Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04745351
Status:
TERMINATED
Last Update Posted:
2023-05-12
First Post:
2021-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606551', 'term': 'remdesivir'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days', 'description': 'All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.\n\nAdverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 166, 'otherNumAffected': 60, 'seriousNumAtRisk': 163, 'deathsNumAffected': 55, 'seriousNumAffected': 82}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 83, 'otherNumAffected': 34, 'seriousNumAtRisk': 80, 'deathsNumAffected': 26, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hepatic ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bacteroides bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Device related bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumocystis jirovecii infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Superinfection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dialysis related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Glomerular filtration rate abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperlipasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.816', 'ciLowerLimit': '0.504', 'ciUpperLimit': '1.321', 'pValueComment': 'P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 29', 'description': 'This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}, {'value': '29.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.830', 'ciLowerLimit': '0.497', 'ciUpperLimit': '1.388', 'pValueComment': 'P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 29', 'description': 'The reported percentage was from the Kaplan-Meier estimate.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Initiation of IMV Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.043', 'ciLowerLimit': '0.493', 'ciUpperLimit': '2.207', 'pValueComment': 'The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 29', 'description': 'The reported percentage was the cumulative-incidence estimate.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'comment': 'Upper bound of range (Q3) was not estimable due to less than 75% of participants with recovery.', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': 'NA'}, {'value': '19', 'comment': 'Upper bound of range (Q3) was not estimable due to less than 75% of participants with recovery.', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First dose date up to Day 29', 'description': 'Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery Independent of Further Worsening by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'comment': 'Q3 was not estimable due to less than 75% of participants with recovery.', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': 'NA'}, {'value': '13', 'comment': 'Q3 was not estimable due to less than 75% of participants with recovery.', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First dose date up to Day 29', 'description': 'Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'title': 'Score: 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score: 2', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}, {'title': 'Score: 3', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Score: 4', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Score: 5', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Score: 6', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Score: 7', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Score: 8', 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8541', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was analysed from proportional odds model including treatment as the independent variable.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'title': 'Score: 1', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Score: 2', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '45.0', 'groupId': 'OG001'}]}]}, {'title': 'Score: 3', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Score: 4', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Score: 5', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Score: 6', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Score: 7', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Score: 8', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4974', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was analysed from proportional odds model including treatment as the independent variable.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '29'}]}]}], 'analyses': [{'pValue': '0.4283', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated based on Wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'First dose date up to Day 29', 'description': 'The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without ESKD at baseline in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '63.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2773', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.731', 'ciUpperLimit': '1.091', 'pValueComment': 'The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 29', 'description': 'Recovery is defined as the first day on which the participant with a baseline score \\>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Recovery Independent of Further Worsening Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7538', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.819', 'ciUpperLimit': '1.155', 'pValueComment': 'The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 29', 'description': 'Recovery is defined as the first day on which the participant with a baseline score \\>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 5 days) plus 30 days', 'description': 'An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 5 days)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Brazil, Portugal, Spain, the United Kingdom, and the United States.', 'preAssignmentDetails': '258 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Remdesivir (RDV)', 'description': 'Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '71', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '69', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Categorical', 'categories': [{'title': '< 18 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>= 18 to < 65 Years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': '>= 65 Years', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Status (8-point Ordinal Scale)', 'classes': [{'categories': [{'title': 'Score: 1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Score: 2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Score: 3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Score: 4', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Score: 5', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Score: 6', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Score: 7', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Score: 8', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The 8-point Ordinal scale assesses the clinical status of participants:1.Not hospitalized, no limitations on activities;2.Not hospitalized, limitation on activities/requiring home oxygen;3.Hospitalized,not requiring supplemental oxygen,no longer require ongoing medical care; 4.Hospitalized,not requiring supplemental oxygen-require ongoing medical care for COVID-19-specific medical care;5.Hospitalized,supplemental oxygen;6.Hospitalized,on noninvasive ventilation or highflow oxygen devices;7.Hospitalized,on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO);8.Death.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-27', 'size': 4690775, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-12T03:24', 'hasProtocol': True}, {'date': '2022-07-22', 'size': 2886554, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-12T03:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'whyStopped': 'The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04323761', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2021-02-08', 'resultsFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-18', 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.'}], 'secondaryOutcomes': [{'measure': 'All-cause Mortality Through Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'The reported percentage was from the Kaplan-Meier estimate.'}, {'measure': 'Percentage of Participants With Initiation of IMV Through Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'The reported percentage was the cumulative-incidence estimate.'}, {'measure': 'Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.'}, {'measure': 'Time to Recovery Independent of Further Worsening by Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.'}, {'measure': 'Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15', 'timeFrame': 'Day 15', 'description': 'Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.'}, {'measure': 'Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29', 'timeFrame': 'Day 29', 'description': 'Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.'}, {'measure': 'Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.'}, {'measure': 'Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'Recovery is defined as the first day on which the participant with a baseline score \\>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.'}, {'measure': 'Percentage of Participants With Recovery Independent of Further Worsening Through Day 29', 'timeFrame': 'First dose date up to Day 29', 'description': 'Recovery is defined as the first day on which the participant with a baseline score \\>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.'}, {'measure': 'Percentage of Participants Experiencing Serious Adverse Events (SAEs)', 'timeFrame': 'First dose date up to last dose date (Maximum: 5 days) plus 30 days', 'description': 'An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)', 'timeFrame': 'First dose date up to last dose date (Maximum: 5 days)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '38913574', 'type': 'DERIVED', 'citation': 'Sise ME, Santos JR, Goldman JD, Tuttle KR, Teixeira JP, Seibert AF, Koullias Y, Llewellyn J, Regan S, Zhao Y, Huang H, Hyland RH, Osinusi A, Winter H, Humeniuk R, Hulter HN, Gottlieb RL, Fusco DN, Birne R, Stancampiano FF, Libertin CR, Small CB, Plate M, McPhail MJ; REDPINE Investigators. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial. Clin Infect Dis. 2024 Nov 22;79(5):1172-1181. doi: 10.1093/cid/ciae333.'}, {'pmid': '36695483', 'type': 'DERIVED', 'citation': 'Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-540-5912', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen\n* Hospitalized for COVID-19\n* Weighing at least 40 kilograms (kg)\n* Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19\n* Have either:\n\n * a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) \\< 30 mL/min/1.73 m\\^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis\n * b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care\n* The interval between COVID-19 symptoms onset and randomization is no more than 10 days\n\nKey Exclusion Criteria:\n\n* Received any investigational drug, RDV, or other antiviral treatment for COVID-19\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal\n* Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI)\n* Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding\n* Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT04745351', 'acronym': 'REDPINE', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19', 'orgStudyIdInfo': {'id': 'GS-US-540-5912'}, 'secondaryIdInfos': [{'id': '2020-005416-22', 'type': 'EUDRACT_NUMBER'}, {'id': 'DOH-27-012022-4779', 'type': 'REGISTRY', 'domain': 'South African Clinical Trials Register'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remdesivir (RDV)', 'description': 'Participants will receive continued Standard of Care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5.', 'interventionNames': ['Drug: Remdesivir', 'Drug: Standard of Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5.', 'interventionNames': ['Drug: RDV Placebo', 'Drug: Standard of Care']}], 'interventions': [{'name': 'Remdesivir', 'type': 'DRUG', 'otherNames': ['GS-5734™', 'Veklury®'], 'description': 'Administered as Intravenous (IV) 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