{"description":"All-Cause Mortality was reported for all randomized participants.\n\nSerious AEs and Other AEs were reported according to treatment course for all randomized participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms \"Neoplasm progression\", \"Malignant neoplasm progression\" and \"Disease progression\" not related to study drug are excluded as AEs.","eventGroups":[{"deathsNumAffected":228,"deathsNumAtRisk":247,"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to approximately 24 months.","id":"EG000","otherNumAffected":215,"otherNumAtRisk":246,"seriousNumAffected":110,"seriousNumAtRisk":246,"title":"Pembrolizumab First Course"},{"deathsNumAffected":243,"deathsNumAtRisk":248,"description":"Participants received standard treatment of either methotrexate 40 mg/m\\^2 IV (could be escalated to 60 mg/m\\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\\^2 IV loading dose on Day 1 and 250 mg/m\\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.","id":"EG001","otherNumAffected":211,"otherNumAtRisk":234,"seriousNumAffected":92,"seriousNumAtRisk":234,"title":"Standard Treatment First Course"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to approximately 24 months) with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to approximately 1 additional year.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"title":"Pembrolizumab Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":246,"numEvents":77},{"groupId":"EG001","numAffected":53,"numAtRisk":234,"numEvents":72},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":246,"numEvents":45},{"groupId":"EG001","numAffected":10,"numAtRisk":234,"numEvents":10},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":246,"numEvents":12},{"groupId":"EG001","numAffected":12,"numAtRisk":234,"numEvents":12},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":246,"numEvents":49},{"groupId":"EG001","numAffected":37,"numAtRisk":234,"numEvents":43},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":246,"numEvents":57},{"groupId":"EG001","numAffected":42,"numAtRisk":234,"numEvents":51},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":246,"numEvents":15},{"groupId":"EG001","numAffected":6,"numAtRisk":234,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":246,"numEvents":22},{"groupId":"EG001","numAffected":15,"numAtRisk":234,"numEvents":16},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":246,"numEvents":45},{"groupId":"EG001","numAffected":44,"numAtRisk":234,"numEvents":52},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":246,"numEvents":9},{"groupId":"EG001","numAffected":26,"numAtRisk":234,"numEvents":34},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":246,"numEvents":28},{"groupId":"EG001","numAffected":23,"numAtRisk":234,"numEvents":34},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":246,"numEvents":50},{"groupId":"EG001","numAffected":42,"numAtRisk":234,"numEvents":54},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":246,"numEvents":53},{"groupId":"EG001","numAffected":63,"numAtRisk":234,"numEvents":81},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":246,"numEvents":21},{"groupId":"EG001","numAffected":36,"numAtRisk":234,"numEvents":51},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":246,"numEvents":38},{"groupId":"EG001","numAffected":25,"numAtRisk":234,"numEvents":36},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":246,"numEvents":10},{"groupId":"EG001","numAffected":13,"numAtRisk":234,"numEvents":18},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":246,"numEvents":16},{"groupId":"EG001","numAffected":10,"numAtRisk":234,"numEvents":13},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":246,"numEvents":11},{"groupId":"EG001","numAffected":24,"numAtRisk":234,"numEvents":29},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":246,"numEvents":7},{"groupId":"EG001","numAffected":13,"numAtRisk":234,"numEvents":19},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":246,"numEvents":24},{"groupId":"EG001","numAffected":25,"numAtRisk":234,"numEvents":25},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":246,"numEvents":37},{"groupId":"EG001","numAffected":45,"numAtRisk":234,"numEvents":50},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":246,"numEvents":16},{"groupId":"EG001","numAffected":13,"numAtRisk":234,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":246,"numEvents":27},{"groupId":"EG001","numAffected":19,"numAtRisk":234,"numEvents":21},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":246,"numEvents":11},{"groupId":"EG001","numAffected":20,"numAtRisk":234,"numEvents":25},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":246,"numEvents":14},{"groupId":"EG001","numAffected":16,"numAtRisk":234,"numEvents":17},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":246,"numEvents":21},{"groupId":"EG001","numAffected":12,"numAtRisk":234,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":246,"numEvents":24},{"groupId":"EG001","numAffected":12,"numAtRisk":234,"numEvents":13},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":246,"numEvents":24},{"groupId":"EG001","numAffected":8,"numAtRisk":234,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":246,"numEvents":20},{"groupId":"EG001","numAffected":17,"numAtRisk":234,"numEvents":17},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":246,"numEvents":13},{"groupId":"EG001","numAffected":7,"numAtRisk":234,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":246,"numEvents":25},{"groupId":"EG001","numAffected":23,"numAtRisk":234,"numEvents":25},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":246,"numEvents":13},{"groupId":"EG001","numAffected":7,"numAtRisk":234,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":246,"numEvents":22},{"groupId":"EG001","numAffected":18,"numAtRisk":234,"numEvents":18},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":246,"numEvents":49},{"groupId":"EG001","numAffected":37,"numAtRisk":234,"numEvents":40},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":246,"numEvents":33},{"groupId":"EG001","numAffected":26,"numAtRisk":234,"numEvents":31},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":246,"numEvents":15},{"groupId":"EG001","numAffected":7,"numAtRisk":234,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":246,"numEvents":16},{"groupId":"EG001","numAffected":5,"numAtRisk":234,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":27,"numAtRisk":234,"numEvents":27},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":18,"numAtRisk":234,"numEvents":28},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":17,"numAtRisk":234,"numEvents":19},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":246,"numEvents":24},{"groupId":"EG001","numAffected":17,"numAtRisk":234,"numEvents":40},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":246,"numEvents":33},{"groupId":"EG001","numAffected":41,"numAtRisk":234,"numEvents":92},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":246,"numEvents":13},{"groupId":"EG001","numAffected":12,"numAtRisk":234,"numEvents":16},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":246,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anaemia of malignant disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":9,"numAtRisk":234,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Lymph node haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":246,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypercalcaemia of malignancy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Autoimmune colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":246,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":246,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Gastrointestinal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Incarcerated inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Malignant dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Oral discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumoperitoneum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":246,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":234,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Ill-defined disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Performance status decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cirrhosis alcoholic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Candida sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Colonic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Disseminated tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Epiglottitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infected fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infective exacerbation of chronic obstructive airways disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Klebsiella infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Lower respiratory tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Oral bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":246,"numEvents":23},{"groupId":"EG001","numAffected":17,"numAtRisk":234,"numEvents":19},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":246,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pulmonary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stoma site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Accidental overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Alcohol poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Post procedural fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Post procedural hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stoma site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stoma site ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Tracheostomy malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Diabetes mellitus inadequate control"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":246,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":246,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Kyphosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Soft tissue haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Astrocytoma, low grade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Infected neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Malignant melanoma in situ"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Oropharyngeal neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Paraneoplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Rectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":246,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Guillain-Barre syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Vocal cord paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Asphyxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":246,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Eosinophilic pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Laryngeal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Laryngeal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Lung disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Oropharyngeal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":246,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":234,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Respiratory tract haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Acute febrile neutrophilic dermatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Fungating wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Stevens-Johnson syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Euthanasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Angiodysplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":246,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":246,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":234,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":246,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":234,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2,"numEvents":0}],"term":"Jugular vein thrombosis"}],"timeFrame":"Up to approximately 92 months"}