Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02657356
Status:
TERMINATED
Last Update Posted:
2025-06-04
First Post:
2016-01-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], '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': 'C445068', 'term': 'bardoxolone methyl'}, {'id': 'C116742', 'term': 'ORF 50 transactivator'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'US Biogen Clinical Trial Center', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 weeks', 'description': 'All adverse events that are observed or reported by the patient during the study (from the time of administration of the first dose at Day 1 until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Capsules', 'description': 'Placebo capsules administered orally once a day for 24 weeks with sham titration.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 79, 'seriousNumAtRisk': 102, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Bardoxolone Methyl Capsules', 'description': 'Bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient was 5 mg and dose-escalated to 10 mg at Week 4, unless contraindicated clinically.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 85, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'N-terminal prohormone brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Proctitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Capsules', 'description': 'Placebo capsules administered orally once a day for 24 weeks with sham titration.'}, {'id': 'OG001', 'title': 'Bardoxolone Methyl Capsules', 'description': 'Bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient was 5 mg and dose-escalated to 10 mg at Week 4, unless contraindicated clinically.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.25', 'spread': '4.954', 'groupId': 'OG000'}, {'value': '-3.61', 'spread': '4.952', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.86', 'ciLowerLimit': '-26.69', 'ciUpperLimit': '0.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.012', 'estimateComment': 'Difference is bardoxolone methyl - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates: screening 6MWT, day 1 hemoglobin, treatment grp, # of PAH medications, time, interactions btwn treatment \\& time, and screening 6MWT \\& time'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 24 weeks after participant receives the first dose', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized patients categorized by their assigned treatment group regardless of treatment exposure)'}, {'type': 'SECONDARY', 'title': 'Time to First Persistent Clinical Improvement Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Capsules', 'description': 'Placebo capsules administered orally once a day for 24 weeks with sham titration.'}, {'id': 'OG001', 'title': 'Bardoxolone Methyl Capsules', 'description': 'Bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient was 5 mg and dose-escalated to 10 mg at Week 4, unless contraindicated clinically.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '1.263', 'groupId': 'OG000'}, {'value': '6.62', 'spread': '0.646', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.984', 'ciLowerLimit': '1.360', 'ciUpperLimit': '2.895', 'estimateComment': 'Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \\>1 indicates a beneficial effect that favors bardoxolone methyl.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through the end of the study', 'description': 'At least one of the following four criteria must have been met:\n\n1. Improvement by at least one WHO functional class coupled with no more than a 15% decrease from baseline in 6MWT\n2. Increase from baseline in 6MWT by at least 10% and stability or improvement in the WHO functional class\n3. Decrease from baseline in creatine kinase (a surrogate biomarker for muscle injury and inflammation) by at least 10% and no worsening in WHO functional class and no more than a 15% decrease from baseline in 6MWT\n4. Improvement in estimated glomerular filtration rate eGFR ≥10% of baseline The persistence of the change in WHO functional class, 6MWT, eGFR, or creatine kinase must be confirmed by a subsequent assessment at least 14 days after the initial assessment, or at the next scheduled assessment. If persistent improvement is confirmed, the date of the event was considered the initial assessment of improved WHO functional class, 6MWT, eGFR, or creatine kinase.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized patients categorized by their assigned treatment group regardless of treatment exposure)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Capsules', 'description': 'Placebo capsules administered orally once a day for 24 weeks with sham titration.'}, {'id': 'FG001', 'title': 'Bardoxolone Methyl Capsules', 'description': 'Bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient was 5 mg and dose-escalated to 10 mg at Week 4, unless contraindicated clinically.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Rolled over to EAP study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Capsules', 'description': 'Placebo capsules administered orally once a day for 24 weeks with sham titration.'}, {'id': 'BG001', 'title': 'Bardoxolone Methyl Capsules', 'description': 'Bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient was 5 mg and dose-escalated to 10 mg at Week 4, unless contraindicated clinically.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '13.17', 'groupId': 'BG000'}, {'value': '55', 'spread': '13.57', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '13.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Median Age', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '75'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '75'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '143', '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': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', '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': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Six Minute Walk Distance (6MWD)', 'classes': [{'categories': [{'measurements': [{'value': '380.4', 'spread': '91.19', 'groupId': 'BG000'}, {'value': '389.1', 'spread': '107.78', 'groupId': 'BG001'}, {'value': '384.7', 'spread': '99.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline 6MWD measured using the Six Minute Walk Test (6MWT)', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent to treat (ITT) population (all randomized patients categorized by their assigned treatment group regardless of treatment exposure)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-18', 'size': 1117549, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-05T16:20', 'hasProtocol': True}, {'date': '2020-05-26', 'size': 1129753, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-05T16:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'whyStopped': 'Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2021-04-28', 'completionDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2016-01-13', 'dispFirstSubmitQcDate': '2021-04-28', 'resultsFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2016-01-14', 'dispFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-25', 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24', 'timeFrame': 'Baseline through 24 weeks after participant receives the first dose'}], 'secondaryOutcomes': [{'measure': 'Time to First Persistent Clinical Improvement Event', 'timeFrame': 'Baseline through the end of the study', 'description': 'At least one of the following four criteria must have been met:\n\n1. Improvement by at least one WHO functional class coupled with no more than a 15% decrease from baseline in 6MWT\n2. Increase from baseline in 6MWT by at least 10% and stability or improvement in the WHO functional class\n3. Decrease from baseline in creatine kinase (a surrogate biomarker for muscle injury and inflammation) by at least 10% and no worsening in WHO functional class and no more than a 15% decrease from baseline in 6MWT\n4. Improvement in estimated glomerular filtration rate eGFR ≥10% of baseline The persistence of the change in WHO functional class, 6MWT, eGFR, or creatine kinase must be confirmed by a subsequent assessment at least 14 days after the initial assessment, or at the next scheduled assessment. If persistent improvement is confirmed, the date of the event was considered the initial assessment of improved WHO functional class, 6MWT, eGFR, or creatine kinase.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Pulmonary Arterial Hypertension', 'Connective Tissue Disease-Associated Pulmonary Arterial Hypertension', 'Bardoxolone methyl', 'PAH', 'RTA 402', '6-minute walk distance'], 'conditions': ['Connective Tissue Disease-Associated Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.', 'detailedDescription': 'This double-blind, randomized, placebo-controlled trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with World Health Organization Group I Connective Tissue Disease Pulmonary Arterial Hypertension (WHO Group I CTD-PAH).\n\nQualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Patients randomized to placebo will remain on placebo throughout the study. Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4 unless contraindicated clinically. Dose de-escalation is permitted during the study if indicated clinically.\n\nAll patients in the study will follow the same visit and assessment schedule. Following randomization, patients will be scheduled to be assessed in person during treatment at Weeks 1, 2, 4, 6, 8, 16, and 24 and by telephone contact on Days 3, 10, 21, 31, 38, 84, and 140. Patients will also be scheduled to be assessed at an in person follow up visit at Week 28, four weeks after the end of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 18.5 kg/m2;\n* Symptomatic pulmonary hypertension WHO/NYHA FC class II and III;\n* WHO Group I PAH associated with connective tissue disease;\n* Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PAH according to all the following criteria:\n\n * Mean pulmonary artery pressure ≥ 25 mm Hg (at rest);\n * Pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg;\n * Pulmonary vascular resistance \\> 240 dyn.sec/cm5 or \\> 3 mm Hg/liter (L)/minute;\n* Has BNP level ≤ 400 pg/mL;\n* Had an average 6MWD ≥ 150 meters on two consecutive tests performed on different days prior to randomization, with both tests measuring within 15% of one another;\n* Has been receiving no more than two (2) approved disease-specific PAH therapies. PAH therapy must have been at a stable dose for at least 90 days prior to Day 1. No additions or changes should be made to PAH therapies and doses should remain stable for the duration of the study;\n* Has maintained a stable dose for 30 days prior to Day 1 if receiving any of the following therapies that may affect PAH: vasodilators (including calcium channel blockers), digoxin, L-arginine supplementation, or oxygen supplementation. No additions or changes should be made to therapies and doses should remain stable for the duration of the study;\n* If receiving treatment for CTD with prednisone or any other drugs, doses must remain stable for at least 30 days prior to Day 1 and for the duration of the study Had pulmonary function tests (PFTs) within 90 days prior to Day 1 with total lung capacity ≥ 65% (predicted);\n* Had a ventilation-perfusion (V/Q) lung scan, spiral/helical/electron beam computed tomography (CT), or pulmonary angiogram prior to Day 1 that shows no evidence of thromboembolic disease (i.e., should note normal or low probability for pulmonary embolism). If V/Q scan was abnormal (i.e., results other than normal or low probability), then a confirmatory CT or selective pulmonary angiography must exclude chronic thromboembolic pulmonary hypertension;\n* Has adequate kidney function defined as an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 as measured by the central lab;\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;\n* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any patient-mandated procedures\n\nExclusion Criteria:\n\n* Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1;\n* Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day 1 or planned initiation during the study;\n* Stopped receiving any PAH chronic therapy within 60 days prior to Day 1;\n* Received a dose of prednisone \\> 20 mg/day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1;\n* Received intravenous (iv) or subcutaneous (sc) prostacyclin/prostacyclin analogues within 90 days prior to Day 1;\n* Received intravenous inotropes within 30 days prior to Day 1;\n* Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) \\> 160 mm Hg or sitting diastolic BP \\> 100 mm Hg during Screening after a period of rest;\n* Has systolic BP \\< 90 mm Hg during Screening after a period of rest;\n* Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:\n\n * Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension;\n * Pericardial constriction;\n * Restrictive or congestive cardiomyopathy;\n * Left ventricular ejection fraction \\< 40% per echocardiogram (ECHO) within 90 days of Day 1;\n * Symptomatic coronary artery disease within the last 3 years;\n* Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment;\n* Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction:\n\n * Age \\> 65 years;\n * BMI ≥ 30 kg/m2;\n * History of systemic hypertension;\n * History of type 2 diabetes;\n * History of atrial fibrillation;\n * History of atrial septostomy within 180 days prior to Day 1;\n * History of uncontrolled obstructive sleep apnea;\n* Has a history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication) defined as mild to severe hepatic impairment (Child-Pugh Class A-C);\n* Serum aminotransferase (ALT or AST) levels \\> 1.5X the upper limit of normal (ULN) at Screening;\n* Hemoglobin (Hgb) concentration \\< 8.5 g/dL at Screening;\n* Diagnosis of Down syndrome;\n* History of malignancy within 5 years prior to screening, with the exception of localized skin or cervical carcinomas;\n* Untreated or uncontrolled active bacterial, fungal, or viral infection;\n* Known or suspected active drug or alcohol abuse, per investigator judgment;\n* Use of Herbalife supplements within 14 days prior to Day 1;\n* Major surgery within 30 days prior to Day 1 or planned to occur during the course of the study;\n* Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;\n* Use of inhaled nitric oxide within 7 days prior to Screening and Day 1 visits, excluding acute vasodilator testing during diagnostic cardiac catheterization;\n* Women who are pregnant or breastfeeding;\n* Any disability or impairment that would prohibit performance of the 6MWT;\n* Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment;\n* Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;\n* Known hypersensitivity to any component of the study drug;\n* Unable to communicate or cooperate with the investigator because of language problems, poor mental development, or impaired cerebral function.'}, 'identificationModule': {'nctId': 'NCT02657356', 'briefTitle': 'Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'RTA 402-C-1504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules', 'description': 'Placebo capsules will be administered orally once a day for 24 weeks.', 'interventionNames': ['Drug: Placebo capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Bardoxolone methyl capsules', 'description': 'Each patient will receive bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient is 5 mg and will dose-escalate to 10 mg at Week 4, unless contraindicated clinically.', 'interventionNames': ['Drug: Bardoxolone methyl capsules']}], 'interventions': [{'name': 'Placebo capsules', 'type': 'DRUG', 'armGroupLabels': ['Placebo capsules']}, {'name': 'Bardoxolone methyl capsules', 'type': 'DRUG', 'otherNames': ['RTA 402 capsules'], 'armGroupLabels': ['Bardoxolone methyl capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center, Phoenix Advanced Lung Disease Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pulmonary Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Regents of The University of California', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Pulmonary Research, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Pulmonary Associates', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center - Department of Rheumatology', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30106', 'city': 'Austell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont-Georgia Lung', 'geoPoint': {'lat': 33.81261, 'lon': -84.63438}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana Pulmonary Associates', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester - University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wexner Medical Center at The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Integris Nazih Zuhdi Transplant Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'C1093AAS', 'city': 'Buenos Aires', 'state': 'Ciudad Autónoma de BuenosAires', 'country': 'Argentina', 'facility': 'Fundación Favaloro', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1280AEB', 'city': 'Buenos Aires', 'state': 'Ciudad Autónoma de BuenosAires', 'country': 'Argentina', 'facility': 'Hospital Británico de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ABP', 'city': 'Buenos Aires', 'state': 'Ciudad Autónoma de BuenosAires', 'country': 'Argentina', 'facility': 'Centro Médico Dra de Salvo', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B7600FZN', 'city': 'Buenos Aires', 'state': 'Mar Del Plata', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clínicas Mar Del Plata', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1853AIK', 'city': 'Buenos Aires', 'state': 'Villa Vatteone', 'country': 'Argentina', 'facility': 'Instituto De Enfermedades Respiratorias E Investigacion Medica', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'W3400AMZ', 'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Instituto de Cardiologia de Corrientes Juana Francisca Cabral', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}, {'zip': 'X5004CDP', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Cordoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5016KEH', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Privado Centro Médico de Córdoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '3600', 'city': 'Formosa', 'country': 'Argentina', 'facility': 'Hospital de Alta Complejidad "Pte. 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