{"description":"The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":11,"description":"Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":9,"seriousNumAtRisk":11,"title":"Diffuse Intrinsic Pontine Glioma"},{"deathsNumAffected":6,"deathsNumAtRisk":9,"description":"Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.","id":"EG001","otherNumAffected":8,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"Ependymoma"},{"deathsNumAffected":15,"deathsNumAtRisk":23,"description":"Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.","id":"EG002","otherNumAffected":20,"otherNumAtRisk":22,"seriousNumAffected":14,"seriousNumAtRisk":22,"title":"High-grade Glioma"},{"deathsNumAffected":9,"deathsNumAtRisk":10,"description":"Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.","id":"EG003","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":4,"seriousNumAtRisk":10,"title":"Medulloblastoma"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":7,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":6,"numAtRisk":9},{"groupId":"EG002","numAffected":8,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":10}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":6,"numAtRisk":9},{"groupId":"EG002","numAffected":6,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":7,"numAtRisk":9},{"groupId":"EG002","numAffected":9,"numAtRisk":22},{"groupId":"EG003","numAffected":4,"numAtRisk":10}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":8,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":10}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Blindness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Conjunctival hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Mydriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Salivary hypersecretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":4,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":22},{"groupId":"EG003","numAffected":4,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Molluscum contagiosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Otitis externa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Parotitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Temporomandibular joint syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Haemangioma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":4,"numAtRisk":9},{"groupId":"EG002","numAffected":5,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":10}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Muscle spasticity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pyramidal tract syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"VIth nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Personality change"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Urinary hesitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Bronchostenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pharyngeal erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Sleep apnoea syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Tonsillar inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":10}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pallor"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Anorectal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Encephalitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Mastoiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Respiratory syncytial virus bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dysmetria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Generalised tonic-clonic seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Intracranial pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Monoplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Neurological decompensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":10}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":10}],"term":"Respiratory failure"}],"timeFrame":"Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months)."}