Viewing Study NCT02554903

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Ignite Creation Date: 2025-12-24 @ 7:34 PM
Ignite Modification Date: 2026-02-25 @ 9:47 PM
Study NCT ID: NCT02554903
Status: COMPLETED
Last Update Posted: 2025-03-30
First Post: 2015-09-08
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
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': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533860', 'term': 'macitentan'}, {'id': 'D000095485', 'term': 'Bulk Drugs'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Medical Affairs Associate Director', 'organization': 'Actelion Pharmaceuticals US, Inc'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A limitation of this study was its slow enrollment and a final sample size that was less than the predefined target.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 16 weeks', 'description': 'The safety analysis included all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with pulmonary hypertension \\[PH\\] after a left ventricular assist device \\[LVAD\\] implantation) received macitentan 10 mg orally once daily up to Week 12.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 24, 'seriousNumAtRisk': 28, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 24, 'seriousNumAtRisk': 29, 'deathsNumAffected': 2, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cardiorenal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Systolic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Catheter Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Complication Associated with Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Feeling Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Impaired Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Medical Device Site Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Medical Device Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Medical Device Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Candida Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Medical Device Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ophthalmic Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fractured Sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Anticoagulation Drug Level above Therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Anticoagulation Drug Level below Therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Potassium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Sodium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Triglycerides Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Urea Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Uric Acid Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Body Temperature Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cystatin C Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Echocardiogram Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ejection Fraction Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Electrocardiogram St Segment Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haematocrit Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haemoglobin Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Heart Rate Irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 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subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Loss Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Leukaemoid Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Right Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Complication Associated with Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Enterococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Groin Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Streptococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Anticoagulation Drug Level below Therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'International Normalised Ratio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Left Ventricular End-Diastolic Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Liver Function Test Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Troponin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fluid Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Chest Wall Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Reversible Ischaemic Neurological Deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with pulmonary hypertension \\[PH\\] after a left ventricular assist device \\[LVAD\\] implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.585', 'spread': '0.2280', 'groupId': 'OG000'}, {'value': '0.757', 'spread': '0.2578', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7393', 'ciLowerLimit': '0.5798', 'ciUpperLimit': '0.9426', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Full Analysis Set (FAS) included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. Imputation for missing PAWP value was done using mPAP and CO or with left ventricular end diastolic pressure (LVEDP) values of same visit (if available)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '4.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'mRAP was collected in the eCRF (electronic case record form). Right atrial pressure (RAP) is the blood pressure in the right atrium of the heart. Change from baseline to Week 12 in mRAP was measured at rest and no correction for multiple testing was applied.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.84', 'spread': '8.821', 'groupId': 'OG000'}, {'value': '-3.86', 'spread': '7.982', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'mPAP was collected in the eCRF. The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Change from baseline to Week 12 in mPAP was measured at rest and no correction for multiple testing was applied.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '7.86', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '4.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "PAWP was collected in the eCRF. PAWP is pressure within the pulmonary arterial system when the catheter tip is 'wedged' in the tapering branch of one of the pulmonary arteries. Change from baseline to Week 12 in PAWP was measured at rest and no correction for multiple testing was applied.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Cardiac Index (CI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.093', 'spread': '0.4680', 'groupId': 'OG000'}, {'value': '0.041', 'spread': '0.4576', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'CI was calculated as Cardiac Output (CO)/body surface area (BSA), where CO is Thermodilution Cardiac Output (Liters per minute \\[L/min\\]) and BSA (m\\^2) equals to 0.007184\\*weight\\^0.425 (kilograms)\\*height\\^0.725 (centimeter). CI was represented in liters per minute per square meter (L/min/m\\^2). Change from baseline to Week 12 in CI was measured at rest and no correction for multiple testing was applied.', 'unitOfMeasure': 'L/min/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.399', 'spread': '2.2515', 'groupId': 'OG000'}, {'value': '-0.993', 'spread': '2.2596', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'TPR was calculated as mPAP/CO where mPAP is mean pulmonary arterial pressure and CO is cardiac output. Change from baseline to Week 12 in TPR was calculated at rest and no correction for multiple testing was applied.', 'unitOfMeasure': 'Wood Unit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) includes all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.260', 'spread': '17.1523', 'groupId': 'OG000'}, {'value': '4.100', 'spread': '8.5202', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Mixed venous oxygen saturation measures the end result of oxygen consumption and delivery. Change from baseline to Week 12 in SvO2 was reported and measured at rest and no correction for multiple testing was applied.', 'unitOfMeasure': 'Percentage of SvO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '1325.68', 'spread': '1214.719', 'groupId': 'OG000'}, {'value': '1573.44', 'spread': '2327.632', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'NT-proBNP levels in the blood are used for diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.', 'unitOfMeasure': 'nanograms/Liter (ng/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'classes': [{'title': 'Worsening', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Improvement', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'WHO FC is a classification which reflects disease severity based on symptoms. WHO Functional Classification of pulmonary hypertension comprises of Class I (participants with pulmonary hypertension but without resulting limitation of physical activity), II (participants with pulmonary hypertension resulting in slight limitation of physical activity), III (participants with pulmonary hypertension resulting in marked limitation of physical activity) and IV (participants with pulmonary hypertension with inability to carry out any physical activity without symptoms). Change from baseline in WHO FC was reported. WHO FC was categorized as worsening (change greater than \\[\\>\\] 0); improvement (change less than \\[\\<\\] 0); or no change (change equals to \\[=\\] 0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with pulmonary hypertension \\[PH\\] after a left ventricular assist device \\[LVAD\\] implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Heart Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Macitentan 10 Milligrams (mg)', 'description': 'Participants (with pulmonary hypertension \\[PH\\] after a left ventricular assist device \\[LVAD\\] implantation) received macitentan 10 mg orally once daily up to Week 12.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '8.21', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '6.98', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '7.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-10', 'size': 1947565, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-08T10:23', 'hasProtocol': True}, {'date': '2020-07-13', 'size': 1787014, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-08T10:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2015-09-08', 'resultsFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-08', 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline', 'timeFrame': 'Baseline to Week 12', 'description': 'PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)', 'timeFrame': 'Baseline to Week 12', 'description': 'mRAP was collected in the eCRF (electronic case record form). Right atrial pressure (RAP) is the blood pressure in the right atrium of the heart. Change from baseline to Week 12 in mRAP was measured at rest and no correction for multiple testing was applied.'}, {'measure': 'Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)', 'timeFrame': 'Baseline to Week 12', 'description': 'mPAP was collected in the eCRF. The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Change from baseline to Week 12 in mPAP was measured at rest and no correction for multiple testing was applied.'}, {'measure': 'Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP)', 'timeFrame': 'Baseline to Week 12', 'description': "PAWP was collected in the eCRF. PAWP is pressure within the pulmonary arterial system when the catheter tip is 'wedged' in the tapering branch of one of the pulmonary arteries. Change from baseline to Week 12 in PAWP was measured at rest and no correction for multiple testing was applied."}, {'measure': 'Change From Baseline to Week 12 in Cardiac Index (CI)', 'timeFrame': 'Baseline to Week 12', 'description': 'CI was calculated as Cardiac Output (CO)/body surface area (BSA), where CO is Thermodilution Cardiac Output (Liters per minute \\[L/min\\]) and BSA (m\\^2) equals to 0.007184\\*weight\\^0.425 (kilograms)\\*height\\^0.725 (centimeter). CI was represented in liters per minute per square meter (L/min/m\\^2). Change from baseline to Week 12 in CI was measured at rest and no correction for multiple testing was applied.'}, {'measure': 'Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)', 'timeFrame': 'Baseline to Week 12', 'description': 'TPR was calculated as mPAP/CO where mPAP is mean pulmonary arterial pressure and CO is cardiac output. Change from baseline to Week 12 in TPR was calculated at rest and no correction for multiple testing was applied.'}, {'measure': 'Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2)', 'timeFrame': 'Baseline to Week 12', 'description': 'Mixed venous oxygen saturation measures the end result of oxygen consumption and delivery. Change from baseline to Week 12 in SvO2 was reported and measured at rest and no correction for multiple testing was applied.'}, {'measure': 'Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels', 'timeFrame': 'Baseline to Week 12', 'description': 'NT-proBNP levels in the blood are used for diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.'}, {'measure': 'Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)', 'timeFrame': 'Baseline to Week 12', 'description': 'WHO FC is a classification which reflects disease severity based on symptoms. WHO Functional Classification of pulmonary hypertension comprises of Class I (participants with pulmonary hypertension but without resulting limitation of physical activity), II (participants with pulmonary hypertension resulting in slight limitation of physical activity), III (participants with pulmonary hypertension resulting in marked limitation of physical activity) and IV (participants with pulmonary hypertension with inability to carry out any physical activity without symptoms). Change from baseline in WHO FC was reported. WHO FC was categorized as worsening (change greater than \\[\\>\\] 0); improvement (change less than \\[\\<\\] 0); or no change (change equals to \\[=\\] 0).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LVAD'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '39635465', 'type': 'DERIVED', 'citation': 'Frantz RP, Desai SS, Ewald G, Franco V, Hage A, Horn EM, LaRue SJ, Mathier MA, Mandras S, Park MH, Ravichandran AK, Schilling JD, Wang IW, Zolty R, Rendon GG, Rocco MA, Selej M, Zhao C, Rame JE. SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation. Pulm Circ. 2024 Dec 4;14(4):e12446. doi: 10.1002/pul2.12446. eCollection 2024 Oct.'}]}, 'descriptionModule': {'briefSummary': 'STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.\n\nSecondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation.\n\nTo evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation.\n\nExploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function in subjects with PH after LVAD implantation.\n\nTo explore the potential effect of macitentan 10 mg as compared to placebo on selected clinical events in subjects with PH after LVAD implantation.\n\nTo explore the potential effect of macitentan 10 mg as compared to placebo on renal function as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written Informed Consent prior to initiation of any study-mandated procedure.\n2. Males or females ≥ 18 years of age.\n3. Surgical implantation of LVAD within 90 days prior to Randomization.\n4. Hemodynamic evidence of PH on Baseline right heart catheterization (RHC) by the thermodilution method. Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to the first dose of study treatment. PH is defined as:\n\n 1. Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and\n 2. Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg and\n 3. PVR \\> 3 Wood units.\n5. Stabilization of the patient for 48 h prior to the Baseline RHC, defined as:\n\n 1. No LVAD pump speed/flow rate changes and\n 2. Stable dose of oral diuretics and\n 3. No intravenous (i.v.) inotropes or vasopressors and\n 4. Patient able to ambulate.\n6. A woman of childbearing potential is eligible only if she has:\n\n 1. A negative serum pregnancy test result during the Screening period (Visit 1) and Randomization (Visit 2) and\n 2. Agreement to undertake monthly serum pregnancy tests during the study and up to 30 days after study treatment discontinuation and\n 3. Agreement to use one of the methods of contraception / follow the contraception scheme described in Section 4.5 from Screening and up to at least 30 days after study treatment discontinuation.\n7. Patient must be randomized within 14 days of Baseline RHC.\n\nExclusion Criteria:\n\n1. Documented severe obstructive lung disease defined as: forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) \\< 0.7 associated with FEV1 \\< 50% of predicted value after bronchodilator administration.\n2. Documented moderate to severe restrictive lung disease defined as: total lung capacity \\< 60% of predicted value.\n3. Documented pulmonary veno-occlusive disease.\n4. Patients undergoing dialysis.\n5. Hemoglobin \\< 8.5 g/dL at Randomization.\n6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 × the upper limit of normal (ULN) at Randomization.\n7. Severe hepatic impairment, e.g., Child-Pugh Class C liver disease.\n8. Body weight \\< 40 kg at Randomization.\n9. Doppler mean blood pressure \\< 65 mmHg at Randomization.\n10. GFR \\< 30 mL/min at Randomization.\n11. Pregnant, planning to become pregnant during the study period, or breastfeeding.\n12. Treatment with endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5) inhibitors, i.v., subcutaneous (s.c.), or oral prostanoids, or guanylate cyclase stimulators within 7 days prior to Baseline RHC or study treatment initiation.\n13. Treatment with inhaled prostanoids (e.g., iloprost, epoprostenol) or nitric oxide within 24 h prior to Baseline RHC or study treatment initiation.\n14. Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 28 days prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort).\n15. Treatment with strong inhibitors of CYP3A4 within 28 days prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, saquinavir, boceprevir, telaprevir, iopinavir, fosamprenavir, darunavir, tipranavir, atazanavir, nelfinavir, amprenavir, and idinavir).\n16. Treatment with another investigational drug (planned, or taken) within 28 days prior to study treatment initiation.\n17. Known hypersensitivity to ERAs, or to any of the study treatment excipients.\n18. Any condition that prevents compliance with the protocol or adherence to therapy.\n19. Known concomitant life-threatening disease with a life expectancy \\< 12 months."}, 'identificationModule': {'nctId': 'NCT02554903', 'acronym': 'SOPRANO', 'briefTitle': 'Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation', 'orgStudyIdInfo': {'id': 'AC-055-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Macitentan 10 mg po', 'description': 'Approximately 78 adult subjects with PH post-LVAD implantation will be randomized (1:1) to receive either macitentan 10 mg, or matching placebo, once daily orally.', 'interventionNames': ['Drug: Macitentan 10mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo sugar pill', 'description': 'Approximately 78 adult subjects with PH post-LVAD implantation will be randomized (1:1) to receive either macitentan 10 mg, or matching placebo, once daily orally.', 'interventionNames': ['Drug: Placebo sugar pill']}], 'interventions': [{'name': 'Macitentan 10mg', 'type': 'DRUG', 'otherNames': ['Active drug'], 'description': '2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo', 'armGroupLabels': ['Macitentan 10 mg po']}, {'name': 'Placebo sugar pill', 'type': 'DRUG', 'otherNames': ['placebo comparator'], 'description': '2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo', 'armGroupLabels': ['Placebo sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': '#125_Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': '#144_University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': '#106_Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': '#154_University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': '#110_Sutter Heart Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': '#132_University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': '#123_MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': '#126_Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': '#135_University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': '#113_Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': '#108_Indiana University Health Physicians Cardiology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46260', 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