{"description":"The Safety population included all participants who received at least 1 dose of study drug. All-cause mortality was reported in ITT population.","eventGroups":[{"deathsNumAffected":161,"deathsNumAtRisk":436,"description":"Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.","id":"EG000","otherNumAffected":427,"otherNumAtRisk":434,"seriousNumAffected":88,"seriousNumAtRisk":434,"title":"T-DXd"},{"deathsNumAffected":174,"deathsNumAtRisk":430,"description":"Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.","id":"EG001","otherNumAffected":383,"otherNumAtRisk":417,"seriousNumAffected":67,"seriousNumAtRisk":417,"title":"Chemotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":434,"numEvents":61},{"groupId":"EG001","numAffected":34,"numAtRisk":417,"numEvents":36}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":434,"numEvents":57},{"groupId":"EG001","numAffected":20,"numAtRisk":417,"numEvents":21}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":434,"numEvents":199},{"groupId":"EG001","numAffected":63,"numAtRisk":417,"numEvents":148}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":434,"numEvents":179},{"groupId":"EG001","numAffected":60,"numAtRisk":417,"numEvents":79}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":148,"numAtRisk":434,"numEvents":228},{"groupId":"EG001","numAffected":112,"numAtRisk":417,"numEvents":177}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":434,"numEvents":24},{"groupId":"EG001","numAffected":16,"numAtRisk":417,"numEvents":16}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":434,"numEvents":63},{"groupId":"EG001","numAffected":20,"numAtRisk":417,"numEvents":23}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":434,"numEvents":33},{"groupId":"EG001","numAffected":7,"numAtRisk":417,"numEvents":7}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":301,"numAtRisk":434,"numEvents":585},{"groupId":"EG001","numAffected":126,"numAtRisk":417,"numEvents":198}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":434,"numEvents":75},{"groupId":"EG001","numAffected":37,"numAtRisk":417,"numEvents":45}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":145,"numAtRisk":434,"numEvents":286},{"groupId":"EG001","numAffected":48,"numAtRisk":417,"numEvents":63}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":434,"numEvents":182},{"groupId":"EG001","numAffected":71,"numAtRisk":417,"numEvents":102}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":157,"numAtRisk":434,"numEvents":288},{"groupId":"EG001","numAffected":106,"numAtRisk":417,"numEvents":216}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":117,"numAtRisk":434,"numEvents":156},{"groupId":"EG001","numAffected":83,"numAtRisk":417,"numEvents":95}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":434,"numEvents":54},{"groupId":"EG001","numAffected":18,"numAtRisk":417,"numEvents":23}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":434,"numEvents":39},{"groupId":"EG001","numAffected":59,"numAtRisk":417,"numEvents":67}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":434,"numEvents":64},{"groupId":"EG001","numAffected":28,"numAtRisk":417,"numEvents":35}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":101,"numAtRisk":434,"numEvents":107},{"groupId":"EG001","numAffected":51,"numAtRisk":417,"numEvents":53}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":434,"numEvents":27},{"groupId":"EG001","numAffected":15,"numAtRisk":417,"numEvents":19}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":434,"numEvents":40},{"groupId":"EG001","numAffected":20,"numAtRisk":417,"numEvents":23}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":93,"numAtRisk":434,"numEvents":142},{"groupId":"EG001","numAffected":48,"numAtRisk":417,"numEvents":85}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":117,"numAtRisk":434,"numEvents":190},{"groupId":"EG001","numAffected":44,"numAtRisk":417,"numEvents":80}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":434,"numEvents":62},{"groupId":"EG001","numAffected":17,"numAtRisk":417,"numEvents":26}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":434,"numEvents":48},{"groupId":"EG001","numAffected":20,"numAtRisk":417,"numEvents":42}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":434,"numEvents":41},{"groupId":"EG001","numAffected":12,"numAtRisk":417,"numEvents":13}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":434,"numEvents":46},{"groupId":"EG001","numAffected":9,"numAtRisk":417,"numEvents":13}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":434,"numEvents":69},{"groupId":"EG001","numAffected":11,"numAtRisk":417,"numEvents":30}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":434,"numEvents":433},{"groupId":"EG001","numAffected":66,"numAtRisk":417,"numEvents":265}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":434,"numEvents":160},{"groupId":"EG001","numAffected":15,"numAtRisk":417,"numEvents":40}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":434,"numEvents":35},{"groupId":"EG001","numAffected":8,"numAtRisk":417,"numEvents":9}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":434,"numEvents":376},{"groupId":"EG001","numAffected":53,"numAtRisk":417,"numEvents":265}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":112,"numAtRisk":434,"numEvents":183},{"groupId":"EG001","numAffected":47,"numAtRisk":417,"numEvents":53}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":434,"numEvents":48},{"groupId":"EG001","numAffected":12,"numAtRisk":417,"numEvents":25}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":434,"numEvents":87},{"groupId":"EG001","numAffected":14,"numAtRisk":417,"numEvents":17}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":434,"numEvents":38},{"groupId":"EG001","numAffected":45,"numAtRisk":417,"numEvents":53}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":434,"numEvents":40},{"groupId":"EG001","numAffected":34,"numAtRisk":417,"numEvents":37}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":434,"numEvents":25},{"groupId":"EG001","numAffected":27,"numAtRisk":417,"numEvents":30}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":434,"numEvents":30},{"groupId":"EG001","numAffected":23,"numAtRisk":417,"numEvents":27}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":434,"numEvents":45},{"groupId":"EG001","numAffected":26,"numAtRisk":417,"numEvents":26}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":434,"numEvents":55},{"groupId":"EG001","numAffected":24,"numAtRisk":417,"numEvents":24}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":434,"numEvents":111},{"groupId":"EG001","numAffected":42,"numAtRisk":417,"numEvents":44}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":434,"numEvents":11},{"groupId":"EG001","numAffected":36,"numAtRisk":417,"numEvents":39}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":434,"numEvents":13},{"groupId":"EG001","numAffected":49,"numAtRisk":417,"numEvents":57}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":434,"numEvents":34},{"groupId":"EG001","numAffected":19,"numAtRisk":417,"numEvents":19}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":434,"numEvents":30},{"groupId":"EG001","numAffected":18,"numAtRisk":417,"numEvents":21}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":434,"numEvents":84},{"groupId":"EG001","numAffected":38,"numAtRisk":417,"numEvents":47}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":434,"numEvents":30},{"groupId":"EG001","numAffected":41,"numAtRisk":417,"numEvents":42}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":434,"numEvents":56},{"groupId":"EG001","numAffected":15,"numAtRisk":417,"numEvents":16}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":434,"numEvents":26},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":434,"numEvents":25},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":210,"numAtRisk":434,"numEvents":212},{"groupId":"EG001","numAffected":87,"numAtRisk":417,"numEvents":89}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":434,"numEvents":24},{"groupId":"EG001","numAffected":15,"numAtRisk":417,"numEvents":15}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":434,"numEvents":66},{"groupId":"EG001","numAffected":17,"numAtRisk":417,"numEvents":34}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":434,"numEvents":4},{"groupId":"EG001","numAffected":145,"numAtRisk":417,"numEvents":176}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":434,"numEvents":30},{"groupId":"EG001","numAffected":31,"numAtRisk":417,"numEvents":35}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":434,"numEvents":36},{"groupId":"EG001","numAffected":23,"numAtRisk":417,"numEvents":28}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Anal fissure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":417,"numEvents":3}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":417,"numEvents":3}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Femoral hernia strangulated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":434,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Neutropenic colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Tooth disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":434,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":434,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":434,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Acute hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":417,"numEvents":3}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Drug-induced liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Portal vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Anaphylactic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Bartholin's abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":434,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":417,"numEvents":5}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Cytomegalovirus hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Empyema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Enteritis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Enterococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Escherichia pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Human ehrlichiosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Kidney infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Meningoencephalitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":417,"numEvents":3}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Proteus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Pseudomembranous colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Acetabulum fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Toxic cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":417,"numEvents":3}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Patella fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Uterine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Liver function test increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":434,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":434,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":417,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Fracture pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Blindness unilateral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Malignant melanoma in situ"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Melanoma recurrent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Nervous system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Paraplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Parkinson's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Peroneal nerve palsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Vertebrobasilar insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Renal colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":434,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":417,"numEvents":5}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":434,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":434,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":434,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":417,"numEvents":3}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Paraneoplastic dermatomyositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":434,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":417,"numEvents":1}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":434,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":417,"numEvents":0}],"term":"Haematoma"}],"timeFrame":"From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months)."}