{"description":"All-Cause Mortality: all randomized participants. Serious \\& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms \"Neoplasm progression\", \"Malignant neoplasm progression\" \\& \"Disease progression\" not related to study treatment are excluded as AEs.","eventGroups":[{"deathsNumAffected":225,"deathsNumAtRisk":322,"description":"Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\\^2 every 3 weeks \\[Q3W\\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.","id":"EG000","otherNumAffected":319,"otherNumAtRisk":320,"seriousNumAffected":178,"seriousNumAtRisk":320,"title":"Pembrolizumab + Paclitaxel ± Bevacizumab"},{"deathsNumAffected":244,"deathsNumAtRisk":321,"description":"Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\\^2 every 3 weeks \\[Q3W\\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.","id":"EG001","otherNumAffected":307,"otherNumAtRisk":318,"seriousNumAffected":122,"seriousNumAtRisk":318,"title":"Placebo + Paclitaxel ± Bevacizumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":169,"numAtRisk":320,"numEvents":365},{"groupId":"EG001","numAffected":148,"numAtRisk":318,"numEvents":263}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":320,"numEvents":77},{"groupId":"EG001","numAffected":27,"numAtRisk":318,"numEvents":100}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":320,"numEvents":186},{"groupId":"EG001","numAffected":81,"numAtRisk":318,"numEvents":205}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":320,"numEvents":67},{"groupId":"EG001","numAffected":19,"numAtRisk":318,"numEvents":23}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":320,"numEvents":30},{"groupId":"EG001","numAffected":26,"numAtRisk":318,"numEvents":29}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":320,"numEvents":95},{"groupId":"EG001","numAffected":82,"numAtRisk":318,"numEvents":109}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":320,"numEvents":22},{"groupId":"EG001","numAffected":20,"numAtRisk":318,"numEvents":31}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":320,"numEvents":103},{"groupId":"EG001","numAffected":79,"numAtRisk":318,"numEvents":102}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":139,"numAtRisk":320,"numEvents":285},{"groupId":"EG001","numAffected":126,"numAtRisk":318,"numEvents":252}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":320,"numEvents":26},{"groupId":"EG001","numAffected":28,"numAtRisk":318,"numEvents":32}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":320,"numEvents":32},{"groupId":"EG001","numAffected":16,"numAtRisk":318,"numEvents":19}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":130,"numAtRisk":320,"numEvents":229},{"groupId":"EG001","numAffected":114,"numAtRisk":318,"numEvents":170}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":320,"numEvents":77},{"groupId":"EG001","numAffected":33,"numAtRisk":318,"numEvents":40}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":320,"numEvents":145},{"groupId":"EG001","numAffected":73,"numAtRisk":318,"numEvents":104}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":320,"numEvents":95},{"groupId":"EG001","numAffected":65,"numAtRisk":318,"numEvents":91}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":129,"numAtRisk":320,"numEvents":163},{"groupId":"EG001","numAffected":119,"numAtRisk":318,"numEvents":147}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":320,"numEvents":34},{"groupId":"EG001","numAffected":15,"numAtRisk":318,"numEvents":18}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":320,"numEvents":29},{"groupId":"EG001","numAffected":16,"numAtRisk":318,"numEvents":52}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":320,"numEvents":45},{"groupId":"EG001","numAffected":27,"numAtRisk":318,"numEvents":30}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":320,"numEvents":65},{"groupId":"EG001","numAffected":43,"numAtRisk":318,"numEvents":50}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":320,"numEvents":95},{"groupId":"EG001","numAffected":37,"numAtRisk":318,"numEvents":46}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":320,"numEvents":47},{"groupId":"EG001","numAffected":47,"numAtRisk":318,"numEvents":48}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":320,"numEvents":37},{"groupId":"EG001","numAffected":23,"numAtRisk":318,"numEvents":27}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":320,"numEvents":33},{"groupId":"EG001","numAffected":28,"numAtRisk":318,"numEvents":29}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":320,"numEvents":20},{"groupId":"EG001","numAffected":7,"numAtRisk":318,"numEvents":11}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":320,"numEvents":45},{"groupId":"EG001","numAffected":35,"numAtRisk":318,"numEvents":41}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":320,"numEvents":172},{"groupId":"EG001","numAffected":69,"numAtRisk":318,"numEvents":110}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":320,"numEvents":68},{"groupId":"EG001","numAffected":33,"numAtRisk":318,"numEvents":58}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":320,"numEvents":75},{"groupId":"EG001","numAffected":32,"numAtRisk":318,"numEvents":48}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":320,"numEvents":30},{"groupId":"EG001","numAffected":18,"numAtRisk":318,"numEvents":21}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":320,"numEvents":39},{"groupId":"EG001","numAffected":16,"numAtRisk":318,"numEvents":23}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":320,"numEvents":62},{"groupId":"EG001","numAffected":18,"numAtRisk":318,"numEvents":46}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":92,"numAtRisk":320,"numEvents":520},{"groupId":"EG001","numAffected":71,"numAtRisk":318,"numEvents":335}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":320,"numEvents":35},{"groupId":"EG001","numAffected":10,"numAtRisk":318,"numEvents":33}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":320,"numEvents":63},{"groupId":"EG001","numAffected":15,"numAtRisk":318,"numEvents":15}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":78,"numAtRisk":320,"numEvents":467},{"groupId":"EG001","numAffected":59,"numAtRisk":318,"numEvents":317}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":320,"numEvents":103},{"groupId":"EG001","numAffected":61,"numAtRisk":318,"numEvents":70}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":320,"numEvents":41},{"groupId":"EG001","numAffected":25,"numAtRisk":318,"numEvents":49}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":320,"numEvents":77},{"groupId":"EG001","numAffected":22,"numAtRisk":318,"numEvents":24}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":320,"numEvents":29},{"groupId":"EG001","numAffected":12,"numAtRisk":318,"numEvents":22}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":320,"numEvents":58},{"groupId":"EG001","numAffected":28,"numAtRisk":318,"numEvents":48}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":320,"numEvents":99},{"groupId":"EG001","numAffected":48,"numAtRisk":318,"numEvents":80}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":320,"numEvents":61},{"groupId":"EG001","numAffected":29,"numAtRisk":318,"numEvents":46}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":320,"numEvents":79},{"groupId":"EG001","numAffected":47,"numAtRisk":318,"numEvents":66}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":320,"numEvents":52},{"groupId":"EG001","numAffected":45,"numAtRisk":318,"numEvents":52}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":320,"numEvents":44},{"groupId":"EG001","numAffected":34,"numAtRisk":318,"numEvents":49}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":320,"numEvents":36},{"groupId":"EG001","numAffected":28,"numAtRisk":318,"numEvents":39}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":320,"numEvents":38},{"groupId":"EG001","numAffected":25,"numAtRisk":318,"numEvents":31}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":320,"numEvents":39},{"groupId":"EG001","numAffected":33,"numAtRisk":318,"numEvents":36}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":320,"numEvents":50},{"groupId":"EG001","numAffected":54,"numAtRisk":318,"numEvents":67}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":320,"numEvents":29},{"groupId":"EG001","numAffected":13,"numAtRisk":318,"numEvents":16}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":126,"numAtRisk":320,"numEvents":160},{"groupId":"EG001","numAffected":104,"numAtRisk":318,"numEvents":133}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":320,"numEvents":23},{"groupId":"EG001","numAffected":21,"numAtRisk":318,"numEvents":25}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":320,"numEvents":50},{"groupId":"EG001","numAffected":37,"numAtRisk":318,"numEvents":42}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":320,"numEvents":36},{"groupId":"EG001","numAffected":36,"numAtRisk":318,"numEvents":37}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":320,"numEvents":57},{"groupId":"EG001","numAffected":27,"numAtRisk":318,"numEvents":45}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":320,"numEvents":81},{"groupId":"EG001","numAffected":49,"numAtRisk":318,"numEvents":57}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":320,"numEvents":23},{"groupId":"EG001","numAffected":14,"numAtRisk":318,"numEvents":15}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":320,"numEvents":61},{"groupId":"EG001","numAffected":46,"numAtRisk":318,"numEvents":52}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":102,"numAtRisk":320,"numEvents":131},{"groupId":"EG001","numAffected":80,"numAtRisk":318,"numEvents":102}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":320,"numEvents":20},{"groupId":"EG001","numAffected":17,"numAtRisk":318,"numEvents":19}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":320,"numEvents":18},{"groupId":"EG001","numAffected":17,"numAtRisk":318,"numEvents":20}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":122,"numAtRisk":320,"numEvents":124},{"groupId":"EG001","numAffected":112,"numAtRisk":318,"numEvents":114}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":320,"numEvents":23},{"groupId":"EG001","numAffected":11,"numAtRisk":318,"numEvents":15}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":320,"numEvents":18},{"groupId":"EG001","numAffected":18,"numAtRisk":318,"numEvents":20}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":320,"numEvents":25},{"groupId":"EG001","numAffected":16,"numAtRisk":318,"numEvents":18}],"term":"Nail discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":320,"numEvents":55},{"groupId":"EG001","numAffected":42,"numAtRisk":318,"numEvents":47}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":320,"numEvents":45},{"groupId":"EG001","numAffected":32,"numAtRisk":318,"numEvents":34}],"term":"Onycholysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":320,"numEvents":42},{"groupId":"EG001","numAffected":28,"numAtRisk":318,"numEvents":29}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":320,"numEvents":87},{"groupId":"EG001","numAffected":42,"numAtRisk":318,"numEvents":59}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":320,"numEvents":95},{"groupId":"EG001","numAffected":58,"numAtRisk":318,"numEvents":98}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":318,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Haemolytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":3}],"term":"Myelosuppression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Coronary artery stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Ventricular extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Thyroiditis subacute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Anal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":7}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":320,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Duodenal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Erosive oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":2}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Gastrointestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Gastrointestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hiatus hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Ileus paralytic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":320,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Incarcerated umbilical hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":11,"numAtRisk":318,"numEvents":12}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":320,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Intestinal pseudo-obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Intra-abdominal fluid collection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Noninfective sialoadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Oesophageal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Oesophageal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Proctitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Rectal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":318,"numEvents":4}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Small intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Superior mesenteric artery syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Administration site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Adverse drug reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Catheter site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":320,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":3}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Vascular device occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hepatitis toxic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated hepatic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Abdominal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Appendicitis perforated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":320,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Fournier's gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Gastrointestinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Peritoneal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":320,"numEvents":14},{"groupId":"EG001","numAffected":4,"numAtRisk":318,"numEvents":4}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":4}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Psoas abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":320,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Streptococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Tracheobronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":320,"numEvents":17},{"groupId":"EG001","numAffected":6,"numAtRisk":318,"numEvents":6}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Vulval cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Vulvitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Intestinal anastomosis complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Liver function test increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":320,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":318,"numEvents":8}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":2}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":320,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":3}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Metabolic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Type 1 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Bursitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Mobility decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Polymyalgia rheumatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Malignant neoplasm of ampulla of Vater"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Myelodysplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cerebrospinal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Embolic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Intracranial aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Posterior reversible encephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":3}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Bladder tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Tubulointerstitial nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Urinary tract disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Female genital tract fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Acute interstitial pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Acute pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Haemothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Malignant pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":320,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":320,"numEvents":9},{"groupId":"EG001","numAffected":7,"numAtRisk":318,"numEvents":7}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Dermatitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Immune-mediated dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Assisted suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Arteriosclerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":318,"numEvents":3}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hypertensive crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Hypertensive urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":320,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"May-Thurner syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":320,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":320,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Vena cava thrombosis"}],"timeFrame":"Up to approximately 38 months"}