{"description":"TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.","eventGroups":[{"deathsNumAffected":52,"deathsNumAtRisk":133,"description":"Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .","id":"EG000","otherNumAffected":120,"otherNumAtRisk":133,"seriousNumAffected":53,"seriousNumAtRisk":133,"title":"Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)"},{"deathsNumAffected":16,"deathsNumAtRisk":22,"description":"Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.","id":"EG001","otherNumAffected":22,"otherNumAtRisk":22,"seriousNumAffected":15,"seriousNumAtRisk":22,"title":"Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma"}],"frequencyThreshold":"5.0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":133,"numEvents":139},{"groupId":"EG001","numAffected":11,"numAtRisk":22,"numEvents":41}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":133,"numEvents":104},{"groupId":"EG001","numAffected":4,"numAtRisk":22,"numEvents":13}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":133,"numEvents":60},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":133,"numEvents":56},{"groupId":"EG001","numAffected":5,"numAtRisk":22,"numEvents":5}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":133,"numEvents":28},{"groupId":"EG001","numAffected":4,"numAtRisk":22,"numEvents":5}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":133,"numEvents":13},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":133,"numEvents":13},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":4}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":133,"numEvents":28},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":133,"numEvents":27},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":133,"numEvents":22},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":133,"numEvents":18},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":133,"numEvents":33},{"groupId":"EG001","numAffected":4,"numAtRisk":22,"numEvents":4}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":133,"numEvents":16},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Cytomegalovirus viraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":133,"numEvents":117},{"groupId":"EG001","numAffected":9,"numAtRisk":22,"numEvents":40}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":133,"numEvents":54},{"groupId":"EG001","numAffected":6,"numAtRisk":22,"numEvents":18}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":133,"numEvents":26},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":5}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":133,"numEvents":20},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":7}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":133,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":133,"numEvents":17},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":4}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":133,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":133,"numEvents":19},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":4}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":133,"numEvents":25},{"groupId":"EG001","numAffected":4,"numAtRisk":22,"numEvents":8}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":133,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":6}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":7}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":133,"numEvents":24},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":133,"numEvents":12},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":13}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":133,"numEvents":18},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":10}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":133,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":133,"numEvents":9},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":11}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":133,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":4}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":22,"numEvents":8}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":133,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":133,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":133,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":133,"numEvents":44},{"groupId":"EG001","numAffected":5,"numAtRisk":22,"numEvents":6}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":133,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":133,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":133,"numEvents":20},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":133,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":133,"numEvents":19},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":133,"numEvents":16},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":133,"numEvents":17},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":133,"numEvents":11},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":133,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Coombs negative haemolytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":3}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Umbilical hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Gastric haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":133,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":133,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Haemophagocytic lymphohistiocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":133,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Citrobacter bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Necrotising fasciitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pseudomonal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Bacterial abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Cytomegalovirus viraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pneumonia adenoviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Pneumonia respiratory syncytial viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Adult failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Hyperlactacidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Acute myeloid leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Malignant neoplasm papilla of Vater"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Generalised tonic-clonic seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"IIIrd nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Motor dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":2}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":133,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Cellulite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0}],"term":"Shock haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Superior vena cava syndrome"}],"timeFrame":"Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months"}