{"description":"Adverse events were reported as per MedDRA v21.1 for Part A arm and MedDRA v22.0 for Part B.","eventGroups":[{"deathsNumAffected":63,"deathsNumAtRisk":88,"description":"Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.","id":"EG000","otherNumAffected":86,"otherNumAtRisk":88,"seriousNumAffected":48,"seriousNumAtRisk":88,"title":"Part A: Avelumab"},{"deathsNumAffected":72,"deathsNumAtRisk":116,"description":"Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.","id":"EG001","otherNumAffected":114,"otherNumAtRisk":116,"seriousNumAffected":58,"seriousNumAtRisk":116,"title":"Part B: Avelumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":88},{"groupId":"EG001","numAffected":19,"numAtRisk":116}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":9,"numAtRisk":116}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":6,"numAtRisk":116}],"term":"Eosinophilia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":88},{"groupId":"EG001","numAffected":11,"numAtRisk":116}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":88},{"groupId":"EG001","numAffected":29,"numAtRisk":116}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":88},{"groupId":"EG001","numAffected":18,"numAtRisk":116}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":88},{"groupId":"EG001","numAffected":22,"numAtRisk":116}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":88},{"groupId":"EG001","numAffected":10,"numAtRisk":116}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":88},{"groupId":"EG001","numAffected":24,"numAtRisk":116}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":88},{"groupId":"EG001","numAffected":14,"numAtRisk":116}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":88},{"groupId":"EG001","numAffected":27,"numAtRisk":116}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":88},{"groupId":"EG001","numAffected":15,"numAtRisk":116}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":88},{"groupId":"EG001","numAffected":13,"numAtRisk":116}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":88},{"groupId":"EG001","numAffected":8,"numAtRisk":116}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":8,"numAtRisk":116}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":7,"numAtRisk":116}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":88},{"groupId":"EG001","numAffected":10,"numAtRisk":116}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":9,"numAtRisk":116}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":9,"numAtRisk":116}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":6,"numAtRisk":116}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":6,"numAtRisk":116}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":10,"numAtRisk":116}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":7,"numAtRisk":116}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":10,"numAtRisk":116}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":88},{"groupId":"EG001","numAffected":18,"numAtRisk":116}],"term":"Weight decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":88},{"groupId":"EG001","numAffected":16,"numAtRisk":116}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":9,"numAtRisk":116}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":7,"numAtRisk":116}],"term":"Hypomagnesaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":11,"numAtRisk":116}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":88},{"groupId":"EG001","numAffected":10,"numAtRisk":116}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":88},{"groupId":"EG001","numAffected":13,"numAtRisk":116}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Muscle spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":6,"numAtRisk":116}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":88},{"groupId":"EG001","numAffected":28,"numAtRisk":116}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":88},{"groupId":"EG001","numAffected":16,"numAtRisk":116}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":9,"numAtRisk":116}],"term":"Actinic keratosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":9,"numAtRisk":116}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":7,"numAtRisk":116}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":88},{"groupId":"EG001","numAffected":18,"numAtRisk":116}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":88},{"groupId":"EG001","numAffected":11,"numAtRisk":116}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":7,"numAtRisk":116}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":88},{"groupId":"EG001","numAffected":11,"numAtRisk":116}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Weight increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Muscular weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Lymphoedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Leukocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Microcytic anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Normochromic normocytic anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Atrial flutter"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Eyelid function disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Glaucoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Retinal artery occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Ulcerative keratitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Enterocolitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Faecaloma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Gastric haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Ileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Oesophageal spasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":88},{"groupId":"EG001","numAffected":10,"numAtRisk":116}],"term":"Disease progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":88},{"groupId":"EG001","numAffected":6,"numAtRisk":116}],"term":"General physical health deterioration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Liver injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Diabetic foot infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Erysipelas"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Klebsiella sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Streptococcal sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":3,"numAtRisk":116}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Transaminases increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Diabetes mellitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":3,"numAtRisk":116}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Chondrocalcinosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Musculoskeletal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Synovitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Bundle branch block right"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Myocarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Diplopia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Diverticulum"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Faeces discoloured"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Large intestine perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Influenza like illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Endocarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Infective exacerbation of bronchiectasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Peritonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":4,"numAtRisk":116}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Streptococcal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Hip fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Radiation mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Radiation skin injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Tendon rupture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Liver function test increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Weight decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Tumour lysis syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Myopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Myositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Spondylitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Malignant neoplasm progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Metastases to meninges"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Neoplasm progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Pericardial effusion malignant"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Squamous cell carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Basal cell carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Bowen's disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Lung adenocarcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Metastases to central nervous system"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Metastasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Paraneoplastic syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Prostate cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Tumour compression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Post herpetic neuralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Autoimmune neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Cerebrovascular accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Dysarthria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Paraneoplastic encephalomyelitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Polyneuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Polyneuropathy in malignant disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Transient ischaemic attack"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Confusional state"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Delirium"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Tubulointerstitial nephritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":3,"numAtRisk":116}],"term":"Hydronephrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Renal impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Dyspnoea exertional"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Epiglottic cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Pleural thickening"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Productive cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Superior vena cava syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":2,"numAtRisk":116}],"term":"Lymphoedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Shock haemorrhagic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Vascular purpura"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":88},{"groupId":"EG001","numAffected":1,"numAtRisk":116}],"term":"Knee arthroplasty"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Cardiac tamponade"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Diabetes insipidus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Abdominal hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Autoimmune colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Autoimmune disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Eye infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Haematoma infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Herpes zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Spinal cord infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Femoral neck fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Intraocular pressure increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Hypernatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Muscle spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Haematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Diabetic foot"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1and 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":88},{"groupId":"EG001","numAffected":0,"numAtRisk":116}],"term":"Thrombocytopenia"}],"timeFrame":"Part A: Up to 325 weeks; Part B: Up to 396 weeks"}