{"description":"The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.","eventGroups":[{"deathsNumAffected":311,"deathsNumAtRisk":394,"description":"Bevacizumab+Paclitaxel+Carboplatin","id":"EG000","otherNumAffected":381,"otherNumAtRisk":394,"seriousNumAffected":142,"seriousNumAtRisk":394,"title":"Arm C (Bev+CP)"},{"deathsNumAffected":285,"deathsNumAtRisk":393,"description":"Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin","id":"EG001","otherNumAffected":375,"otherNumAtRisk":393,"seriousNumAffected":190,"seriousNumAtRisk":393,"title":"Arm B (Atezo+Bev+CP)"},{"deathsNumAffected":293,"deathsNumAtRisk":400,"description":"Atezolizumab+Paclitaxel+Carboplatin","id":"EG002","otherNumAffected":385,"otherNumAtRisk":400,"seriousNumAffected":170,"seriousNumAtRisk":400,"title":"Arm A (Atezo+CP)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":104,"numAtRisk":394,"numEvents":124},{"groupId":"EG001","numAffected":116,"numAtRisk":393,"numEvents":134},{"groupId":"EG002","numAffected":146,"numAtRisk":400,"numEvents":183}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":394,"numEvents":17},{"groupId":"EG001","numAffected":14,"numAtRisk":393,"numEvents":20},{"groupId":"EG002","numAffected":20,"numAtRisk":400,"numEvents":35}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":394,"numEvents":107},{"groupId":"EG001","numAffected":72,"numAtRisk":393,"numEvents":111},{"groupId":"EG002","numAffected":60,"numAtRisk":400,"numEvents":85}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":394,"numEvents":64},{"groupId":"EG001","numAffected":53,"numAtRisk":393,"numEvents":74},{"groupId":"EG002","numAffected":49,"numAtRisk":400,"numEvents":78}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":394,"numEvents":13},{"groupId":"EG001","numAffected":50,"numAtRisk":393,"numEvents":56},{"groupId":"EG002","numAffected":33,"numAtRisk":400,"numEvents":40}],"term":"HYPOTHYROIDISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":394,"numEvents":24},{"groupId":"EG001","numAffected":36,"numAtRisk":393,"numEvents":48},{"groupId":"EG002","numAffected":29,"numAtRisk":400,"numEvents":36}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":92,"numAtRisk":394,"numEvents":115},{"groupId":"EG001","numAffected":122,"numAtRisk":393,"numEvents":151},{"groupId":"EG002","numAffected":103,"numAtRisk":400,"numEvents":128}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":394,"numEvents":133},{"groupId":"EG001","numAffected":125,"numAtRisk":393,"numEvents":221},{"groupId":"EG002","numAffected":82,"numAtRisk":400,"numEvents":137}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":394,"numEvents":6},{"groupId":"EG001","numAffected":20,"numAtRisk":393,"numEvents":22},{"groupId":"EG002","numAffected":13,"numAtRisk":400,"numEvents":16}],"term":"DRY MOUTH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":394,"numEvents":11},{"groupId":"EG001","numAffected":20,"numAtRisk":393,"numEvents":20},{"groupId":"EG002","numAffected":11,"numAtRisk":400,"numEvents":13}],"term":"GASTROOESOPHAGEAL REFLUX DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":394,"numEvents":177},{"groupId":"EG001","numAffected":149,"numAtRisk":393,"numEvents":223},{"groupId":"EG002","numAffected":130,"numAtRisk":400,"numEvents":210}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":394,"numEvents":30},{"groupId":"EG001","numAffected":54,"numAtRisk":393,"numEvents":73},{"groupId":"EG002","numAffected":23,"numAtRisk":400,"numEvents":27}],"term":"STOMATITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":394,"numEvents":105},{"groupId":"EG001","numAffected":71,"numAtRisk":393,"numEvents":99},{"groupId":"EG002","numAffected":69,"numAtRisk":400,"numEvents":92}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":394,"numEvents":107},{"groupId":"EG001","numAffected":84,"numAtRisk":393,"numEvents":143},{"groupId":"EG002","numAffected":76,"numAtRisk":400,"numEvents":127}],"term":"ASTHENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":394,"numEvents":32},{"groupId":"EG001","numAffected":35,"numAtRisk":393,"numEvents":37},{"groupId":"EG002","numAffected":38,"numAtRisk":400,"numEvents":44}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":107,"numAtRisk":394,"numEvents":125},{"groupId":"EG001","numAffected":137,"numAtRisk":393,"numEvents":157},{"groupId":"EG002","numAffected":111,"numAtRisk":400,"numEvents":129}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":394,"numEvents":13},{"groupId":"EG001","numAffected":27,"numAtRisk":393,"numEvents":43},{"groupId":"EG002","numAffected":20,"numAtRisk":400,"numEvents":27}],"term":"MALAISE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":394,"numEvents":27},{"groupId":"EG001","numAffected":38,"numAtRisk":393,"numEvents":42},{"groupId":"EG002","numAffected":10,"numAtRisk":400,"numEvents":10}],"term":"MUCOSAL INFLAMMATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":394,"numEvents":20},{"groupId":"EG001","numAffected":35,"numAtRisk":393,"numEvents":42},{"groupId":"EG002","numAffected":29,"numAtRisk":400,"numEvents":33}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":394,"numEvents":17},{"groupId":"EG001","numAffected":26,"numAtRisk":393,"numEvents":31},{"groupId":"EG002","numAffected":22,"numAtRisk":400,"numEvents":23}],"term":"PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":394,"numEvents":44},{"groupId":"EG001","numAffected":67,"numAtRisk":393,"numEvents":88},{"groupId":"EG002","numAffected":53,"numAtRisk":400,"numEvents":66}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":394,"numEvents":17},{"groupId":"EG001","numAffected":28,"numAtRisk":393,"numEvents":37},{"groupId":"EG002","numAffected":15,"numAtRisk":400,"numEvents":16}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":394,"numEvents":18},{"groupId":"EG001","numAffected":27,"numAtRisk":393,"numEvents":34},{"groupId":"EG002","numAffected":31,"numAtRisk":400,"numEvents":50}],"term":"NASOPHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":394,"numEvents":17},{"groupId":"EG001","numAffected":19,"numAtRisk":393,"numEvents":22},{"groupId":"EG002","numAffected":21,"numAtRisk":400,"numEvents":23}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":394,"numEvents":20},{"groupId":"EG001","numAffected":37,"numAtRisk":393,"numEvents":56},{"groupId":"EG002","numAffected":24,"numAtRisk":400,"numEvents":43}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":394,"numEvents":37},{"groupId":"EG001","numAffected":35,"numAtRisk":393,"numEvents":57},{"groupId":"EG002","numAffected":37,"numAtRisk":400,"numEvents":51}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":394,"numEvents":24},{"groupId":"EG001","numAffected":30,"numAtRisk":393,"numEvents":45},{"groupId":"EG002","numAffected":22,"numAtRisk":400,"numEvents":26}],"term":"ALANINE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":394,"numEvents":19},{"groupId":"EG001","numAffected":30,"numAtRisk":393,"numEvents":48},{"groupId":"EG002","numAffected":22,"numAtRisk":400,"numEvents":29}],"term":"ASPARTATE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":394,"numEvents":72},{"groupId":"EG001","numAffected":49,"numAtRisk":393,"numEvents":87},{"groupId":"EG002","numAffected":33,"numAtRisk":400,"numEvents":64}],"term":"NEUTROPHIL COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":394,"numEvents":76},{"groupId":"EG001","numAffected":57,"numAtRisk":393,"numEvents":84},{"groupId":"EG002","numAffected":41,"numAtRisk":400,"numEvents":59}],"term":"PLATELET COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":394,"numEvents":46},{"groupId":"EG001","numAffected":52,"numAtRisk":393,"numEvents":56},{"groupId":"EG002","numAffected":29,"numAtRisk":400,"numEvents":32}],"term":"WEIGHT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":394,"numEvents":39},{"groupId":"EG001","numAffected":26,"numAtRisk":393,"numEvents":42},{"groupId":"EG002","numAffected":17,"numAtRisk":400,"numEvents":27}],"term":"WHITE BLOOD CELL COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":394,"numEvents":102},{"groupId":"EG001","numAffected":119,"numAtRisk":393,"numEvents":157},{"groupId":"EG002","numAffected":100,"numAtRisk":400,"numEvents":129}],"term":"DECREASED APPETITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":394,"numEvents":16},{"groupId":"EG001","numAffected":33,"numAtRisk":393,"numEvents":42},{"groupId":"EG002","numAffected":7,"numAtRisk":400,"numEvents":7}],"term":"DEHYDRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":394,"numEvents":18},{"groupId":"EG001","numAffected":36,"numAtRisk":393,"numEvents":47},{"groupId":"EG002","numAffected":24,"numAtRisk":400,"numEvents":30}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":394,"numEvents":29},{"groupId":"EG001","numAffected":55,"numAtRisk":393,"numEvents":76},{"groupId":"EG002","numAffected":38,"numAtRisk":400,"numEvents":49}],"term":"HYPOMAGNESAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":394,"numEvents":20},{"groupId":"EG001","numAffected":23,"numAtRisk":393,"numEvents":32},{"groupId":"EG002","numAffected":13,"numAtRisk":400,"numEvents":14}],"term":"HYPONATRAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":102,"numAtRisk":394,"numEvents":155},{"groupId":"EG001","numAffected":130,"numAtRisk":393,"numEvents":227},{"groupId":"EG002","numAffected":105,"numAtRisk":400,"numEvents":175}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":394,"numEvents":50},{"groupId":"EG001","numAffected":57,"numAtRisk":393,"numEvents":67},{"groupId":"EG002","numAffected":51,"numAtRisk":400,"numEvents":70}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":394,"numEvents":19},{"groupId":"EG001","numAffected":23,"numAtRisk":393,"numEvents":33},{"groupId":"EG002","numAffected":16,"numAtRisk":400,"numEvents":18}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":394,"numEvents":8},{"groupId":"EG001","numAffected":20,"numAtRisk":393,"numEvents":24},{"groupId":"EG002","numAffected":10,"numAtRisk":400,"numEvents":10}],"term":"MUSCLE SPASMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":394,"numEvents":81},{"groupId":"EG001","numAffected":69,"numAtRisk":393,"numEvents":118},{"groupId":"EG002","numAffected":67,"numAtRisk":400,"numEvents":104}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":394,"numEvents":43},{"groupId":"EG001","numAffected":50,"numAtRisk":393,"numEvents":63},{"groupId":"EG002","numAffected":45,"numAtRisk":400,"numEvents":52}],"term":"PAIN IN EXTREMITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":394,"numEvents":31},{"groupId":"EG001","numAffected":27,"numAtRisk":393,"numEvents":34},{"groupId":"EG002","numAffected":28,"numAtRisk":400,"numEvents":39}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":394,"numEvents":24},{"groupId":"EG001","numAffected":24,"numAtRisk":393,"numEvents":27},{"groupId":"EG002","numAffected":15,"numAtRisk":400,"numEvents":16}],"term":"DYSGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":394,"numEvents":65},{"groupId":"EG001","numAffected":70,"numAtRisk":393,"numEvents":87},{"groupId":"EG002","numAffected":41,"numAtRisk":400,"numEvents":49}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":394,"numEvents":77},{"groupId":"EG001","numAffected":92,"numAtRisk":393,"numEvents":105},{"groupId":"EG002","numAffected":104,"numAtRisk":400,"numEvents":117}],"term":"NEUROPATHY PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":394,"numEvents":50},{"groupId":"EG001","numAffected":53,"numAtRisk":393,"numEvents":59},{"groupId":"EG002","numAffected":37,"numAtRisk":400,"numEvents":42}],"term":"PARAESTHESIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":394,"numEvents":59},{"groupId":"EG001","numAffected":65,"numAtRisk":393,"numEvents":73},{"groupId":"EG002","numAffected":58,"numAtRisk":400,"numEvents":65}],"term":"PERIPHERAL SENSORY NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":394,"numEvents":23},{"groupId":"EG001","numAffected":31,"numAtRisk":393,"numEvents":31},{"groupId":"EG002","numAffected":23,"numAtRisk":400,"numEvents":23}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":394,"numEvents":13},{"groupId":"EG001","numAffected":25,"numAtRisk":393,"numEvents":26},{"groupId":"EG002","numAffected":15,"numAtRisk":400,"numEvents":16}],"term":"DEPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":394,"numEvents":41},{"groupId":"EG001","numAffected":42,"numAtRisk":393,"numEvents":43},{"groupId":"EG002","numAffected":50,"numAtRisk":400,"numEvents":56}],"term":"INSOMNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":394,"numEvents":81},{"groupId":"EG001","numAffected":80,"numAtRisk":393,"numEvents":128},{"groupId":"EG002","numAffected":9,"numAtRisk":400,"numEvents":13}],"term":"PROTEINURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":77,"numAtRisk":394,"numEvents":94},{"groupId":"EG001","numAffected":86,"numAtRisk":393,"numEvents":107},{"groupId":"EG002","numAffected":82,"numAtRisk":400,"numEvents":99}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":394,"numEvents":19},{"groupId":"EG001","numAffected":27,"numAtRisk":393,"numEvents":27},{"groupId":"EG002","numAffected":11,"numAtRisk":400,"numEvents":12}],"term":"DYSPHONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":394,"numEvents":66},{"groupId":"EG001","numAffected":67,"numAtRisk":393,"numEvents":81},{"groupId":"EG002","numAffected":86,"numAtRisk":400,"numEvents":107}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":394,"numEvents":108},{"groupId":"EG001","numAffected":67,"numAtRisk":393,"numEvents":89},{"groupId":"EG002","numAffected":17,"numAtRisk":400,"numEvents":22}],"term":"EPISTAXIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":394,"numEvents":21},{"groupId":"EG001","numAffected":21,"numAtRisk":393,"numEvents":24},{"groupId":"EG002","numAffected":16,"numAtRisk":400,"numEvents":27}],"term":"HAEMOPTYSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":394,"numEvents":10},{"groupId":"EG001","numAffected":22,"numAtRisk":393,"numEvents":25},{"groupId":"EG002","numAffected":9,"numAtRisk":400,"numEvents":10}],"term":"OROPHARYNGEAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":180,"numAtRisk":394,"numEvents":183},{"groupId":"EG001","numAffected":188,"numAtRisk":393,"numEvents":195},{"groupId":"EG002","numAffected":180,"numAtRisk":400,"numEvents":182}],"term":"ALOPECIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":394,"numEvents":9},{"groupId":"EG001","numAffected":29,"numAtRisk":393,"numEvents":31},{"groupId":"EG002","numAffected":24,"numAtRisk":400,"numEvents":28}],"term":"DRY SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":394,"numEvents":29},{"groupId":"EG001","numAffected":58,"numAtRisk":393,"numEvents":76},{"groupId":"EG002","numAffected":52,"numAtRisk":400,"numEvents":72}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":394,"numEvents":34},{"groupId":"EG001","numAffected":72,"numAtRisk":393,"numEvents":92},{"groupId":"EG002","numAffected":71,"numAtRisk":400,"numEvents":94}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":87,"numAtRisk":394,"numEvents":102},{"groupId":"EG001","numAffected":104,"numAtRisk":393,"numEvents":149},{"groupId":"EG002","numAffected":16,"numAtRisk":400,"numEvents":16}],"term":"HYPERTENSION"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":394,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":393,"numEvents":5},{"groupId":"EG002","numAffected":5,"numAtRisk":400,"numEvents":6}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BONE MARROW FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":394,"numEvents":18},{"groupId":"EG001","numAffected":27,"numAtRisk":393,"numEvents":30},{"groupId":"EG002","numAffected":13,"numAtRisk":400,"numEvents":13}],"term":"FEBRILE NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MYELOSUPPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":393,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"NORMOCHROMIC ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PANCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SPONTANEOUS HAEMATOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":393,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ACUTE MYOCARDIAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"ATRIAL FIBRILLATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ATRIAL FLUTTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ATRIOVENTRICULAR BLOCK SECOND DEGREE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"AUTOIMMUNE MYOCARDITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CARDIAC ARREST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CARDIAC FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CARDIAC FAILURE CONGESTIVE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CORONARY ARTERY DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LEFT VENTRICULAR DYSFUNCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"MYOCARDIAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"MYOCARDIAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PERICARDIAL EFFUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PERICARDITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"TACHYARRHYTHMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"VENTRICULAR TACHYCARDIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ADRENAL INSUFFICIENCY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ADRENOCORTICAL INSUFFICIENCY ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DIABETES INSIPIDUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HYPOPHYSITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HYPOTHYROIDISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SECONDARY ADRENOCORTICAL INSUFFICIENCY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"OPTIC NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ABDOMINAL PAIN LOWER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ABDOMINAL PAIN UPPER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":393,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"COLITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"COLITIS ISCHAEMIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":10,"numAtRisk":393,"numEvents":11},{"groupId":"EG002","numAffected":8,"numAtRisk":400,"numEvents":8}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DIVERTICULAR PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DUODENAL ULCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":3}],"term":"DYSPHAGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"FAECALOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"FOOD POISONING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"GASTRIC HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":393,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"GASTRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"GASTROINTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"GLOSSODYNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ILEUS PARALYTIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INGUINAL HERNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INTESTINAL ANGINA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"INTESTINAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INTESTINAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INTESTINAL OBSTRUCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INTESTINAL PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"IRRITABLE BOWEL SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LARGE INTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LARGE INTESTINE PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":393,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"OESOPHAGEAL FOOD IMPACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PANCREATITIS ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":393,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":400,"numEvents":5}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ASTHENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CATHETER SITE ERYTHEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":394,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":393,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":2}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"COMPLICATION ASSOCIATED WITH DEVICE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DEATH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"INFLUENZA LIKE ILLNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INFUSION SITE EXTRAVASATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MUCOSAL INFLAMMATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"NON-CARDIAC CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":393,"numEvents":8},{"groupId":"EG002","numAffected":6,"numAtRisk":400,"numEvents":6}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CHOLANGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CHOLANGITIS ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CHOLELITHIASIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HEPATITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HEPATOMEGALY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HEPATOTOXICITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"ANAPHYLACTIC REACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"DRUG HYPERSENSITIVITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HYPERSENSITIVITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ABDOMINAL SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ANAL ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BACTERIAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BONE ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":393,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BURSITIS INFECTIVE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CELLULITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CHRONIC SINUSITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CLOSTRIDIUM DIFFICILE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"DEVICE RELATED INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DIVERTICULITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"EMPYEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ENCEPHALITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ENDOCARDITIS BACTERIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ENTERITIS INFECTIOUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ENTEROCOLITIS BACTERIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"FEBRILE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"GASTROENTERITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"GASTROENTERITIS CLOSTRIDIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HAEMORRHAGIC PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HEPATITIS A"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HEPATITIS C"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INFECTED SKIN ULCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"INFECTIOUS PLEURAL EFFUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"INFLUENZA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"KLEBSIELLA SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LARGE INTESTINE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":4}],"term":"LOWER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"NEUTROPENIC SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"OSTEOMYELITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PARAINFLUENZAE VIRUS INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PAROTITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":394,"numEvents":19},{"groupId":"EG001","numAffected":28,"numAtRisk":393,"numEvents":30},{"groupId":"EG002","numAffected":21,"numAtRisk":400,"numEvents":23}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PNEUMONIA ADENOVIRAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PNEUMONIA BACTERIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PROSTATIC ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PYOPNEUMOTHORAX"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"RESPIRATORY SYNCYTIAL VIRUS INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":393,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"RESPIRATORY TRACT INFECTION FUNGAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SALMONELLOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"SCROTAL ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":394,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"SEPTIC SHOCK"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"STAPHYLOCOCCAL BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"STAPHYLOCOCCAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"TOOTH ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":400,"numEvents":4}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"VASCULAR DEVICE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"VIRAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ACCIDENTAL OVERDOSE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"FALL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"FEMUR FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"HIP FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HUMERUS FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"INFUSION RELATED REACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PROCEDURAL COMPLICATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PROCEDURAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"RIB FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SPINAL COMPRESSION FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"STERNAL FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"WOUND COMPLICATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ALANINE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ASPARTATE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"BLOOD LACTATE DEHYDROGENASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BLOOD PRESSURE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"C-REACTIVE PROTEIN INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"GENERAL PHYSICAL CONDITION ABNORMAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HEPATIC ENZYME INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LIPASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"NEUTROPHIL COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PLATELET COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"TRANSAMINASES INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"TROPONIN INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"WEIGHT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"WHITE BLOOD CELL COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DECREASED APPETITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":394,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":393,"numEvents":9},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"DEHYDRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"FAILURE TO THRIVE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HYPERCALCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HYPERGLYCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HYPONATRAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HYPOPHOSPHATAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"COMPARTMENT SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"FLANK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MUSCULAR WEAKNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MUSCULOSKELETAL CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"OSTEOLYSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PAIN IN EXTREMITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SOFT TISSUE NECROSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SPINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"VERTEBRAL FORAMINAL STENOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ADENOCARCINOMA GASTRIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"B-CELL LYMPHOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BLADDER NEOPLASM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BLADDER TRANSITIONAL CELL CARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MARROW HYPERPLASIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"MENINGIOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"METASTASES TO MENINGES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"TUMOUR PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"TUMOUR PSEUDOPROGRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ATAXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"CEREBRAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CEREBRAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CEREBRAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":393,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"CEREBROVASCULAR ACCIDENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"COGNITIVE DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DEPRESSED LEVEL OF CONSCIOUSNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DIZZINESS POSTURAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DYSAESTHESIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ENCEPHALOPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"FOCAL DYSCOGNITIVE SEIZURES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HAEMORRHAGE INTRACRANIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HEMIPARESIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":394,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"ISCHAEMIC STROKE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"LOSS OF CONSCIOUSNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"METABOLIC ENCEPHALOPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"NEUROPATHY PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"PARTIAL SEIZURES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PERIPHERAL SENSORY NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PRESYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":393,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":3}],"term":"SEIZURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SOMNOLENCE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SPINAL CORD COMPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"SYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"TRANSIENT ISCHAEMIC ATTACK"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ALCOHOL WITHDRAWAL SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BIPOLAR DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"CONFUSIONAL STATE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DELIRIUM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"DELUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"MENTAL STATUS CHANGES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PSYCHOTIC DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"SUICIDAL IDEATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"ACUTE KIDNEY INJURY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"GLOMERULONEPHROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HAEMATURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"NEPHROLITHIASIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PRERENAL FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"RENAL FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":2}],"term":"RENAL IMPAIRMENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"RENAL INJURY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"TUBULOINTERSTITIAL NEPHRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"URINARY TRACT OBSTRUCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ACUTE RESPIRATORY DISTRESS SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"ACUTE RESPIRATORY FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"BRONCHOSTENOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":393,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":394,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":400,"numEvents":4}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"EPISTAXIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":8,"numAtRisk":393,"numEvents":8},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":4}],"term":"HAEMOPTYSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HICCUPS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"HYPOXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"IMMUNE-MEDIATED PNEUMONITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"INTERSTITIAL LUNG DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"PLEURAL EFFUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PLEURISY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PLEURITIC PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PNEUMONIA ASPIRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":393,"numEvents":7},{"groupId":"EG002","numAffected":8,"numAtRisk":400,"numEvents":8}],"term":"PNEUMONITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":394,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":400,"numEvents":4}],"term":"PNEUMOTHORAX"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":394,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":393,"numEvents":5},{"groupId":"EG002","numAffected":8,"numAtRisk":400,"numEvents":8}],"term":"PULMONARY EMBOLISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":394,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PULMONARY HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PULMONARY NECROSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"PULMONARY OEDEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"RESPIRATORY FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DERMATITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"ERYTHEMA MULTIFORME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PEMPHIGOID"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":400,"numEvents":3}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"RASH MACULO-PAPULAR"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"VERTEBROPLASTY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"ANEURYSM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"AORTIC DISSECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ARTERIAL OCCLUSIVE DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DEEP VEIN THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"DIABETIC VASCULAR DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":400,"numEvents":2}],"term":"EMBOLISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"EMBOLISM VENOUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HAEMATOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"LYMPHOEDEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"ORTHOSTATIC HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PERIPHERAL ARTERIAL OCCLUSIVE DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PERIPHERAL ARTERY THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":393,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"PERIPHERAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":400,"numEvents":0}],"term":"PERIPHERAL VASCULAR DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":394,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":393,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":394,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":393,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":400,"numEvents":1}],"term":"VENOUS THROMBOSIS LIMB"}],"timeFrame":"From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)"}