Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-01 @ 1:52 AM
Study NCT ID:
NCT04502433
Status:
TERMINATED
Last Update Posted:
2023-06-23
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C068291', 'term': 'poractant alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials_info@chiesi.com', 'phone': '+ 39 0521 2791', 'title': 'Clinical Trial Transparency', 'organization': 'Chiesi Farmaceutici S.p.A.'}, 'certainAgreement': {'otherDetails': 'Chiesi can publish and/or present any results of this study at scientific meetings, and to submit the clinical trial data to national and international Regulatory Authorities. Chiesi reserves the right to use such data for industrial purposes. Investigators will inform Chiesi before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.'}}, 'adverseEventsModule': {'timeFrame': 'From screening procedures (Day 0) to the end of the study (Day 28).', 'description': 'Analysis of adverse events (AEs) was performed on TEAEs, defined as AEs that started at or after treatment start (for the poractant alfa group) or at or after randomisation (for the control group).\n\nSafety set (SAF) was used to evaluate AEs and serious AEs (SAEs). The SAF included all enrolled patients, except for one, who was randomised to receive poractant alfa was not treated. All patients included in the SAF were also included in the ITT.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 4, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperpyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemophagocytic lymphohistiocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Enterococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Proteus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Refractoriness to platelet transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumatosis intestinalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nosocomial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Days Alive and Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 21 days', 'description': 'The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation.\n\nMechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics.\n\nDue to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Alive and Free of Respiratory Failure at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at Day 28', 'description': 'The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics.\n\nDue to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Number of Days Alive and Ventilator-Free at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 28', 'description': 'The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Mortality at Day 21 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': 'Dead at Day 21', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Dead at Day 28', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Day 21 and at Day 28', 'description': 'Mortality at Day 21 and Day 28 of the study by treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': 'Days alive and free from invasive ventilation at Day 21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Days alive and free from invasive ventilation at Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 21 and Day 28', 'description': 'The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': 'Days alive and free from non-invasive ventilation at Day 21', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}]}]}, {'title': 'Days alive and free from non-invasive ventilation at Day 28', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 21 and Day 28', 'description': 'The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 or Discharge, whichever comes first', 'description': 'The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented.\n\nSeverity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below\\*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge.\n\nAt Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time.\n\n\\*Mild: 200 mmHg \\< PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg \\< PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '-53.50', 'upperLimit': '197.08'}, {'value': '13.00', 'groupId': 'OG001', 'lowerLimit': '-67.50', 'upperLimit': '67.51'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.00', 'groupId': 'OG000', 'lowerLimit': '-60.58', 'upperLimit': '220.00'}, {'value': '10.01', 'groupId': 'OG001', 'lowerLimit': '-60.00', 'upperLimit': '82.51'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.00', 'groupId': 'OG000', 'lowerLimit': '-69.42', 'upperLimit': '235.00'}, {'value': '2.36', 'groupId': 'OG001', 'lowerLimit': '-57.01', 'upperLimit': '67.00'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.00', 'groupId': 'OG000', 'lowerLimit': '-104.92', 'upperLimit': '182.00'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '-41.02', 'upperLimit': '143.00'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.00', 'groupId': 'OG000', 'lowerLimit': '-103.80', 'upperLimit': '203.00'}, {'value': '31.00', 'groupId': 'OG001', 'lowerLimit': '-35.40', 'upperLimit': '165.02'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.00', 'groupId': 'OG000', 'lowerLimit': '-83.11', 'upperLimit': '183.00'}, {'value': '15.65', 'groupId': 'OG001', 'lowerLimit': '-38.00', 'upperLimit': '89.00'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.00', 'groupId': 'OG000', 'lowerLimit': '-132.19', 'upperLimit': '304.00'}, {'value': '25.07', 'groupId': 'OG001', 'lowerLimit': '-54.61', 'upperLimit': '98.00'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-103.06', 'upperLimit': '308.00'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '-56.00', 'upperLimit': '120.01'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'groupId': 'OG000', 'lowerLimit': '-39.41', 'upperLimit': '278.00'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-41.85', 'upperLimit': '67.00'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.50', 'groupId': 'OG000', 'lowerLimit': '-21.00', 'upperLimit': '128.00'}, {'value': '20.00', 'groupId': 'OG001', 'lowerLimit': '-93.45', 'upperLimit': '135.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nPartial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.\n\nThe fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement >20% Compared to Baseline at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (\\>20%) at all timepoints post-baseline are summarised by treatment group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '20.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-35.0', 'upperLimit': '20.0'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-25.0', 'upperLimit': '20.0'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-50.0', 'upperLimit': '15.0'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '15.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-45.0', 'upperLimit': '55.0'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '5.7'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-50.0', 'upperLimit': '25.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '15.0'}, {'value': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-50.0', 'upperLimit': '10.0'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'groupId': 'OG000', 'lowerLimit': '-35.0', 'upperLimit': '45.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-55.0', 'upperLimit': '55.0'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'groupId': 'OG000', 'lowerLimit': '-50.0', 'upperLimit': '15.7'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-55.0', 'upperLimit': '50.0'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '-40.0', 'upperLimit': '20.0'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-60.0', 'upperLimit': '20.0'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'groupId': 'OG000', 'lowerLimit': '-50.0', 'upperLimit': '10.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-55.0', 'upperLimit': '50.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.3', 'groupId': 'OG000', 'lowerLimit': '-60.0', 'upperLimit': '10.0'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-60.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change.', 'unitOfMeasure': 'percent (absolute change)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Length of ICU Stay (Days) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '28'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days', 'description': 'The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'The percentage of patients alive and out of ICU at Day 28 is presented by treatment group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': 'SOFA score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '5'}]}]}, {'title': 'SOFA score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '11'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '2'}]}]}, {'title': 'Respiratory system score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}, {'title': 'Respiratory system score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}, {'title': 'Neurological system score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Neurological system score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '0'}]}]}, {'title': 'Cardiovascular system score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '3'}]}]}, {'title': 'Cardiovascular system score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '1'}]}]}, {'title': 'Hepatic system score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '2'}]}]}, {'title': 'Hepatic system score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Coagulatory system score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}, {'title': 'Coagulatory system score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}, {'title': 'Renal system score -- Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Renal system score -- Day 28 / Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3 and Day 28 or discharge -- whichever comes first', 'description': 'The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment.\n\nThe total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.\n\nA score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at day 28 or discharge -- whichever comes first', 'description': 'The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group.\n\nThe total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.\n\nA score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '-101.0', 'upperLimit': '152.0'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-90.0', 'upperLimit': '93.0'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '-67.0', 'upperLimit': '194.0'}, {'value': '13.00', 'groupId': 'OG001', 'lowerLimit': '-170.0', 'upperLimit': '129.0'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.00', 'groupId': 'OG000', 'lowerLimit': '-252.0', 'upperLimit': '166.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-170.0', 'upperLimit': '147.0'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.00', 'groupId': 'OG000', 'lowerLimit': '-53.0', 'upperLimit': '514.8'}, {'value': '-18.00', 'groupId': 'OG001', 'lowerLimit': '-119.0', 'upperLimit': '79.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.50', 'groupId': 'OG000', 'lowerLimit': '-219.0', 'upperLimit': '532.4'}, {'value': '13.40', 'groupId': 'OG001', 'lowerLimit': '-67.0', 'upperLimit': '146.0'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.00', 'groupId': 'OG000', 'lowerLimit': '-125.0', 'upperLimit': '512.0'}, {'value': '-17.00', 'groupId': 'OG001', 'lowerLimit': '-160.0', 'upperLimit': '230.0'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '-250.0', 'upperLimit': '521.0'}, {'value': '30.00', 'groupId': 'OG001', 'lowerLimit': '-116.0', 'upperLimit': '320.0'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.00', 'groupId': 'OG000', 'lowerLimit': '-129.0', 'upperLimit': '233.0'}, {'value': '17.00', 'groupId': 'OG001', 'lowerLimit': '-141.0', 'upperLimit': '256.0'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.50', 'groupId': 'OG000', 'lowerLimit': '-272.0', 'upperLimit': '271.6'}, {'value': '11.50', 'groupId': 'OG001', 'lowerLimit': '-136.0', 'upperLimit': '234.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '-257.0', 'upperLimit': '35.8'}, {'value': '-90.50', 'groupId': 'OG001', 'lowerLimit': '-325.0', 'upperLimit': '-26.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nTidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.', 'unitOfMeasure': 'mL/kg BW', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '1.0'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '8.0'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '6.0'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '17.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '4.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-11.0', 'upperLimit': '11.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '4.0'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '-11.0', 'upperLimit': '11.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '4.0'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '14.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-15.0', 'upperLimit': '8.0'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '13.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-15.0', 'upperLimit': '15.0'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '13.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-14.0', 'upperLimit': '13.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '12.0'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nRespiratory rate is the number of breaths taken per minute.', 'unitOfMeasure': 'breaths/minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '9.2'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '13.3'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '15.5'}, {'value': '-0.70', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '3.5'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '-11.7', 'upperLimit': '6.3'}, {'value': '-0.55', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '2.9'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.50', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '46.0'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '188.8'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '63.0'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '6.2'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-10.5', 'upperLimit': '103.0'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '-12.8', 'upperLimit': '14.2'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '-23.9', 'upperLimit': '105.0'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '11.3'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '7.0'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-3.9', 'upperLimit': '5.2'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-25.7', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '14.5'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.25', 'groupId': 'OG000', 'lowerLimit': '-24.5', 'upperLimit': '14.0'}, {'value': '-3.10', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nDynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance.', 'unitOfMeasure': 'mL/cmH2O', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '9.2'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '12.2'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '8.5'}, {'value': '-0.81', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '4.3'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.3'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '5.1'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '8.0'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '12.8'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '7.5'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '6.2'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.50', 'groupId': 'OG000', 'lowerLimit': '-10.5', 'upperLimit': '7.4'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-5.7', 'upperLimit': '9.2'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '-23.9', 'upperLimit': '7.1'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '6.4'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '7.0'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '5.6'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-25.7', 'upperLimit': '7.0'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '13.2'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.50', 'groupId': 'OG000', 'lowerLimit': '-24.5', 'upperLimit': '-24.5'}, {'value': '-2.70', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nStatic Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed.', 'unitOfMeasure': 'mL/cmH2O', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '2.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '0.1'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '0.3'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '2.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '7.0'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '2.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '1.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '5.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '1.0'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '3.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '1.0'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '3.0'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-7.6', 'upperLimit': '1.0'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '3.0'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '1.0'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '3.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '1.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.20', 'groupId': 'OG000', 'lowerLimit': '-11.8', 'upperLimit': '-1.0'}, {'value': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nPositive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients.', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-18.0', 'upperLimit': '5.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '4.0'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '5.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '3.4'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '6.0'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '2.2'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '6.0'}, {'value': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '6.0'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '2.1'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '10.0'}, {'value': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '8.0'}, {'value': '-3.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '1.0'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-6.1', 'upperLimit': '7.0'}, {'value': '-3.00', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '2.0'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '12.0'}, {'value': '-3.00', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '4.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '5.0'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nPeak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O).', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '2.0'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '-1.50', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '2.0'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '6.0'}, {'value': '-1.50', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '2.0'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '6.0'}, {'value': '-3.00', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '1.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}, {'value': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '1.0'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}, {'value': '-3.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '1.0'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}, {'value': '-3.50', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '1.0'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '7.0'}, {'value': '-2.50', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '2.0'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '11.0'}, {'value': '-3.00', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '3.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '6.0'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '15.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nPlateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli.', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '-0.020', 'upperLimit': '0.100'}, {'value': '0.0080', 'groupId': 'OG001', 'lowerLimit': '-0.240', 'upperLimit': '0.127'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0050', 'groupId': 'OG000', 'lowerLimit': '-0.080', 'upperLimit': '0.080'}, {'value': '0.0100', 'groupId': 'OG001', 'lowerLimit': '-0.150', 'upperLimit': '0.149'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0315', 'groupId': 'OG000', 'lowerLimit': '-0.110', 'upperLimit': '0.150'}, {'value': '0.0160', 'groupId': 'OG001', 'lowerLimit': '-0.150', 'upperLimit': '0.110'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0300', 'groupId': 'OG000', 'lowerLimit': '-0.090', 'upperLimit': '0.150'}, {'value': '0.0100', 'groupId': 'OG001', 'lowerLimit': '-0.120', 'upperLimit': '0.210'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0050', 'groupId': 'OG000', 'lowerLimit': '-0.110', 'upperLimit': '0.180'}, {'value': '0.0260', 'groupId': 'OG001', 'lowerLimit': '-0.080', 'upperLimit': '0.170'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0050', 'groupId': 'OG000', 'lowerLimit': '-0.100', 'upperLimit': '0.160'}, {'value': '0.0300', 'groupId': 'OG001', 'lowerLimit': '-0.320', 'upperLimit': '0.170'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0500', 'groupId': 'OG000', 'lowerLimit': '-0.150', 'upperLimit': '0.457'}, {'value': '0.0185', 'groupId': 'OG001', 'lowerLimit': '-0.230', 'upperLimit': '0.170'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0500', 'groupId': 'OG000', 'lowerLimit': '-0.140', 'upperLimit': '0.348'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.369', 'upperLimit': '0.140'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0400', 'groupId': 'OG000', 'lowerLimit': '-0.170', 'upperLimit': '0.270'}, {'value': '0.0120', 'groupId': 'OG001', 'lowerLimit': '-0.369', 'upperLimit': '0.180'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0400', 'groupId': 'OG000', 'lowerLimit': '-0.050', 'upperLimit': '-0.021'}, {'value': '0.0500', 'groupId': 'OG001', 'lowerLimit': '-0.010', 'upperLimit': '0.230'}]}]}, {'title': 'ICU Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0450', 'groupId': 'OG001', 'lowerLimit': '0.045', 'upperLimit': '0.045'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameters -- pH.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nArterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.', 'unitOfMeasure': 'pH', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.210', 'groupId': 'OG000', 'lowerLimit': '-10.40', 'upperLimit': '5.00'}, {'value': '1.535', 'groupId': 'OG001', 'lowerLimit': '-14.25', 'upperLimit': '49.00'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.150', 'groupId': 'OG000', 'lowerLimit': '-11.00', 'upperLimit': '11.00'}, {'value': '1.730', 'groupId': 'OG001', 'lowerLimit': '-21.76', 'upperLimit': '22.10'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.610', 'groupId': 'OG000', 'lowerLimit': '-19.00', 'upperLimit': '18.00'}, {'value': '-2.000', 'groupId': 'OG001', 'lowerLimit': '-29.26', 'upperLimit': '18.10'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.700', 'groupId': 'OG000', 'lowerLimit': '-11.40', 'upperLimit': '10.60'}, {'value': '1.880', 'groupId': 'OG001', 'lowerLimit': '-21.50', 'upperLimit': '20.25'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.350', 'groupId': 'OG000', 'lowerLimit': '-15.00', 'upperLimit': '23.00'}, {'value': '1.720', 'groupId': 'OG001', 'lowerLimit': '-13.50', 'upperLimit': '12.00'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.500', 'groupId': 'OG000', 'lowerLimit': '-11.00', 'upperLimit': '10.20'}, {'value': '0.300', 'groupId': 'OG001', 'lowerLimit': '-14.50', 'upperLimit': '16.00'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.600', 'groupId': 'OG000', 'lowerLimit': '-38.50', 'upperLimit': '13.60'}, {'value': '-1.500', 'groupId': 'OG001', 'lowerLimit': '-13.00', 'upperLimit': '30.00'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.400', 'groupId': 'OG000', 'lowerLimit': '-5.40', 'upperLimit': '28.00'}, {'value': '-0.230', 'groupId': 'OG001', 'lowerLimit': '-10.00', 'upperLimit': '19.00'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-10.87', 'upperLimit': '33.00'}, {'value': '0.750', 'groupId': 'OG001', 'lowerLimit': '-18.00', 'upperLimit': '33.10'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.150', 'groupId': 'OG000', 'lowerLimit': '-8.00', 'upperLimit': '52.00'}, {'value': '12.000', 'groupId': 'OG001', 'lowerLimit': '-13.40', 'upperLimit': '30.01'}]}]}, {'title': 'ICU Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.600', 'groupId': 'OG001', 'lowerLimit': '-9.60', 'upperLimit': '-9.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameter -- pCO2.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nArterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '-9.00', 'upperLimit': '210.01'}, {'value': '6.550', 'groupId': 'OG001', 'lowerLimit': '-14.60', 'upperLimit': '165.61'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.500', 'groupId': 'OG000', 'lowerLimit': '-8.85', 'upperLimit': '158.70'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '-20.78', 'upperLimit': '50.85'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '-6.30', 'upperLimit': '82.70'}, {'value': '1.100', 'groupId': 'OG001', 'lowerLimit': '-19.28', 'upperLimit': '98.26'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '-11.40', 'upperLimit': '181.10'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '-25.28', 'upperLimit': '29.10'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '-13.30', 'upperLimit': '171.10'}, {'value': '2.600', 'groupId': 'OG001', 'lowerLimit': '-16.35', 'upperLimit': '28.35'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.250', 'groupId': 'OG000', 'lowerLimit': '-10.30', 'upperLimit': '63.10'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-19.20', 'upperLimit': '52.00'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.300', 'groupId': 'OG000', 'lowerLimit': '-23.33', 'upperLimit': '116.10'}, {'value': '2.250', 'groupId': 'OG001', 'lowerLimit': '-29.56', 'upperLimit': '43.00'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.000', 'groupId': 'OG000', 'lowerLimit': '-13.05', 'upperLimit': '156.10'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-32.26', 'upperLimit': '21.00'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '-6.30', 'upperLimit': '103.10'}, {'value': '5.100', 'groupId': 'OG001', 'lowerLimit': '-7.00', 'upperLimit': '50.25'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.100', 'groupId': 'OG000', 'lowerLimit': '-7.00', 'upperLimit': '33.00'}, {'value': '-7.700', 'groupId': 'OG001', 'lowerLimit': '-26.78', 'upperLimit': '34.50'}]}]}, {'title': 'ICU Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.730', 'groupId': 'OG001', 'lowerLimit': '-10.73', 'upperLimit': '-10.73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameter -- pO2.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nArterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '19.3'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '4.4'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '5.0'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '5.6'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '6.7'}, {'value': '1.80', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '5.5'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '5.7'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '6.3'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '7.5'}, {'value': '2.70', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '6.9'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '7.8'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '-13.4', 'upperLimit': '7.7'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '-19.1', 'upperLimit': '8.9'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '-11.4', 'upperLimit': '5.8'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.30', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '10.7'}, {'value': '2.80', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '9.1'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '10.4'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '11.6'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '-6.4', 'upperLimit': '33.0'}, {'value': '13.20', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '17.5'}]}]}, {'title': 'ICU Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.90', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-3.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3).\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nMeasured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Parameter -- Lactate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'title': '6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.1'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.5'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '1.8'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '0.6'}]}]}, {'title': '24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '1.3'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '0.5'}]}]}, {'title': '30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '1.2'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '1.0'}]}]}, {'title': '36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '1.5'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '9.8'}]}]}, {'title': '48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '1.5'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '17.6'}]}]}, {'title': '54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '1.3'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '21.6'}]}]}, {'title': '60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '1.4'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '19.6'}]}]}, {'title': '72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.9'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '1.0'}]}]}, {'title': '28 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '1.4'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '0.4'}]}]}, {'title': 'ICU Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.30', 'groupId': 'OG001', 'lowerLimit': '-2.30', 'upperLimit': '-2.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood parameter -- Lactate\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nArterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) population: all randomised patients who had at least one available evaluation of efficacy after baseline.\n\nData was summarised by treatment group using, descriptive statistics. Due to low recruitment rate the study was terminated early for non-safety reasons.'}, {'type': 'SECONDARY', 'title': 'Mortality -- TEAEs Leading to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'OG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to day 28', 'description': 'The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all randomised patients (who received at least one dose of the study treatment if poractant alfa-treated).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Cohort', 'description': 'Patients receiving standard-of-care (SoC)'}, {'id': 'FG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The planned 70 randomised patients in a 3:2 ratio, according to the inclusion and exclusion criteria. This was not achieved; owing to a global improvement in the pandemic situation in the countries where the study was performed (Italy, UK, US), patient recruitment was lower than expected (i.e. 22 patients were randomised, 14 patients and 8 patients in the poractant alfa and control groups, respectively); the study was terminated early before reaching the target sample size.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Cohort', 'description': 'Patients receiving SoC'}, {'id': 'BG001', 'title': 'Poractant Alfa Treated Cohort', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '18.2', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], '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': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '36.44', 'spread': '9.90', 'groupId': 'BG000'}, {'value': '29.78', 'spread': '5.05', 'groupId': 'BG001'}, {'value': '32.32', 'spread': '7.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Arterial Partial Pressure of Oxygen/Fraction of inspired oxygen (PaO2/FiO2) ratio', 'classes': [{'categories': [{'measurements': [{'value': '109.70', 'spread': '51.15', 'groupId': 'BG000'}, {'value': '111.85', 'spread': '38.72', 'groupId': 'BG001'}, {'value': '111.03', 'spread': '42.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2) is an indicator of pulmonary shunt fraction. PaO2/FiO2 (P/F) ratio is used to classify severity of acute respiratory distress syndrome (ARDS).\n\nTo calculate the P/F Ratio: PaO2 / FIO2. "P" represents PaO2 (arterial pO2) from the arterial blood gas. "F" represents the FIO2 - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40). P divided by F = P/F ratio', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fraction of inspired oxygen (FiO2)', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '18.1', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '23.2', 'groupId': 'BG001'}, {'value': '67.1', 'spread': '21.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The fraction of inspired oxygen, FiO2, is an estimation of the oxygen content a person inhales and is thus involved in gas exchange at the alveolar level.', 'unitOfMeasure': 'percentage of inspired oxygen', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sequential Organ Failure Assessment (SOFA) score', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.\n\nTotal score ranged from 0 to 24 points; to be considered organ failure free, a patient had to have a score of 0.', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention-to-Treat (ITT) population used for this parameter.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-02', 'size': 520259, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-16T06:55', 'hasProtocol': True}, {'date': '2022-07-27', 'size': 1237930, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-16T06:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': "The enrolment was extended. Nevertheless, despite the Sponsor's attempts, the infection status did not permit the identification of eligible patients for the study to complete it in a reasonable time.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2020-08-03', 'resultsFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-31', 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Days Alive and Ventilator-free Days', 'timeFrame': 'up to 21 days', 'description': 'The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation.\n\nMechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Alive and Free of Respiratory Failure at Day 28', 'timeFrame': 'at Day 28', 'description': 'The percentage of patients alive and free of respiratory failure (i.e. without need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation, or high-flow nasal cannula oxygen delivery) at Day 28.'}, {'measure': 'Number of Days Alive and Ventilator-Free at Day 28', 'timeFrame': 'at Day 28', 'description': 'The number of days alive and ventilator-free (i.e. free of any mechanical ventilation for at least 12 hours) at Day 28.'}, {'measure': 'Mortality at Day 21 and Day 28', 'timeFrame': 'at Day 21 and at Day 28', 'description': 'Mortality at Day 21 and Day 28 of the study by treatment group.'}, {'measure': 'Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28', 'timeFrame': 'Day 21 and Day 28', 'description': 'The number of days alive and free from invasive ventilation at Day 21 and Day 28 is presented by treatment group.'}, {'measure': 'Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28', 'timeFrame': 'Day 21 and Day 28', 'description': 'The number of days alive and free from non-invasive ventilation at Day 21 and Day 28 is presented by treatment group.'}, {'measure': 'Percentage of Patients With Improvement in Severity Status at Day 28 or Discharge (Severity Score: Mild, Moderate, Severe, or Death)', 'timeFrame': 'Day 28 or Discharge, whichever comes first', 'description': 'The severity status of patients at baseline and at Day 28/Discharge and the percentage of patients with improvement in severity status (i.e. a decrease of at least 1 point in severity status) at Day 28/Discharge relative to baseline is presented.\n\nSeverity was assessed using a point score system: Severity score was defined as mild, moderate, severe (see below\\*), or death and was based on PaO2/FiO2 ratio and patient status at Day 28/Discharge and numerically rated from 1-4, respectively. An improvement in severity was defined as a decrease of at least 1 point between baseline and Day 28/Discharge.\n\nAt Day 28 the last follow up evaluation took place on the ICU if, still requiring critical care, or by phone call if the patient has been discharged from ICU by that time.\n\n\\*Mild: 200 mmHg \\< PaO2/FiO2 ratio ≤300 mmHg; Moderate: 100 mmHg \\< PaO2/FiO2 ratio ≤200 mmHg; Severe: PaO2/FiO2 ratio ≤100 mmHg'}, {'measure': 'Change From Baseline in Arterial Partial Pressure of Oxygen / Fraction of Inspired Oxygen (PaO2/FiO2) Ratio at Each Timepoint', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in PaO2/FiO2 ratio measured at each timepoint following administration of each dose in the treatment and control group.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nPartial pressure of oxygen (PaO2) is the oxygen pressure in arterial blood. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.\n\nThe fraction of inspired oxygen (PaO2/FiO2) ratio is widely used in ICUs as an indicator of oxygenation status.'}, {'measure': 'Percentage of Patients Alive and With PaO2/FiO2 Ratio Improvement >20% Compared to Baseline at Each Timepoint', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'The percentages of patients in categories of PaO2/FiO2 ratio improvement compared to baseline (\\>20%) at all timepoints post-baseline are summarised by treatment group.'}, {'measure': 'Change From Baseline in Fraction of Inspired Oxygen (FiO2) at Each Timepoint', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'The FiO2 at baseline and at selected timepoints post-baseline was measured. Results are shown as changes from baseline, summarised by treatment group.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline. The unit for the variable is percent (%) and what is reported is an absolute change.'}, {'measure': 'Length of ICU Stay (Days) at Day 28', 'timeFrame': 'up to 28 days', 'description': 'The length of ICU stay (days) at Day 28 is presented by treatment by treatment group. Patients who died or were mechanically ventilated longer than this period were assigned with 28 days.'}, {'measure': 'Percentage of Patients Alive and Out of Intensive Care Unit (ICU) at Day 28', 'timeFrame': 'Day 28', 'description': 'The percentage of patients alive and out of ICU at Day 28 is presented by treatment group.'}, {'measure': 'Delta Sequential Organ Failure Assessment (SOFA) Score and Sub-component Measure at Day 3 and Day 28', 'timeFrame': 'Day 3 and Day 28 or discharge -- whichever comes first', 'description': 'The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body. The SOFA score was used to determine the extent of organ failure at Day 3 and Day 28/Discharge with respect to a pre-randomisation assessment.\n\nThe total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.\n\nA score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.'}, {'measure': 'Percentage of Patients Alive and Free of Organ Failure (SOFA Score=0)', 'timeFrame': 'at day 28 or discharge -- whichever comes first', 'description': 'The percentage of patients alive and organ failure free (defined as SOFA score=0) at Day 28/Discharge is presented by treatment group.\n\nThe total score was derived from six sub-scores system categories: respiratory, neurological, cardiovascular, hepatic, coagulation, and renal systems; respective sub-scores were calculated primarily considering PaO2/FiO2 ratio, Glasgow Coma Scale, mean arterial pressure (MAP) or requirement for vasopressor administration, bilirubin levels, platelet levels and creatinine levels or daily urine output.\n\nA score of 0, 1, 2, 3, or 4) was assigned to each of the six system category. The total score ranged from 0 (min) to 24 (max) points. To be considered organ failure free, a patient had to have a score of 0.'}, {'measure': 'Ventilatory Parameter: Tidal Volume -- Change From Baseline in Tidal Volume (mL/kg BW) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Change from baseline in tidal volume (mL/kg BW) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nTidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.'}, {'measure': 'Ventilatory Parameter: Respiratory Rate -- Change From Baseline in Respiratory Rate (Breaths/Minute) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Change from baseline in respiratory rate (breaths/minute) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nRespiratory rate is the number of breaths taken per minute.'}, {'measure': 'Ventilatory Parameter: Dynamic Compliance -- Change From Baseline in Dynamic Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Change from baseline in dynamic compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nDynamic compliance: is the continuous measurement of pulmonary compliance calculated at each point representing schematic changes during rhythmic breathing. Dynamic compliance monitors both elastic and airway resistance.'}, {'measure': 'Ventilatory Parameter: Static Compliance -- Change From Baseline in Static Compliance (mL/cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: static compliance -- change from baseline in static compliance (mL/cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nStatic Compliance: represents pulmonary compliance at a given fixed volume when there is no airflow, and muscles are relaxed.'}, {'measure': 'Ventilatory Parameter: Positive End-Expiratory Pressure (PEEP) -- Change From Baseline in PEEP (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Positive End-Expiratory Pressure -- Change from baseline in PEEP (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nPositive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients.'}, {'measure': 'Ventilatory Parameter: Peak Inspiratory Pressure -- Change From Baseline in Peak Inspiratory Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation and Day 28', 'description': 'Ventilatory parameter: Peak Inspiratory Pressure -- Change from baseline in peak inspiratory pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nPeak inspiratory pressure (PIP) is the highest level of pressure applied to the lungs during inhalation. In mechanical ventilation the number reflects a positive pressure in centimetres of water pressure (cmH2O).'}, {'measure': 'Ventilatory Parameter: Plateau Pressure -- Change From Baseline in Plateau Pressure (cmH2O) at All Timepoints up to Day 3 (72 Hours) and at Day 28', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Ventilatory parameter: Plateau Pressure -- Change from baseline in plateau pressure (cmH2O) at all timepoints up to Day 3 (72 hours) and at Day 28.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nPlateau pressure is the pressure that is applied by the mechanical ventilator to the small airways and alveoli.'}, {'measure': 'Blood Gas Analysis Acid-base Balance Parameters: Change From Baseline in Blood Gas Analysis Acid-base Balance Parameters -- pH', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameters -- pH.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nArterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.'}, {'measure': 'Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Carbon Dioxide (pCO2)', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameter -- pCO2.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nArterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.'}, {'measure': 'Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Partial Pressure of Oxygen (pO2)', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameter -- pO2.\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nArterial blood gas was measured at 6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.'}, {'measure': 'Change From Baseline in Blood Gas Analysis Acid-base Balance Parameter -- Bicarbonate (HCO3)', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood gas analysis acid-base balance parameter -- Bicarbonate (HCO3).\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nMeasured at 6-12-24h after each poractant alfa administration up to 72 hours and at similar timepoints in the control group (6, 12, 24, 30, 36, 48, 54, 60 and 72 hours after randomisation) and then every 24 hours till the patient is discharged from the ICU'}, {'measure': 'Change From Baseline in Blood Parameter -- Lactate', 'timeFrame': 'up to 28 days: 6, 12, 24, 30, 36, 48, 54, 60, 72 hours after randomisation, and Day 28', 'description': 'Change from baseline in blood parameter -- Lactate\n\nThe change was calculated from two time points as the value at the later time point minus the value at baseline.\n\nAt each time point the number of patients that contributed with a result value is indicated for both study arms.\n\nArterial blood lactate was measured at 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours after randomisation and up to Day 28 or till the patient was discharged from the ICU - whichever occurred earlier.'}, {'measure': 'Mortality -- TEAEs Leading to Death', 'timeFrame': 'up to day 28', 'description': 'The incidence of treatment-emergent adverse event (TEAEs) leading to death is presented by treatment group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute respiratory distress syndrome', 'ARDS', 'Adults', 'Surfactant', 'Poractant alfa (porcine surfactant, Curosurf®),', 'Curosurf®', 'Coronavirus disease (COVID-19)', 'Coronavirus 2019 Disease'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002632-75/results', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).', 'detailedDescription': 'This was a multicentre, open-label, randomized phase II proof-of-concept study.\n\nThe efficacy and safety of poractant alfa was evaluated in terms of ventilatory free days during the 21 days after randomization, in adult patients diagnosed with ARDS due to SARS-COV-19 infection.\n\nEach patient randomized to the study treatment received 3 administrations of Curosurf ® with a 24 hours dosing interval. The assessment collection was up to Day 28, when the evaluation occurred at the Intensive Care Unit (ICU), or by phone call if the patient has already been discharged.\n\nSeventy patients were planned to be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm). The control arm population received Standard of Care (SoC). This study was conducted in United Kingdom (UK), United States of America (US), and Italy.\n\nOverall, 13 patients (Curosurf ® group) and 8 patients (control group) were randomised in the study. Due to low recruitment rate the study was terminated early for non-safety reasons.\n\nCurosurf® is a pulmonary surfactant of natural origin which, when delivered endotracheally (ET). Curosurf® is currently approved for marketing as treatment of premature neonates with RDS or at risk of Respiratory Distress Syndrome (RDS). Chiesi Farmaceutici S.p.A (Chiesi) conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to evaluate the efficacy and safety in ventilated adult patients who were critically unwell in intensive care with SARS-COV-19 ARDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants were eligible to be included in the study if the following criteria apply:\n\n1. Male or female ≥18 and ≤ 80 years of age\n2. Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure)\n3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before randomisation\n4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio \\< 150 mmHg\n5. Lung compliance ≤45 ml/cmH20\n6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration\n\nExclusion Criteria:\n\nParticipants were excluded from the study if any of the following criteria apply:\n\n1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax)\n2. Weight \\< 40kg\n3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) \\< 30)\n4. Pregnancy\n5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration\n6. Extracorporeal membrane oxygenation (ECMO)'}, 'identificationModule': {'nctId': 'NCT04502433', 'briefTitle': 'Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa(Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS)', 'orgStudyIdInfo': {'id': 'CLI-050000-04'}, 'secondaryIdInfos': [{'id': '2020-002632-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients treated with standard-of-care (SoC), as control cohort'}, {'type': 'EXPERIMENTAL', 'label': 'Poractant alfa', 'description': 'Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)', 'interventionNames': ['Drug: CUROSURF® (poractant alfa)']}], 'interventions': [{'name': 'CUROSURF® (poractant alfa)', 'type': 'DRUG', 'description': 'Three administrations with a 24 hours dosing interval.\n\nEach endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus:\n\n30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW.', 'armGroupLabels': ['Poractant alfa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Chiesi site # 14', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'Chiesi site #13', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'UCLH and UCL 250 Euston Road', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chiesi site #4', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Chiesi site # 12', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Clark Howard, Prof. /MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}