Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-01 @ 6:27 AM
Study NCT ID:
NCT04377620
Status:
TERMINATED
Last Update Posted:
2022-01-19
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Sponsor:
Organization:
Raw JSON
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Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 2 months.', 'description': 'All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).', 'eventGroups': [{'id': 'EG000', 'title': 'Ruxolitinib 15 mg BID', 'description': 'Ruxolitinib 15 mg BID', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 35, 'seriousNumAtRisk': 77, 'deathsNumAffected': 42, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Ruxolitinib 5 mg BID', 'description': 'Ruxolitinib 5 mg BID', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 46, 'seriousNumAtRisk': 87, 'deathsNumAffected': 48, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 47, 'otherNumAffected': 21, 'seriousNumAtRisk': 45, 'deathsNumAffected': 36, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 102, 'seriousNumAtRisk': 209, 'deathsNumAffected': 124, 'seriousNumAffected': 55}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 45, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 28, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 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{'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 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{'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 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'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Strongyloidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Have Died Due to Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + 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random effect.'}, {'pValue': '0.0280', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.171', 'ciUpperLimit': '1.023', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.'}], 'paramType': 'NUMBER', 'timeFrame': 'Study start to Day 29', 'description': 'To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant 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[{'value': '6.31', 'spread': '9.047', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '8.398', 'groupId': 'OG001'}, {'value': '2.98', 'spread': '7.228', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days participant did not require mechanical ventilation', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Number of ICU Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '7.716', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '7.517', 'groupId': 'OG001'}, {'value': '2.45', 'spread': '6.362', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days participant is out of the ICU', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Oxygen Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'spread': '6.073', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '6.745', 'groupId': 'OG001'}, {'value': '1.53', 'spread': '4.690', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days participant did not receive supplemental oxygen', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Vasopressor Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.95', 'spread': '11.738', 'groupId': 'OG000'}, {'value': '7.53', 'spread': '10.861', 'groupId': 'OG001'}, {'value': '4.47', 'spread': '9.322', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days without use of vasopressor therapy', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Hospital Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.09', 'spread': '4.889', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '5.259', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '3.976', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days Partcipant is out of the hospital', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '33.'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '24.7'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '23.1'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '41.5'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '36.0'}, {'value': '17.0', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study start to Days 15 and 29', 'description': 'Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '30.4', 'upperLimit': '53.4'}, {'value': '32.9', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '44.0'}, {'value': '21.3', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '35.7'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '55.3'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '43.7'}, {'value': '17.0', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study start to Days 15 and 29', 'description': 'Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.711', 'upperLimit': '0.992'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.614', 'upperLimit': '0.867'}, {'value': '0.61', 'groupId': 'OG002', 'lowerLimit': '0.408', 'upperLimit': '0.818'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Study Start to Day 29', 'description': 'TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With the COVID-19 Ordinal Scale Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'title': 'Score 0 = Uninfected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Score 1 = Ambulatory (no limitation of activities)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Score 2 = Ambulatory (limitation of activities)', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Score 3 = Hospitalized/Mild Disease (no oxygen therapy)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs)', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '4.3', 'groupId': 'OG002'}]}]}, {'title': 'Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Score 8 - Death', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}, {'value': '70.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study start to Day 29', 'description': 'Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Please note that in the 15mg BID arm, 3 participants were missing scale reporting on Day 29. In the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.'}, {'type': 'SECONDARY', 'title': 'Change in the COVID-19 9-point Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'title': 'Change from Day 1 to Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.69', 'groupId': 'OG002'}]}]}, {'title': 'Change from Day 1 to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study start to Days 15 and 29', 'description': 'Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. In the 15mg BID arm, 3 participants were missing scale reportingon Day 29. IN the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.'}, {'type': 'SECONDARY', 'title': 'Change in SOFA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'title': 'Baseline - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '2.69', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.14', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '5.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '4.58', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '6.60', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '6.30', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '7.87', 'groupId': 'OG002'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '7.02', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '8.26', 'groupId': 'OG002'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '7.72', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '7.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '7.04', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '5.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to Days 3, 5, 8, 11, 15, and 29', 'description': "Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Numbers of participants decreased after Day 1 because data was no longer collected if a patient was discharged from ICU and/or deceased.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'OG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'classes': [{'title': 'Treatment-Emergent Adverse Events (TEAEs)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study start to Day 29', 'description': 'Treatment-emergent AEs are judged as related by the investigator or have a missing causality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all participants who received at least 1 dose of ruxolitinib/placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ruxolitininb 15mg + Standard of Care', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'FG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'FG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 33 study centers in the United States (29) and Russia (4), and 211 participants were enrolled and analyzed for efficacy.; 209 participants were analyzed for safety. Enrollment in this study was stopped early and was not due to safety reasons.', 'preAssignmentDetails': 'Participants were randomly assigned in a 2:2:1 ratio to receive ruxolitinib 5 mg BID, ruxolitinib 15 mg BID, or placebo for an initial treatment period of 14 days; participants randomly assigned to receive placebo were randomly assigned in a 1:1 ratio to receive placebo matching ruxolitinib 5 mg BID or placebo matching ruxolitinib 15 mg BID. Randomization was stratified by ARDS severity (severe vs mild/moderate at the time of randomization) and investigative site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'BG001', 'title': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'BG002', 'title': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '12.92', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '12.25', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '13.34', 'groupId': 'BG002'}, {'value': '63.4', 'spread': '12.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized to the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-02', 'size': 855995, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-17T11:30', 'hasProtocol': True}, {'date': '2021-02-22', 'size': 535007, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-17T11:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'whyStopped': 'Study terminated by sponsor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04355793', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2020-05-04', 'resultsFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-14', 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Have Died Due to Any Cause', 'timeFrame': 'Study start to Day 29', 'description': 'To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.'}], 'secondaryOutcomes': [{'measure': 'Number of Ventilator Free Days', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days participant did not require mechanical ventilation'}, {'measure': 'Number of ICU Free Days', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days participant is out of the ICU'}, {'measure': 'Oxygen Free Days', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days participant did not receive supplemental oxygen'}, {'measure': 'Vasopressor Free Days', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days without use of vasopressor therapy'}, {'measure': 'Hospital Free Days', 'timeFrame': 'Study start to Day 29', 'description': 'Number of days Partcipant is out of the hospital'}, {'measure': 'Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale', 'timeFrame': 'Study start to Days 15 and 29', 'description': 'Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead'}, {'measure': 'Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale', 'timeFrame': 'Study start to Days 15 and 29', 'description': 'Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead'}, {'measure': 'Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale', 'timeFrame': 'Study Start to Day 29', 'description': 'TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead'}, {'measure': 'Percentage of Participants With the COVID-19 Ordinal Scale Reported', 'timeFrame': 'Study start to Day 29', 'description': 'Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead'}, {'measure': 'Change in the COVID-19 9-point Ordinal Scale', 'timeFrame': 'Study start to Days 15 and 29', 'description': 'Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead'}, {'measure': 'Change in SOFA Score', 'timeFrame': 'from baseline to Days 3, 5, 8, 11, 15, and 29', 'description': "Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality)."}, {'measure': 'Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events', 'timeFrame': 'Study start to Day 29', 'description': 'Treatment-emergent AEs are judged as related by the investigator or have a missing causality.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cytokine storm', 'COVID-19', 'ARDS', 'SARS-CoV-2', 'ruxolitinib', 'pneumonia'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '36226977', 'type': 'DERIVED', 'citation': "Rein L, Calero K, Shah R, Ojielo C, Hudock KM, Lodhi S, Sadaka F, Bellam S, Palma C, Hager DN, Daniel J, Schaub R, O'Hayer K, Theodoropoulos NM. Randomized Phase 3 Trial of Ruxolitinib for COVID-19-Associated Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Dec 1;50(12):1701-1713. doi: 10.1097/CCM.0000000000005682. Epub 2022 Oct 13."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant or guardian health proxy must provide informed consent before any study assessment is performed.\n* Male or female participants aged ≥ 12 years.\n* Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval.\n* Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization.\n\nParticipants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.\n\nExclusion Criteria:\n\n* Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.\n* Presence of severely impaired renal function defined by estimated creatinine clearance \\< 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening.\n* In the opinion of the investigator, unlikely to survive for \\> 24 hours from randomization.\n* Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).\n* Currently receiving ECMO.\n* Participant may not be sharing a ventilator, or co-ventilating, with any other patient.\n* Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization.\n* Treatment with a JAK inhibitor within 30 days of randomization.\n* Participants who are on long-term use of antirejection or immunomodulatory drugs.\n* Pregnant or nursing (lactating) women.'}, 'identificationModule': {'nctId': 'NCT04377620', 'briefTitle': 'Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)', 'orgStudyIdInfo': {'id': 'INCB 18424-369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Standard of Care (SoC)', 'description': 'Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib 5mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Ruxolitininb 15mg + Standard of Care (SoC)', 'description': 'Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.', 'interventionNames': ['Drug: Ruxolitinib']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered BID approximately 12 hours apart', 'armGroupLabels': ['Placebo + Standard of Care (SoC)']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['INCB018424', 'Oral Jak Inhibitor'], 'description': 'Ruxolitinb administered BID approximately 12 hours apart', 'armGroupLabels': ['Ruxolitinib 5mg + Standard of Care (SoC)', 'Ruxolitininb 15mg + Standard of Care (SoC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Teradan Clinical Trials', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60678', 'city': 'Chicago', 'state': 'Illinois', 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