{"description":"The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.","eventGroups":[{"description":"Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.","id":"EG000","otherNumAffected":81,"otherNumAtRisk":91,"seriousNumAffected":25,"seriousNumAtRisk":91,"title":"Placebo"},{"description":"Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.","id":"EG001","otherNumAffected":89,"otherNumAtRisk":94,"seriousNumAffected":35,"seriousNumAtRisk":94,"title":"Palifermin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":91},{"groupId":"EG001","numAffected":21,"numAtRisk":94}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":91},{"groupId":"EG001","numAffected":21,"numAtRisk":94}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":91},{"groupId":"EG001","numAffected":10,"numAtRisk":94}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":91},{"groupId":"EG001","numAffected":11,"numAtRisk":94}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":91},{"groupId":"EG001","numAffected":31,"numAtRisk":94}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":91},{"groupId":"EG001","numAffected":7,"numAtRisk":94}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":91},{"groupId":"EG001","numAffected":9,"numAtRisk":94}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":91},{"groupId":"EG001","numAffected":27,"numAtRisk":94}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":91},{"groupId":"EG001","numAffected":46,"numAtRisk":94}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":91},{"groupId":"EG001","numAffected":9,"numAtRisk":94}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":91},{"groupId":"EG001","numAffected":9,"numAtRisk":94}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":91},{"groupId":"EG001","numAffected":24,"numAtRisk":94}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":91},{"groupId":"EG001","numAffected":4,"numAtRisk":94}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":91},{"groupId":"EG001","numAffected":21,"numAtRisk":94}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":91},{"groupId":"EG001","numAffected":6,"numAtRisk":94}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":91},{"groupId":"EG001","numAffected":16,"numAtRisk":94}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":91},{"groupId":"EG001","numAffected":11,"numAtRisk":94}],"term":"Candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":91},{"groupId":"EG001","numAffected":17,"numAtRisk":94}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Oral fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":91},{"groupId":"EG001","numAffected":25,"numAtRisk":94}],"term":"Radiation skin injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":91},{"groupId":"EG001","numAffected":7,"numAtRisk":94}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":91},{"groupId":"EG001","numAffected":25,"numAtRisk":94}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":91},{"groupId":"EG001","numAffected":12,"numAtRisk":94}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":91},{"groupId":"EG001","numAffected":10,"numAtRisk":94}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":91},{"groupId":"EG001","numAffected":19,"numAtRisk":94}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":91},{"groupId":"EG001","numAffected":3,"numAtRisk":94}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":91},{"groupId":"EG001","numAffected":18,"numAtRisk":94}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":91},{"groupId":"EG001","numAffected":10,"numAtRisk":94}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":91},{"groupId":"EG001","numAffected":9,"numAtRisk":94}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":91},{"groupId":"EG001","numAffected":11,"numAtRisk":94}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":91},{"groupId":"EG001","numAffected":16,"numAtRisk":94}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":91},{"groupId":"EG001","numAffected":11,"numAtRisk":94}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":91},{"groupId":"EG001","numAffected":6,"numAtRisk":94}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":91},{"groupId":"EG001","numAffected":20,"numAtRisk":94}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":6,"numAtRisk":94}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":91},{"groupId":"EG001","numAffected":4,"numAtRisk":94}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":91},{"groupId":"EG001","numAffected":9,"numAtRisk":94}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":6,"numAtRisk":94}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Agranulocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Haemoglobinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hypoacusis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Pancreatitis necrotising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":3,"numAtRisk":94}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":4,"numAtRisk":94}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hepatic cirrhosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Portal vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Bronchitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Bronchopneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Clostridial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Colitis pseudomembranous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Infected epidermal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Pulmonary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Alcohol poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Device occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Injury asphyxiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Lumbar vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Tracheostomy malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Blood bilirubin abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Blood creatinine abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Blood lactate dehydrogenase abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Blood potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Blood sodium abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Gamma-glutamyltransferase abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":5,"numAtRisk":94}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":91},{"groupId":"EG001","numAffected":4,"numAtRisk":94}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Food intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Laryngeal neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Peritoneal carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Syncope vasovagal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Depression suicidal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Psychotic disorder due to a general medical condition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Cryptogenic organizing pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":2,"numAtRisk":94}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Laryngeal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Pharyngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Pharyngeal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":94}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":94}],"term":"Hypertension"}],"timeFrame":"Approximately 8 weeks"}