{"description":"All-cause mortality table includes all randomized participants. Serious and other AEs include participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms \"Neoplasm progression\", \"Malignant neoplasm progression\" and \"Disease progression\" unrelated to drug were excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for all-cause mortality and AEs separately.","eventGroups":[{"deathsNumAffected":283,"deathsNumAtRisk":312,"description":"Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to \\~2 years).","id":"EG000","otherNumAffected":259,"otherNumAtRisk":309,"seriousNumAffected":65,"seriousNumAtRisk":309,"title":"Pembrolizumab First Course"},{"deathsNumAffected":289,"deathsNumAtRisk":310,"description":"Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.","id":"EG001","otherNumAffected":263,"otherNumAtRisk":292,"seriousNumAffected":60,"seriousNumAtRisk":292,"title":"Chemotherapy"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"Qualified participants who received the first course of pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to \\~2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 17 administrations (up to \\~1 year).","id":"EG002","otherNumAffected":4,"otherNumAtRisk":8,"seriousNumAffected":1,"seriousNumAtRisk":8,"title":"Pembrolizumab Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":309,"numEvents":31},{"groupId":"EG001","numAffected":46,"numAtRisk":292,"numEvents":80},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":61,"numAtRisk":292,"numEvents":146},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":309,"numEvents":26},{"groupId":"EG001","numAffected":4,"numAtRisk":292,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":309,"numEvents":18},{"groupId":"EG001","numAffected":15,"numAtRisk":292,"numEvents":18},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":309,"numEvents":56},{"groupId":"EG001","numAffected":51,"numAtRisk":292,"numEvents":59},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":309,"numEvents":34},{"groupId":"EG001","numAffected":60,"numAtRisk":292,"numEvents":83},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":309,"numEvents":63},{"groupId":"EG001","numAffected":89,"numAtRisk":292,"numEvents":117},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":309,"numEvents":7},{"groupId":"EG001","numAffected":23,"numAtRisk":292,"numEvents":24},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":309,"numEvents":30},{"groupId":"EG001","numAffected":33,"numAtRisk":292,"numEvents":44},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":309,"numEvents":40},{"groupId":"EG001","numAffected":38,"numAtRisk":292,"numEvents":42},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":309,"numEvents":67},{"groupId":"EG001","numAffected":54,"numAtRisk":292,"numEvents":61},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":309,"numEvents":9},{"groupId":"EG001","numAffected":15,"numAtRisk":292,"numEvents":17},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":22,"numAtRisk":292,"numEvents":22},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":309,"numEvents":17},{"groupId":"EG001","numAffected":14,"numAtRisk":292,"numEvents":17},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":309,"numEvents":46},{"groupId":"EG001","numAffected":34,"numAtRisk":292,"numEvents":49},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":309,"numEvents":22},{"groupId":"EG001","numAffected":14,"numAtRisk":292,"numEvents":20},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":309,"numEvents":18},{"groupId":"EG001","numAffected":20,"numAtRisk":292,"numEvents":24},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":309,"numEvents":25},{"groupId":"EG001","numAffected":24,"numAtRisk":292,"numEvents":43},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":309,"numEvents":39},{"groupId":"EG001","numAffected":28,"numAtRisk":292,"numEvents":51},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":309,"numEvents":8},{"groupId":"EG001","numAffected":44,"numAtRisk":292,"numEvents":144},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":309,"numEvents":10},{"groupId":"EG001","numAffected":16,"numAtRisk":292,"numEvents":16},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":309,"numEvents":11},{"groupId":"EG001","numAffected":30,"numAtRisk":292,"numEvents":103},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":309,"numEvents":31},{"groupId":"EG001","numAffected":38,"numAtRisk":292,"numEvents":43},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":309,"numEvents":14},{"groupId":"EG001","numAffected":17,"numAtRisk":292,"numEvents":21},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":309,"numEvents":46},{"groupId":"EG001","numAffected":24,"numAtRisk":292,"numEvents":28},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":309,"numEvents":24},{"groupId":"EG001","numAffected":30,"numAtRisk":292,"numEvents":33},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":309,"numEvents":20},{"groupId":"EG001","numAffected":24,"numAtRisk":292,"numEvents":28},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":309,"numEvents":15},{"groupId":"EG001","numAffected":20,"numAtRisk":292,"numEvents":21},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":309,"numEvents":61},{"groupId":"EG001","numAffected":34,"numAtRisk":292,"numEvents":43},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":309,"numEvents":4},{"groupId":"EG001","numAffected":26,"numAtRisk":292,"numEvents":28},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":309,"numEvents":6},{"groupId":"EG001","numAffected":19,"numAtRisk":292,"numEvents":20},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":309,"numEvents":9},{"groupId":"EG001","numAffected":17,"numAtRisk":292,"numEvents":18},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":309,"numEvents":60},{"groupId":"EG001","numAffected":31,"numAtRisk":292,"numEvents":33},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":309,"numEvents":41},{"groupId":"EG001","numAffected":32,"numAtRisk":292,"numEvents":39},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":43,"numAtRisk":292,"numEvents":44},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":36,"numAtRisk":292,"numEvents":47},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":309,"numEvents":44},{"groupId":"EG001","numAffected":12,"numAtRisk":292,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":309,"numEvents":25},{"groupId":"EG001","numAffected":13,"numAtRisk":292,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":309,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":292,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":3}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":309,"numEvents":3},{"groupId":"EG001","numAffected":8,"numAtRisk":292,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":309,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":292,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":309,"numEvents":11},{"groupId":"EG001","numAffected":4,"numAtRisk":292,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Leukocyturia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":292,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":292,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cardiogenic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Secondary adrenocortical insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":292,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Large intestine polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Oesophageal achalasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Small intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":292,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":309,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Hyperthermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":309,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Liver disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Enterococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Klebsiella infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Mastitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pharyngotonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":309,"numEvents":6},{"groupId":"EG001","numAffected":8,"numAtRisk":292,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Systemic candida"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Post procedural complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Radiation associated pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Blood corticotrophin abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Type 1 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":309,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Infected neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Inflammatory carcinoma of the breast"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Myelodysplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pelvic neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Horner's syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Post herpetic neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Completed suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Tubulointerstitial nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":309,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Haemothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":309,"numEvents":8},{"groupId":"EG001","numAffected":3,"numAtRisk":292,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":309,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":292,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Circulatory collapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":292,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Peripheral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":309,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":309,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":292,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Hepatotoxicity"}],"timeFrame":"All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 60 months"}