Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-03-09 @ 4:22 AM
Study NCT ID:
NCT01865812
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2013-05-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
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': 'C464660', 'term': 'obeticholic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@interceptpharma.com', 'phone': '+1 844-782-4278', 'title': 'Medical Information', 'organization': 'Intercept Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Principal Investigators must wait 18 months after the study ends to publish their results and a multi-center publication must come first. The sponsor has a 45 day review period with the option to extend to an additional 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time of the first dose of investigational product until the participant fully completed participation in the study, up to 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 17, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '-0.24'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'PRIMARY', 'title': 'Absolute Change From Baseline In HDL Particle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '-0.25'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.25', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'unitOfMeasure': 'nm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'PRIMARY', 'title': 'Absolute Change From Baseline In HDL Particle Number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-1.58', 'upperLimit': '1.46'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '1.46', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'unitOfMeasure': 'umol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2072', 'groupId': 'OG000', 'lowerLimit': '-0.5957', 'upperLimit': '-0.0259'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3108', 'groupId': 'OG000', 'lowerLimit': '-0.4403', 'upperLimit': '-0.0777'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0518', 'groupId': 'OG000', 'lowerLimit': '-0.2849', 'upperLimit': '0.1554'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '-0.10'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '-0.10'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'unitOfMeasure': 'nm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '-2.60', 'upperLimit': '1.60'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '1.70'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '3.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Week 8 In HDL Cholesterol Concentration At Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3108', 'groupId': 'OG000', 'lowerLimit': '0.1036', 'upperLimit': '0.5180'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8, Week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Week 8 In HDL Particle Size At Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8, Week 12', 'unitOfMeasure': 'nm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Week 8 In HDL Particle Number At Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '3.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8, Week 12', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) Of OCA And Conjugates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'title': 'OCA', 'categories': [{'measurements': [{'value': '107', 'spread': '112', 'groupId': 'OG000'}]}]}, {'title': 'Glycine Conjugate (Glyco)-OCA', 'categories': [{'measurements': [{'value': '212', 'spread': '144', 'groupId': 'OG000'}]}]}, {'title': 'Taurine Conjugate (Tauro)-OCA', 'categories': [{'measurements': [{'value': '219', 'spread': '208', 'groupId': 'OG000'}]}]}, {'title': 'Total-OCA', 'categories': [{'measurements': [{'value': '409', 'spread': '299', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Results are reported in nanograms per milliliter (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses.'}, {'type': 'SECONDARY', 'title': 'Time To Reach Cmax (Tmax) For OCA And Conjugates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'title': 'OCA', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.750', 'upperLimit': '4.00'}]}]}, {'title': 'Glyco-OCA', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '6.00'}]}]}, {'title': 'Tauro-OCA', 'categories': [{'measurements': [{'value': '5.98', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '6.00'}]}]}, {'title': 'Total-OCA', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8', 'description': 'Results are reported in hours (h).', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses.'}, {'type': 'SECONDARY', 'title': 'Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}], 'classes': [{'title': 'OCA', 'categories': [{'measurements': [{'value': '189', 'spread': '185', 'groupId': 'OG000'}]}]}, {'title': 'Glyco-OCA', 'categories': [{'measurements': [{'value': '702', 'spread': '644', 'groupId': 'OG000'}]}]}, {'title': 'Tauro-OCA', 'categories': [{'measurements': [{'value': '698', 'spread': '653', 'groupId': 'OG000'}]}]}, {'title': 'Total-OCA', 'categories': [{'measurements': [{'value': '1360', 'spread': '1150', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Results are reported in hour\\*nanograms per milliliter (h\\*ng/mL).', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0518', 'groupId': 'OG000', 'lowerLimit': '-0.8806', 'upperLimit': '0.2590'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2849', 'groupId': 'OG000', 'lowerLimit': '-0.7770', 'upperLimit': '0.0777'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2331', 'groupId': 'OG000', 'lowerLimit': '-0.3885', 'upperLimit': '0.4662'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1813', 'groupId': 'OG001', 'lowerLimit': '-0.8806', 'upperLimit': '0.1295'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0777', 'groupId': 'OG001', 'lowerLimit': '-0.1554', 'upperLimit': '0.5698'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2849', 'groupId': 'OG001', 'lowerLimit': '-0.2590', 'upperLimit': '0.9842'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0777', 'groupId': 'OG001', 'lowerLimit': '-0.4144', 'upperLimit': '0.2849'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.285', 'groupId': 'OG001', 'lowerLimit': '-0.259', 'upperLimit': '0.699'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0226', 'groupId': 'OG000', 'lowerLimit': '-0.2260', 'upperLimit': '0.0678'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0565', 'groupId': 'OG000', 'lowerLimit': '-0.1130', 'upperLimit': '0.2373'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1130', 'groupId': 'OG000', 'lowerLimit': '-0.0113', 'upperLimit': '0.2147'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1469', 'groupId': 'OG001', 'lowerLimit': '-0.4633', 'upperLimit': '0.0791'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0113', 'groupId': 'OG001', 'lowerLimit': '-0.2938', 'upperLimit': '0.2260'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0565', 'groupId': 'OG001', 'lowerLimit': '-0.2034', 'upperLimit': '0.2260'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.2260', 'upperLimit': '0.1130'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.068', 'groupId': 'OG001', 'lowerLimit': '-0.260', 'upperLimit': '0.226'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Low-density Lipoprotein (LDL) Cholesterol (Direct)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.36'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.41'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.39'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3108', 'groupId': 'OG001', 'lowerLimit': '-0.0777', 'upperLimit': '0.6216'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4403', 'groupId': 'OG001', 'lowerLimit': '0.1036', 'upperLimit': '0.7511'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5957', 'groupId': 'OG001', 'lowerLimit': '0.1813', 'upperLimit': '1.0360'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3108', 'groupId': 'OG001', 'lowerLimit': '0.1295', 'upperLimit': '0.6216'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.518', 'groupId': 'OG001', 'lowerLimit': '0.233', 'upperLimit': '0.648'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In LDL Particle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '-0.10'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '0.10'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '0.20'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '0.30'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '0.30'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '0.10'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.20', 'upperLimit': '0.20'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'nm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total LDL Particles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.0', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '231.0'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.0', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '273.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '159.0', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '197.0'}]}]}, {'title': 'Month 6 (Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '148.0', 'groupId': 'OG001', 'lowerLimit': '-17.0', 'upperLimit': '295.0'}]}]}, {'title': 'Month 12 (Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '318.0'}]}]}, {'title': 'Month 18 (Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '-15.0', 'upperLimit': '261.0'}]}]}, {'title': 'Month 24/EOT (Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '74.0'}]}]}, {'title': 'Last Dose (Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '-23.0', 'upperLimit': '98.0'}]}]}, {'title': 'Month 6 (Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '-102.0', 'upperLimit': '138.0'}]}]}, {'title': 'Month 12 (Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-53.0', 'groupId': 'OG001', 'lowerLimit': '-190.0', 'upperLimit': '155.0'}]}]}, {'title': 'Month 18 (Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.0', 'groupId': 'OG001', 'lowerLimit': '-199.0', 'upperLimit': '143.0'}]}]}, {'title': 'Month 24/EOT (Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-122.0', 'groupId': 'OG001', 'lowerLimit': '-229.0', 'upperLimit': '60.0'}]}]}, {'title': 'Last Dose (Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-243.0', 'upperLimit': '162.0'}]}]}, {'title': 'Month 6 (Intermediate-density Lipoprotein [IDL])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'groupId': 'OG001', 'lowerLimit': '-121.0', 'upperLimit': '72.0'}]}]}, {'title': 'Month 12 (IDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-57.0', 'groupId': 'OG001', 'lowerLimit': '-117.0', 'upperLimit': '21.0'}]}]}, {'title': 'Month 18 (IDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-43.0', 'groupId': 'OG001', 'lowerLimit': '-104.0', 'upperLimit': '112.0'}]}]}, {'title': 'Month 24/EOT (IDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG001', 'lowerLimit': '-17.0', 'upperLimit': '151.0'}]}]}, {'title': 'Last Dose (IDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '-89.0', 'upperLimit': '129.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'description': 'Results are reported in nanomoles per liter (nmol/L).', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Very Low-density Lipoprotein (VLDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '7.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.0', 'groupId': 'OG001', 'lowerLimit': '-41.0', 'upperLimit': '7.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'groupId': 'OG001', 'lowerLimit': '-29.0', 'upperLimit': '7.0'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'groupId': 'OG001', 'lowerLimit': '-25.0', 'upperLimit': '3.0'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '15.0'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'groupId': 'OG001', 'lowerLimit': '-29.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'description': 'Results are reported in milligrams per deciliter (mg/dL).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In VLDL Particle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.55', 'groupId': 'OG000', 'lowerLimit': '39.20', 'upperLimit': '44.75'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.40', 'groupId': 'OG000', 'lowerLimit': '39.70', 'upperLimit': '45.90'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.10', 'groupId': 'OG000', 'lowerLimit': '43.30', 'upperLimit': '48.40'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.80', 'groupId': 'OG001', 'lowerLimit': '-9.50', 'upperLimit': '0.90'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.50', 'groupId': 'OG001', 'lowerLimit': '-8.20', 'upperLimit': '0.50'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.90', 'groupId': 'OG001', 'lowerLimit': '-6.00', 'upperLimit': '2.90'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '-2.05', 'upperLimit': '5.20'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.10', 'groupId': 'OG001', 'lowerLimit': '-5.95', 'upperLimit': '1.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'nm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In VLDL Particles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.55', 'groupId': 'OG000', 'lowerLimit': '-17.20', 'upperLimit': '-1.60'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.70', 'groupId': 'OG000', 'lowerLimit': '-14.80', 'upperLimit': '9.10'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'groupId': 'OG000', 'lowerLimit': '-9.50', 'upperLimit': '10.90'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'groupId': 'OG001', 'lowerLimit': '-34.50', 'upperLimit': '9.50'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.20', 'groupId': 'OG001', 'lowerLimit': '-27.90', 'upperLimit': '19.20'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.80', 'groupId': 'OG001', 'lowerLimit': '-25.10', 'upperLimit': '0.30'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-16.10', 'upperLimit': '12.60'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.80', 'groupId': 'OG001', 'lowerLimit': '-19.00', 'upperLimit': '6.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Apolipoprotein A1 (ApoA1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '00', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1000', 'groupId': 'OG000', 'lowerLimit': '-0.1600', 'upperLimit': '0.0000'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0600', 'groupId': 'OG000', 'lowerLimit': '-0.2700', 'upperLimit': '0.0000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0400', 'groupId': 'OG000', 'lowerLimit': '-0.0200', 'upperLimit': '0.1500'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1400', 'groupId': 'OG001', 'lowerLimit': '-0.2100', 'upperLimit': '0.0700'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0900', 'groupId': 'OG001', 'lowerLimit': '-0.2000', 'upperLimit': '0.0100'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1000', 'groupId': 'OG001', 'lowerLimit': '-0.1800', 'upperLimit': '0.0300'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0100', 'groupId': 'OG001', 'lowerLimit': '-0.0600', 'upperLimit': '0.0700'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.045', 'groupId': 'OG001', 'lowerLimit': '-0.170', 'upperLimit': '0.030'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'description': 'Results are reported in grams per liter (g/L).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Apolipoprotein B (ApoB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0950', 'groupId': 'OG000', 'lowerLimit': '-0.0300', 'upperLimit': '0.1200'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0700', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.1200'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0500', 'groupId': 'OG000', 'lowerLimit': '-0.0400', 'upperLimit': '0.1000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0400', 'groupId': 'OG001', 'lowerLimit': '0.0100', 'upperLimit': '0.1100'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0400', 'groupId': 'OG001', 'lowerLimit': '-0.0200', 'upperLimit': '0.1000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0600', 'groupId': 'OG001', 'lowerLimit': '0.0400', 'upperLimit': '0.1700'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0900', 'groupId': 'OG001', 'lowerLimit': '0.0300', 'upperLimit': '0.1500'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.060', 'groupId': 'OG001', 'lowerLimit': '0.040', 'upperLimit': '0.170'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In ApoA1/ApoB Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0503', 'groupId': 'OG000', 'lowerLimit': '-0.1856', 'upperLimit': '0.1939'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2174', 'groupId': 'OG001', 'lowerLimit': '-0.3638', 'upperLimit': '-0.0775'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1659', 'groupId': 'OG001', 'lowerLimit': '-0.4509', 'upperLimit': '-0.0352'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2860', 'groupId': 'OG001', 'lowerLimit': '-0.3918', 'upperLimit': '-0.0206'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1172', 'groupId': 'OG001', 'lowerLimit': '-0.3060', 'upperLimit': '0.1613'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.291', 'groupId': 'OG001', 'lowerLimit': '-0.390', 'upperLimit': '0.015'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Apolipoprotein E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-1.80', 'upperLimit': '0.20'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'groupId': 'OG000', 'lowerLimit': '-2.10', 'upperLimit': '0.30'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '1.20'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '0.30'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '0.50'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.70', 'upperLimit': '0.30'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.60', 'upperLimit': '1.00'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.70', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Lipoprotein-a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '-0.0714', 'upperLimit': '0.0000'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '-0.0571', 'upperLimit': '0.0000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '-0.0357', 'upperLimit': '0.0357'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0571', 'upperLimit': '0.0357'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0357', 'upperLimit': '0.0357'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0357', 'upperLimit': '0.0000'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0286', 'upperLimit': '0.0107'}]}]}, {'title': 'Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.036', 'upperLimit': '0.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Lecithin-cholesterol Acyltransferase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'groupId': 'OG000', 'lowerLimit': '-74.5', 'upperLimit': '21.5'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'groupId': 'OG000', 'lowerLimit': '-87.5', 'upperLimit': '18.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '61.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-47.0', 'groupId': 'OG001', 'lowerLimit': '-107.0', 'upperLimit': '49.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG001', 'lowerLimit': '-29.0', 'upperLimit': '75.0'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.0', 'groupId': 'OG001', 'lowerLimit': '-87.0', 'upperLimit': '55.0'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-56.0', 'groupId': 'OG001', 'lowerLimit': '-105.0', 'upperLimit': '-28.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in nanomoles/milliliter/hour (nmol/mL/h).', 'unitOfMeasure': 'nmol/mL/h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Cholesteryl Ester Transfer Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.95', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '3.25'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '-2.70', 'upperLimit': '3.20'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.70', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '10.10'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG001', 'lowerLimit': '-1.40', 'upperLimit': '4.40'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG001', 'lowerLimit': '-2.70', 'upperLimit': '2.50'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '4.50'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '-3.70', 'upperLimit': '4.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in picomole/milliliter/minute (pmol/mL/min).', 'unitOfMeasure': 'pmol/mL/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Prebeta-1 HDL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '-11.50', 'upperLimit': '11.45'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.55', 'groupId': 'OG000', 'lowerLimit': '-7.35', 'upperLimit': '58.85'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.90', 'groupId': 'OG001', 'lowerLimit': '-22.00', 'upperLimit': '9.00'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.05', 'groupId': 'OG001', 'lowerLimit': '-31.95', 'upperLimit': '5.37'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG001', 'lowerLimit': '-6.80', 'upperLimit': '4.30'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'groupId': 'OG001', 'lowerLimit': '-5.90', 'upperLimit': '3.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in microgram/milliliter (ug/mL).', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Macrophage Cholesterol Efflux', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.800', 'groupId': 'OG000', 'lowerLimit': '-2.465', 'upperLimit': '0.120'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.705', 'groupId': 'OG000', 'lowerLimit': '-1.240', 'upperLimit': '0.350'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.745', 'groupId': 'OG001', 'lowerLimit': '-3.170', 'upperLimit': '-0.140'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.940', 'groupId': 'OG001', 'lowerLimit': '-3.110', 'upperLimit': '0.160'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.450', 'groupId': 'OG001', 'lowerLimit': '-3.500', 'upperLimit': '-0.680'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.770', 'groupId': 'OG001', 'lowerLimit': '-2.610', 'upperLimit': '0.580'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported as a percentage of cholesterol.', 'unitOfMeasure': 'percentage of cholesterol', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '12.3812'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '-9.5340', 'upperLimit': '4.7620'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4288', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '28.5720'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.76', 'upperLimit': '0.00'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.76', 'upperLimit': '0.00'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.76', 'upperLimit': '0.00'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Glycoprotein A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '36.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.0', 'groupId': 'OG001', 'lowerLimit': '-54.0', 'upperLimit': '15.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.0', 'groupId': 'OG001', 'lowerLimit': '-61.0', 'upperLimit': '10.0'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.0', 'groupId': 'OG001', 'lowerLimit': '-41.0', 'upperLimit': '19.0'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '48.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in picograms/milliliter (pg/mL).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Fibroblast Growth Factor-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.8800', 'groupId': 'OG000', 'lowerLimit': '-25.5290', 'upperLimit': '316.0650'}]}]}, {'title': 'Week 8/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112.5460', 'groupId': 'OG000', 'lowerLimit': '36.5310', 'upperLimit': '226.1710'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8400', 'groupId': 'OG000', 'lowerLimit': '-35.4980', 'upperLimit': '30.6920'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.390', 'groupId': 'OG001', 'lowerLimit': '-6.600', 'upperLimit': '201.000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.220', 'groupId': 'OG001', 'lowerLimit': '-49.190', 'upperLimit': '144.350'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.230', 'groupId': 'OG001', 'lowerLimit': '4.320', 'upperLimit': '127.290'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.740', 'groupId': 'OG001', 'lowerLimit': '-53.770', 'upperLimit': '22.910'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline.'}, {'type': 'SECONDARY', 'title': 'Participants With Lipoprotein X', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'OG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Last Dose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12 and Last Dose', 'description': 'Lipoprotein samples were assessed using nuclear magnetic resonance spectroscopy for the presence/absence of Lipoprotein X. Lipoprotein X sometimes appears with advanced cholestasis and can confound assessment of other lipoprotein concentrations, particularly LDL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-43.40', 'groupId': 'OG000', 'lowerLimit': '-87.10', 'upperLimit': '-13.10'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.50', 'groupId': 'OG000', 'lowerLimit': '-69.90', 'upperLimit': '-6.70'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.90', 'groupId': 'OG000', 'lowerLimit': '-47.20', 'upperLimit': '1.70'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.40', 'groupId': 'OG000', 'lowerLimit': '-28.75', 'upperLimit': '38.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in units/Liter (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Gamma-glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-59.40', 'groupId': 'OG000', 'lowerLimit': '-80.90', 'upperLimit': '-21.30'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-41.60', 'groupId': 'OG000', 'lowerLimit': '-92.30', 'upperLimit': '-28.30'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-40.80', 'groupId': 'OG000', 'lowerLimit': '-90.80', 'upperLimit': '-27.70'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.05', 'groupId': 'OG000', 'lowerLimit': '-49.50', 'upperLimit': '6.35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.80', 'groupId': 'OG000', 'lowerLimit': '-15.90', 'upperLimit': '-3.60'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.80', 'groupId': 'OG000', 'lowerLimit': '-16.20', 'upperLimit': '-1.00'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.80', 'groupId': 'OG000', 'lowerLimit': '-25.00', 'upperLimit': '-3.40'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.95', 'groupId': 'OG000', 'lowerLimit': '-14.85', 'upperLimit': '7.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.30', 'groupId': 'OG000', 'lowerLimit': '-15.00', 'upperLimit': '-1.40'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.60', 'groupId': 'OG000', 'lowerLimit': '-8.20', 'upperLimit': '1.60'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.00', 'groupId': 'OG000', 'lowerLimit': '-18.60', 'upperLimit': '-1.70'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'groupId': 'OG000', 'lowerLimit': '-13.50', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total And Unconjugated (Direct) Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000', 'lowerLimit': '-1.80', 'upperLimit': '3.20'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-2.10', 'upperLimit': '3.20'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '4.30'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '3.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'g/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Prothrombin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.500', 'upperLimit': '0.900'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.050', 'groupId': 'OG000', 'lowerLimit': '-0.600', 'upperLimit': '0.400'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.400', 'groupId': 'OG000', 'lowerLimit': '0.100', 'upperLimit': '0.800'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.200', 'groupId': 'OG000', 'lowerLimit': '-0.200', 'upperLimit': '0.750'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in seconds (sec).', 'unitOfMeasure': 'sec', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Prothrombin International Normalized Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.1000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.1000'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0500'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Enhanced Liver Fibrosis (ELF) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.300', 'upperLimit': '0.500'}]}]}, {'title': 'Week 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.150', 'groupId': 'OG000', 'lowerLimit': '-0.050', 'upperLimit': '0.550'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'description': 'Change in ELF was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis.\n\nChange in ELF scores ranged from -0.56 (good) to + 0.68 (bad).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Hyaluronic Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.700', 'groupId': 'OG000', 'lowerLimit': '-21.020', 'upperLimit': '15.770'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.805', 'groupId': 'OG000', 'lowerLimit': '-16.665', 'upperLimit': '17.830'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Amino-terminal Propeptide Of Type III Procollagen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.670', 'groupId': 'OG000', 'lowerLimit': '-0.220', 'upperLimit': '1.200'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.095', 'groupId': 'OG000', 'lowerLimit': '1.010', 'upperLimit': '3.310'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'description': 'Results are reported in micrograms/Liter (ug/L).', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Tissue Inhibitor Of Metalloproteinases 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.600', 'groupId': 'OG000', 'lowerLimit': '-15.700', 'upperLimit': '16.600'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '-14.300', 'upperLimit': '23.650'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Hepatic Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'groupId': 'OG000', 'lowerLimit': '-9.60', 'upperLimit': '0.40'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.70', 'groupId': 'OG000', 'lowerLimit': '-4.20', 'upperLimit': '-0.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'description': 'Results are reported in kilopascal (kPa).', 'unitOfMeasure': 'kPa', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat was comprised of all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. The number of participants analyzed includes the subjects who were available at the specific time point of analysis.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Bile Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'groupId': 'OG000', 'lowerLimit': '-5.23', 'upperLimit': '2.58'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-8.94', 'upperLimit': '2.88'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.61', 'groupId': 'OG000', 'lowerLimit': '-9.21', 'upperLimit': '2.80'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.91', 'groupId': 'OG000', 'lowerLimit': '-9.81', 'upperLimit': '1.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Endogenous Bile Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'groupId': 'OG000', 'lowerLimit': '-3.17', 'upperLimit': '-0.09'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-3.54', 'upperLimit': '0.18'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.19', 'groupId': 'OG000', 'lowerLimit': '-4.62', 'upperLimit': '-0.48'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'groupId': 'OG000', 'lowerLimit': '-4.22', 'upperLimit': '0.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total UDCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'groupId': 'OG000', 'lowerLimit': '-2.67', 'upperLimit': '3.47'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-4.19', 'upperLimit': '2.69'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.89', 'groupId': 'OG000', 'lowerLimit': '-4.95', 'upperLimit': '2.50'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.68', 'groupId': 'OG000', 'lowerLimit': '-6.17', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Chenodeoxycholic Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.85', 'upperLimit': '0.07'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'groupId': 'OG000', 'lowerLimit': '-1.69', 'upperLimit': '0.10'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'groupId': 'OG000', 'lowerLimit': '-1.84', 'upperLimit': '-0.06'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'groupId': 'OG000', 'lowerLimit': '-1.76', 'upperLimit': '0.33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Lithocholic Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.11'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.05', 'upperLimit': '0.06'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.00'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Cholic Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'groupId': 'OG000', 'lowerLimit': '-1.39', 'upperLimit': '0.00'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-1.44', 'upperLimit': '0.00'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'groupId': 'OG000', 'lowerLimit': '-1.49', 'upperLimit': '-0.09'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'groupId': 'OG000', 'lowerLimit': '-1.18', 'upperLimit': '-0.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline In Total Deoxycholic Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000', 'lowerLimit': '-0.89', 'upperLimit': '-0.04'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'groupId': 'OG000', 'lowerLimit': '-1.14', 'upperLimit': '0.01'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'groupId': 'OG000', 'lowerLimit': '-1.21', 'upperLimit': '-0.27'}]}]}, {'title': 'Month 24/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000', 'lowerLimit': '-1.10', 'upperLimit': '0.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline In HDL Cholesterol Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.852', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 24/EOT', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat was comprised of all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. The number of participants analyzed includes the subjects who were available at the specific time point of analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline In HDL Particle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.19'}]}]}], 'analyses': [{'pValue': '0.549', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 24/EOT', 'unitOfMeasure': 'nm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat was comprised of all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. The number of participants analyzed includes the subjects who were available at the specific time point of analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline In HDL Particle Number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-1.78', 'upperLimit': '1.59'}]}]}], 'analyses': [{'pValue': '0.912', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 24/EOT', 'unitOfMeasure': 'umol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Treatment Phase', 'description': 'All participants were treated with obeticholic acid (OCA) (oral administration, 10 milligrams \\[mg\\], once daily \\[QD\\]) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years.'}, {'id': 'FG001', 'title': 'Long-term Safety Extension Phase', 'description': 'Participants received OCA 10 mg QD for up to 2 years.'}], 'periods': [{'title': 'Primary Treatment Phase', 'milestones': [{'type': 'STARTED', 'comment': "One participant was thought to have been incorrectly dispensed 5-mg OCA during the PTP. This participant was not included in the ITT population and this participant's data was not included in any of the analyses.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'comment': "One participant was thought to have been incorrectly dispensed 5-mg OCA during the PTP. This participant was not included in the ITT population and this participant's data was not included in any of the analyses.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Long-term Safety Extension Phase', 'milestones': [{'type': 'STARTED', 'comment': 'Only eligible participants who completed the PTP phase enrolled in the LTSE phase.', 'achievements': [{'comment': 'Only eligible participants who completed the PTP phase enrolled in the LTSE phase.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Only eligible participants who completed the PTP phase enrolled in the LTSE phase.', 'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pruritus', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant Unavailable for Final Study Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment started 19-Nov-2013 and completed 16-May-2014 in the primary treatment phase (PTP). Thirty-three participants were screened and 27 enrolled.', 'preAssignmentDetails': 'Screening window was up to 20 days in duration to assess eligibility. Stable dose of ursodeoxycholic acid (UDCA) for 3 months prior to Day 0 was required. A 28-day washout period for bile acid sequestrants and no serum-lipid modifying agents for 3 months prior to Day 0 was also required. After the PTP, participants were offered the opportunity to enter the open-label, long-term safety extension (LTSE) phase of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Obeticholic Acid', 'description': 'All participants were treated with OCA (oral administration, 10 mg, QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, eligible participants entered the open-label LTSE phase and received 10 mg OCA QD for up to 2 years.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '9.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Non-White/Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'High-density Lipoprotein (HDL) Cholesterol Concentration', 'classes': [{'categories': [{'measurements': [{'value': '1.86', 'spread': '0.51798', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure reported in millimoles/liter (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL Particle Size', 'classes': [{'categories': [{'measurements': [{'value': '10.19', 'spread': '0.734', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure reported in nanometers (nm).', 'unitOfMeasure': 'nm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL Particle Concentration (total)', 'classes': [{'categories': [{'measurements': [{'value': '30.08', 'spread': '7.228', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure reported in micromoles/L (umol/L).', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2016-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2013-05-23', 'resultsFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-25', 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Absolute Change From Baseline In HDL Particle Size', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Absolute Change From Baseline In HDL Particle Number', 'timeFrame': 'Baseline, Week 8'}], 'secondaryOutcomes': [{'measure': 'Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12'}, {'measure': 'Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12'}, {'measure': 'Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12'}, {'measure': 'Median Change From Week 8 In HDL Cholesterol Concentration At Week 12', 'timeFrame': 'Week 8, Week 12'}, {'measure': 'Median Change From Week 8 In HDL Particle Size At Week 12', 'timeFrame': 'Week 8, Week 12'}, {'measure': 'Median Change From Week 8 In HDL Particle Number At Week 12', 'timeFrame': 'Week 8, Week 12'}, {'measure': 'Maximum Plasma Concentration (Cmax) Of OCA And Conjugates', 'timeFrame': 'Week 8', 'description': 'Results are reported in nanograms per milliliter (ng/mL).'}, {'measure': 'Time To Reach Cmax (Tmax) For OCA And Conjugates', 'timeFrame': 'Week 8', 'description': 'Results are reported in hours (h).'}, {'measure': 'Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates', 'timeFrame': 'Week 8', 'description': 'Results are reported in hour\\*nanograms per milliliter (h\\*ng/mL).'}, {'measure': 'Median Change From Baseline In Total Cholesterol', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Total Triglycerides', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Low-density Lipoprotein (LDL) Cholesterol (Direct)', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In LDL Particle Size', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Total LDL Particles', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'description': 'Results are reported in nanomoles per liter (nmol/L).'}, {'measure': 'Median Change From Baseline In Very Low-density Lipoprotein (VLDL) Cholesterol', 'timeFrame': 'Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'description': 'Results are reported in milligrams per deciliter (mg/dL).'}, {'measure': 'Median Change From Baseline In VLDL Particle Size', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In VLDL Particles', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Apolipoprotein A1 (ApoA1)', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose', 'description': 'Results are reported in grams per liter (g/L).'}, {'measure': 'Median Change From Baseline In Apolipoprotein B (ApoB)', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In ApoA1/ApoB Ratio', 'timeFrame': 'Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Apolipoprotein E', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Lipoprotein-a', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose'}, {'measure': 'Median Change From Baseline In Lecithin-cholesterol Acyltransferase Activity', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in nanomoles/milliliter/hour (nmol/mL/h).'}, {'measure': 'Median Change From Baseline In Cholesteryl Ester Transfer Protein', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in picomole/milliliter/minute (pmol/mL/min).'}, {'measure': 'Median Change From Baseline In Prebeta-1 HDL Concentration', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in microgram/milliliter (ug/mL).'}, {'measure': 'Median Change From Baseline In Macrophage Cholesterol Efflux', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported as a percentage of cholesterol.'}, {'measure': 'Median Change From Baseline In C-reactive Protein', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Glycoprotein A', 'timeFrame': 'Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in picograms/milliliter (pg/mL).'}, {'measure': 'Median Change From Baseline In Fibroblast Growth Factor-19', 'timeFrame': 'Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Participants With Lipoprotein X', 'timeFrame': 'Week 12 and Last Dose', 'description': 'Lipoprotein samples were assessed using nuclear magnetic resonance spectroscopy for the presence/absence of Lipoprotein X. Lipoprotein X sometimes appears with advanced cholestasis and can confound assessment of other lipoprotein concentrations, particularly LDL.'}, {'measure': 'Median Change From Baseline In Alkaline Phosphatase', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in units/Liter (U/L).'}, {'measure': 'Median Change From Baseline In Gamma-glutamyl Transferase', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Alanine Aminotransferase', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Aspartate Aminotransferase', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total And Unconjugated (Direct) Bilirubin', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Albumin', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Prothrombin Time', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT', 'description': 'Results are reported in seconds (sec).'}, {'measure': 'Median Change From Baseline In Prothrombin International Normalized Ratio', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Enhanced Liver Fibrosis (ELF) Score', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'description': 'Change in ELF was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis.\n\nChange in ELF scores ranged from -0.56 (good) to + 0.68 (bad).'}, {'measure': 'Median Change From Baseline In Hyaluronic Acid', 'timeFrame': 'Baseline, Month 12, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Amino-terminal Propeptide Of Type III Procollagen', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'description': 'Results are reported in micrograms/Liter (ug/L).'}, {'measure': 'Median Change From Baseline In Tissue Inhibitor Of Metalloproteinases 1', 'timeFrame': 'Baseline, Month 12, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Hepatic Stiffness', 'timeFrame': 'Baseline, Month 12, Month 24/EOT', 'description': 'Results are reported in kilopascal (kPa).'}, {'measure': 'Median Change From Baseline In Total Bile Acids', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total Endogenous Bile Acid', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total UDCA', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total Chenodeoxycholic Acid', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total Lithocholic Acid', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total Cholic Acid', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Median Change From Baseline In Total Deoxycholic Acid', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24/EOT'}, {'measure': 'Absolute Change From Baseline In HDL Cholesterol Concentration', 'timeFrame': 'Baseline, Month 24/EOT'}, {'measure': 'Absolute Change From Baseline In HDL Particle Size', 'timeFrame': 'Baseline, Month 24/EOT'}, {'measure': 'Absolute Change From Baseline In HDL Particle Number', 'timeFrame': 'Baseline, Month 24/EOT'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Biliary Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).', 'detailedDescription': "This was a phase 2, open-label, multicenter study evaluating the effects of OCA on lipoprotein metabolism in participants with PBC; in particular, OCA's effects on high-density lipoprotein cholesterol. Nuclear magnetic resonance spectroscopy was utilized to quantify the changes in lipoprotein particle sizes and concentrations. Components of reverse cholesterol transport were also assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Definite or probable PBC diagnosis as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:\n\n * History of elevated alkaline phosphatase levels for at least 6 months\n * A positive anti-microbial antibody (AMA) titer or, if AMA negative or in low titer (\\<1:80), PBC-specific antibodies\n * Liver biopsy consistent with PBC\n2. Taking UDCA for at least 12 months (stable dose for ≥ 3 months) prior to Day 0 or unable to tolerate UDCA (no UDCA for ≥ 3 months prior to Day 0).\n3. Contraception: Female participants must have been postmenopausal, surgically sterile, or if premenopausal, were prepared to use ≥ 1 effective (≤ 1% failure rate) method of contraception during the trial and until at least 30 days after the last dose of Investigational Product.\n4. Must have provided written informed consent and agreed to comply with the trial protocol.\n\nKey Exclusion Criteria:\n\n1. Participants with decompensated PBC (as determined by the Investigator).\n2. Severe pruritus or systemic treatment for pruritus (for example, treatment with bile acid sequestrants or rifampicin) within 2 months of Day 0.\n3. History or presence of other significant liver diseases including:\n\n * Active or chronic Hepatitis B or C virus infection\n * Primary sclerosing cholangitis\n * Alcoholic liver disease\n * Definite autoimmune liver disease or overlap hepatitis\n * Nonalcoholic steatohepatitis\n\n Note: Participants with Gilbert's disease or those with a history of hepatitis B who were currently antigen negative and seroconverted were not considered exclusionary.\n4. Uncontrolled diabetes or other uncontrolled or unstable medical condition that may have interfered with trial results.\n5. Administration of any of the following medications as specified below:\n\n * Prohibited 28 days prior to Day 0: bile acid sequestrants including cholestyramine, colesevelam, colestipol or omega-3 fatty acid containing dietary supplements\n * Prohibited 3 months prior to Day 0 and throughout trial participation: serum-lipid modifying agents including 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, fenofibrate or other fibrates, nicotinic acid and derivatives, ezetimibe, Vitamin E (other than as standard dietary supplement)\n * Prohibited 6 months prior to Day 0 and throughout the trial participation: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; budesonide and other systemic corticosteroids; potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)\n * Prohibited 12 months prior to Day 0 and throughout the trial participation: antibodies or immunotherapy directed against interleukins or other cytokines or chemokines\n6. Planned change in diet or exercise habits during participation in the trial.\n7. Presence or history of clinically significant cardiac arrhythmias that may have prohibited the participant from participating in the trial.\n8. If female: known pregnancy, or had a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n9. Recent (3 months prior to day 0) participation in another trial involving OCA or participation in another investigational trial (30 days prior to Day 0) and during the trial."}, 'identificationModule': {'nctId': 'NCT01865812', 'briefTitle': 'Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercept Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis', 'orgStudyIdInfo': {'id': '747-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCA: 10 mg', 'description': 'Obeticholic acid, oral administration, 10 milligrams (mg), 8 weeks', 'interventionNames': ['Drug: Obeticholic Acid']}], 'interventions': [{'name': 'Obeticholic Acid', 'type': 'DRUG', 'otherNames': ['6α-Ethyl chenodeoxycholic acid (6-ECDCA)', 'INT-747'], 'description': 'All participants were treated with OCA (oral administration, 10 mg, once daily \\[QD\\]) for 8 weeks and continued their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8-week Primary Treatment Phase of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter an open-label, long-term safety extension phase, during which they could receive 10 mg OCA QD for up to 2 years.', 'armGroupLabels': ['OCA: 10 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire DVAMC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'George Harb, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intercept Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercept Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}