Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT04369469
Status:
TERMINATED
Last Update Posted:
2022-05-24
First Post:
2020-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629409', 'term': 'ravulizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alexion.com', 'phone': '+1 855-752-2356', 'title': 'Alexion Pharmaceuticals, Inc.', 'organization': 'Alexion Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Day 90', 'description': 'Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 135, 'otherNumAffected': 97, 'seriousNumAtRisk': 127, 'deathsNumAffected': 55, 'seriousNumAffected': 79}, {'id': 'EG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 66, 'otherNumAffected': 49, 'seriousNumAtRisk': 67, 'deathsNumAffected': 25, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Microangiopathic haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastrointestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cryptococcosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Enterobacter pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fungal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Herpes simplex pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood beta-D-glucan positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood lactic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematoma muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intensive care unit acquired weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Organizing pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Shock hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0205', 'ciLowerLimit': '-0.1703', 'ciUpperLimit': '0.1293', 'pValueComment': 'One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.', 'estimateComment': 'Two-sided 95% confidence interval using the Sato variance estimator, combined overall imputations.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Number Of Days Free Of Mechanical Ventilation At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.79', 'groupId': 'OG000', 'lowerLimit': '4.79', 'upperLimit': '8.80'}, {'value': '6.81', 'groupId': 'OG001', 'lowerLimit': '4.19', 'upperLimit': '9.43'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Days the Participants Were Alive and Not in ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.09', 'groupId': 'OG000', 'lowerLimit': '4.31', 'upperLimit': '7.87'}, {'value': '6.71', 'groupId': 'OG001', 'lowerLimit': '4.38', 'upperLimit': '9.03'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '4.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '112.43', 'groupId': 'OG000'}, {'value': '134.0', 'spread': '104.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Days the Participants Were Alive and Not in the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '4.29'}, {'value': '3.47', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '5.12'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'title': 'Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 60 and Up to Day 90', 'description': 'For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, "Number Analyzed" signifies those participants who were evaluable for the assessment at the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'title': 'Day 1 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '231.35', 'spread': '149.741', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 29', 'description': 'Results are reported in micrograms/milliliter (μg/mL).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics/Pharmacodynamics (PK/PD) Population: participants in the ITT population with at least 1 postdose PK or PD result.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '-156.31', 'spread': '61.599', 'groupId': 'OG000'}, {'value': '21.79', 'spread': '67.918', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Terminal Complement Complex C5b-9 At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'OG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '-133.23', 'spread': '202.070', 'groupId': 'OG000'}, {'value': '-277.21', 'spread': '604.742', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'FG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Intent to Treat (ITT) Population', 'comment': 'The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Pharmacokinetic (PK)', 'comment': 'The PK Set included participants in the ITT population with at least one postdose PK result.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Safety Population', 'comment': 'All randomized participants who received at least 1 dose of study drug. Participants were analyzed as treated.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did Not Meet Inclusion/Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not Qualified due to History of Anaphylaxis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to Provide Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of the 210 participants screened, 8 (3.8%) participants were screen failures. A total of 202 participants were randomized and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 - Ravulizumab + BSC', 'description': 'Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.'}, {'id': 'BG001', 'title': 'Group 2 - BSC Alone', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '13.23', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '12.40', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '12.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Missing/Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Missing/Unknown', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-09', 'size': 1299085, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-15T12:17', 'hasProtocol': True}, {'date': '2020-07-31', 'size': 605407, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-15T12:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'whyStopped': 'Met futility bar at interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2020-04-28', 'resultsFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-04', 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29', 'timeFrame': 'Day 29', 'description': 'Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.'}], 'secondaryOutcomes': [{'measure': 'Number Of Days Free Of Mechanical Ventilation At Day 29', 'timeFrame': 'Day 29', 'description': 'The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation.'}, {'measure': 'Number of Days the Participants Were Alive and Not in ICU', 'timeFrame': 'Day 1 through Day 29', 'description': 'The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented.'}, {'measure': 'Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29', 'timeFrame': 'Baseline, Day 29', 'description': 'Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition.'}, {'measure': 'Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29', 'timeFrame': 'Baseline, Day 29', 'description': 'Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point.'}, {'measure': 'Number of Days the Participants Were Alive and Not in the Hospital', 'timeFrame': 'Day 1 through Day 29', 'description': 'The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented.'}, {'measure': 'Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90', 'timeFrame': 'Up to Day 60 and Up to Day 90', 'description': 'For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section.'}, {'measure': 'Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29', 'timeFrame': 'Day 1 and Day 29', 'description': 'Results are reported in micrograms/milliliter (μg/mL).'}, {'measure': 'Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29', 'timeFrame': 'Baseline, Day 29'}, {'measure': 'Change From Baseline In Terminal Complement Complex C5b-9 At Day 29', 'timeFrame': 'Baseline, Day 29'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute lung injury', 'acute respiratory distress syndrome', 'antibodies, monoclonal, humanized', 'COVID-19', 'hospitalization', 'pneumonia', 'severe pneumonia', 'severe acute respiratory syndrome', 'severe acute respiratory syndrome coronavirus 2', 'randomized controlled study', 'ravulizumab', 'respiratory distress syndrome, adult', 'Ultomiris', 'viral'], 'conditions': ['COVID-19 Severe Pneumonia', 'Acute Lung Injury', 'Acute Respiratory Distress Syndrome', 'Pneumonia, Viral']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.'}, {'pmid': '33826106', 'type': 'RESULT', 'citation': 'McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7.'}, {'pmid': '32660611', 'type': 'RESULT', 'citation': 'Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z.'}, {'pmid': '36958364', 'type': 'DERIVED', 'citation': 'Annane D, Pittock SJ, Kulkarni HS, Pickering BW, Khoshnevis MR, Siegel JL, Powell CA, Castro P, Fujii T, Dunn D, Smith K, Mitter S, Kazani S, Kulasekararaj A. Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2023 Dec;11(12):1051-1063. doi: 10.1016/S2213-2600(23)00082-6. Epub 2023 Mar 20.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}, {'pmid': '32554923', 'type': 'DERIVED', 'citation': 'Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15):e140711. doi: 10.1172/jci.insight.140711.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time of providing informed consent.\n2. Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (for example, via polymerase chain reaction and/or antibody test) presenting as severe COVID-19 requiring hospitalization.\n3. Severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by computed tomography or X-ray at Screening or within the 3 days prior to Screening, as part of the participant's routine clinical care.\n4. Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure or bilevel positive airway pressure).\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.\n\nExclusion Criteria:\n\n1. Participant was not expected to survive for more than 24 hours.\n2. Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.\n3. Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).\n4. Participant had an unresolved Neisseria meningitidis infection.\n5. Used the following medications and therapies:\n\n * Current treatment with a complement inhibitor or\n * Intravenous immunoglobulin within 4 weeks prior to randomization on Day 1\n6. Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever was greater. Exceptions:\n\n * Investigational therapies were allowed if received as part of BSC through an expanded access protocol or emergency approval for the treatment of COVID-19.\n * Investigational antiviral therapies (such as remdesivir) were allowed even if received as part of a clinical study.\n7. Female participants who were breastfeeding or who have a positive pregnancy test result at Screening.\n8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.\n9. Participant who was not currently vaccinated against Neisseria meningitidis, unless the participant agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the participant receives vaccination against Neisseria meningitidis."}, 'identificationModule': {'nctId': 'NCT04369469', 'briefTitle': 'Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'ALXN1210-COV-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - Ravulizumab + BSC', 'interventionNames': ['Biological: Ravulizumab', 'Other: BSC']}, {'type': 'OTHER', 'label': 'Group 2 - BSC alone', 'interventionNames': ['Other: BSC']}], 'interventions': [{'name': 'Ravulizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Ultomiris', 'ALXN1210'], 'description': 'Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15.', 'armGroupLabels': ['Group 1 - Ravulizumab + BSC']}, {'name': 'BSC', 'type': 'OTHER', 'description': 'Participants received medications, therapies, and interventions per standard hospital treatment protocols.', 'armGroupLabels': ['Group 1 - Ravulizumab + BSC', 'Group 2 - BSC alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Veterans Healthcare System', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC/USC Health Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 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