Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-29 @ 3:18 AM
Study NCT ID:
NCT02955602
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
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': 'C572244', 'term': '(2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid'}, {'id': 'C000713688', 'term': 'seladelpar'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@cymabay.com', 'phone': '510-293-8800', 'title': 'Elaine Watkins, DO, MSPH, Vice President of Clinical Development', 'organization': 'CymaBay Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'First, there was an imbalance in baseline ALP levels among cohorts. Second, the criteria for dose uptitration were not standardized, except that uptitration could only be done at or after Week 12. Third, this was not a placebo-controlled study. Finally, multiplicity adjustments were not made for efficacy endpoints. Nominal p-values were provided for descriptive purposes.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 56', 'eventGroups': [{'id': 'EG000', 'title': 'MBX-8025 2 mg', 'description': 'MBX-8025 2 mg capsule once dailyMBX-8025 2 mg Capsule: Initial 8-week treatment:• MBX-8025 2 mgSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MBX-8025 5 mg', 'description': 'MBX-8025 5 mg capsule once dailyMBX-8025 5 mg Capsule: Initial 8-week treatment:• MBX-8025 5 mgSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 45, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'MBX-8025 10 mg', 'description': 'MBX-8025 10 mg capsule once dailyMBX-8025 10 mg Capsule: Initial 8-week treatment:• MBX-8025 10 mgSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 47, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyschezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Feeling of body temperature change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Allergy to vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urine odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pruritus genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyonephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.06', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '-33.38', 'spread': '17.81', 'groupId': 'OG001'}, {'value': '-41.42', 'spread': '13.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.2242', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 5 mg treatment groups after 8 weeks of treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.0021', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 10 mg treatment groups after 8 weeks of treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.0024', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 5 mg and 10 mg treatment groups after 8 weeks of treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Relative change from baseline in serum ALP levels at Week 8 (endpoint). The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. n, denotes number of subjects evaluable for the respective timepoints', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Absolute Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-68.318', 'spread': '63.276', 'groupId': 'OG000'}, {'value': '-135.902', 'spread': '150.954', 'groupId': 'OG001'}, {'value': '-127.867', 'spread': '60.284', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-101.150', 'spread': '107.956', 'groupId': 'OG000'}, {'value': '-158.310', 'spread': '143.668', 'groupId': 'OG001'}, {'value': '-133.760', 'spread': '76.151', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Absolute change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population: The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'spread': '16.72', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '24.28', 'groupId': 'OG001'}, {'value': '-3.35', 'spread': '10.55', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.05', 'spread': '10.50', 'groupId': 'OG000'}, {'value': '-6.18', 'spread': '13.98', 'groupId': 'OG001'}, {'value': '-6.14', 'spread': '9.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in AST levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change in Alanine Aminotransferase (ALT) From Baseline to 12 Weeks and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.59', 'spread': '16.07', 'groupId': 'OG000'}, {'value': '-10.48', 'spread': '21.41', 'groupId': 'OG001'}, {'value': '-10.87', 'spread': '20.25', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.30', 'spread': '25.12', 'groupId': 'OG000'}, {'value': '-17.29', 'spread': '17.46', 'groupId': 'OG001'}, {'value': '-15.32', 'spread': '13.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in ALT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change in Gamma-glutamyl Transferase (GGT) From Baseline to 12 Weeks and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-43.68', 'spread': '56.87', 'groupId': 'OG000'}, {'value': '-75.35', 'spread': '87.57', 'groupId': 'OG001'}, {'value': '-80.82', 'spread': '109.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-78.60', 'spread': '81.59', 'groupId': 'OG000'}, {'value': '-91.37', 'spread': '102.23', 'groupId': 'OG001'}, {'value': '-88.08', 'spread': '122.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in GGT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change in Bilirubin - Total Bilirubin (TB) From Baseline to 12 Weeks and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '-0.055', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '-0.067', 'spread': '0.199', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.263', 'groupId': 'OG001'}, {'value': '-0.068', 'spread': '0.190', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in TB levels at endpoint is being reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meet Composite Endpoint Criteria of ALP and Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks and 52 Weeks', 'description': 'Participant meets composite endpoint is defined by participant meets all of the following criteria:\n\n* ALP \\< 1.67 × upper limit of normal (ULN)\n* Total Bilirubin within normal limit\n* \\> 15% decrease in ALP\n\nEndpoint of Alkaline Phosphatase and Total Bilirubin by Visit (mITT Population)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meet Published PBC Response Criteria - Paris I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '76.1', 'groupId': 'OG001'}, {'value': '75.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '81.0', 'groupId': 'OG001'}, {'value': '79.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (≤) 3x ULN and aspartate aminotransferase (AST) less than or equal to (≤) 2 x ULN and Total Bilirubin ≤ 1 mg/dL.\n\nThe mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meet Published PBC Response Criteria - Paris II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}, {'value': '59.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}, {'value': '60.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Paris II risk score was defined as ALP≤1.5xULN and AST≤1.5xULN and Total Bilirubin ≤ 1 mg/dL.\n\nThe mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meet Published PBC Response Criteria - Toronto I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}, {'value': '78.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '57.8', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Toronto I risk score defined as ALP ≤ 1.67 x ULN. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'UK-PBC Risk Score Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': '5 years, week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3929', 'spread': '0.6976', 'groupId': 'OG000'}, {'value': '2.2553', 'spread': '2.5145', 'groupId': 'OG001'}, {'value': '1.8124', 'spread': '1.7267', 'groupId': 'OG002'}]}]}, {'title': '5 years, week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3145', 'spread': '0.7704', 'groupId': 'OG000'}, {'value': '2.3485', 'spread': '3.432', 'groupId': 'OG001'}, {'value': '1.7244', 'spread': '1.6121', 'groupId': 'OG002'}]}]}, {'title': '10 years week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5705', 'spread': '2.2479', 'groupId': 'OG000'}, {'value': '7.1229', 'spread': '7.4904', 'groupId': 'OG001'}, {'value': '5.8293', 'spread': '5.3605', 'groupId': 'OG002'}]}]}, {'title': '10 years, week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3128', 'spread': '2.4649', 'groupId': 'OG000'}, {'value': '7.2322', 'spread': '9.5794', 'groupId': 'OG001'}, {'value': '5.5607', 'spread': '5.0092', 'groupId': 'OG002'}]}]}, {'title': '15 years, week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.3008', 'spread': '3.9932', 'groupId': 'OG000'}, {'value': '12.4002', 'spread': '12.1785', 'groupId': 'OG001'}, {'value': '10.3469', 'spread': '9.1269', 'groupId': 'OG002'}]}]}, {'title': '15 years, week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8325', 'spread': '4.3413', 'groupId': 'OG000'}, {'value': '12.3028', 'spread': '14.5701', 'groupId': 'OG001'}, {'value': '9.9008', 'spread': '8.5396', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'The UK-PBC Risk Score at endpoint is defined by the mean percentage risk that a PBC patient treated with ursodeoxycholic acid (UDCA) would develop liver failure requiring liver transplantation in 5, 10 and 15 years from diagnosis. The higher the score might indicate higher risk to death or live transplantation. Formula used for UK-PBC risk score = 1- 0.982 \\^EXP(0.0287854\\*(ALP12 x ULN-1.722136304) - 0.0422873\\*(((TA12 xULN/10)\\^-1) - 8.675729006) + 1.4199 \\* (LN(BIL12 x ULN/10)+2.709607778)-1.960303\\*(Albumin x LLN-1.17673001)-0.4161954\\*(Platelet x LLN-1.873564875)). Where, Baseline survivor function = 0.982, 0.941, and 0.893 for 5 years, 10 years and 15 years respectively. ALP12, TA12 and BIL12 refers to the ALP, transaminases (ALT, AST), and total bilirubin assessments, respectively. The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus Visual Analog Score (VAS) at Week 12 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '-12.3', 'spread': '22.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '-16.5', 'spread': '23.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'VAS is the commonly used graphic tool for self-reporting of pruritus intensity in patients. VAS is a simple to use, validated, reliable and widely applicable tool that does not determine the impact of pruritus to quality of life. It comprises of a 100-mm horizontal line labelled as "no symptom" on left end and "worst imaginable symptom" on right end. Based on the intensity of the itch patient is instructed to draw a vertical line on the horizontal scale having a range \\[VAS values (unit: mm) ranging from 0 to 100, where 0 represents "no itching" and 100 "worst possible itching"\\].\n\nThe modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PBC-40 Quality of Life (QoL) at Week 12 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'General Symptoms, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'General Symptoms, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Itch, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': 'Itch, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Cognitive Function, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Cognitive Function, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Social, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Social, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': 'Emotional, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Emotional, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'The PBC-40 QoL questionnaire is a disease-specific health-related tool developed for measuring the psychometric profile in PBC patients. It has 10 domains and 43 questions relevant to PBC, including Cognitive, Social, Emotional Function, Fatigue, Itch, and Other Symptoms. Questions in domains: 1) digestion and diet (questions 1-3); 2) experiences (questions 4-7); 3) itching (questions 8-10); 4) fatigue (questions 11-18); 5) effort and planning (questions 19-21); 6) memory and concentration (questions 22-27); 7) affects to you as person (questions 28-33); 8) affects to your social life (questions 34-37); 9) overall impact on your life (questions 38-40); 10) general health and well-being (questions A-C). Within a domain, items are scored from 1 to 5 and the individual item scores are summed to give a total domain score. High scores represent high impact and low scores low impact of PBC on QoL (mITT Population).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meet Published PBC Response Criteria - Barcelona', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '65.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Barcelona risk scores was defined as Normalization of ALP or a Decrease of ALP ≥ 40%. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in MELD Score From Baseline to 12 Weeks and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': "Change from baseline to 12 weeks and 52 weeks in Model for End-stage Liver Disease (MELD) Score (mITT Population) The MELD score ranges from 6 to 40 and is a measure of how severe a patient's liver disease is. The higher the score, the more likely the patients will need a liver transplant. A calculated prognostic risk factor used to assess the potential need for a liver transplant.\n\nMELD(i) score = 10\\*\\[0.957\\*ln(creatinine mg/dL) + 0. 378\\*ln(total bilirubin mg/dL) + 1.120\\*ln (INR) + 0.643\\].\n\nIf MELD(i) is less than or equal to 11 then MELD = MELD(i). If MELD(i) is greater than 11 then MELD = MELD(i) + (1.32 \\*(137 - (Na)) - (0.033\\*MELD(i)\\*(137 - Na))", 'unitOfMeasure': 'Change from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Change in GLOBE PBC Score From Baseline to 12 Weeks and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.079', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '-0.292', 'spread': '0.304', 'groupId': 'OG001'}, {'value': '-0.346', 'spread': '0.269', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.180', 'spread': '0.217', 'groupId': 'OG000'}, {'value': '-0.271', 'spread': '0.354', 'groupId': 'OG001'}, {'value': '-0.404', 'spread': '0.298', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from Baseline to 12 weeks and 52 weeks in Global PBC Study Group (GLOBE) score (mITT Population)\n\nThe GLOBE score is a validated risk assessment tool providing an estimate of transplant-free survival for patients with PBC. It was developed by the Global PBC Study Group using Cox regression model on over 4,000 patients with PBC. Lower GLOBE score predicts lower risk. It is calculated from the following equation:\n\nGLOBE score = (0.044378 \\* age + 0.93982 \\* LN(total bilirubin/ULN) +(0.335648 \\* LN(alkaline phosphatase/ULN)) - 2.266708 \\* albumin /LLN -0.002581 \\* platelet count per 109/L) + 1.216865', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Participants Meet Rotterdam Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Early Stage,12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Early Stage, 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Moderately advanced at 12 Weeks: Either abnormal Albumin or abnormal Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Moderately advanced: 52 Weeks, Either abnormal Albumin or abnormal Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Advanced: 12 Weeks, Both abnormal Albumin and abnormal Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Advanced: 52 Weeks Both abnormal Albumin and abnormal Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 52 weeks', 'description': 'participants with Response Based on Rotterdam Criteria at Weeks 12 and 52 Rotterdam Published PBC Response Criteria by Visit (mITT Population) Rotterdam criteria: Early (normal total bilirubin and normal albumin), Moderately advanced (either abnormal albumin or abnormal total bilirubin), and Advanced (both abnormal albumin and abnormal total bilirubin). From Early stage to Moderate Stage and to Advanced Stage, it becomes worse and worse in abnormality.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meet Composite Endpoint of AP and Total Bilirubin Criteria at Week 12 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with Response Defined by Composite Endpoint (ALP\\< 1.67 \\* Upper Limit of Normal \\[ULN\\] at Endpoint, Total Bilirubin \\[BIL\\] within Normal Limits at Endpoint, and Greater Than Equal To \\[≥\\] 15% ALP Reduction) from Baseline to Week 12 and Week 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'OG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'classes': [{'title': 'Relative Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.56', 'spread': '13.92', 'groupId': 'OG000'}, {'value': '-34.49', 'spread': '20.62', 'groupId': 'OG001'}, {'value': '-43.20', 'spread': '12.39', 'groupId': 'OG002'}]}]}, {'title': 'Relative Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-32.72', 'spread': '22.48', 'groupId': 'OG000'}, {'value': '-40.09', 'spread': '24.23', 'groupId': 'OG001'}, {'value': '-44.19', 'spread': '15.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percent change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.', 'unitOfMeasure': 'percentage Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'FG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'FG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 192 subjects were screened of which 121 subjects randomized (2 subjects were not treated) into the study and 71 were screen failures. Subjects were randomized to the 5 and 10 mg treatment groups for entry to the 8-week initial treatment period study, while those in the 2 mg treatment group entered after being sequentially assigned their dose'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily\n\nMBX-8025 2 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nSubjects received two seladelpar 1 milligram (mg) capsules orally once daily for 8 weeks with a 44-week extension period. Dose up-titration for efficacy reasons could be made after 12 weeks of treatment up to 10 mg.'}, {'id': 'BG001', 'title': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily\n\nMBX-8025 5 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nSubjects were randomized to receive one seladelpar 5 mg capsule orally once daily for 8 weeks with a 44-week extension period. Dose up-titration to 10 mg for efficacy reasons could be made after 12 weeks of treatment.'}, {'id': 'BG002', 'title': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily\n\nMBX-8025 10 mg Capsule: Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nSubjects were randomized to receive one seladelpar 10 mg capsule orally once daily for 8 weeks with a 44-week extension period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '57.5', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '56.4', 'spread': '9.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}, {'title': 'Black or African-American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subjects'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '18 to 75 years of age (inclusive)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-20', 'size': 3565022, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-21T16:48', 'hasProtocol': True}, {'date': '2019-11-26', 'size': 1793480, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-21T16:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2016-11-02', 'resultsFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-21', 'studyFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8', 'timeFrame': '8 weeks', 'description': 'Relative change from baseline in serum ALP levels at Week 8 (endpoint). The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. n, denotes number of subjects evaluable for the respective timepoints'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Absolute change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in AST levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Change in Alanine Aminotransferase (ALT) From Baseline to 12 Weeks and 52 Weeks', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in ALT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Change in Gamma-glutamyl Transferase (GGT) From Baseline to 12 Weeks and 52 Weeks', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in GGT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Change in Bilirubin - Total Bilirubin (TB) From Baseline to 12 Weeks and 52 Weeks', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from baseline in TB levels at endpoint is being reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Percentage of Participants Meet Composite Endpoint Criteria of ALP and Total Bilirubin', 'timeFrame': '12 Weeks and 52 Weeks', 'description': 'Participant meets composite endpoint is defined by participant meets all of the following criteria:\n\n* ALP \\< 1.67 × upper limit of normal (ULN)\n* Total Bilirubin within normal limit\n* \\> 15% decrease in ALP\n\nEndpoint of Alkaline Phosphatase and Total Bilirubin by Visit (mITT Population)'}, {'measure': 'Percentage of Participants Meet Published PBC Response Criteria - Paris I', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (≤) 3x ULN and aspartate aminotransferase (AST) less than or equal to (≤) 2 x ULN and Total Bilirubin ≤ 1 mg/dL.\n\nThe mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Percentage of Participants Meet Published PBC Response Criteria - Paris II', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Paris II risk score was defined as ALP≤1.5xULN and AST≤1.5xULN and Total Bilirubin ≤ 1 mg/dL.\n\nThe mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Percentage of Participants Meet Published PBC Response Criteria - Toronto I', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Toronto I risk score defined as ALP ≤ 1.67 x ULN. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'UK-PBC Risk Score Value', 'timeFrame': '12 weeks and 52 weeks', 'description': 'The UK-PBC Risk Score at endpoint is defined by the mean percentage risk that a PBC patient treated with ursodeoxycholic acid (UDCA) would develop liver failure requiring liver transplantation in 5, 10 and 15 years from diagnosis. The higher the score might indicate higher risk to death or live transplantation. Formula used for UK-PBC risk score = 1- 0.982 \\^EXP(0.0287854\\*(ALP12 x ULN-1.722136304) - 0.0422873\\*(((TA12 xULN/10)\\^-1) - 8.675729006) + 1.4199 \\* (LN(BIL12 x ULN/10)+2.709607778)-1.960303\\*(Albumin x LLN-1.17673001)-0.4161954\\*(Platelet x LLN-1.873564875)). Where, Baseline survivor function = 0.982, 0.941, and 0.893 for 5 years, 10 years and 15 years respectively. ALP12, TA12 and BIL12 refers to the ALP, transaminases (ALT, AST), and total bilirubin assessments, respectively. The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Change From Baseline in Pruritus Visual Analog Score (VAS) at Week 12 and Week 52', 'timeFrame': '12 weeks and 52 weeks', 'description': 'VAS is the commonly used graphic tool for self-reporting of pruritus intensity in patients. VAS is a simple to use, validated, reliable and widely applicable tool that does not determine the impact of pruritus to quality of life. It comprises of a 100-mm horizontal line labelled as "no symptom" on left end and "worst imaginable symptom" on right end. Based on the intensity of the itch patient is instructed to draw a vertical line on the horizontal scale having a range \\[VAS values (unit: mm) ranging from 0 to 100, where 0 represents "no itching" and 100 "worst possible itching"\\].\n\nThe modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Change From Baseline in PBC-40 Quality of Life (QoL) at Week 12 and Week 52', 'timeFrame': '12 weeks and 52 weeks', 'description': 'The PBC-40 QoL questionnaire is a disease-specific health-related tool developed for measuring the psychometric profile in PBC patients. It has 10 domains and 43 questions relevant to PBC, including Cognitive, Social, Emotional Function, Fatigue, Itch, and Other Symptoms. Questions in domains: 1) digestion and diet (questions 1-3); 2) experiences (questions 4-7); 3) itching (questions 8-10); 4) fatigue (questions 11-18); 5) effort and planning (questions 19-21); 6) memory and concentration (questions 22-27); 7) affects to you as person (questions 28-33); 8) affects to your social life (questions 34-37); 9) overall impact on your life (questions 38-40); 10) general health and well-being (questions A-C). Within a domain, items are scored from 1 to 5 and the individual item scores are summed to give a total domain score. High scores represent high impact and low scores low impact of PBC on QoL (mITT Population).'}, {'measure': 'Percentage of Participants Meet Published PBC Response Criteria - Barcelona', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with response based on Barcelona risk scores was defined as Normalization of ALP or a Decrease of ALP ≥ 40%. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Absolute Change in MELD Score From Baseline to 12 Weeks and 52 Weeks', 'timeFrame': '12 weeks and 52 weeks', 'description': "Change from baseline to 12 weeks and 52 weeks in Model for End-stage Liver Disease (MELD) Score (mITT Population) The MELD score ranges from 6 to 40 and is a measure of how severe a patient's liver disease is. The higher the score, the more likely the patients will need a liver transplant. A calculated prognostic risk factor used to assess the potential need for a liver transplant.\n\nMELD(i) score = 10\\*\\[0.957\\*ln(creatinine mg/dL) + 0. 378\\*ln(total bilirubin mg/dL) + 1.120\\*ln (INR) + 0.643\\].\n\nIf MELD(i) is less than or equal to 11 then MELD = MELD(i). If MELD(i) is greater than 11 then MELD = MELD(i) + (1.32 \\*(137 - (Na)) - (0.033\\*MELD(i)\\*(137 - Na))"}, {'measure': 'Change in GLOBE PBC Score From Baseline to 12 Weeks and 52 Weeks', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Change from Baseline to 12 weeks and 52 weeks in Global PBC Study Group (GLOBE) score (mITT Population)\n\nThe GLOBE score is a validated risk assessment tool providing an estimate of transplant-free survival for patients with PBC. It was developed by the Global PBC Study Group using Cox regression model on over 4,000 patients with PBC. Lower GLOBE score predicts lower risk. It is calculated from the following equation:\n\nGLOBE score = (0.044378 \\* age + 0.93982 \\* LN(total bilirubin/ULN) +(0.335648 \\* LN(alkaline phosphatase/ULN)) - 2.266708 \\* albumin /LLN -0.002581 \\* platelet count per 109/L) + 1.216865'}, {'measure': 'Participants Meet Rotterdam Criteria', 'timeFrame': '12 weeks and 52 weeks', 'description': 'participants with Response Based on Rotterdam Criteria at Weeks 12 and 52 Rotterdam Published PBC Response Criteria by Visit (mITT Population) Rotterdam criteria: Early (normal total bilirubin and normal albumin), Moderately advanced (either abnormal albumin or abnormal total bilirubin), and Advanced (both abnormal albumin and abnormal total bilirubin). From Early stage to Moderate Stage and to Advanced Stage, it becomes worse and worse in abnormality.'}, {'measure': 'Percentage of Participants Meet Composite Endpoint of AP and Total Bilirubin Criteria at Week 12 and Week 52', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percentage of participants with Response Defined by Composite Endpoint (ALP\\< 1.67 \\* Upper Limit of Normal \\[ULN\\] at Endpoint, Total Bilirubin \\[BIL\\] within Normal Limits at Endpoint, and Greater Than Equal To \\[≥\\] 15% ALP Reduction) from Baseline to Week 12 and Week 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}, {'measure': 'Percent Change in Serum Alkaline Phosphatase (ALP)', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Percent change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.'}]}, 'conditionsModule': {'keywords': ['PBC', 'Primary Biliary Cholangitis (PBC)'], 'conditions': ['Primary Biliary Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '35367282', 'type': 'DERIVED', 'citation': 'Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dorffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, Thuluvath PJ, Levy C, Swain MG, Neff GW, Sheridan DA, Stanca CM, Berg CP, Goel A, Shiffman ML, Vierling JM, Boudes P, Steinberg A, Choi YJ, McWherter CA. A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis. J Hepatol. 2022 Aug;77(2):353-364. doi: 10.1016/j.jhep.2022.02.033. Epub 2022 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)', 'detailedDescription': 'Primary:\n\nTo evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment\n\nSecondary:\n\nTo evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment\n\nTo evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment\n\nTo evaluate the pharmacokinetics (PK) of MBX-8025\n\nExploratory:\n\nTo evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function\n\nMBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated) and any authorizations required by local law\n2. 18 to 75 years old (inclusive)\n3. Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n * History of AP above ULN for at least six months\n * Positive AMA titers (\\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies\n * Documented liver biopsy result consistent with PBC\n4. On a stable and recommended dose of UDCA for the past twelve months or intolerant to UDCA\n5. AP ≥ 1.67 × ULN\n6. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n\nExclusion Criteria:\n\n1. A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment)\n2. AST or ALT \\> 3 × ULN\n3. Total bilirubin \\> 2.0 mg/dL\n4. Total bilirubin \\> ULN AND albumin \\< LLN with the exception to subjects with Gilbert's Syndrome. Subjects with Gilbert's syndrome are excluded if Direct Bilirubin \\> ULN.\n5. Auto-immune hepatitis\n6. Primary sclerosing cholangitis\n7. Known history of alpha-1-Antitrypsin deficiency\n8. Known history of chronic viral hepatitis\n9. Creatine kinase above ULN\n10. Serum creatinine above ULN\n11. For females, pregnancy or breast-feeding\n12. Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening\n13. Current use of fibrates or simvastatin\n14. Current use of obeticholic acid\n15. Use of an experimental or unapproved treatment for PBC\n16. Use of experimental or unapproved immunosuppressant\n17. Adverse event leading to MBX-8025 discontinuation from CymaBay's phase 2 PBC study (CB8025-21528)\n18. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator"}, 'identificationModule': {'nctId': 'NCT02955602', 'briefTitle': 'Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)', 'orgStudyIdInfo': {'id': 'CB8025-21629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBX-8025 (2 mg)', 'description': 'MBX-8025 2 mg capsule once daily', 'interventionNames': ['Drug: MBX-8025 2 mg Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'MBX-8025 (5 mg)', 'description': 'MBX-8025 5 mg capsule once daily', 'interventionNames': ['Drug: MBX-8025 5 mg Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'MBX-8025 (10 mg)', 'description': 'MBX-8025 10 mg capsule once daily', 'interventionNames': ['Drug: MBX-8025 10 mg Capsule']}], 'interventions': [{'name': 'MBX-8025 2 mg Capsule', 'type': 'DRUG', 'otherNames': ['MBX-8025', 'seladelpar'], 'description': "Initial 8-week treatment:\n\n• MBX-8025 2 mg\n\nExtension:\n\nThe 2 mg group will be started after safety and efficacy review of the 5 mg and the 10 mg groups has been completed.\n\nSubjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.", 'armGroupLabels': ['MBX-8025 (2 mg)']}, {'name': 'MBX-8025 5 mg Capsule', 'type': 'DRUG', 'otherNames': ['MBX-8025', 'seladelpar'], 'description': "Initial 8-week treatment:\n\n• MBX-8025 5 mg\n\nExtension:\n\nSubjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.", 'armGroupLabels': ['MBX-8025 (5 mg)']}, {'name': 'MBX-8025 10 mg Capsule', 'type': 'DRUG', 'otherNames': ['MBX-8025', 'seladelpar'], 'description': "Initial 8-week treatment:\n\n• MBX-8025 10 mg\n\nExtension:\n\nSubjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.", 'armGroupLabels': ['MBX-8025 (10 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Institute for Liver Health', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Standford University Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura Clinical Trials', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '34211', 'city': 'Lakewood Rch', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Research Institute', 'geoPoint': {'lat': 27.3863, 'lon': -82.4332}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami - Center for Liver Diseases', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Gastroenterology Associates, LLC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Digestive Healthcare of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48377', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University, Gastroenterology & Hepatology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health - Center for Liver Disease and Transplantation', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northest Clinical Research Center, LLC.', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center Investigation Drug Service', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78233', 'city': 'Live Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Gastroenterology Consultants of SA', 'geoPoint': {'lat': 29.56523, 'lon': -98.3364}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': "Bon Secours St. Mary's Immaculate Hospital", 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Liver Unit', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Centre for Liver Disease', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Outpatient Clinic of Internal Medicine', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Center of Internal Medicine - Medical School of Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'University Medical Centre of the Johannes Guttenberg-University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Universitatsklinikum Giessen und Marburg GmbH', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Medizinische Universitatsklinik Tubingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'B15 2GW', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull and East Yorkshire Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'NW3 2QR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}