{"description":"Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study intervention.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":59,"description":"Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.","id":"EG000","otherNumAffected":59,"otherNumAtRisk":59,"seriousNumAffected":25,"seriousNumAtRisk":59,"title":"Treatment-Naive"},{"deathsNumAffected":7,"deathsNumAtRisk":39,"description":"Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.","id":"EG001","otherNumAffected":38,"otherNumAtRisk":39,"seriousNumAffected":17,"seriousNumAtRisk":39,"title":"Previously Treated"},{"deathsNumAffected":12,"deathsNumAtRisk":98,"description":"Sum of all participants in the Study C4221008 (ARRAY-818-202)","id":"EG002","otherNumAffected":97,"otherNumAtRisk":98,"seriousNumAffected":42,"seriousNumAtRisk":98,"title":"Total"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":59},{"groupId":"EG001","numAffected":10,"numAtRisk":39},{"groupId":"EG002","numAffected":30,"numAtRisk":98}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":59},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":20,"numAtRisk":98}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":59},{"groupId":"EG001","numAffected":19,"numAtRisk":39},{"groupId":"EG002","numAffected":56,"numAtRisk":98}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":59},{"groupId":"EG001","numAffected":20,"numAtRisk":39},{"groupId":"EG002","numAffected":49,"numAtRisk":98}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":59},{"groupId":"EG001","numAffected":13,"numAtRisk":39},{"groupId":"EG002","numAffected":36,"numAtRisk":98}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":59},{"groupId":"EG001","numAffected":8,"numAtRisk":39},{"groupId":"EG002","numAffected":26,"numAtRisk":98}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":59},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":20,"numAtRisk":98}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":8,"numAtRisk":98}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":59},{"groupId":"EG001","numAffected":16,"numAtRisk":39},{"groupId":"EG002","numAffected":45,"numAtRisk":98}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":59},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":22,"numAtRisk":98}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":59},{"groupId":"EG001","numAffected":8,"numAtRisk":39},{"groupId":"EG002","numAffected":20,"numAtRisk":98}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":59},{"groupId":"EG001","numAffected":9,"numAtRisk":39},{"groupId":"EG002","numAffected":16,"numAtRisk":98}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":8,"numAtRisk":98}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"COVID-19"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":15,"numAtRisk":98}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":59},{"groupId":"EG001","numAffected":5,"numAtRisk":39},{"groupId":"EG002","numAffected":15,"numAtRisk":98}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":59},{"groupId":"EG001","numAffected":7,"numAtRisk":39},{"groupId":"EG002","numAffected":15,"numAtRisk":98}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":15,"numAtRisk":98}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":13,"numAtRisk":98}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":11,"numAtRisk":98}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":11,"numAtRisk":98}],"term":"Weight increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":8,"numAtRisk":98}],"term":"Ejection fraction decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":8,"numAtRisk":98}],"term":"SARS-CoV-2 test positive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"Weight decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Amylase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":14,"numAtRisk":98}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":59},{"groupId":"EG001","numAffected":5,"numAtRisk":39},{"groupId":"EG002","numAffected":12,"numAtRisk":98}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"Hyperglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"Hypoalbuminaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":5,"numAtRisk":98}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":59},{"groupId":"EG001","numAffected":8,"numAtRisk":39},{"groupId":"EG002","numAffected":19,"numAtRisk":98}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":59},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":15,"numAtRisk":98}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":7,"numAtRisk":39},{"groupId":"EG002","numAffected":13,"numAtRisk":98}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":12,"numAtRisk":98}],"term":"Muscle spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":10,"numAtRisk":98}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"Muscular weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":98}],"term":"Seborrhoeic keratosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":59},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":16,"numAtRisk":98}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":10,"numAtRisk":98}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":8,"numAtRisk":98}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":5,"numAtRisk":98}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":10,"numAtRisk":98}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Pollakiuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":59},{"groupId":"EG001","numAffected":7,"numAtRisk":39},{"groupId":"EG002","numAffected":23,"numAtRisk":98}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":59},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":17,"numAtRisk":98}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":11,"numAtRisk":98}],"term":"Productive cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":59},{"groupId":"EG001","numAffected":8,"numAtRisk":39},{"groupId":"EG002","numAffected":15,"numAtRisk":98}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":13,"numAtRisk":98}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":12,"numAtRisk":98}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":59},{"groupId":"EG001","numAffected":5,"numAtRisk":39},{"groupId":"EG002","numAffected":11,"numAtRisk":98}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":8,"numAtRisk":98}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Hair texture abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":5,"numAtRisk":98}],"term":"Hyperkeratosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":10,"numAtRisk":98}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":3,"numAtRisk":98}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":98}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Supraventricular tachyarrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Retinal detachment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":98}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Duodenal ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Small intestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":4,"numAtRisk":39},{"groupId":"EG002","numAffected":6,"numAtRisk":98}],"term":"Disease progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":98}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Cholelithiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":98}],"term":"Device related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":98}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"COVID-19"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"COVID-19 pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Clostridium difficile colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Empyema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Herpes zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Ophthalmic herpes zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Pneumonia mycoplasmal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Urosepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Femur fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Head injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Hip fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Upper limb fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":98}],"term":"Neoplasm progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Cerebrovascular accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Cognitive disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Haemorrhage intracranial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Hemiparesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Presyncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Confusional state"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Hallucination, auditory"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":3,"numAtRisk":98}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":98}],"term":"Haemothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":98}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Chronic respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Haemoptysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":59},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":59},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":98}],"term":"Peripheral embolism"}],"timeFrame":"From the time the participant provided informed consent, through and including a minimum of 30 calendar days, after the last administration of the study intervention, and the safety follow-up visit (30 days [±7 days] after the EOT visit) (up to 36 months)"}