Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-10 @ 2:08 PM
Study NCT ID:
NCT02516605
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630573', 'term': 'tropifexor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.', 'eventGroups': [{'id': 'EG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 16, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Trifascicular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Overgrowth bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal 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'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fold Change in Serum Gamma-glutamyl Transferase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Pooled Placebo', 'description': 'Placebo data from all cohorts were pooled.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.90'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.33', 'upperLimit': '0.50'}, {'value': '0.28', 'groupId': 'OG002', 'lowerLimit': '0.23', 'upperLimit': '0.33'}, {'value': 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'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'adjusted fold change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.36', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.47', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28', 'unitOfMeasure': 'fold-change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'PRIMARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 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'groupId': 'OG002'}, {'value': '129.5', 'spread': '17.42', 'groupId': 'OG003'}, {'value': '123.0', 'spread': '15.40', 'groupId': 'OG004'}]}]}, {'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '124.7', 'spread': '17.66', 'groupId': 'OG000'}, {'value': '128.4', 'spread': '13.83', 'groupId': 'OG001'}, {'value': '122.0', 'spread': '18.18', 'groupId': 'OG002'}, {'value': '132.3', 'spread': '18.09', 'groupId': 'OG003'}, {'value': '118.7', 'spread': '12.76', 'groupId': 'OG004'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '129.6', 'spread': '20.48', 'groupId': 'OG000'}, {'value': '122.4', 'spread': '20.24', 'groupId': 'OG001'}, {'value': '119.9', 'spread': '11.84', 'groupId': 'OG002'}, {'value': '129.1', 'spread': '25.12', 'groupId': 'OG003'}, {'value': '123.0', 'spread': '21.84', 'groupId': 'OG004'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '127.2', 'spread': '20.18', 'groupId': 'OG000'}, {'value': '123.7', 'spread': '13.04', 'groupId': 'OG001'}, {'value': '125.6', 'spread': '14.22', 'groupId': 'OG002'}, {'value': '128.0', 'spread': '26.58', 'groupId': 'OG003'}, {'value': '120.9', 'spread': '19.57', 'groupId': 'OG004'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '122.4', 'spread': '16.30', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '20.67', 'groupId': 'OG001'}, {'value': '127.1', 'spread': '16.45', 'groupId': 'OG002'}, {'value': '127.3', 'spread': '12.45', 'groupId': 'OG003'}, {'value': '118.7', 'spread': '12.88', 'groupId': 'OG004'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '121.5', 'spread': '11.25', 'groupId': 'OG000'}, {'value': '126.3', 'spread': '27.65', 'groupId': 'OG001'}, {'value': '123.9', 'spread': '13.14', 'groupId': 'OG002'}, {'value': '124.0', 'spread': '14.23', 'groupId': 'OG003'}, {'value': '124.5', 'spread': '19.8', 'groupId': 'OG004'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '118.0', 'spread': '11.22', 'groupId': 'OG000'}, {'value': '127.1', 'spread': '28.55', 'groupId': 'OG001'}, {'value': '121.4', 'spread': '12.82', 'groupId': 'OG002'}, {'value': '126.0', 'spread': '7.71', 'groupId': 'OG003'}, {'value': '120.1', 'spread': '22.38', 'groupId': 'OG004'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '121.4', 'spread': '10.76', 'groupId': 'OG000'}, {'value': '125.4', 'spread': '18.48', 'groupId': 'OG001'}, {'value': '121.5', 'spread': '11.55', 'groupId': 'OG002'}, {'value': '129.1', 'spread': '26.45', 'groupId': 'OG003'}, {'value': '123.8', 'spread': '19.74', 'groupId': 'OG004'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '131.3', 'spread': '16.04', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '15.77', 'groupId': 'OG001'}, {'value': '122.3', 'spread': '7.70', 'groupId': 'OG002'}, {'value': '130.4', 'spread': '25.51', 'groupId': 'OG003'}, {'value': '123.6', 'spread': '19.09', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Vital signs - Systolic Blood pressure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '68.6', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '61.2', 'spread': '7.05', 'groupId': 'OG001'}, {'value': '75.3', 'spread': '8.22', 'groupId': 'OG002'}, {'value': '72.8', 'spread': '8.26', 'groupId': 'OG003'}, {'value': '69.3', 'spread': '10.69', 'groupId': 'OG004'}]}]}, {'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '8.70', 'groupId': 'OG001'}, {'value': '70.8', 'spread': '8.63', 'groupId': 'OG002'}, {'value': '74.4', 'spread': '5.15', 'groupId': 'OG003'}, {'value': '66.3', 'spread': '9.30', 'groupId': 'OG004'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '11.93', 'groupId': 'OG000'}, {'value': '64.2', 'spread': '8.07', 'groupId': 'OG001'}, {'value': '69.7', 'spread': '7.50', 'groupId': 'OG002'}, {'value': '74.1', 'spread': '11.62', 'groupId': 'OG003'}, {'value': '67.6', 'spread': '8.35', 'groupId': 'OG004'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '65.2', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '11.31', 'groupId': 'OG001'}, {'value': '70.1', 'spread': '11.64', 'groupId': 'OG002'}, {'value': '73.5', 'spread': '8.33', 'groupId': 'OG003'}, {'value': '65.2', 'spread': '8.92', 'groupId': 'OG004'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '62.9', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '64.8', 'spread': '8.09', 'groupId': 'OG001'}, {'value': '70.5', 'spread': '14.16', 'groupId': 'OG002'}, {'value': '75.1', 'spread': '6.74', 'groupId': 'OG003'}, {'value': '66.1', 'spread': '9.61', 'groupId': 'OG004'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '65.5', 'spread': '8.26', 'groupId': 'OG000'}, {'value': '65.8', 'spread': '11.18', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '8.43', 'groupId': 'OG002'}, {'value': '72.5', 'spread': '6.75', 'groupId': 'OG003'}, {'value': '67.7', 'spread': '10.18', 'groupId': 'OG004'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '65.5', 'spread': '10.83', 'groupId': 'OG000'}, {'value': '68.9', 'spread': '10.60', 'groupId': 'OG001'}, {'value': '68.5', 'spread': '9.01', 'groupId': 'OG002'}, {'value': '67.2', 'spread': '3.42', 'groupId': 'OG003'}, {'value': '65.8', 'spread': '9.29', 'groupId': 'OG004'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '66.8', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '7.53', 'groupId': 'OG001'}, {'value': '69.7', 'spread': '8.17', 'groupId': 'OG002'}, {'value': '69.7', 'spread': '4.07', 'groupId': 'OG003'}, {'value': '68.1', 'spread': '10.11', 'groupId': 'OG004'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '65.6', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '9.11', 'groupId': 'OG001'}, {'value': '70.2', 'spread': '8.14', 'groupId': 'OG002'}, {'value': '72.8', 'spread': '8.12', 'groupId': 'OG003'}, {'value': '68.1', 'spread': '9.82', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Vital signs', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.605', 'spread': '0.2813', 'groupId': 'OG000'}, {'value': '36.567', 'spread': '0.2000', 'groupId': 'OG001'}, {'value': '36.424', 'spread': '0.3429', 'groupId': 'OG002'}, {'value': '36.650', 'spread': '0.1604', 'groupId': 'OG003'}, {'value': '36.460', 'spread': '0.4500', 'groupId': 'OG004'}]}]}, {'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.582', 'spread': '0.2960', 'groupId': 'OG000'}, {'value': '36.644', 'spread': '0.2128', 'groupId': 'OG001'}, {'value': '36.398', 'spread': '0.3385', 'groupId': 'OG002'}, {'value': '36.638', 'spread': '0.1506', 'groupId': 'OG003'}, {'value': '36.376', 'spread': '0.5118', 'groupId': 'OG004'}]}]}, {'title': 'day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.436', 'spread': '0.3139', 'groupId': 'OG000'}, {'value': '36.537', 'spread': '0.3076', 'groupId': 'OG001'}, {'value': '36.482', 'spread': '0.2636', 'groupId': 'OG002'}, {'value': '36.575', 'spread': '0.1982', 'groupId': 'OG003'}, {'value': '36.390', 'spread': '0.4867', 'groupId': 'OG004'}]}]}, {'title': 'day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.582', 'spread': '0.2040', 'groupId': 'OG000'}, {'value': '36.533', 'spread': '0.1323', 'groupId': 'OG001'}, {'value': '36.258', 'spread': '0.3965', 'groupId': 'OG002'}, {'value': '36.600', 'spread': '0.1195', 'groupId': 'OG003'}, {'value': '36.345', 'spread': '0.4639', 'groupId': 'OG004'}]}]}, {'title': 'day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.516', 'spread': '0.1793', 'groupId': 'OG000'}, {'value': '36.444', 'spread': '0.2007', 'groupId': 'OG001'}, {'value': '36.291', 'spread': '0.4109', 'groupId': 'OG002'}, {'value': '36.500', 'spread': '0.1826', 'groupId': 'OG003'}, {'value': '36.310', 'spread': '0.4576', 'groupId': 'OG004'}]}]}, {'title': 'day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.500', 'spread': '0.2490', 'groupId': 'OG000'}, {'value': '36.267', 'spread': '0.4637', 'groupId': 'OG001'}, {'value': '36.308', 'spread': '0.3288', 'groupId': 'OG002'}, {'value': '36.433', 'spread': '0.1966', 'groupId': 'OG003'}, {'value': '36.455', 'spread': '0.4236', 'groupId': 'OG004'}]}]}, {'title': 'day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.382', 'spread': '0.2228', 'groupId': 'OG000'}, {'value': '36.444', 'spread': '0.2128', 'groupId': 'OG001'}, {'value': '36.308', 'spread': '0.3397', 'groupId': 'OG002'}, {'value': '36.520', 'spread': '0.2950', 'groupId': 'OG003'}, {'value': '36.380', 'spread': '0.4047', 'groupId': 'OG004'}]}]}, {'title': 'day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.527', 'spread': '0.2102', 'groupId': 'OG000'}, {'value': '36.500', 'spread': '0.2179', 'groupId': 'OG001'}, {'value': '36.350', 'spread': '0.4602', 'groupId': 'OG002'}, {'value': '36.443', 'spread': '0.3309', 'groupId': 'OG003'}, {'value': '36.285', 'spread': '0.4246', 'groupId': 'OG004'}]}]}, {'title': 'day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.482', 'spread': '0.2483', 'groupId': 'OG000'}, {'value': '36.500', 'spread': '0.1500', 'groupId': 'OG001'}, {'value': '36.383', 'spread': '0.2980', 'groupId': 'OG002'}, {'value': '36.638', 'spread': '0.1506', 'groupId': 'OG003'}, {'value': '36.295', 'spread': '0.4248', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Vital signs', 'unitOfMeasure': 'Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'ECG - Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '65.8', 'spread': '11.32', 'groupId': 'OG000'}, {'value': '61.8', 'spread': '9.97', 'groupId': 'OG001'}, {'value': '67.3', 'spread': '5.58', 'groupId': 'OG002'}, {'value': '67.8', 'spread': '6.54', 'groupId': 'OG003'}, {'value': '63.4', 'spread': '9.35', 'groupId': 'OG004'}]}]}, {'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '61.4', 'spread': '8.75', 'groupId': 'OG001'}, {'value': '64.6', 'spread': '7.95', 'groupId': 'OG002'}, {'value': '67.9', 'spread': '6.45', 'groupId': 'OG003'}, {'value': '63.8', 'spread': '9.41', 'groupId': 'OG004'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '11.17', 'groupId': 'OG001'}, {'value': '63.9', 'spread': '8.21', 'groupId': 'OG002'}, {'value': '66.9', 'spread': '11.97', 'groupId': 'OG003'}, {'value': '63.5', 'spread': '7.12', 'groupId': 'OG004'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '65.2', 'spread': '11.95', 'groupId': 'OG001'}, {'value': '63.5', 'spread': '9.95', 'groupId': 'OG002'}, {'value': '65.8', 'spread': '4.55', 'groupId': 'OG003'}, {'value': '60.8', 'spread': '7.03', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Baseline, day 1, day 28', 'description': 'Electrocardiogram (ECG)', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'ECG Intervals - PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '159.2', 'spread': '27.34', 'groupId': 'OG000'}, {'value': '158.0', 'spread': '23.71', 'groupId': 'OG001'}, {'value': '172.0', 'spread': '24.12', 'groupId': 'OG002'}, {'value': '159.9', 'spread': '17.24', 'groupId': 'OG003'}, {'value': '162.6', 'spread': '19.03', 'groupId': 'OG004'}]}]}, {'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '165.8', 'spread': '20.81', 'groupId': 'OG000'}, {'value': '156.2', 'spread': '18.99', 'groupId': 'OG001'}, {'value': '175.0', 'spread': '34.96', 'groupId': 'OG002'}, {'value': '152.0', 'spread': '22.21', 'groupId': 'OG003'}, {'value': '160.3', 'spread': '19.77', 'groupId': 'OG004'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '165.5', 'spread': '21.76', 'groupId': 'OG000'}, {'value': '162.9', 'spread': '27.06', 'groupId': 'OG001'}, {'value': '175.7', 'spread': '28.29', 'groupId': 'OG002'}, {'value': '160.0', 'spread': '20.32', 'groupId': 'OG003'}, {'value': '161.6', 'spread': '20.28', 'groupId': 'OG004'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '164.9', 'spread': '19.75', 'groupId': 'OG000'}, {'value': '157.1', 'spread': '26.70', 'groupId': 'OG001'}, {'value': '180.4', 'spread': '31.63', 'groupId': 'OG002'}, {'value': '155.4', 'spread': '23.51', 'groupId': 'OG003'}, {'value': '160.2', 'spread': '28.70', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Baseline, day 1, day 28', 'description': 'Electrocardiogram (ECG)', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '127.9', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '125.6', 'spread': '11.70', 'groupId': 'OG001'}, {'value': '130.5', 'spread': '9.73', 'groupId': 'OG002'}, {'value': '133.9', 'spread': '12.70', 'groupId': 'OG003'}, {'value': '132.2', 'spread': '8.81', 'groupId': 'OG004'}]}]}, {'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '126.5', 'spread': '8.58', 'groupId': 'OG000'}, {'value': '127.4', 'spread': '11.85', 'groupId': 'OG001'}, {'value': '130.5', 'spread': '11.90', 'groupId': 'OG002'}, {'value': '134.6', 'spread': '13.24', 'groupId': 'OG003'}, {'value': '131.3', 'spread': '8.02', 'groupId': 'OG004'}]}]}, {'title': 'day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '124.7', 'spread': '8.21', 'groupId': 'OG000'}, {'value': '132.9', 'spread': '10.05', 'groupId': 'OG001'}, {'value': '127.0', 'spread': '9.03', 'groupId': 'OG002'}, {'value': '133.1', 'spread': '11.37', 'groupId': 'OG003'}, {'value': '126.8', 'spread': '7.63', 'groupId': 'OG004'}]}]}, {'title': 'day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '124.0', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '128.8', 'spread': '16.97', 'groupId': 'OG001'}, {'value': '132.4', 'spread': '10.66', 'groupId': 'OG002'}, {'value': '134.0', 'spread': '8.75', 'groupId': 'OG003'}, {'value': '128.6', 'spread': '9.18', 'groupId': 'OG004'}]}]}, {'title': 'day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '126.5', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '127.3', 'spread': '12.64', 'groupId': 'OG001'}, {'value': '128.6', 'spread': '7.82', 'groupId': 'OG002'}, {'value': '135.4', 'spread': '13.50', 'groupId': 'OG003'}, {'value': '128.7', 'spread': '10.84', 'groupId': 'OG004'}]}]}, {'title': 'day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '127.5', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '128.0', 'spread': '13.49', 'groupId': 'OG001'}, {'value': '130.5', 'spread': '10.40', 'groupId': 'OG002'}, {'value': '134.2', 'spread': '9.91', 'groupId': 'OG003'}, {'value': '128.8', 'spread': '10.79', 'groupId': 'OG004'}]}]}, {'title': 'day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '125.3', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '127.1', 'spread': '14.67', 'groupId': 'OG001'}, {'value': '129.6', 'spread': '10.02', 'groupId': 'OG002'}, {'value': '136.4', 'spread': '13.50', 'groupId': 'OG003'}, {'value': '125.7', 'spread': '9.71', 'groupId': 'OG004'}]}]}, {'title': 'day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '126.7', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '125.8', 'spread': '11.15', 'groupId': 'OG001'}, {'value': '128.6', 'spread': '10.63', 'groupId': 'OG002'}, {'value': '133.6', 'spread': '12.00', 'groupId': 'OG003'}, {'value': '129.3', 'spread': '11.39', 'groupId': 'OG004'}]}]}, {'title': 'day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '126.5', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '124.9', 'spread': '9.75', 'groupId': 'OG001'}, {'value': '125.9', 'spread': '11.19', 'groupId': 'OG002'}, {'value': '131.1', 'spread': '10.91', 'groupId': 'OG003'}, {'value': '129.3', 'spread': '9.24', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 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[{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.98', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '24.5', 'spread': '15.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.95', 'spread': '4.21', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '5.30', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '8.70', 'groupId': 'OG002'}, {'value': '44.2', 'spread': '25.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 28', 'description': "Tropifexor levels were determined in plasma using a validated LC-MS/MS method. AUC0-t=The area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration \\[mass x time / volume\\]", 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma PK Parameter - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.484', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.585', 'groupId': 'OG001'}, {'value': '2.37', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '4.84', 'spread': '2.59', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.559', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '0.946', 'groupId': 'OG001'}, {'value': '4.30', 'spread': '2.10', 'groupId': 'OG002'}, {'value': '6.37', 'spread': '3.40', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 28', 'description': 'Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Cmax=The observed maximum plasma concentration following drug administration \\[mass /volume\\]', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Plasma PK Parameter - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.12', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '8.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '3.70', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7.83'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '4.18'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.08', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '8.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '3.13', 'upperLimit': '7.60'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG003', 'lowerLimit': '3.03', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1, Day 28', 'description': 'Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Tmax = The time to reach the maximum concentration after drug administration \\[time\\]', 'unitOfMeasure': 'hr', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Total PBC-40 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days.'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days.'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-14', 'upperLimit': '16'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '-7', 'upperLimit': '13'}, {'value': '-1.0', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '43'}, {'value': '-2.0', 'groupId': 'OG004', 'lowerLimit': '-23', 'upperLimit': '26'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '29'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '23'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-15', 'upperLimit': '16'}, {'value': '-3.0', 'groupId': 'OG003', 'lowerLimit': '-28', 'upperLimit': '3'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '-12', 'upperLimit': '30'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-12', 'upperLimit': '13'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-14', 'upperLimit': '16'}, {'value': '-3.5', 'groupId': 'OG002', 'lowerLimit': '-38', 'upperLimit': '10'}, {'value': '-1.0', 'groupId': 'OG003', 'lowerLimit': '-12', 'upperLimit': '5'}, {'value': '1.5', 'groupId': 'OG004', 'lowerLimit': '-38', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.898', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '6.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.593', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '10.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.509', 'groupIds': ['OG000'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.0', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '4.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.591', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.5', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '7.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.702', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.0', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '4.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.838', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '8.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.297', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.0', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '8.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.236', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.0', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.192', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.5', 'ciLowerLimit': '-15.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.605', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '9.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.037', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.0', 'ciLowerLimit': '-21.0', 'ciUpperLimit': '-1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.397', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.5', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '3.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 28, Day 56, Day 84', 'description': 'Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. All questions within a domain are summed and all domain totals are summed to obtain a total score. The total score range is between a minimum of 40 and a maximum of 200. Higher scores represent a poorer quality of life. The median difference from baseline in total sum score for each treatment group is presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Subdomain of PBC-40 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days.'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days.'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '-2', 'upperLimit': '10'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-4', 'upperLimit': '9'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-3', 'upperLimit': '12'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-3', 'upperLimit': '8'}]}]}], 'analyses': [{'pValue': '0.342', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.699', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.377', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.132', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.292', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.979', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.102', 'groupIds': ['OG002'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '4.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.717', 'groupIds': ['OG002'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '1.000', 'groupIds': ['OG002'], 'paramType': 'Median difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.142', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '5.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.975', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.602', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 28, Day 56, Day 84', 'description': 'Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. This dataset focuses on the itch subdomain which consists of 3 questions. These 3 questions within the itch subdomain are summed to obtain a total score for the itch subdomain. The total score range is between a minimum of 3 and a maximum of 15. Higher scores represent a poorer quality of life. The median change from baseline in total itch subdomain score in each treatment group is presented.', 'unitOfMeasure': 'UNITS ON A SCALE', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Itch Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days.'}, {'id': 'OG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'OG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'OG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.04', 'groupId': 'OG000', 'lowerLimit': '-13.84', 'upperLimit': '9.75'}, {'value': '12.08', 'groupId': 'OG001', 'lowerLimit': '0.33', 'upperLimit': '23.83'}, {'value': '14.66', 'groupId': 'OG002', 'lowerLimit': '4.16', 'upperLimit': '25.16'}, {'value': '27.45', 'groupId': 'OG003', 'lowerLimit': '15.00', 'upperLimit': '39.89'}, {'value': '0.74', 'groupId': 'OG004', 'lowerLimit': '-7.17', 'upperLimit': '8.66'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-8.04', 'groupId': 'OG000', 'lowerLimit': '-19.55', 'upperLimit': '3.48'}, {'value': '13.77', 'groupId': 'OG001', 'lowerLimit': '2.30', 'upperLimit': '25.23'}, {'value': '6.51', 'groupId': 'OG002', 'lowerLimit': '-3.76', 'upperLimit': '16.78'}, {'value': '14.20', 'groupId': 'OG003', 'lowerLimit': '1.26', 'upperLimit': '27.13'}, {'value': '6.03', 'groupId': 'OG004', 'lowerLimit': '-1.70', 'upperLimit': '13.76'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.53', 'groupId': 'OG000', 'lowerLimit': '-1.66', 'upperLimit': '22.72'}, {'value': '19.54', 'groupId': 'OG001', 'lowerLimit': '7.40', 'upperLimit': '31.68'}, {'value': '7.76', 'groupId': 'OG002', 'lowerLimit': '-3.11', 'upperLimit': '18.64'}, {'value': '8.65', 'groupId': 'OG003', 'lowerLimit': '-5.90', 'upperLimit': '23.20'}, {'value': '2.74', 'groupId': 'OG004', 'lowerLimit': '-5.44', 'upperLimit': '10.93'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.62', 'groupId': 'OG000', 'lowerLimit': '-4.24', 'upperLimit': '21.48'}, {'value': '15.64', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '28.44'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '-9.69', 'upperLimit': '13.26'}, {'value': '10.50', 'groupId': 'OG003', 'lowerLimit': '-5.52', 'upperLimit': '26.51'}, {'value': '1.59', 'groupId': 'OG004', 'lowerLimit': '-7.04', 'upperLimit': '10.22'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-7.81', 'groupId': 'OG000', 'lowerLimit': '-17.87', 'upperLimit': '2.26'}, {'value': '5.69', 'groupId': 'OG001', 'lowerLimit': '-4.33', 'upperLimit': '15.72'}, {'value': '-6.38', 'groupId': 'OG002', 'lowerLimit': '-15.35', 'upperLimit': '2.59'}, {'value': '-3.64', 'groupId': 'OG003', 'lowerLimit': '-14.58', 'upperLimit': '7.30'}, {'value': '7.44', 'groupId': 'OG004', 'lowerLimit': '0.68', 'upperLimit': '14.20'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-5.14', 'groupId': 'OG000', 'lowerLimit': '-17.15', 'upperLimit': '6.88'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '-11.08', 'upperLimit': '12.85'}, {'value': '-6.44', 'groupId': 'OG002', 'lowerLimit': '-17.13', 'upperLimit': '4.26'}, {'value': '-5.14', 'groupId': 'OG003', 'lowerLimit': '-17.81', 'upperLimit': '7.53'}, {'value': '11.79', 'groupId': 'OG004', 'lowerLimit': '3.73', 'upperLimit': '19.86'}]}]}], 'analyses': [{'pValue': '0.743', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.78', 'ciLowerLimit': '-16.91', 'ciUpperLimit': '11.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.436', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 7'}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-14.07', 'ciLowerLimit': '-27.85', 'ciUpperLimit': '-0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.229', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 14'}, {'pValue': '0.376', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.78', 'ciLowerLimit': '-6.81', 'ciUpperLimit': '22.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.710', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 21'}, {'pValue': '0.448', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.03', 'ciLowerLimit': '-8.36', 'ciUpperLimit': '22.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.187', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-15.25', 'ciLowerLimit': '-27.30', 'ciUpperLimit': '-3.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.192', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.93', 'ciLowerLimit': '-31.31', 'ciUpperLimit': '-2.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.592', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.185', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.34', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '25.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.434', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 7'}, {'pValue': '0.351', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.74', 'ciLowerLimit': '-6.05', 'ciUpperLimit': '21.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.226', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 14'}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '16.79', 'ciLowerLimit': '2.20', 'ciUpperLimit': '31.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.707', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'day 21'}, {'pValue': '0.132', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '14.05', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '29.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.184', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.809', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.75', 'ciLowerLimit': '-13.80', 'ciUpperLimit': '10.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.190', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.210', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-10.90', 'ciLowerLimit': '-25.29', 'ciUpperLimit': '3.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.590', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.086', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciPctValue': '90', 'paramValue': '13.92', 'ciLowerLimit': '0.58', 'ciUpperLimit': '27.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.963', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'day 7'}, {'pValue': '0.951', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.48', 'ciLowerLimit': '-12.57', 'ciUpperLimit': '13.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.787', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 14'}, {'pValue': '0.545', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.02', 'ciLowerLimit': '-8.79', 'ciUpperLimit': '18.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.244', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'day 21'}, {'pValue': '0.982', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.19', 'ciLowerLimit': '-14.38', 'ciUpperLimit': '14.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.697', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.047', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.82', 'ciLowerLimit': '-25.21', 'ciUpperLimit': '-2.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.797', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'day 56'}, {'pValue': '0.029', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-18.23', 'ciLowerLimit': '-31.81', 'ciUpperLimit': '-4.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.110', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}, {'pValue': '0.004', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '26.70', 'ciLowerLimit': '11.97', 'ciUpperLimit': '41.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.799', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 7'}, {'pValue': '0.370', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.17', 'ciLowerLimit': '-6.96', 'ciUpperLimit': '23.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.032', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 14'}, {'pValue': '0.558', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.90', 'ciLowerLimit': '-10.86', 'ciUpperLimit': '22.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.014', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 21'}, {'pValue': '0.418', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.91', 'ciLowerLimit': '-9.34', 'ciUpperLimit': '27.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.911', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 28'}, {'pValue': '0.156', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.08', 'ciLowerLimit': '-23.95', 'ciUpperLimit': '1.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.690', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 56'}, {'pValue': '0.064', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Median difference from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.93', 'ciLowerLimit': '-31.94', 'ciUpperLimit': '-1.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.961', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Day 84'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Day 14, Day 21, Day 28, Day 56, and Day 84', 'description': 'Baseline is defined as the latest available predose value. The Global Itch Visual Analogue Scale, a 100 mm visual analogue scale (VAS), was used to assess the severity of patients itch (ranging from 0 = none at all to 100 = the worst imaginable itch). The score range is between a minimum of 0 and a maximum of 100. The score (distance in mm from left) on the VAS was recorded by the patient marking with a line and used to test for an effect of tropifexor over placebo. The mean change from baseline in itch VAS score in each treatment group is presented.', 'unitOfMeasure': 'mm', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days'}, {'id': 'FG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'FG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'FG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'FG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study comprised of an escalating multiple dose design in PBC patients with incomplete biochemical response to, but still taking, ursodeoxycholic acid (UDCA).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'LJN452 - 0.03 mg qd', 'description': 'Tropifexor 0.03 mg daily for 28 days'}, {'id': 'BG001', 'title': 'LJN452 - 0.06 mg qd', 'description': 'Tropifexor 0.06 mg daily for 28 days'}, {'id': 'BG002', 'title': 'LJN452 - 0.09 mg qd', 'description': 'Tropifexor 0.09 mg daily for 28 days'}, {'id': 'BG003', 'title': 'LJN452 - 0.15 mg qd', 'description': 'Tropifexor 0.15 mg daily for 28 days'}, {'id': 'BG004', 'title': 'Placebo qd', 'description': 'Tropifexor placebo daily for 28 days'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '12.42', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '11.21', 'groupId': 'BG001'}, {'value': '53.6', 'spread': '7.42', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '13.81', 'groupId': 'BG003'}, {'value': '53.7', 'spread': '10.19', 'groupId': 'BG004'}, {'value': '55.7', 'spread': '10.70', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The safety analysis set included all subjects who received any study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-27', 'size': 916444, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-01T09:56', 'hasProtocol': True}, {'date': '2018-10-04', 'size': 306013, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-16T16:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2015-08-04', 'resultsFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-25', 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fold Change in Serum Gamma-glutamyl Transferase (GGT)', 'timeFrame': 'Baseline to Day 28', 'description': 'Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28'}, {'measure': 'Blood Pressure', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Vital signs - Systolic Blood pressure'}, {'measure': 'Pulse Rate', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Vital signs'}, {'measure': 'Body Temperature', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Vital signs'}, {'measure': 'ECG - Heart Rate', 'timeFrame': 'Screening, Baseline, day 1, day 28', 'description': 'Electrocardiogram (ECG)'}, {'measure': 'ECG Intervals - PR Interval', 'timeFrame': 'Screening, Baseline, day 1, day 28', 'description': 'Electrocardiogram (ECG)'}, {'measure': 'Haemoglobin', 'timeFrame': 'Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84', 'description': 'Hematology panel for safety laboratory assessments.'}], 'secondaryOutcomes': [{'measure': 'Plasma PK Parameter - AUC 0-8h', 'timeFrame': 'Day 1, Day 28', 'description': "Tropifexor levels were determined in plasma using a validated LC-MS/MS method. AUC0-t=The area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration \\[mass x time / volume\\]"}, {'measure': 'Plasma PK Parameter - Cmax', 'timeFrame': 'Day 1, Day 28', 'description': 'Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Cmax=The observed maximum plasma concentration following drug administration \\[mass /volume\\]'}, {'measure': 'Plasma PK Parameter - Tmax', 'timeFrame': 'Day 1, Day 28', 'description': 'Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Tmax = The time to reach the maximum concentration after drug administration \\[time\\]'}, {'measure': 'Changes From Baseline in Total PBC-40 Score', 'timeFrame': 'Baseline, Day 28, Day 56, Day 84', 'description': 'Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. All questions within a domain are summed and all domain totals are summed to obtain a total score. The total score range is between a minimum of 40 and a maximum of 200. Higher scores represent a poorer quality of life. The median difference from baseline in total sum score for each treatment group is presented.'}, {'measure': 'Change From Baseline in Itch Subdomain of PBC-40 Score', 'timeFrame': 'Baseline, Day 28, Day 56, Day 84', 'description': 'Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. This dataset focuses on the itch subdomain which consists of 3 questions. These 3 questions within the itch subdomain are summed to obtain a total score for the itch subdomain. The total score range is between a minimum of 3 and a maximum of 15. Higher scores represent a poorer quality of life. The median change from baseline in total itch subdomain score in each treatment group is presented.'}, {'measure': 'Change From Baseline in Global Itch Visual Analogue Scale (VAS)', 'timeFrame': 'Day 7, Day 14, Day 21, Day 28, Day 56, and Day 84', 'description': 'Baseline is defined as the latest available predose value. The Global Itch Visual Analogue Scale, a 100 mm visual analogue scale (VAS), was used to assess the severity of patients itch (ranging from 0 = none at all to 100 = the worst imaginable itch). The score range is between a minimum of 0 and a maximum of 100. The score (distance in mm from left) on the VAS was recorded by the patient marking with a line and used to test for an effect of tropifexor over placebo. The mean change from baseline in itch VAS score in each treatment group is presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Biliary Cirrhosis, PBC', 'Primary Biliary Cholangitis'], 'conditions': ['Primary Biliary Cholangitis']}, 'referencesModule': {'references': [{'pmid': '36267872', 'type': 'DERIVED', 'citation': 'Schramm C, Wedemeyer H, Mason A, Hirschfield GM, Levy C, Kowdley KV, Milkiewicz P, Janczewska E, Malova ES, Sanni J, Koo P, Chen J, Choudhury S, Klickstein LB, Badman MK, Jones D. Farnesoid X receptor agonist tropifexor attenuates cholestasis in a randomised trial in patients with primary biliary cholangitis. JHEP Rep. 2022 Jul 21;4(11):100544. doi: 10.1016/j.jhepr.2022.100544. eCollection 2022 Nov.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=322', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of PBC as demonstrated by the presence of at least 2 of the following 3 diagnostic criteria:\n\n * History of alkaline phosphatase (ALP) elevated above upper limit of normal (ULN) for at least 6 months\n * Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (\\<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components (PDC-E2, 2-oxo-glutaric acid dehydrogenase complex))\n * Previous liver biopsy findings consistent with PBC\n* At least 1 of the following markers of disease severity:\n\n * ALP ≥ 1.67 × ULN\n * Total bilirubin \\> ULN but \\< 1.5 × ULN\n* In addition, patients must meet the following biochemical criteria at enrollment:\n\n * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 × ULN\n * Total bilirubin ≤ 1.5 × ULN\n * INR ≤ ULN\n* Taking UDCA for at least 12 months, or for at least 6 months and has reached maximal response to UDCA with a plateau in alkaline phosphatase, with no changes in dose for ≥ 3 months prior to Day 1.\n* Patients must weigh at least 40 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2. BMI = Body weight (kg) / \\[Height (m)\\]2\n\nExclusion Criteria:\n\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception for 30 days before randomization, during dosing and for 30 days following the end of treatment.\n* Presence of other concomitant liver diseases.\n\n * Cirrhosis with complications, including history or presence of:\n * Variceal bleed\n * Uncontrolled ascites\n * Encephalopathy\n * Spontaneous bacterial peritonitis\n* Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.\n* History of conditions that may cause increases in ALP (e.g., Paget's disease).\n* Use of investigational drugs, or immunosuppressive drugs at the time of enrollment, or within 5 half-lives, or 30 days of randomization, whichever is longer; or longer if required by local regulations. Use of high dose oral steroids to treat co-morbid conditions (e.g., airways disease) will be allowed but must be properly documented as such in concomitant medications.\n* Currently taking obeticholic acid or have taken obeticholic acid within 30 days of randomization\n* Previous participation in CLJN452X2201 and received study medication within three months of randomization (or longer if required by local regulations)."}, 'identificationModule': {'nctId': 'NCT02516605', 'briefTitle': 'A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary Cholangitis', 'orgStudyIdInfo': {'id': 'CLJN452X2201'}, 'secondaryIdInfos': [{'id': '2015-001590-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LJN452', 'interventionNames': ['Drug: Part 1: LJN452', 'Drug: Part 2: LJN452 Dose level 1', 'Drug: Part 2: LJN452 Dose level 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Part 1: Placebo', 'Drug: Part 2: Placebo']}], 'interventions': [{'name': 'Part 1: LJN452', 'type': 'DRUG', 'otherNames': ['tropifexor'], 'description': 'LJN452 capsules administered once daily for 28 days', 'armGroupLabels': ['LJN452']}, {'name': 'Part 1: Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules administered once daily for 28 days', 'armGroupLabels': ['Placebo']}, {'name': 'Part 2: LJN452 Dose level 1', 'type': 'DRUG', 'otherNames': ['tropifexor'], 'description': 'LJN452 capsules administered once a day for 12 weeks', 'armGroupLabels': ['LJN452']}, {'name': 'Part 2: Placebo', 'type': 'DRUG', 'description': 'Matching placebo to LJN452 administered once a day for 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Part 2: LJN452 Dose level 2', 'type': 'DRUG', 'otherNames': ['tropifexor'], 'description': 'LJN452', 'armGroupLabels': ['LJN452']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United 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