{"description":"Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.","eventGroups":[{"deathsNumAffected":24,"deathsNumAtRisk":515,"description":"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.","id":"EG000","otherNumAffected":147,"otherNumAtRisk":507,"seriousNumAffected":88,"seriousNumAtRisk":507,"title":"Remdesivir Plus Baricitinib"},{"deathsNumAffected":37,"deathsNumAtRisk":518,"description":"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.","id":"EG001","otherNumAffected":164,"otherNumAtRisk":509,"seriousNumAffected":109,"seriousNumAtRisk":509,"title":"Remdesivir Plus Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":507,"numEvents":52},{"groupId":"EG001","numAffected":45,"numAtRisk":509,"numEvents":46}],"term":"Glomerular filtration rate decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":507,"numEvents":34},{"groupId":"EG001","numAffected":40,"numAtRisk":509,"numEvents":47}],"term":"Hyperglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":507,"numEvents":32},{"groupId":"EG001","numAffected":31,"numAtRisk":509,"numEvents":32}],"term":"Haemoglobin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":507,"numEvents":28},{"groupId":"EG001","numAffected":36,"numAtRisk":509,"numEvents":36}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":507,"numEvents":28},{"groupId":"EG001","numAffected":31,"numAtRisk":509,"numEvents":40}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":507,"numEvents":26},{"groupId":"EG001","numAffected":28,"numAtRisk":509,"numEvents":28}],"term":"Blood glucose increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":507,"numEvents":17},{"groupId":"EG001","numAffected":27,"numAtRisk":509,"numEvents":28}],"term":"Acute kidney injury"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":507,"numEvents":30},{"groupId":"EG001","numAffected":37,"numAtRisk":509,"numEvents":38}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":507,"numEvents":18},{"groupId":"EG001","numAffected":16,"numAtRisk":509,"numEvents":16}],"term":"Acute respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":507,"numEvents":5},{"groupId":"EG001","numAffected":11,"numAtRisk":509,"numEvents":11}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":507,"numEvents":4},{"groupId":"EG001","numAffected":10,"numAtRisk":509,"numEvents":10}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":507,"numEvents":4},{"groupId":"EG001","numAffected":8,"numAtRisk":509,"numEvents":8}],"term":"Septic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":507,"numEvents":6},{"groupId":"EG001","numAffected":5,"numAtRisk":509,"numEvents":5}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":507,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":509,"numEvents":7}],"term":"Respiratory distress"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":8,"numAtRisk":509,"numEvents":8}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":509,"numEvents":6}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":507,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":507,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":509,"numEvents":4}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":509,"numEvents":4}],"term":"Shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":509,"numEvents":3}],"term":"Cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":509,"numEvents":4}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":509,"numEvents":4}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":509,"numEvents":5}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":509,"numEvents":5}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Pulseless electrical activity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":509,"numEvents":2}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":509,"numEvents":2}],"term":"Cerebrovascular accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":509,"numEvents":2}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":509,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":507,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Cardio-respiratory arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Respiratory arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":509,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Distributive shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Guillain-Barre syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Intervertebral discitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Nervous system disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Procedural hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Prostatic abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Sickle cell anaemia with crisis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Thrombophlebitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Visual impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Acidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Aortic valve stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Aspergillus infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Atrioventricular block"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Blood glucose decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Diabetic ketoacidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Embolism venous"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":2}],"term":"Endotracheal intubation complication"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Haematoma muscle"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Haemoglobin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Haemorrhage intracranial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Hepatic haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Hepatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Hypoglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Injection site induration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Left ventricular failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Lung abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Metabolic acidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Overdose"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Pneumomediastinum"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Right ventricular dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Subdural haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":509,"numEvents":2}],"term":"Tachypnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Troponin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":507,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":509,"numEvents":1}],"term":"Urosepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":507,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":509,"numEvents":0}],"term":"Lipoma"}],"timeFrame":"Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported."}