{"eventGroups":[{"deathsNumAffected":178,"deathsNumAtRisk":356,"description":"Participants received cemiplimab monotherapy","id":"EG000","otherNumAffected":287,"otherNumAtRisk":356,"seriousNumAffected":131,"seriousNumAtRisk":356,"title":"Cemiplimab"},{"deathsNumAffected":60,"deathsNumAtRisk":85,"description":"Participants originally assigned to cemiplimab received cemiplimab with chemotherapy after initial disease progression.","id":"EG001","otherNumAffected":70,"otherNumAtRisk":85,"seriousNumAffected":23,"seriousNumAtRisk":85,"title":"Extended Treatment: Cemiplimab + Chemotherapy"},{"deathsNumAffected":116,"deathsNumAtRisk":343,"description":"Participants received platinum-based doublet chemotherapy","id":"EG002","otherNumAffected":319,"otherNumAtRisk":343,"seriousNumAffected":103,"seriousNumAtRisk":343,"title":"Chemotherapy"},{"deathsNumAffected":141,"deathsNumAtRisk":191,"description":"Participants received cemiplimab after initial disease progression on chemotherapy.","id":"EG003","otherNumAffected":141,"otherNumAtRisk":191,"seriousNumAffected":57,"seriousNumAtRisk":191,"title":"Crossover: Chemotherapy to Cemiplimab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":356,"numEvents":54},{"groupId":"EG001","numAffected":7,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":66,"numAtRisk":343,"numEvents":72},{"groupId":"EG003","numAffected":19,"numAtRisk":191,"numEvents":22}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":356,"numEvents":37},{"groupId":"EG001","numAffected":7,"numAtRisk":85,"numEvents":10},{"groupId":"EG002","numAffected":27,"numAtRisk":343,"numEvents":36},{"groupId":"EG003","numAffected":19,"numAtRisk":191,"numEvents":22}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":356,"numEvents":34},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":8},{"groupId":"EG002","numAffected":15,"numAtRisk":343,"numEvents":19},{"groupId":"EG003","numAffected":10,"numAtRisk":191,"numEvents":14}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":356,"numEvents":19},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":18,"numAtRisk":343,"numEvents":23},{"groupId":"EG003","numAffected":9,"numAtRisk":191,"numEvents":20}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":356,"numEvents":15},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":8},{"groupId":"EG002","numAffected":32,"numAtRisk":343,"numEvents":43},{"groupId":"EG003","numAffected":17,"numAtRisk":191,"numEvents":25}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":356,"numEvents":15},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":10,"numAtRisk":343,"numEvents":11},{"groupId":"EG003","numAffected":8,"numAtRisk":191,"numEvents":9}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":356,"numEvents":52},{"groupId":"EG001","numAffected":7,"numAtRisk":85,"numEvents":9},{"groupId":"EG002","numAffected":65,"numAtRisk":343,"numEvents":76},{"groupId":"EG003","numAffected":19,"numAtRisk":191,"numEvents":23}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":356,"numEvents":32},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":16,"numAtRisk":343,"numEvents":16},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":5}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":356,"numEvents":25},{"groupId":"EG001","numAffected":9,"numAtRisk":85,"numEvents":13},{"groupId":"EG002","numAffected":30,"numAtRisk":343,"numEvents":39},{"groupId":"EG003","numAffected":13,"numAtRisk":191,"numEvents":14}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":356,"numEvents":23},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":12,"numAtRisk":343,"numEvents":16},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":4}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":356,"numEvents":47},{"groupId":"EG001","numAffected":6,"numAtRisk":85,"numEvents":6},{"groupId":"EG002","numAffected":20,"numAtRisk":343,"numEvents":24},{"groupId":"EG003","numAffected":20,"numAtRisk":191,"numEvents":29}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":356,"numEvents":45},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":5},{"groupId":"EG002","numAffected":16,"numAtRisk":343,"numEvents":22},{"groupId":"EG003","numAffected":21,"numAtRisk":191,"numEvents":30}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":356,"numEvents":38},{"groupId":"EG001","numAffected":4,"numAtRisk":85,"numEvents":4},{"groupId":"EG002","numAffected":12,"numAtRisk":343,"numEvents":15},{"groupId":"EG003","numAffected":12,"numAtRisk":191,"numEvents":16}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":356,"numEvents":44},{"groupId":"EG001","numAffected":8,"numAtRisk":85,"numEvents":9},{"groupId":"EG002","numAffected":26,"numAtRisk":343,"numEvents":34},{"groupId":"EG003","numAffected":14,"numAtRisk":191,"numEvents":23}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":356,"numEvents":25},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":5},{"groupId":"EG002","numAffected":26,"numAtRisk":343,"numEvents":26},{"groupId":"EG003","numAffected":12,"numAtRisk":191,"numEvents":13}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":356,"numEvents":32},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":4},{"groupId":"EG003","numAffected":6,"numAtRisk":191,"numEvents":7}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":356,"numEvents":6},{"groupId":"EG001","numAffected":6,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":39,"numAtRisk":343,"numEvents":56},{"groupId":"EG003","numAffected":9,"numAtRisk":191,"numEvents":13}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":356,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":33,"numAtRisk":343,"numEvents":53},{"groupId":"EG003","numAffected":3,"numAtRisk":191,"numEvents":4}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":43,"numAtRisk":343,"numEvents":54},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":356,"numEvents":46},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":22,"numAtRisk":343,"numEvents":32},{"groupId":"EG003","numAffected":5,"numAtRisk":191,"numEvents":6}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":356,"numEvents":64},{"groupId":"EG001","numAffected":6,"numAtRisk":85,"numEvents":9},{"groupId":"EG002","numAffected":37,"numAtRisk":343,"numEvents":64},{"groupId":"EG003","numAffected":17,"numAtRisk":191,"numEvents":24}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":356,"numEvents":28},{"groupId":"EG001","numAffected":8,"numAtRisk":85,"numEvents":8},{"groupId":"EG002","numAffected":23,"numAtRisk":343,"numEvents":28},{"groupId":"EG003","numAffected":10,"numAtRisk":191,"numEvents":12}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":356,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":16,"numAtRisk":343,"numEvents":21},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":4}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":356,"numEvents":52},{"groupId":"EG001","numAffected":16,"numAtRisk":85,"numEvents":21},{"groupId":"EG002","numAffected":32,"numAtRisk":343,"numEvents":34},{"groupId":"EG003","numAffected":9,"numAtRisk":191,"numEvents":14}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":356,"numEvents":31},{"groupId":"EG001","numAffected":6,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":58,"numAtRisk":343,"numEvents":74},{"groupId":"EG003","numAffected":11,"numAtRisk":191,"numEvents":12}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":356,"numEvents":32},{"groupId":"EG001","numAffected":16,"numAtRisk":85,"numEvents":31},{"groupId":"EG002","numAffected":99,"numAtRisk":343,"numEvents":166},{"groupId":"EG003","numAffected":10,"numAtRisk":191,"numEvents":13}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":356,"numEvents":19},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":7,"numAtRisk":343,"numEvents":8},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":5}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":356,"numEvents":20},{"groupId":"EG001","numAffected":7,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":49,"numAtRisk":343,"numEvents":76},{"groupId":"EG003","numAffected":6,"numAtRisk":191,"numEvents":6}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":356,"numEvents":44},{"groupId":"EG001","numAffected":6,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":25,"numAtRisk":343,"numEvents":26},{"groupId":"EG003","numAffected":11,"numAtRisk":191,"numEvents":13}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":356,"numEvents":40},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":34,"numAtRisk":343,"numEvents":39},{"groupId":"EG003","numAffected":16,"numAtRisk":191,"numEvents":19}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":356,"numEvents":27},{"groupId":"EG001","numAffected":4,"numAtRisk":85,"numEvents":4},{"groupId":"EG002","numAffected":20,"numAtRisk":343,"numEvents":28},{"groupId":"EG003","numAffected":7,"numAtRisk":191,"numEvents":7}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":356,"numEvents":93},{"groupId":"EG001","numAffected":27,"numAtRisk":85,"numEvents":31},{"groupId":"EG002","numAffected":175,"numAtRisk":343,"numEvents":256},{"groupId":"EG003","numAffected":39,"numAtRisk":191,"numEvents":48}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":356,"numEvents":13},{"groupId":"EG001","numAffected":12,"numAtRisk":85,"numEvents":12},{"groupId":"EG002","numAffected":62,"numAtRisk":343,"numEvents":104},{"groupId":"EG003","numAffected":5,"numAtRisk":191,"numEvents":8}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":356,"numEvents":12},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":52,"numAtRisk":343,"numEvents":78},{"groupId":"EG003","numAffected":6,"numAtRisk":191,"numEvents":8}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":356,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":5},{"groupId":"EG002","numAffected":32,"numAtRisk":343,"numEvents":54},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":356,"numEvents":43},{"groupId":"EG001","numAffected":4,"numAtRisk":85,"numEvents":5},{"groupId":"EG002","numAffected":12,"numAtRisk":343,"numEvents":12},{"groupId":"EG003","numAffected":10,"numAtRisk":191,"numEvents":10}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":356,"numEvents":33},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":4},{"groupId":"EG002","numAffected":11,"numAtRisk":343,"numEvents":13},{"groupId":"EG003","numAffected":9,"numAtRisk":191,"numEvents":36}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":356,"numEvents":4},{"groupId":"EG001","numAffected":19,"numAtRisk":85,"numEvents":21},{"groupId":"EG002","numAffected":86,"numAtRisk":343,"numEvents":87},{"groupId":"EG003","numAffected":3,"numAtRisk":191,"numEvents":3}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":356,"numEvents":38},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":15,"numAtRisk":191,"numEvents":19}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":356,"numEvents":23},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":8,"numAtRisk":343,"numEvents":8},{"groupId":"EG003","numAffected":10,"numAtRisk":191,"numEvents":12}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":356,"numEvents":37},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":343,"numEvents":9},{"groupId":"EG003","numAffected":7,"numAtRisk":191,"numEvents":7}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":356,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":39,"numAtRisk":343,"numEvents":39},{"groupId":"EG003","numAffected":7,"numAtRisk":191,"numEvents":8}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":356,"numEvents":35},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":27,"numAtRisk":343,"numEvents":28},{"groupId":"EG003","numAffected":10,"numAtRisk":191,"numEvents":10}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":356,"numEvents":25},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":20,"numAtRisk":343,"numEvents":20},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":4}],"term":"Insomnia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":356,"numEvents":31},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":20,"numAtRisk":343,"numEvents":24},{"groupId":"EG003","numAffected":9,"numAtRisk":191,"numEvents":9}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":356,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":356,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":356,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hepatitis B"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pulmonary tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":4}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Anorectal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Atypical pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Dengue fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Lung abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pleural infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Salmonellosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":356,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":6,"numAtRisk":191,"numEvents":7}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":356,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":343,"numEvents":6},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":356,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":356,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":343,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":356,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Bronchopleural fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Immune-mediated lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Lower respiratory tract inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Chronic respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Respiratory tract inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":356,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Atrial tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Autoimmune myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Ventricular extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":343,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":356,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":191,"numEvents":4}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":356,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Immune-mediated enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pancreatitis chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Anal fissure haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Ileus paralytic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Protein-losing gastroenteropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":343,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":356,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Embolic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hemiplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Lumbosacral radiculopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Central nervous system inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cerebellar ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Cerebral artery embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cerebral thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Cerebral venous thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Haemorrhagic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Ischaemic cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Myasthenic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Paraplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":356,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":16,"numAtRisk":343,"numEvents":22},{"groupId":"EG003","numAffected":6,"numAtRisk":191,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":343,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":343,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":343,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":356,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":356,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Immune-mediated hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hepatic cirrhosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hepatitis toxic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Dermatomyositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Osteoporotic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Axial spondyloarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Chondrocalcinosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Lumbar spinal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":4}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Diabetic metabolic decompensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":191,"numEvents":2}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Arterial thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Embolism venous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypertensive crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Shock haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Vascular occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Arterial insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Superficial vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Vena cava thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Dermatitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Pemphigoid"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"International normalised ratio increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Cortisol decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Urethral stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":343,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hyperparathyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Tumour hyperprogression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Acute myeloid leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Metastases to lung"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Completed suicide"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":343,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Vertigo positional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":343,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":191,"numEvents":0}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (28.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":356,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":343,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":191,"numEvents":1}],"term":"Hypersensitivity"}],"timeFrame":"From signing of first informed consent up to 94 months."}