"title":"Everolimus All"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":4,"numAtRisk":114},{"groupId":"EG003","numAffected":21,"numAtRisk":361}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":117},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":14,"numAtRisk":361}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":117},{"groupId":"EG001","numAffected":4,"numAtRisk":130},{"groupId":"EG002","numAffected":5,"numAtRisk":114},{"groupId":"EG003","numAffected":19,"numAtRisk":361}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":117},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":5,"numAtRisk":114},{"groupId":"EG003","numAffected":22,"numAtRisk":361}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":117},{"groupId":"EG001","numAffected":23,"numAtRisk":130},{"groupId":"EG002","numAffected":10,"numAtRisk":114},{"groupId":"EG003","numAffected":44,"numAtRisk":361}],"term":"Aphthous ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":117},{"groupId":"EG001","numAffected":12,"numAtRisk":130},{"groupId":"EG002","numAffected":7,"numAtRisk":114},{"groupId":"EG003","numAffected":28,"numAtRisk":361}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":11,"numAtRisk":361}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":117},{"groupId":"EG001","numAffected":42,"numAtRisk":130},{"groupId":"EG002","numAffected":30,"numAtRisk":114},{"groupId":"EG003","numAffected":117,"numAtRisk":361}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":117},{"groupId":"EG001","numAffected":44,"numAtRisk":130},{"groupId":"EG002","numAffected":22,"numAtRisk":114},{"groupId":"EG003","numAffected":102,"numAtRisk":361}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":16,"numAtRisk":361}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":117},{"groupId":"EG001","numAffected":48,"numAtRisk":130},{"groupId":"EG002","numAffected":41,"numAtRisk":114},{"groupId":"EG003","numAffected":130,"numAtRisk":361}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":117},{"groupId":"EG001","numAffected":35,"numAtRisk":130},{"groupId":"EG002","numAffected":16,"numAtRisk":114},{"groupId":"EG003","numAffected":79,"numAtRisk":361}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":117},{"groupId":"EG001","numAffected":11,"numAtRisk":130},{"groupId":"EG002","numAffected":5,"numAtRisk":114},{"groupId":"EG003","numAffected":24,"numAtRisk":361}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":117},{"groupId":"EG001","numAffected":56,"numAtRisk":130},{"groupId":"EG002","numAffected":31,"numAtRisk":114},{"groupId":"EG003","numAffected":134,"numAtRisk":361}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":117},{"groupId":"EG001","numAffected":17,"numAtRisk":130},{"groupId":"EG002","numAffected":8,"numAtRisk":114},{"groupId":"EG003","numAffected":36,"numAtRisk":361}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":117},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":25,"numAtRisk":361}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":117},{"groupId":"EG001","numAffected":19,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":33,"numAtRisk":361}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":117},{"groupId":"EG001","numAffected":15,"numAtRisk":130},{"groupId":"EG002","numAffected":7,"numAtRisk":114},{"groupId":"EG003","numAffected":35,"numAtRisk":361}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":117},{"groupId":"EG001","numAffected":4,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":13,"numAtRisk":361}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":5,"numAtRisk":130},{"groupId":"EG002","numAffected":4,"numAtRisk":114},{"groupId":"EG003","numAffected":15,"numAtRisk":361}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":117},{"groupId":"EG001","numAffected":18,"numAtRisk":130},{"groupId":"EG002","numAffected":9,"numAtRisk":114},{"groupId":"EG003","numAffected":43,"numAtRisk":361}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":10,"numAtRisk":361}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":117},{"groupId":"EG001","numAffected":35,"numAtRisk":130},{"groupId":"EG002","numAffected":26,"numAtRisk":114},{"groupId":"EG003","numAffected":94,"numAtRisk":361}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":117},{"groupId":"EG001","numAffected":18,"numAtRisk":130},{"groupId":"EG002","numAffected":8,"numAtRisk":114},{"groupId":"EG003","numAffected":37,"numAtRisk":361}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":9,"numAtRisk":361}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":117},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":5,"numAtRisk":114},{"groupId":"EG003","numAffected":23,"numAtRisk":361}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":15,"numAtRisk":130},{"groupId":"EG002","numAffected":8,"numAtRisk":114},{"groupId":"EG003","numAffected":26,"numAtRisk":361}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":117},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":4,"numAtRisk":114},{"groupId":"EG003","numAffected":24,"numAtRisk":361}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":117},{"groupId":"EG001","numAffected":42,"numAtRisk":130},{"groupId":"EG002","numAffected":22,"numAtRisk":114},{"groupId":"EG003","numAffected":96,"numAtRisk":361}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":117},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":28,"numAtRisk":361}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":18,"numAtRisk":361}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":10,"numAtRisk":361}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":16,"numAtRisk":361}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":117},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":8,"numAtRisk":114},{"groupId":"EG003","numAffected":33,"numAtRisk":361}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":4,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":13,"numAtRisk":361}],"term":"Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":5,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":13,"numAtRisk":361}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":117},{"groupId":"EG001","numAffected":20,"numAtRisk":130},{"groupId":"EG002","numAffected":17,"numAtRisk":114},{"groupId":"EG003","numAffected":51,"numAtRisk":361}],"term":"Blood cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":21,"numAtRisk":361}],"term":"Blood triglycerides increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":17,"numAtRisk":361}],"term":"Low density lipoprotein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":8,"numAtRisk":114},{"groupId":"EG003","numAffected":25,"numAtRisk":361}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":117},{"groupId":"EG001","numAffected":20,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":39,"numAtRisk":361}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":117},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":15,"numAtRisk":361}],"term":"Hyperlipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":117},{"groupId":"EG001","numAffected":12,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":27,"numAtRisk":361}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":117},{"groupId":"EG001","numAffected":19,"numAtRisk":130},{"groupId":"EG002","numAffected":10,"numAtRisk":114},{"groupId":"EG003","numAffected":48,"numAtRisk":361}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":117},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":4,"numAtRisk":114},{"groupId":"EG003","numAffected":21,"numAtRisk":361}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":14,"numAtRisk":361}],"term":"Aggression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":10,"numAtRisk":361}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":117},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":18,"numAtRisk":361}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":4,"numAtRisk":130},{"groupId":"EG002","numAffected":7,"numAtRisk":114},{"groupId":"EG003","numAffected":16,"numAtRisk":361}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":11,"numAtRisk":361}],"term":"Menstruation irregular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":117},{"groupId":"EG001","numAffected":33,"numAtRisk":130},{"groupId":"EG002","numAffected":15,"numAtRisk":114},{"groupId":"EG003","numAffected":77,"numAtRisk":361}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":117},{"groupId":"EG001","numAffected":12,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":19,"numAtRisk":361}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":12,"numAtRisk":361}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":10,"numAtRisk":130},{"groupId":"EG002","numAffected":5,"numAtRisk":114},{"groupId":"EG003","numAffected":20,"numAtRisk":361}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":117},{"groupId":"EG001","numAffected":9,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":22,"numAtRisk":361}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":14,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":26,"numAtRisk":361}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":117},{"groupId":"EG001","numAffected":8,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":14,"numAtRisk":361}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":11,"numAtRisk":361}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":11,"numAtRisk":361}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":117},{"groupId":"EG001","numAffected":21,"numAtRisk":130},{"groupId":"EG002","numAffected":13,"numAtRisk":114},{"groupId":"EG003","numAffected":48,"numAtRisk":361}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":6,"numAtRisk":114},{"groupId":"EG003","numAffected":19,"numAtRisk":361}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Blepharitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Meibomianitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Retinopathy proliferative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":5,"numAtRisk":361}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Food poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Gastric ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Intestinal ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":4,"numAtRisk":361}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":4,"numAtRisk":361}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Swollen tongue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":4,"numAtRisk":361}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":4,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":11,"numAtRisk":361}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Sudden unexplained death in epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":3,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":6,"numAtRisk":361}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Campylobacter colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Corona virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Croup infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Dacryocanaliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Febrile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":117},{"groupId":"EG001","numAffected":5,"numAtRisk":130},{"groupId":"EG002","numAffected":4,"numAtRisk":114},{"groupId":"EG003","numAffected":14,"numAtRisk":361}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Gastrointestinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"H1N1 influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Herpangina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":6,"numAtRisk":361}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Mastoiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Meningitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Periorbital cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Perirectal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":4,"numAtRisk":361}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Pharyngitis streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":117},{"groupId":"EG001","numAffected":13,"numAtRisk":130},{"groupId":"EG002","numAffected":9,"numAtRisk":114},{"groupId":"EG003","numAffected":38,"numAtRisk":361}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Pneumonia influenzal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Pneumonia mycoplasmal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Pneumonia viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Pseudocroup"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":4,"numAtRisk":361}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Rotavirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":5,"numAtRisk":361}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Varicella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Viraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":3,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Craniocerebral injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Tibia fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Tongue injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Feeding intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":3,"numAtRisk":361}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Febrile convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Generalised tonic-clonic seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":2,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Moyamoya disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":117},{"groupId":"EG001","numAffected":7,"numAtRisk":130},{"groupId":"EG002","numAffected":4,"numAtRisk":114},{"groupId":"EG003","numAffected":18,"numAtRisk":361}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Seizure cluster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":117},{"groupId":"EG001","numAffected":6,"numAtRisk":130},{"groupId":"EG002","numAffected":2,"numAtRisk":114},{"groupId":"EG003","numAffected":15,"numAtRisk":361}],"term":"Status epilepticus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Stupor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Affect lability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Aggression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Mood altered"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Psychotic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Post streptococcal glomerulonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Menorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Lung disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":2,"numAtRisk":361}],"term":"Erythema nodosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":1,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":1,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Sexual abuse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":117},{"groupId":"EG001","numAffected":0,"numAtRisk":130},{"groupId":"EG002","numAffected":0,"numAtRisk":114},{"groupId":"EG003","numAffected":1,"numAtRisk":361}],"term":"Hypertension"}],"timeFrame":"Adverse Events were collected during everolimus treatment from start of everolimus up to permanent discontinuation of everolimus, an average of 2.3 years"}