Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-04-29 @ 1:13 AM
Study NCT ID:
NCT03085758
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2017-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706631', 'term': 'enibarcimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jzimmermann@adrenomed.com', 'phone': '+49 (0) 3302 20 77 810', 'title': 'Jens Zimmermann', 'organization': 'Adrenomed AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events whether serious or non-serious and judged related or unrelated to the study drug occurring during the study period (Day 1 (inclusion and single IMP administration) until 90 days after study drug administration (=Day1)) were collected. The study period was 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 44, 'seriousNumAtRisk': 72, 'deathsNumAffected': 26, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 68, 'seriousNumAtRisk': 77, 'deathsNumAffected': 24, 'seriousNumAffected': 42}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 84, 'seriousNumAtRisk': 152, 'deathsNumAffected': 54, 'seriousNumAffected': 96}], 'otherEvents': [{'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'seriousEvents': [{'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Fistula of small intestine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Clostridium colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Electrocardiogram repolarisation abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Intensive care unit acquired weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Bronchial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Enterococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 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'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period: Interruption of infusion due to intolerability of ADRECIZUMAB', 'unitOfMeasure': 'Interruptions', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Mild Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with mild severity treatment emergent events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Moderate Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with moderate severity treatment emergent events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Severe Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with severe severity treatment emergent events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Efficacy to be Determined by Sepsis Support Index (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '5.20', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '5.18', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '5.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The primary efficacy endpoint of this study is the Sepsis Support Index (SSI) defined as: days with organ support or dead within 14 day follow up More precisely: In the time frame of 14 day follow-up, each day on support with vasopressor, and/or mechanical ventilation, and/or renal dysfunction (defined as renal SOFA = 4), or not alive, is counted as 1. The sum over the follow up period is defined as SSI.\n\nMinimum value possible is 0, maximum value is 14. A higher score means a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Sepsis Support Index (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '10.76', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '10.82', 'groupId': 'OG002'}, {'value': '12.8', 'spread': '11.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Sepsis Support Index (SSI) at 28 day follow-up Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Penalized Sepsis Support Index (pSSI) at 14 Day Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '5.20', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '5.22', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '5.42', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 14', 'description': 'Penalized Sepsis Support Index (pSSI) at day 14, defined similar to the SSI with the exception that patients that die get penalized by assigning the maximum value, i.e. the pSSI is set to 14 or 28, respectively.\n\nMinimum value possible is 0, maximum value is 14. A higher score means a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Persistent Organ Dysfunction or Death at 14 and 28 Day Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14 and day 28', 'description': 'Persistent organ dysfunction or death at 14 and 28 day follow-up. Count of participants with either persistent organ dysfunction or death at Day 14 and Day 28. Persistent Organ Dysfunction is defined as the persistence of organ dysfunction requiring supportive technologies during the convalescent phase of critical illness and it is present when a patient has an ongoing requirement for vasopressors, dialysis, or mechanical ventilation at the outcome assessments time points, as defined by Heyland et al.; Persistent organ dysfunction plus death: a novel,composite outcome measure for critical care trials. Critical Care 2011, 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab Adrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab Adrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Group A and Treatment Group B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3484', 'spread': '0.8694', 'groupId': 'OG000'}, {'value': '17.5630', 'spread': '0.6592', 'groupId': 'OG001'}, {'value': '20.5162', 'spread': '0.5903', 'groupId': 'OG002'}, {'value': '22.8783', 'spread': '0.7627', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 28', 'description': 'Day 28 mortality rate', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'SSI and pSSI Excluding the Renal Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'SSI Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '5.24', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '5.24', 'groupId': 'OG002'}, {'value': '7.9', 'spread': '5.42', 'groupId': 'OG003'}]}]}, {'title': 'SSI Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '10.80', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '10.90', 'groupId': 'OG002'}, {'value': '12.6', 'spread': '11.17', 'groupId': 'OG003'}]}]}, {'title': 'pSSI Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '5.24', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '5.28', 'groupId': 'OG002'}, {'value': '7.9', 'spread': '5.43', 'groupId': 'OG003'}]}]}, {'title': 'pSSI Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '10.92', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '11.17', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '11.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 14 and day 28', 'description': 'Sepsis Support Index (SSI) and penalized Sepsis Support Index (pSSI) excluding the renal component. pSSI is a version of the SSI where mortality is given extra weight: Patients being alive during the 14 days\' follow up will have an SSI ranging up to 14, while patients who died within that period will be assigned a score of "14 plus the number of days not being alive". Thus the SSI and pSSI score may range between zero and 28. A higher score means a worse outcome. The number of participants analyzed differs per row due to missing data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'SSI Weighted for Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '7.65', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '7.68', 'groupId': 'OG002'}, {'value': '9.9', 'spread': '8.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 14', 'description': 'Sepsis Support Index (SSI) Weighted for Mortality. Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Individual Sepsis Support Index Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'SSI cardiac component day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '3.60', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '3.84', 'groupId': 'OG003'}]}]}, {'title': 'SSI cardiac component day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.61', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '5.35', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '4.55', 'groupId': 'OG003'}]}]}, {'title': 'SSI respiratory component day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '5.98', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '5.78', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '5.57', 'groupId': 'OG003'}]}]}, {'title': 'SSI respiratory component day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '9.85', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '9.57', 'groupId': 'OG002'}, {'value': '5.8', 'spread': '8.08', 'groupId': 'OG003'}]}]}, {'title': 'SSI renal failure component day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '3.39', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '3.37', 'groupId': 'OG003'}]}]}, {'title': 'SSI renal failure component day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '4.63', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '4.93', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '3.79', 'groupId': 'OG003'}]}]}, {'title': 'SSI death component day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '4.02', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '3.93', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '4.34', 'groupId': 'OG003'}]}]}, {'title': 'SSI death component day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '9.07', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '9.12', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '9.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 14 and day 28', 'description': 'Individual Sepsis Support Index (SSI) components (hemodynamic, respiratory and renal failure) with and without mortality.\n\nMinimum value possible is 0, maximum value is 14. A higher score means a worse outcome. The number of participants analyzed differs per row due to missing data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Sequential Organ Failure Assessment (SOFA) Score : Composite Measure: SOFA Score and Its Changes Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'SOFA change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '4.87', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '4.87', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '5.33', 'groupId': 'OG003'}]}]}, {'title': 'SOFA Delta score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.80', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '3.16', 'groupId': 'OG003'}]}]}, {'title': 'SOFA maximum score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '4.46', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '4.13', 'groupId': 'OG002'}, {'value': '9.7', 'spread': '3.94', 'groupId': 'OG003'}]}]}, {'title': 'SOFA mean score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.957', 'spread': '3.7546', 'groupId': 'OG000'}, {'value': '8.319', 'spread': '3.8129', 'groupId': 'OG001'}, {'value': '8.143', 'spread': '3.7751', 'groupId': 'OG002'}, {'value': '7.644', 'spread': '3.5105', 'groupId': 'OG003'}]}]}, {'title': 'SOFA total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.9', 'spread': '33.69', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '55.56', 'groupId': 'OG001'}, {'value': '47.1', 'spread': '46.78', 'groupId': 'OG002'}, {'value': '44.1', 'spread': '48.59', 'groupId': 'OG003'}]}]}, {'title': 'SOFA-3 change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.81', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.80', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '2.92', 'groupId': 'OG003'}]}]}, {'title': 'SOFA-3 Delta score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.11', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '2.50', 'groupId': 'OG003'}]}]}, {'title': 'SOFA-3 maximum score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '2.38', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '2.61', 'groupId': 'OG003'}]}]}, {'title': 'SOFA-3 mean score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.909', 'spread': '6.5681', 'groupId': 'OG000'}, {'value': '9.336', 'spread': '7.2622', 'groupId': 'OG001'}, {'value': '9.129', 'spread': '6.9118', 'groupId': 'OG002'}, {'value': '8.311', 'spread': '8.0551', 'groupId': 'OG003'}]}]}, {'title': 'SOFA-3 total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.2', 'spread': '42.36', 'groupId': 'OG000'}, {'value': '56.4', 'spread': '51.13', 'groupId': 'OG001'}, {'value': '50.6', 'spread': '47.40', 'groupId': 'OG002'}, {'value': '44.3', 'spread': '46.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Sequential Organ Failure Assessment (SOFA) Score:\n\nSOFA score change at Day 3 - baseline, delta = difference between maximum and minimum score during ICU stay, mean/maximum/total daily score during ICU stay, SOFA-3 (score limited to cardiovascular, respiratory and renal function). Measured at baseline and Day 3.\n\nSOFA score: Minimum possible score is 0, maximum is 24. A higher score meas a worse outcome. Measured at baseline, Day 2 to Day 28.\n\nSOFA-3 score: Minimum possible score is 0, maximum is 12. A higher score meas a worse outcome. Measured at baseline, Day 2 to Day 28.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Renal Function (Creatinine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'creatinine change baseline to day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-27.9', 'spread': '85.65', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '77.99', 'groupId': 'OG001'}, {'value': '-27.9', 'spread': '85.65', 'groupId': 'OG002'}, {'value': '-25.6', 'spread': '109.12', 'groupId': 'OG003'}]}]}, {'title': 'creatinine change baseline to day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-46.6', 'spread': '140.38', 'groupId': 'OG000'}, {'value': '-44.9', 'spread': '98.44', 'groupId': 'OG001'}, {'value': '-45.7', 'spread': '120.10', 'groupId': 'OG002'}, {'value': '-50.5', 'spread': '125.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1, day 3 and day 7', 'description': 'Change in renal function as change in creatinine (day 3 - day 1, day 7 - day 1)', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Duration of Stay at ICU/ Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Duration of hospital stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '11.87', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '7.71', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '11.2', 'spread': '7.72', 'groupId': 'OG003'}]}]}, {'title': 'Duration of ICU stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '6.27', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '7.26', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '6.77', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '7.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Duration of stay at ICU / hospital. The number of participants analyzed differs per row due to missing data.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Mean Arterial Pressure During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Change from Baseline (minimum)', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '18.44', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '19.84', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '23.52', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline (maximum)', 'categories': [{'measurements': [{'value': '18.9', 'spread': '23.64', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '19.73', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '21.64', 'groupId': 'OG002'}, {'value': '20.2', 'spread': '21.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of Mean Arterial Pressure (MAP). Change from baseline to day 28/last day in ICU was calculated (value at day 28 or last collected value minus value at baseline). MAP was collected at screening and daily from day 1 to day 28 or discharge as well as on the follow-up visit day 28. Vital signs were assessed as min/max values within 24 hours except at screening and on the follow-up visit day 28.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Creatinine During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '189.649', 'spread': '116.1689', 'groupId': 'OG000'}, {'value': '199.891', 'spread': '130.9752', 'groupId': 'OG001'}, {'value': '194.944', 'spread': '123.7293', 'groupId': 'OG002'}, {'value': '192.801', 'spread': '131.6193', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.217', 'spread': '88.1051', 'groupId': 'OG000'}, {'value': '79.488', 'spread': '65.9763', 'groupId': 'OG001'}, {'value': '81.380', 'spread': '73.3867', 'groupId': 'OG002'}, {'value': '153.072', 'spread': '120.3464', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of creatinine. Measurement for baseline and Day 28 given. Creatinine was measured in the daily blood sample during ICU stay until discharge or Day 28 in a local laboratory assessment.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Partial Pressure of Oxygen in Arterial Blood(PaO2) / Fraction of Inspired Oxygen (FiO2) During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39.83', 'spread': '155.237', 'groupId': 'OG000'}, {'value': '63.80', 'spread': '156.771', 'groupId': 'OG001'}, {'value': '52.08', 'spread': '155.896', 'groupId': 'OG002'}, {'value': '15.91', 'spread': '164.238', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of Partial Pressure of Oxygen in Arterial Blood (PaO2) / Fraction of inspired oxygen (FiO2) from baseline to the last observed value are measured. PaO2 and FiO2 was collected if an arterial line was in place. The arterial blood was assessed for PaO2 and FiO2. Both were measured in mmHg.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Blood Lactate During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.94', 'spread': '3.133', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '5.247', 'groupId': 'OG001'}, {'value': '-1.74', 'spread': '4.340', 'groupId': 'OG002'}, {'value': '-1.49', 'spread': '7.158', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of blood lactate from baseline to Day 28 or discharge. Blood lactate was measured in the daily blood sample from baseline to ICU discharge or until Day 28.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Fluid Balance During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Low', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}, {'value': '82.6', 'groupId': 'OG002'}, {'value': '80.9', 'groupId': 'OG003'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}, {'value': '17.4', 'groupId': 'OG002'}, {'value': '18.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Changes of fluid balance - Last Observed Value. Percentage of Participants with low (\\</=1000 mL) and high (\\>1000 mL) Fluid balance at the last observed value.\n\nDaily fluid intake will be calculated as the sum of all intravenous and oral fluids. The daily fluid output will be calculated as the sum of the volume of urine output, ultrafiltration fluid, drain fluid, and estimated gastrointestinal losses (including stools only in the presence of profound diarrhea). Insensitive losses will not be taken into account because they are difficult to assess reliably. Daily fluid balance (according to baseline patient weight) will be calculated by subtracting the total fluid output from the total intake.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Mid-Regional Pro-Adrenomedullin (MR-proADM) During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.029', 'spread': '5.2829', 'groupId': 'OG000'}, {'value': '-4.608', 'spread': '4.9512', 'groupId': 'OG001'}, {'value': '-4.815', 'spread': '5.1006', 'groupId': 'OG002'}, {'value': '-4.030', 'spread': '5.2887', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of Mid-Regional pro-Adrenomedullin (MR-proADM) between baseline and last observed value. MR-proADM was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Inflammatory Marker Procalcitonine (PCT) During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.402', 'spread': '125.0852', 'groupId': 'OG000'}, {'value': '-52.661', 'spread': '78.1064', 'groupId': 'OG001'}, {'value': '-47.208', 'spread': '103.2929', 'groupId': 'OG002'}, {'value': '-37.219', 'spread': '78.3425', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of inflammatory marker Procalcitonine (PCT) between baseline and last observed value. PCT was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Inflammatory Marker Interleukin-6 (IL-6) During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-27648.3', 'spread': '72859.19', 'groupId': 'OG000'}, {'value': '-37780.4', 'spread': '119945.41', 'groupId': 'OG001'}, {'value': '-32872.7', 'spread': '99694.28', 'groupId': 'OG002'}, {'value': '-26236.2', 'spread': '70315.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of inflammatory marker Interleukin-6 (IL-6) between baseline and last observed value. IL-6 was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Changes of Functional Parameter Dipeptidyl Peptidase 3 (DPP3) During Stay at ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.56', 'spread': '53.030', 'groupId': 'OG000'}, {'value': '-12.47', 'spread': '42.270', 'groupId': 'OG001'}, {'value': '-12.03', 'spread': '47.596', 'groupId': 'OG002'}, {'value': '-9.38', 'spread': '122.031', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Changes of dipeptidyl peptidase 3 (DPP3) between baseline and last observed value. DPP3 was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vasopressor Use (Drug, Highest Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'OTHER AGENTS FOR LOCAL ORAL TREATMENT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}, {'title': 'LOCAL HEMOSTATICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}, {'title': 'ADRENERGIC AND DOPAMINERGIC AGENTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.1414', 'spread': '7.89069', 'groupId': 'OG000'}, {'value': '1.7307', 'spread': '2.03233', 'groupId': 'OG001'}, {'value': '2.4124', 'spread': '5.70006', 'groupId': 'OG002'}, {'value': '1.8276', 'spread': '4.86110', 'groupId': 'OG003'}]}]}, {'title': 'PHOSPHODIESTERASE INHIBITORS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '3.7763', 'spread': '1.05962', 'groupId': 'OG003'}]}]}, {'title': 'VASOPRESSIN AND ANALOGUES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0324', 'spread': '0.02597', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.0289', 'spread': '0.02265', 'groupId': 'OG002'}, {'value': '0.0343', 'spread': '0.02434', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS, PLAIN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}, {'title': 'R03AA ALPHA- AND BETA-ADRENORECEPTOR AGONISTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}, {'title': 'R03CA ALPHA- AND BETA-ADRENORECEPTOR AGONISTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS IN GLAUCOMA THERAPY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}, {'title': 'HOMEOPATHIC PREPARATION', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1236', 'spread': '1.44760', 'groupId': 'OG000'}, {'value': '2.1319', 'spread': '1.53579', 'groupId': 'OG001'}, {'value': '1.5018', 'spread': '1.51582', 'groupId': 'OG002'}, {'value': '1.9888', 'spread': '2.60114', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Vasopressor use (drug, highest dose). Vasopressor use was recorded from admission to ICU at time point of diagnosis of septic shock and daily thereafter from day 1 through day 28 or discharge from ICU (whatever comes first).', 'unitOfMeasure': 'μg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes : Quality of Life by Euro-QoL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Change 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '22.11', 'groupId': 'OG000'}, {'value': '-19.3', 'spread': '22.76', 'groupId': 'OG001'}, {'value': '-16.5', 'spread': '22.45', 'groupId': 'OG002'}, {'value': '-7.6', 'spread': '27.49', 'groupId': 'OG003'}]}]}, {'title': 'Change 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '16.21', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '19.40', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '17.83', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '21.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 28 and day 90', 'description': 'Patient reported outcomes: Quality of Life Form by EuroQoL Group, version "Euro-QoL-5" (day 28 and day 90). Change 1 = Visual analog scale (VAS) at discharge - VAS at day 90. Change 2 = VAS at day 28 - VAS at day 90. Minimum value on the scale is 0, maximum value on the scale is 100. A lower score indicates a worse outcome. As the change between two scores is calculated, a negative number indicates a worsening.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'Heart Rate Change Day 7 (Maximum)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '33.24', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '21.85', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '27.46', 'groupId': 'OG002'}, {'value': '13.5', 'spread': '28.25', 'groupId': 'OG003'}]}]}, {'title': 'Heart Rate Change Day 7 (Minimum)', 'categories': [{'measurements': [{'value': '-27.2', 'spread': '22.91', 'groupId': 'OG000'}, {'value': '-18.5', 'spread': '20.53', 'groupId': 'OG001'}, {'value': '-22.4', 'spread': '21.96', 'groupId': 'OG002'}, {'value': '-18.1', 'spread': '24.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Vital signs: heart rate (beat per minute) Change from baseline to Day 7.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Penalized Sepsis Support Index (pSSI) at 28 Day Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '10.87', 'groupId': 'OG001'}, {'value': '14.3', 'spread': '11.07', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '11.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 28', 'description': 'Penalized Sepsis Support Index (pSSI) at 28 day follow-up, is a version of the SSI where mortality is given extra weight: Patients being alive duringthe 14 days\' follow up will have an SSI ranging up to 14 (as defined above), while patients who died within that period will be assigned a score of "14 plus the number of days not being alive". Thus the weighted SSI score may range between zero and 28. A higher score means a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vasopressor Use (Drug, Duration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'OTHER AGENTS FOR LOCAL ORAL TREATMENT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '1.641', 'groupId': 'OG003'}]}]}, {'title': 'LOCAL HEMOSTATICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '1.641', 'groupId': 'OG003'}]}]}, {'title': 'ADRENERGIC AND DOPAMINERGIC AGENTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': '1.767', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '2.183', 'groupId': 'OG001'}, {'value': '3.10', 'spread': '1.994', 'groupId': 'OG002'}, {'value': '3.34', 'spread': '2.512', 'groupId': 'OG003'}]}]}, {'title': 'PHOSPHODIESTERASE INHIBITORS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '4.00', 'spread': '1.732', 'groupId': 'OG003'}]}]}, {'title': 'AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'VASOPRESSIN AND ANALOGUES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.500', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '1.673', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '1.434', 'groupId': 'OG002'}, {'value': '2.21', 'spread': '1.701', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS, PLAIN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.70', 'spread': '1.567', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS, COMBINATIONS EXCL. CORTICOSTEROIDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'R03AA ALPHA- AND BETA-ADRENORECEPTOR AGONISTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '1.641', 'groupId': 'OG003'}]}]}, {'title': 'R03CA ALPHA- AND BETA-ADRENORECEPTOR AGONISTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '1.641', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS IN GLAUCOMA THERAPY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '1.641', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS EXCL. ANTIGLAUCOMA PREPARATIONS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'SYMPATHOMIMETICS USED AS DECONGESTANTS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'HOMEOPATHIC PREPARATION', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '1.658', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.352', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '1.641', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Vasopressor use (drug, duration). Vasopressor use was recorded from admission to ICU at time point of diagnosis of septic shock and daily thereafter from day 1 through day 28 or discharge from ICU (whatever comes first).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Renal Function (penKid)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'PenKid change baseline to day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-28.3', 'spread': '57.25', 'groupId': 'OG000'}, {'value': '-21.4', 'spread': '59.07', 'groupId': 'OG001'}, {'value': '-24.8', 'spread': '58.10', 'groupId': 'OG002'}, {'value': '-34.8', 'spread': '63.91', 'groupId': 'OG003'}]}]}, {'title': 'PenKid change baseline to day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.5', 'spread': '83.88', 'groupId': 'OG000'}, {'value': '-19.7', 'spread': '70.80', 'groupId': 'OG001'}, {'value': '-19.6', 'spread': '77.11', 'groupId': 'OG002'}, {'value': '-29.8', 'spread': '83.27', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1, day 3 and day 7', 'description': 'Change in renal function as change in penKid (day 3 - day 1, day 7 - day 1). penKid was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'OG002', 'title': 'Adrecizumab Overall', 'description': 'Treatment Arm A and Treatment Arm B combined'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'classes': [{'title': 'MAP Change Day 7 (Maximum)', 'categories': [{'measurements': [{'value': '29.5', 'spread': '22.26', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '16.29', 'groupId': 'OG001'}, {'value': '28.8', 'spread': '19.13', 'groupId': 'OG002'}, {'value': '31.7', 'spread': '21.09', 'groupId': 'OG003'}]}]}, {'title': 'MAP Change Day 7 (Minimum)', 'categories': [{'measurements': [{'value': '-9.6', 'spread': '17.20', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '11.51', 'groupId': 'OG001'}, {'value': '-7.9', 'spread': '14.37', 'groupId': 'OG002'}, {'value': '-8.7', 'spread': '18.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Vital signs: blood pressure - mean arterial pressure (MAP) mmHg Change from baseline to Day 7.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Sub-study Key Pharmacokinetic Parameters Peak Plasma Concentrations (Cmax) Are to be Determined in 80 Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '38.193', 'spread': '10.3942', 'groupId': 'OG000'}, {'value': '86.854', 'spread': '22.2438', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'peak plasma concentrations (Cmax). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Sub-study Key Pharmacokinetic Parameters Time to Cmax (Tmax) Are to be Determined in 80 Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}], 'classes': [{'title': '0.25 h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '0.37 h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0.42 h', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '0.45 h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '0.47 h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '0.5 h', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '0.57 h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0.58 h', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '0.67 h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '0.73 h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2.5 h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '21.97 h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '24.75 h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '25.12 h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Time to Cmax (tmax) in hours (h)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Sub-study Key Pharmacokinetic Parameter AUC is to be Determined in 80 Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '4910.33', 'spread': '1222.414', 'groupId': 'OG000'}, {'value': '11245.28', 'spread': '3462.585', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'systemic exposure : Area under the plasma concentration versus time curve (AUC). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.', 'unitOfMeasure': 'h*μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Sub-study Key Pharmacokinetic Parameter Volume of Distribution is to be Determined in 80 Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.277', 'spread': '1.9220', 'groupId': 'OG000'}, {'value': '3.737', 'spread': '0.9427', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'volume of distribution (V). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Sub-study Key Pharmacokinetic Parameter Systemic Clearance is to be Determined in 80 Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0286', 'spread': '0.00790', 'groupId': 'OG000'}, {'value': '0.0280', 'spread': '0.00826', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'systemic clearance (CL). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In Sub-study Key Pharmacokinetic Parameter Elimination Half-life is to be Determined in 80 Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '206.48', 'spread': '43.809', 'groupId': 'OG000'}, {'value': '177.90', 'spread': '44.250', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'elimination half-life (t½). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'FG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Refusal to recall it up to day 90', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pt seen by doctor in digestive surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient enrolled: 08-Dec-2017 Last patient completed: 20-Dec-2019 Total study duration: 25 months'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 2 mg/kg'}, {'id': 'BG001', 'title': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab\n\nAdrecizumab: Single i.v. dose of 4 mg/kg'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab\n\nPlacebo: Single i.v. dose of placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '94'}, {'value': '68.8', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '89'}, {'value': '69.3', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '94'}, {'value': '68.4', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '94'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Location before ICU admission', 'classes': [{'title': 'Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '277', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Origin of sepsis', 'classes': [{'title': 'Peritonitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}, {'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}, {'title': 'Urinary tract', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Skin and soft tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Bile duct infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Blood stream', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Central nervous system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.41', 'groupId': 'BG000', 'lowerLimit': '16.7', 'upperLimit': '45.7'}, {'value': '26.72', 'groupId': 'BG001', 'lowerLimit': '17.0', 'upperLimit': '43.3'}, {'value': '27.78', 'groupId': 'BG002', 'lowerLimit': '14.1', 'upperLimit': '45.5'}, {'value': '27.18', 'groupId': 'BG003', 'lowerLimit': '14.1', 'upperLimit': '45.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because height was not determined for one subject, therefore, no BMI was calculated.\n\nTreatment group C Row population differs from the Overall because height was not determined for one subject, therefore, no BMI was calculated.'}, {'title': 'Body temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '284', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37.06', 'groupId': 'BG000', 'lowerLimit': '34.6', 'upperLimit': '39.9'}, {'value': '36.97', 'groupId': 'BG001', 'lowerLimit': '33.4', 'upperLimit': '39.9'}, {'value': '37.08', 'groupId': 'BG002', 'lowerLimit': '33.8', 'upperLimit': '40.5'}, {'value': '37.05', 'groupId': 'BG003', 'lowerLimit': '33.4', 'upperLimit': '40.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees C', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because body temperature was not done for 6 subjects.\n\nTreatment group B Row population differs from the Overall because body temperature was not done for 4 subjects.\n\nTreatment group C Row population differs from the Overall because body temperature was not done for 7 subjects.'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '104.38', 'groupId': 'BG000', 'lowerLimit': '51.0', 'upperLimit': '158.0'}, {'value': '97.40', 'groupId': 'BG001', 'lowerLimit': '60.0', 'upperLimit': '151.0'}, {'value': '96.37', 'groupId': 'BG002', 'lowerLimit': '44.0', 'upperLimit': '153.0'}, {'value': '98.55', 'groupId': 'BG003', 'lowerLimit': '44.0', 'upperLimit': '158.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mean arterial pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '73.18', 'groupId': 'BG000', 'lowerLimit': '43.0', 'upperLimit': '99.0'}, {'value': '71.35', 'groupId': 'BG001', 'lowerLimit': '32.0', 'upperLimit': '104.0'}, {'value': '72.49', 'groupId': 'BG002', 'lowerLimit': '22.0', 'upperLimit': '110.0'}, {'value': '72.36', 'groupId': 'BG003', 'lowerLimit': '22.0', 'upperLimit': '110.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Respiratory rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23.63', 'groupId': 'BG000', 'lowerLimit': '8.0', 'upperLimit': '44.0'}, {'value': '21.90', 'groupId': 'BG001', 'lowerLimit': '10.0', 'upperLimit': '37.0'}, {'value': '21.96', 'groupId': 'BG002', 'lowerLimit': '8.0', 'upperLimit': '36.0'}, {'value': '22.34', 'groupId': 'BG003', 'lowerLimit': '8.0', 'upperLimit': '44.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because respiratory rate was not done for 2 subjects\n\nTreatment group C Row population differs from the Overall because respiratory rate was not done for 3 subjects'}, {'title': 'Bio-ADM', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '284.30', 'groupId': 'BG000', 'lowerLimit': '74.9', 'upperLimit': '1967.1'}, {'value': '305.15', 'groupId': 'BG001', 'lowerLimit': '74.6', 'upperLimit': '2328.9'}, {'value': '755.92', 'groupId': 'BG002', 'lowerLimit': '74.3', 'upperLimit': '3000'}, {'value': '527.80', 'groupId': 'BG003', 'lowerLimit': '74.3', 'upperLimit': '3000'}]}]}], 'paramType': 'MEAN', 'description': 'bio-ADM measures the plasma level of the biological active Adrenomedullin, a vasoactive hormone that regulates blood pressure and vascular integrity\n\nNote results characterized as "3000" are to be read as \\>3000', 'unitOfMeasure': 'pg/mL (local)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Blood lactate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.11', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '15.0'}, {'value': '4.19', 'groupId': 'BG001', 'lowerLimit': '0.9', 'upperLimit': '17.0'}, {'value': '4.23', 'groupId': 'BG002', 'lowerLimit': '0.6', 'upperLimit': '64.0'}, {'value': '4.19', 'groupId': 'BG003', 'lowerLimit': '0.6', 'upperLimit': '64.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because blood lactate was not done for 4 subjects Treatment group B Row population differs from the Overall because blood lactate was not done for 2 subjects Treatment group C Row population differs from the Overall because blood lactate was not done for 3 subjects'}, {'title': 'Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '189.649', 'groupId': 'BG000', 'lowerLimit': '31.82', 'upperLimit': '582.00'}, {'value': '199.891', 'groupId': 'BG001', 'lowerLimit': '53.04', 'upperLimit': '834.50'}, {'value': '192.801', 'groupId': 'BG002', 'lowerLimit': '32.10', 'upperLimit': '912.29'}, {'value': '193.854', 'groupId': 'BG003', 'lowerLimit': '31.82', 'upperLimit': '912.29'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because creatinine was not done for 1 subject Treatment group B Row population differs from the Overall because creatinine was not done for 1 subject'}, {'title': 'Apache II Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '42'}, {'value': '31.8', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '42'}, {'value': '31.5', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '53'}, {'value': '31.6', 'groupId': 'BG003', 'lowerLimit': '14', 'upperLimit': '53'}]}]}], 'paramType': 'MEAN', 'description': 'Minimum score = 0; maximum score = 71. Increasing score is associated with increasing risk of hospital death.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because Apache II Score was not done for 10 subjects Treatment group B Row population differs from the Overall because Apache II Score was not done for 11 subjects Treatment group C Row population differs from the Overall because Apache II Score was not done for 8 subjects'}, {'title': 'Sequential Organ Failure Assessment (SOFA) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '17'}, {'value': '10.0', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '9.6', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '9.9', 'groupId': 'BG003', 'lowerLimit': '4', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'description': 'The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems.\n\nSOFA score: Minimum possible score is 0, maximum is 24. A higher score meas a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Treatment group A Row population differs from the Overall because SOFA Score was not done for 11 subjects Treatment group B Row population differs from the Overall because SOFA Score was not done for 16 subjects Treatment group C Row population differs from the Overall because SOFA Score was not done for 20 subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-28', 'size': 1661631, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-17T12:04', 'hasProtocol': True}, {'date': '2020-02-05', 'size': 1566551, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-17T12:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blind, Placebo-Controlled, Randomized, Multicenter Proof of Concept and Dose-Finding Phase II Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2017-02-22', 'resultsFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-01', 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'In Sub-study Key Pharmacokinetic Parameters Peak Plasma Concentrations (Cmax) Are to be Determined in 80 Patients', 'timeFrame': '28 days', 'description': 'peak plasma concentrations (Cmax). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.'}, {'measure': 'In Sub-study Key Pharmacokinetic Parameters Time to Cmax (Tmax) Are to be Determined in 80 Patients', 'timeFrame': '28 days', 'description': 'Time to Cmax (tmax) in hours (h)'}, {'measure': 'In Sub-study Key Pharmacokinetic Parameter AUC is to be Determined in 80 Patients', 'timeFrame': '28 days', 'description': 'systemic exposure : Area under the plasma concentration versus time curve (AUC). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.'}, {'measure': 'In Sub-study Key Pharmacokinetic Parameter Volume of Distribution is to be Determined in 80 Patients', 'timeFrame': '28 days', 'description': 'volume of distribution (V). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.'}, {'measure': 'In Sub-study Key Pharmacokinetic Parameter Systemic Clearance is to be Determined in 80 Patients', 'timeFrame': '28 days', 'description': 'systemic clearance (CL). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.'}, {'measure': 'In Sub-study Key Pharmacokinetic Parameter Elimination Half-life is to be Determined in 80 Patients', 'timeFrame': '28 days', 'description': 'elimination half-life (t½). Time points at which blood samples were taken prior IMP administration, at 30 min, 24 hrs, 48 hrs , 96 hrs, 144 hrs, 648 hrs after IMP administration.'}], 'primaryOutcomes': [{'measure': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective is mortality evaluated over the 90 days study period.'}, {'measure': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period: Interruption of infusion due to intolerability of ADRECIZUMAB'}, {'measure': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs)', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group.'}, {'measure': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Mild Severity', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with mild severity treatment emergent events.'}, {'measure': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Moderate Severity', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with moderate severity treatment emergent events.'}, {'measure': 'Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Severe Severity', 'timeFrame': '90 days', 'description': 'The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with severe severity treatment emergent events.'}], 'secondaryOutcomes': [{'measure': 'Efficacy to be Determined by Sepsis Support Index (SSI)', 'timeFrame': '14 days', 'description': 'The primary efficacy endpoint of this study is the Sepsis Support Index (SSI) defined as: days with organ support or dead within 14 day follow up More precisely: In the time frame of 14 day follow-up, each day on support with vasopressor, and/or mechanical ventilation, and/or renal dysfunction (defined as renal SOFA = 4), or not alive, is counted as 1. The sum over the follow up period is defined as SSI.\n\nMinimum value possible is 0, maximum value is 14. A higher score means a worse outcome.'}, {'measure': 'Sepsis Support Index (SSI)', 'timeFrame': '28 days', 'description': 'Sepsis Support Index (SSI) at 28 day follow-up Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.'}, {'measure': 'Penalized Sepsis Support Index (pSSI) at 14 Day Follow-up', 'timeFrame': 'day 14', 'description': 'Penalized Sepsis Support Index (pSSI) at day 14, defined similar to the SSI with the exception that patients that die get penalized by assigning the maximum value, i.e. the pSSI is set to 14 or 28, respectively.\n\nMinimum value possible is 0, maximum value is 14. A higher score means a worse outcome.'}, {'measure': 'Persistent Organ Dysfunction or Death at 14 and 28 Day Follow-up', 'timeFrame': 'day 14 and day 28', 'description': 'Persistent organ dysfunction or death at 14 and 28 day follow-up. Count of participants with either persistent organ dysfunction or death at Day 14 and Day 28. Persistent Organ Dysfunction is defined as the persistence of organ dysfunction requiring supportive technologies during the convalescent phase of critical illness and it is present when a patient has an ongoing requirement for vasopressors, dialysis, or mechanical ventilation at the outcome assessments time points, as defined by Heyland et al.; Persistent organ dysfunction plus death: a novel,composite outcome measure for critical care trials. Critical Care 2011, 15.'}, {'measure': 'Mortality Rate', 'timeFrame': 'day 28', 'description': 'Day 28 mortality rate'}, {'measure': 'SSI and pSSI Excluding the Renal Component', 'timeFrame': 'day 14 and day 28', 'description': 'Sepsis Support Index (SSI) and penalized Sepsis Support Index (pSSI) excluding the renal component. pSSI is a version of the SSI where mortality is given extra weight: Patients being alive during the 14 days\' follow up will have an SSI ranging up to 14, while patients who died within that period will be assigned a score of "14 plus the number of days not being alive". Thus the SSI and pSSI score may range between zero and 28. A higher score means a worse outcome. The number of participants analyzed differs per row due to missing data.'}, {'measure': 'SSI Weighted for Mortality', 'timeFrame': 'day 14', 'description': 'Sepsis Support Index (SSI) Weighted for Mortality. Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.'}, {'measure': 'Individual Sepsis Support Index Components', 'timeFrame': 'day 14 and day 28', 'description': 'Individual Sepsis Support Index (SSI) components (hemodynamic, respiratory and renal failure) with and without mortality.\n\nMinimum value possible is 0, maximum value is 14. A higher score means a worse outcome. The number of participants analyzed differs per row due to missing data.'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) Score : Composite Measure: SOFA Score and Its Changes Over Time', 'timeFrame': '28 days', 'description': 'Sequential Organ Failure Assessment (SOFA) Score:\n\nSOFA score change at Day 3 - baseline, delta = difference between maximum and minimum score during ICU stay, mean/maximum/total daily score during ICU stay, SOFA-3 (score limited to cardiovascular, respiratory and renal function). Measured at baseline and Day 3.\n\nSOFA score: Minimum possible score is 0, maximum is 24. A higher score meas a worse outcome. Measured at baseline, Day 2 to Day 28.\n\nSOFA-3 score: Minimum possible score is 0, maximum is 12. A higher score meas a worse outcome. Measured at baseline, Day 2 to Day 28.'}, {'measure': 'Change in Renal Function (Creatinine)', 'timeFrame': 'day 1, day 3 and day 7', 'description': 'Change in renal function as change in creatinine (day 3 - day 1, day 7 - day 1)'}, {'measure': 'Duration of Stay at ICU/ Hospital', 'timeFrame': '90 days', 'description': 'Duration of stay at ICU / hospital. The number of participants analyzed differs per row due to missing data.'}, {'measure': 'Changes of Functional Parameter Mean Arterial Pressure During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of Mean Arterial Pressure (MAP). Change from baseline to day 28/last day in ICU was calculated (value at day 28 or last collected value minus value at baseline). MAP was collected at screening and daily from day 1 to day 28 or discharge as well as on the follow-up visit day 28. Vital signs were assessed as min/max values within 24 hours except at screening and on the follow-up visit day 28.'}, {'measure': 'Changes of Functional Parameter Creatinine During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of creatinine. Measurement for baseline and Day 28 given. Creatinine was measured in the daily blood sample during ICU stay until discharge or Day 28 in a local laboratory assessment.'}, {'measure': 'Changes of Functional Parameter Partial Pressure of Oxygen in Arterial Blood(PaO2) / Fraction of Inspired Oxygen (FiO2) During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of Partial Pressure of Oxygen in Arterial Blood (PaO2) / Fraction of inspired oxygen (FiO2) from baseline to the last observed value are measured. PaO2 and FiO2 was collected if an arterial line was in place. The arterial blood was assessed for PaO2 and FiO2. Both were measured in mmHg.'}, {'measure': 'Changes of Functional Parameter Blood Lactate During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of blood lactate from baseline to Day 28 or discharge. Blood lactate was measured in the daily blood sample from baseline to ICU discharge or until Day 28.'}, {'measure': 'Changes of Functional Parameter Fluid Balance During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of fluid balance - Last Observed Value. Percentage of Participants with low (\\</=1000 mL) and high (\\>1000 mL) Fluid balance at the last observed value.\n\nDaily fluid intake will be calculated as the sum of all intravenous and oral fluids. The daily fluid output will be calculated as the sum of the volume of urine output, ultrafiltration fluid, drain fluid, and estimated gastrointestinal losses (including stools only in the presence of profound diarrhea). Insensitive losses will not be taken into account because they are difficult to assess reliably. Daily fluid balance (according to baseline patient weight) will be calculated by subtracting the total fluid output from the total intake.'}, {'measure': 'Changes of Functional Parameter Mid-Regional Pro-Adrenomedullin (MR-proADM) During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of Mid-Regional pro-Adrenomedullin (MR-proADM) between baseline and last observed value. MR-proADM was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).'}, {'measure': 'Changes of Functional Parameter Inflammatory Marker Procalcitonine (PCT) During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of inflammatory marker Procalcitonine (PCT) between baseline and last observed value. PCT was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).'}, {'measure': 'Changes of Functional Parameter Inflammatory Marker Interleukin-6 (IL-6) During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of inflammatory marker Interleukin-6 (IL-6) between baseline and last observed value. IL-6 was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).'}, {'measure': 'Changes of Functional Parameter Dipeptidyl Peptidase 3 (DPP3) During Stay at ICU', 'timeFrame': '28 days', 'description': 'Changes of dipeptidyl peptidase 3 (DPP3) between baseline and last observed value. DPP3 was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).'}, {'measure': 'Vasopressor Use (Drug, Highest Dose)', 'timeFrame': '28 days', 'description': 'Vasopressor use (drug, highest dose). Vasopressor use was recorded from admission to ICU at time point of diagnosis of septic shock and daily thereafter from day 1 through day 28 or discharge from ICU (whatever comes first).'}, {'measure': 'Patient Reported Outcomes : Quality of Life by Euro-QoL-5', 'timeFrame': 'day 28 and day 90', 'description': 'Patient reported outcomes: Quality of Life Form by EuroQoL Group, version "Euro-QoL-5" (day 28 and day 90). Change 1 = Visual analog scale (VAS) at discharge - VAS at day 90. Change 2 = VAS at day 28 - VAS at day 90. Minimum value on the scale is 0, maximum value on the scale is 100. A lower score indicates a worse outcome. As the change between two scores is calculated, a negative number indicates a worsening.'}, {'measure': 'Vital Signs', 'timeFrame': '7 days', 'description': 'Vital signs: heart rate (beat per minute) Change from baseline to Day 7.'}, {'measure': 'Penalized Sepsis Support Index (pSSI) at 28 Day Follow-up', 'timeFrame': 'day 28', 'description': 'Penalized Sepsis Support Index (pSSI) at 28 day follow-up, is a version of the SSI where mortality is given extra weight: Patients being alive duringthe 14 days\' follow up will have an SSI ranging up to 14 (as defined above), while patients who died within that period will be assigned a score of "14 plus the number of days not being alive". Thus the weighted SSI score may range between zero and 28. A higher score means a worse outcome.'}, {'measure': 'Vasopressor Use (Drug, Duration)', 'timeFrame': '28 days', 'description': 'Vasopressor use (drug, duration). Vasopressor use was recorded from admission to ICU at time point of diagnosis of septic shock and daily thereafter from day 1 through day 28 or discharge from ICU (whatever comes first).'}, {'measure': 'Change in Renal Function (penKid)', 'timeFrame': 'day 1, day 3 and day 7', 'description': 'Change in renal function as change in penKid (day 3 - day 1, day 7 - day 1). penKid was measured in the blood samples taken during the ICU stay prior to start of IMP infusion (day 1) and within the time frame of 24 hours (+/- 10 hours) after end of IMP infusion (day 2), at 48 hours, 96 hours and 144 hours after end of infusion (+/- 10 hours) or between scheduled assessments, if discharged earlier from ICU (whatever comes first).'}, {'measure': 'Vital Signs - Blood Pressure', 'timeFrame': '7 days', 'description': 'Vital signs: blood pressure - mean arterial pressure (MAP) mmHg Change from baseline to Day 7.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Septic Shock'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '34605947', 'type': 'DERIVED', 'citation': 'Laterre PF, Pickkers P, Marx G, Wittebole X, Meziani F, Dugernier T, Huberlant V, Schuerholz T, Francois B, Lascarrou JB, Beishuizen A, Oueslati H, Contou D, Hoiting O, Lacherade JC, Chousterman B, Pottecher J, Bauer M, Godet T, Karakas M, Helms J, Bergmann A, Zimmermann J, Richter K, Hartmann O, Pars M, Mebazaa A; AdrenOSS-2 study participants. Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. Intensive Care Med. 2021 Nov;47(11):1284-1294. doi: 10.1007/s00134-021-06537-5. Epub 2021 Oct 4.'}, {'pmid': '30782906', 'type': 'DERIVED', 'citation': 'Geven C, Blet A, Kox M, Hartmann O, Scigalla P, Zimmermann J, Marx G, Laterre PF, Mebazaa A, Pickkers P. A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2). BMJ Open. 2019 Feb 19;9(2):e024475. doi: 10.1136/bmjopen-2018-024475.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of \\> 70 pg/ml.', 'detailedDescription': 'This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of \\> 70 pg/ml.\n\n"Early" septic shock is defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) \\< 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Early is defined as a maximum of less than 12 hours between onset of the cardiovascular organ-dysfunction and administration of ADRECIZUMAB. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician\'s assessment of inadequate hemodynamic results.\n\nIt is intended to enroll 300 patients from surgical, medical and mixed ICU at multiple centers in Europe.\n\nAll patients will be treated according to "International Guidelines for Management of Severe Sepsis and Septic Shock".\n\nEligible patients (confirmed by central verification) will be randomized (1:1:2) to ADRECIZUMAB treatment arm A (2 mg/kg) or to ADRECIZUMAB treatment arm B (4 mg/kg) or to placebo as control group. Patients assigned to the treatment arm A or B will be administered a single dose of ADRECIZUMAB as intravenous infusion over approximately 1 hour; patients assigned to the control group will be administered placebo as intravenous infusion over approximately 1 hour.\n\nAs long as the patients are on the ICU, daily measurements of clinical signs and laboratory data will be collected for safety reasons and for determination of Sequential Organ Failure Assessment Score (SOFA score). Additional blood samples for central laboratory analyses will be taken at inclusion on day 1, day 3, day 5, day 7 or day of discharge (whatever comes first) for measurement of biomarkers.\n\nThe SOFA score and its components will be determined daily for all patients over the entire stay on the ICU (28 days or until discharge whatever comes first). Safety monitoring for each patient will begin at the time of signing the Informed Consent Form and continue for 90 days after end of short-term infusion of study medication.\n\nAt selected study centers a pharmacokinetic (PK) substudy will be performed to determine the profile of ADRECIZUMAB in 80 randomized patients.\n\nAn interim analysis for efficacy is planned after 50% of patients have completed the study (n=150).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent by patient or legal representative (according to country - specific regulations)\n2. Male and female patient, age ≥ 18 years\n3. Body weight 50 kg - 120 kg\n4. Bio-ADM concentration \\> 70 pg/ml\n5. Patient with early septic shock (start of vasopressor therapy \\< 12 hours)\n6. Women of childbearing potential must have a negative serum or urine pregnancy test before randomization\n7. Highly effective method of contraception must be maintained for 6 months after study start by women of childbearing potential and sexually active men.\n8. No care limitation\n\nExclusion Criteria:\n\n1. Moribund\n2. Pre-existing unstable condition (e.g. a recent cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction (all \\< 3 months), congestive heart failure - New York Heart Association (NYHA) Class IV\n3. Patients that required cardiopulmonary resuscitation in the last 4 weeks prior to evaluation for enrollment\n4. Severe Chronic Obstructive Pulmonary Disease (COPD) with chronic oxygen need at home (GOLD IV)\n5. Any organ or bone marrow transplant within the past 24 weeks\n6. Uncontrolled serious hemorrhage (≥ 2 units of blood / platelets in the previous 24 hrs.). Patients may be considered for enrollment if bleeding has stopped and patient is otherwise qualified\n7. Uncontrolled hematological / oncological malignancies\n8. Absolute neutropenia \\< 500 per µL\n9. Severe chronic liver disease (Child-Pugh C)\n10. Systemic fungal infection or active tuberculosis\n11. Neuromuscular disorders that impact breathing / spontaneous ventilation\n12. Burns \\> 30% of body surface\n13. Plasmapheresis\n14. Breastfeeding women\n15. Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion\n16. Unwilling or unable to be fully evaluated for all follow-up visits'}, 'identificationModule': {'nctId': 'NCT03085758', 'acronym': 'AdrenOSS-2', 'briefTitle': 'Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adrenomed AG'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients With Septic Shock and Elevated Adrenomedullin', 'orgStudyIdInfo': {'id': 'ADR-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm A', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab (treatment arm A)', 'interventionNames': ['Biological: Adrecizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm B', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab (treatment arm B)', 'interventionNames': ['Biological: Adrecizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab (control group)', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Adrecizumab', 'type': 'BIOLOGICAL', 'description': 'Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)', 'armGroupLabels': ['Treatment Arm A', 'Treatment Arm B']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single i.v. dose of placebo (control group)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Clinique Universitaire Saint-Luc (UCL Bruxelles)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Antwerp University Hospital (UZA), Critical Care Medicine', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'Groupe Jolimont, Hospitalier de Jolimont', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': '1340', 'city': 'Ottignies', 'country': 'Belgium', 'facility': 'Clinique St. Pierre, Intensive Care', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': '49933', 'city': 'Angers', 'state': 'Cedex', 'country': 'France', 'facility': 'Medical Intensive Care Medicine, Centre hospital - universitaire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '95107', 'city': 'Argenteuil', 'state': 'Cedex', 'country': 'France', 'facility': 'CH Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '92118', 'city': 'Clichy', 'state': 'Cedex', 'country': 'France', 'facility': 'Hopital Beaujon; Anesthesie Reanimation', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '87042', 'city': 'Limoges', 'state': 'Cedex', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '44093', 'city': 'Nantes', 'state': 'Cedex', 'country': 'France', 'facility': 'CHU de Nantes; Medicine Intensive Reanimation', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '37044', 'city': 'Tours', 'state': 'Cedex', 'country': 'France', 'facility': 'CHRU Bretonneau, Medecine Intensive Réanimation', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'University Hospital of Clermont-Ferrand, Dept. of Perioperative Medicine', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'AP-HP, Hopital Louis Mourier, Réanimation Médicale', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD-Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': "Hôpital de Bicêtre, Service d'anesthésie-réanimation chirurgicale", 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital Lariboisière, Dept. d'Anesthesie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière, Réanimation Médicale et Traumatologique', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital Saint-Louis, Service d'Anesthésie-Réanimation", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation Chirurgicale, Université Paris Descartes", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Nouvel Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'facility': "Hôpital de Hautepierre , Hôpitaux Universitaires de Strasbourg, Unité de Réanimation Chirurgicale, Service d'Anesthésie-Réanimation Chirurgicale", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen, Klinik für Operative Intensivmedizin', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf Klinik für Intensivmedizin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitätsmedizin Rostock Klinik und Poliklinik für Anästhesiologie und Intensivtherapie', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '6716 RP', 'city': 'Ede', 'country': 'Netherlands', 'facility': 'Gelderse Vallei Hospital, Department of Intensive Care', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '7512 KZ', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente, Department of Intensive Care', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '6401 CX', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medical Center, Department of Intensive Care', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud UMC Intensive Care', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina-Ziekenhuis (CWZ), Intensive Care', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Jens Zimmermann, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adrenomed AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrenomed AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}