Viewing Study NCT03451292

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Ignite Creation Date: 2025-12-24 @ 3:59 PM
Ignite Modification Date: 2025-12-26 @ 7:08 PM
Study NCT ID: NCT03451292
Status: COMPLETED
Last Update Posted: 2025-06-06
First Post: 2018-02-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'approach_preciosa@grifols.com', 'phone': '+34 93 5710500', 'title': 'Mireia Torres', 'organization': 'Instituto Grifols, S.A.'}, 'certainAgreement': {'otherDetails': "Site may publish results from the Study, after providing Sponsor 30 days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor Inventions.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'The Safety population included the subset of participants who received at least one SMT + Albutein 20% administration or SMT alone.', 'eventGroups': [{'id': 'EG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 51, 'seriousNumAtRisk': 203, 'deathsNumAffected': 53, 'seriousNumAffected': 52}, {'id': 'EG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 47, 'seriousNumAtRisk': 207, 'deathsNumAffected': 67, 'seriousNumAffected': 70}], 'otherEvents': [{'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Systemic Candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Enterococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Clostridium Difficile Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Enterococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Escherichia Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia Escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Staphylococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Staphylococcal Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary Tract Infection Enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myocardial Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oesophagitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Umbilical hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Strangulated incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bone fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colorectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Delirium tremens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gram stain positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}, {'value': '38.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.10', 'groupDescription': 'Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).', 'statisticalMethod': 'Cox Proportional- Hazards (PH) model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 361', 'description': 'Time to one-year transplant-free survival was calculated as earlier of \\[(date of liver transplantation or date of death) - randomization date + 1\\] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 91', 'description': 'Time to 3-months transplant-free survival was calculated as earlier of \\[(date of liver transplantation or date of death) - randomization date + 1\\] for participants who died or had liver transplant within the analysis period of 91 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 91, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 181', 'description': 'Time to 6-months transplant-free survival was calculated as earlier of \\[(date of liver transplantation or date of death) - randomization date + 1\\] for participants who died or had liver transplant within the analysis period of 181 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 181, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 91', 'description': 'Time to 3-months survival was calculated as the earlier of \\[(date of death) - randomization date + 1\\] for those participants who died within the analysis period of 91 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 91 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 181', 'description': 'Time to 6-months survival was calculated as the earlier of \\[(date of death) - randomization date + 1\\] for those participants who died within the analysis period of 181 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 181 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 361', 'description': 'Time to 1 year survival was calculated as the earlier of \\[(date of death) - randomization date + 1\\] for those participants who died within the analysis period of 361 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 361 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Total Number of Paracenteses Through 1 Year After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '5.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 361', 'description': 'Paracenteses is a medical procedure used to remove excess fluid from the abdominal cavity. For each participant, the total number of reported paracenteses on treatment was calculated. Number of paracenteses per participant while on treatment was reported.', 'unitOfMeasure': 'paracenteses per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'OG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 361', 'description': 'Refractory Ascites was defined as ascites that cannot be mobilized, or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic, or the development of diuretic-induced complications that preclude the use of an effective diuretic dosage treatment. Incidence of refractory ascites occurring on treatment was defined as any incidence that occurred with a start date/time on or after the participants date/time of randomization (for SMT Alone group) or commencement of Albutein (SMT+ Albutein 20% group) treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized. Overall number of participants analyzed included participants with at least one refractory ascites assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'FG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '102'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 410 participants took part in the study at 40 investigative sites across 14 countries in Europe and the United States from 24 July 2018 to 21 May 2024.', 'preAssignmentDetails': '476 participants with decompensated cirrhosis and ascites were screened of which 410 participants were randomized in a 1:1 ratio to receive either the Standard Medical Treatment (SMT) + Albutein 20% or the SMT alone.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 g/kg, based on their body weight (maximum 100 grams per participant), as an IV infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with SMT administered as per institution standards for the management of decompensated cirrhosis up to 12 months.'}, {'id': 'BG001', 'title': 'SMT Alone', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '10.30', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '10.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-24', 'size': 1172975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-21T06:35', 'hasProtocol': True}, {'date': '2024-09-09', 'size': 21238984, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-21T06:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2018-02-12', 'resultsFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-21', 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event', 'timeFrame': 'Up to Day 361', 'description': 'Time to one-year transplant-free survival was calculated as earlier of \\[(date of liver transplantation or date of death) - randomization date + 1\\] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\\].'}], 'secondaryOutcomes': [{'measure': 'Time to Liver Transplantation or Death Through 3 Months After Randomization: Percentage of Participants With an Event', 'timeFrame': 'Up to Day 91', 'description': 'Time to 3-months transplant-free survival was calculated as earlier of \\[(date of liver transplantation or date of death) - randomization date + 1\\] for participants who died or had liver transplant within the analysis period of 91 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 91, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\\].'}, {'measure': 'Time to Liver Transplantation or Death Through 6 Months After Randomization: Percentage of Participants With an Event', 'timeFrame': 'Up to Day 181', 'description': 'Time to 6-months transplant-free survival was calculated as earlier of \\[(date of liver transplantation or date of death) - randomization date + 1\\] for participants who died or had liver transplant within the analysis period of 181 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 181, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\\].'}, {'measure': 'Time to Death Through 3 Months After Randomization: Percentage of Participants With an Event', 'timeFrame': 'Up to Day 91', 'description': 'Time to 3-months survival was calculated as the earlier of \\[(date of death) - randomization date + 1\\] for those participants who died within the analysis period of 91 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 91 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 91) / (number of participants in the ITT group)\\].'}, {'measure': 'Time to Death Through 6 Months After Randomization: Percentage of Participants With an Event', 'timeFrame': 'Up to Day 181', 'description': 'Time to 6-months survival was calculated as the earlier of \\[(date of death) - randomization date + 1\\] for those participants who died within the analysis period of 181 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 181 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 181) / (number of participants in the ITT group)\\].'}, {'measure': 'Time to Death Through 1 Year After Randomization: Percentage of Participants With an Event', 'timeFrame': 'Up to Day 361', 'description': 'Time to 1 year survival was calculated as the earlier of \\[(date of death) - randomization date + 1\\] for those participants who died within the analysis period of 361 days. Participants who did not die within the analysis period were censored at the earlier of the date of last contact or analysis cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on death, these events if reported before the analysis cut-off Day 361 of this endpoint, were considered. The percentage of participants with events (death) without censoring participants who underwent liver transplantation within the analysis period were reported. The percentage of participants was calculated as \\[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\\].'}, {'measure': 'Total Number of Paracenteses Through 1 Year After Randomization', 'timeFrame': 'Up to Day 361', 'description': 'Paracenteses is a medical procedure used to remove excess fluid from the abdominal cavity. For each participant, the total number of reported paracenteses on treatment was calculated. Number of paracenteses per participant while on treatment was reported.'}, {'measure': 'Number of Participants With Refractory Ascites According to the International Club of Ascites (ICA) Through 1 Year After Randomization', 'timeFrame': 'Up to Day 361', 'description': 'Refractory Ascites was defined as ascites that cannot be mobilized, or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic, or the development of diuretic-induced complications that preclude the use of an effective diuretic dosage treatment. Incidence of refractory ascites occurring on treatment was defined as any incidence that occurred with a start date/time on or after the participants date/time of randomization (for SMT Alone group) or commencement of Albutein (SMT+ Albutein 20% group) treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decompensated Cirrhosis and Ascites']}, 'referencesModule': {'references': [{'pmid': '30905652', 'type': 'DERIVED', 'citation': 'Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants with decompensated cirrhosis and ascites. The study population will consist of participants being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants ≥18 years of age.\n* Participants with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).\n* Participants who have been hospitalized for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at Screening.\n* In participants with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy.\n* In participants with cirrhosis due to hepatitis C virus, only decompensated participants who will not receive antiviral therapy during the study period will be included (Participants receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).\n* In participants with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.\n* Participants must be willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the participant in accordance with local law and institutional policy.\n* Chronic liver failure-consortium acute decompensation (CLIF-C AD) score \\> 50 points at screening.\n\nExclusion Criteria:\n\n* Participants with ACLF at Screening\n* Participants with type 1 hepatorenal syndrome (HRS) currently on treatment with vasoconstrictors or hemodialysis.\n* Participants with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts.\n* Participants with refractory ascites as defined by the International Club of Ascites (ICA) criteria without any other event of acute decompensation.\n* Participants receiving dual anti-platelet therapy or anti-coagulant therapy (exception: deep vein thrombosis (DVT) prophylaxis).\n* Participants with ongoing endoscopic eradication of esophageal varices with ≤ 2 endoscopic sessions completed before screening.\n* Participants with evidence of current locally advanced or metastatic malignancy.\n* Participants with acute or chronic heart failure (New York Heart Association \\[NYHA\\]).\n* Participants with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease \\[GOLD\\]).\n* Participants with nephropathy with renal failure with serum creatinine \\>2 milligrams/deciliters (mg/dL) or systemic hypertension.\n* Participants with severe psychiatric disorders.\n* Participants with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.\n* Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice effective methods of contraception\n* Participants with previous liver transplantation.\n* Participants with known or suspected hypersensitivity to albumin.\n* Participants participating in another clinical study within 3 months prior to screening.\n* Participants with active drug addiction (exceptions: active alcoholism or marijuana).\n* In the opinion of the investigator, the participants may have compliance problems with the protocol and the procedures of the protocol.\n* Participants with ongoing or recent variceal bleeding (participants can be included 2 weeks after hemorrhagic episode).\n* Participants with septic shock at screening.\n* Participants with ongoing spontaneous bacterial peritonitis (SBP) infection (participants can be included upon resolution).\n* Participants with current infection of coronavirus disease of 2019 (COVID19), those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.'}, 'identificationModule': {'nctId': 'NCT03451292', 'acronym': 'PRECIOSA', 'briefTitle': 'Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': 'Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites', 'orgStudyIdInfo': {'id': 'IG1601'}, 'secondaryIdInfos': [{'id': '2016-001789-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMT + Albutein 20%', 'description': 'Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with standard medical treatment (SMT) administered as per institution standards for the management of decompensated cirrhosis up to 12 months.', 'interventionNames': ['Drug: Albutein 20%', 'Other: SMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SMT', 'description': 'Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.', 'interventionNames': ['Other: SMT']}], 'interventions': [{'name': 'Albutein 20%', 'type': 'DRUG', 'description': 'Injectable solution', 'armGroupLabels': ['SMT + Albutein 20%']}, {'name': 'SMT', 'type': 'OTHER', 'description': 'Participants received SMT according to institution standards for the management of decompensated cirrhosis.', 'armGroupLabels': ['SMT', 'SMT + Albutein 20%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers-New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '65201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of Missouri Hospital', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, 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