{"eventGroups":[{"description":"Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.","id":"EG000","otherNumAffected":229,"otherNumAtRisk":229,"seriousNumAffected":72,"seriousNumAtRisk":229,"title":"Afatinib 40 mg"},{"description":"Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.","id":"EG001","otherNumAffected":108,"otherNumAtRisk":111,"seriousNumAffected":25,"seriousNumAtRisk":111,"title":"Pemetrexed/Cisplatin Chemotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":229},{"groupId":"EG001","numAffected":29,"numAtRisk":111}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":229},{"groupId":"EG001","numAffected":21,"numAtRisk":111}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":229},{"groupId":"EG001","numAffected":35,"numAtRisk":111}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":8,"numAtRisk":111}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":229},{"groupId":"EG001","numAffected":5,"numAtRisk":111}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":229},{"groupId":"EG001","numAffected":8,"numAtRisk":111}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":229},{"groupId":"EG001","numAffected":39,"numAtRisk":111}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":216,"numAtRisk":229},{"groupId":"EG001","numAffected":25,"numAtRisk":111}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":229},{"groupId":"EG001","numAffected":7,"numAtRisk":111}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":229},{"groupId":"EG001","numAffected":3,"numAtRisk":111}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":229},{"groupId":"EG001","numAffected":75,"numAtRisk":111}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":229},{"groupId":"EG001","numAffected":10,"numAtRisk":111}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":229},{"groupId":"EG001","numAffected":50,"numAtRisk":111}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":229},{"groupId":"EG001","numAffected":14,"numAtRisk":111}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":229},{"groupId":"EG001","numAffected":14,"numAtRisk":111}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":229},{"groupId":"EG001","numAffected":39,"numAtRisk":111}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":229},{"groupId":"EG001","numAffected":6,"numAtRisk":111}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":229},{"groupId":"EG001","numAffected":5,"numAtRisk":111}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":229},{"groupId":"EG001","numAffected":13,"numAtRisk":111}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":229},{"groupId":"EG001","numAffected":8,"numAtRisk":111}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":229},{"groupId":"EG001","numAffected":6,"numAtRisk":111}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":229},{"groupId":"EG001","numAffected":3,"numAtRisk":111}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":229},{"groupId":"EG001","numAffected":9,"numAtRisk":111}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":132,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":229},{"groupId":"EG001","numAffected":4,"numAtRisk":111}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":229},{"groupId":"EG001","numAffected":5,"numAtRisk":111}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":229},{"groupId":"EG001","numAffected":3,"numAtRisk":111}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":229},{"groupId":"EG001","numAffected":10,"numAtRisk":111}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":13,"numAtRisk":111}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":8,"numAtRisk":111}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":229},{"groupId":"EG001","numAffected":16,"numAtRisk":111}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":229},{"groupId":"EG001","numAffected":61,"numAtRisk":111}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":229},{"groupId":"EG001","numAffected":4,"numAtRisk":111}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":229},{"groupId":"EG001","numAffected":6,"numAtRisk":111}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":229},{"groupId":"EG001","numAffected":6,"numAtRisk":111}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":229},{"groupId":"EG001","numAffected":13,"numAtRisk":111}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":229},{"groupId":"EG001","numAffected":4,"numAtRisk":111}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":229},{"groupId":"EG001","numAffected":12,"numAtRisk":111}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":229},{"groupId":"EG001","numAffected":9,"numAtRisk":111}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":229},{"groupId":"EG001","numAffected":19,"numAtRisk":111}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":229},{"groupId":"EG001","numAffected":10,"numAtRisk":111}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":229},{"groupId":"EG001","numAffected":21,"numAtRisk":111}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":229},{"groupId":"EG001","numAffected":12,"numAtRisk":111}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":229},{"groupId":"EG001","numAffected":10,"numAtRisk":111}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Nasal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":229},{"groupId":"EG001","numAffected":3,"numAtRisk":111}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":229},{"groupId":"EG001","numAffected":7,"numAtRisk":111}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":229},{"groupId":"EG001","numAffected":20,"numAtRisk":111}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":145,"numAtRisk":229},{"groupId":"EG001","numAffected":11,"numAtRisk":111}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Skin fissures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":229},{"groupId":"EG001","numAffected":14,"numAtRisk":111}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Mitral valve incompetence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":229},{"groupId":"EG001","numAffected":3,"numAtRisk":111}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Abasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Meningitis aseptic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Meningoencephalitis herpetic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Lower limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Splenic rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Synovial rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Thoracic vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Tibia fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Blood sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Liver function test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Diabetes with hyperosmolarity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Metastases to lung"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Intracranial pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Partial seizures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Schizophreniform disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Acute prerenal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":229},{"groupId":"EG001","numAffected":2,"numAtRisk":111}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":3,"numAtRisk":111}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Pulmonary artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":0,"numAtRisk":111}],"term":"Superior vena cava syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":229},{"groupId":"EG001","numAffected":1,"numAtRisk":111}],"term":"Venous thrombosis"}],"timeFrame":"First administration of trial medication until 28 days after last administration of trial medication."}