{"description":"For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.","eventGroups":[{"deathsNumAffected":7,"deathsNumAtRisk":209,"description":"Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends","id":"EG000","otherNumAffected":185,"otherNumAtRisk":209,"seriousNumAffected":68,"seriousNumAtRisk":209,"title":"Nivolumab Arm"},{"deathsNumAffected":5,"deathsNumAtRisk":208,"description":"Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends\n\nOR\n\nPaclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends","id":"EG001","otherNumAffected":204,"otherNumAtRisk":208,"seriousNumAffected":77,"seriousNumAtRisk":208,"title":"Active Comparator Arm （Docetaxel/Paclitaxel）"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":209},{"groupId":"EG001","numAffected":61,"numAtRisk":208}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":18,"numAtRisk":208}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":40,"numAtRisk":208}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":209},{"groupId":"EG001","numAffected":8,"numAtRisk":208}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":209},{"groupId":"EG001","numAffected":40,"numAtRisk":208}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":209},{"groupId":"EG001","numAffected":34,"numAtRisk":208}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":209},{"groupId":"EG001","numAffected":40,"numAtRisk":208}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":209},{"groupId":"EG001","numAffected":26,"numAtRisk":208}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":209},{"groupId":"EG001","numAffected":17,"numAtRisk":208}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":209},{"groupId":"EG001","numAffected":4,"numAtRisk":208}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":209},{"groupId":"EG001","numAffected":52,"numAtRisk":208}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":209},{"groupId":"EG001","numAffected":49,"numAtRisk":208}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":209},{"groupId":"EG001","numAffected":38,"numAtRisk":208}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":209},{"groupId":"EG001","numAffected":9,"numAtRisk":208}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":209},{"groupId":"EG001","numAffected":13,"numAtRisk":208}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":209},{"groupId":"EG001","numAffected":7,"numAtRisk":208}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":209},{"groupId":"EG001","numAffected":7,"numAtRisk":208}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":209},{"groupId":"EG001","numAffected":21,"numAtRisk":208}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":76,"numAtRisk":208}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":209},{"groupId":"EG001","numAffected":11,"numAtRisk":208}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":72,"numAtRisk":208}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":209},{"groupId":"EG001","numAffected":68,"numAtRisk":208}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":209},{"groupId":"EG001","numAffected":25,"numAtRisk":208}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":209},{"groupId":"EG001","numAffected":22,"numAtRisk":208}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":209},{"groupId":"EG001","numAffected":14,"numAtRisk":208}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":23,"numAtRisk":208}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":48,"numAtRisk":208}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":209},{"groupId":"EG001","numAffected":13,"numAtRisk":208}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":209},{"groupId":"EG001","numAffected":25,"numAtRisk":208}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":209},{"groupId":"EG001","numAffected":8,"numAtRisk":208}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":100,"numAtRisk":208}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":209},{"groupId":"EG001","numAffected":15,"numAtRisk":208}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":209},{"groupId":"EG001","numAffected":40,"numAtRisk":208}],"term":"Rash"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":16,"numAtRisk":208}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Bone marrow failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Tracheo-oesophageal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Hypopituitarism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Inappropriate antidiuretic hormone secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Adrenocorticotropic hormone deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Duodenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Gastric fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Aorto-oesophageal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Anaphylactic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Mediastinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":209},{"groupId":"EG001","numAffected":13,"numAtRisk":208}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Muscle abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Abscess neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Intervertebral discitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":5,"numAtRisk":208}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Spinal cord abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Radiation pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Stoma site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Liver function test increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":6,"numAtRisk":208}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Metastases to lymph nodes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Skin cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Lymphangiosis carcinomatosa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Pleurisy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":208}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":3,"numAtRisk":208}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Pneumothorax spontaneous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Oesophagobronchial fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Tracheal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Stevens-Johnson syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":208}],"term":"Jejunostomy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Venous thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":208}],"term":"Embolism"}],"timeFrame":"Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose."}