Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT03053050
Status:
TERMINATED
Last Update Posted:
2020-06-29
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654501', 'term': 'selonsertib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\nThe results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Based on the results of the Week 48 analysis, the study was terminated early for lack of efficacy as prespecified in the clinical study protocol.'}}, 'adverseEventsModule': {'timeFrame': 'First dose date up to last dose (maximum: 111.4 weeks) plus 30 days', 'description': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks.', 'otherNumAtRisk': 322, 'deathsNumAtRisk': 322, 'otherNumAffected': 248, 'seriousNumAtRisk': 322, 'deathsNumAffected': 0, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.', 'otherNumAtRisk': 321, 'deathsNumAtRisk': 321, 'otherNumAffected': 254, 'seriousNumAtRisk': 321, 'deathsNumAffected': 0, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 130, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'Open-Label SEL 18 mg', 'description': 'Open-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 48, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 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'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 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{'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Left ventricular dysfunction', 'stats': 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'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Internal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cystitis interstitial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Testicular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 322, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '13.4'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '16.2'}, {'value': '13.2', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '19.5'}]}]}], 'analyses': [{'pValue': '0.4941', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '4.0', 'pValueComment': 'Difference between SEL 18 mg and Placebo, 95% confidence interval (CI) and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and Enhanced Liver Fibrosis (ELF) test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9321', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '6.0', 'pValueComment': 'Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'timeFrame': 'Week 240', 'description': 'EFS was assessed by the time to the first clinical event, including progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had Progression to Cirrhosis at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '17.2'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '20.0'}, {'value': '15.7', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '22.3'}]}]}], 'analyses': [{'pValue': '0.2593', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-10.8', 'ciUpperLimit': '2.9', 'pValueComment': 'Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8080', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '6.1', 'pValueComment': 'Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from \\< 4 at baseline to 4 at Week 48.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'timeFrame': 'Week 240', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '16.9'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '18.0'}, {'value': '16.4', 'groupId': 'OG002', 'lowerLimit': '11.0', 'upperLimit': '23.0'}]}]}], 'analyses': [{'pValue': '0.5636', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '4.8', 'pValueComment': 'Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5915', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '4.9', 'pValueComment': 'Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'timeFrame': 'Week 240', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '7.9'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '7.2'}, {'value': '8.9', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '14.4'}]}]}], 'analyses': [{'pValue': '0.2455', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '2.2', 'pValueComment': 'Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1371', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '1.3', 'pValueComment': 'Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'timeFrame': 'Week 240', 'description': 'NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks.'}, {'id': 'FG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo-to-match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.'}, {'id': 'FG003', 'title': 'Open-Label SEL 18 mg', 'description': 'Open-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}], 'periods': [{'title': 'Randomized Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '323'}, {'groupId': 'FG002', 'numSubjects': '161'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '323'}, {'groupId': 'FG002', 'numSubjects': '161'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '260'}, {'groupId': 'FG002', 'numSubjects': '128'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entered the Open-Label Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants with hepatic clinical event or progression to cirrhosis had option to go into OL Phase.', 'groupId': 'FG003', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '89'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America, Asia, Europe, Australia, South America, Puerto Rico, and New Zealand. The first participant was screened on 13 February 2017. The last study visit occurred on 19 June 2019.', 'preAssignmentDetails': '2250 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '802', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'BG001', 'title': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks\n\nOL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '57', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '57', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '57', 'spread': '9.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '453', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '559', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted = Local regulators did not allow collection of race or ethnicity information.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '675', 'groupId': 'BG003'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted = Local regulators did not allow collection of race or ethnicity information.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '413', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-31', 'size': 3909193, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-29T04:04', 'hasProtocol': True}, {'date': '2019-01-23', 'size': 1803718, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-29T04:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 808}}, 'statusModule': {'whyStopped': 'This study was terminated early due to lack of efficacy based on the results of the Week 48 analysis as prespecified in the clinical study protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2017-02-10', 'resultsFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-10', 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48', 'timeFrame': 'Week 48', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.'}, {'measure': 'Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event', 'timeFrame': 'Week 240', 'description': 'EFS was assessed by the time to the first clinical event, including progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had Progression to Cirrhosis at Week 48', 'timeFrame': 'Week 48', 'description': 'Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from \\< 4 at baseline to 4 at Week 48.'}, {'measure': 'Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240', 'timeFrame': 'Week 240', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.'}, {'measure': 'Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48', 'timeFrame': 'Week 48', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).'}, {'measure': 'Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240', 'timeFrame': 'Week 240', 'description': 'Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).'}, {'measure': 'Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48', 'timeFrame': 'Week 48', 'description': 'NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.'}, {'measure': 'Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240', 'timeFrame': 'Week 240', 'description': 'NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonalcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '31271665', 'type': 'RESULT', 'citation': 'Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.'}, {'type': 'RESULT', 'citation': 'Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.'}, {'pmid': '30779990', 'type': 'RESULT', 'citation': 'Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.'}, {'type': 'RESULT', 'citation': 'Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.'}, {'type': 'RESULT', 'citation': 'Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.'}, {'type': 'RESULT', 'citation': 'Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.'}, {'type': 'RESULT', 'citation': 'Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.'}, {'pmid': '36750244', 'type': 'DERIVED', 'citation': 'Loomba R, Huang DQ, Sanyal AJ, Anstee QM, Trauner M, Lawitz EJ, Ding D, Ma L, Jia C, Billin A, Huss RS, Chung C, Goodman Z, Wong VW, Okanoue T, Romero-Gomez M, Abdelmalek MF, Muir A, Afdhal N, Bosch J, Harrison S, Younossi ZM, Myers RP. Liver stiffness thresholds to predict disease progression and clinical outcomes in bridging fibrosis and cirrhosis. Gut. 2023 Mar;72(3):581-589. doi: 10.1136/gutjnl-2022-327777. Epub 2022 Sep 9.'}, {'pmid': '33307033', 'type': 'DERIVED', 'citation': 'Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.'}, {'pmid': '32147362', 'type': 'DERIVED', 'citation': 'Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3; STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.'}, {'pmid': '30639779', 'type': 'DERIVED', 'citation': 'Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader\n* Has the following laboratory parameters at the screening visit:\n\n * Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)\n * Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation\n * Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)\n * Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)\n\nKey Exclusion Criteria:\n\n* Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding\n* Child-Pugh (CP) score \\> 6, as determined at screening, unless due to therapeutic anti-coagulation\n* Model for End-stage Liver Disease (MELD) score \\> 12, as determined at screening, unless due to therapeutic anti-coagulation\n* Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.\n* History of liver transplantation\n* Current or history of hepatocellular carcinoma (HCC)\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03053050', 'acronym': 'STELLAR-3', 'briefTitle': 'Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis', 'orgStudyIdInfo': {'id': 'GS-US-384-1943'}, 'secondaryIdInfos': [{'id': '2016-004374-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEL 18 mg', 'description': 'Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks\n\nOpen-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.', 'interventionNames': ['Drug: SEL', 'Drug: Placebo to match SEL 6 mg']}, {'type': 'EXPERIMENTAL', 'label': 'SEL 6 mg', 'description': 'Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks\n\nOL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.', 'interventionNames': ['Drug: SEL', 'Drug: Placebo to match SEL 18 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks\n\nOL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.', 'interventionNames': ['Drug: Placebo to match SEL 6 mg', 'Drug: Placebo to match SEL 18 mg']}], 'interventions': [{'name': 'SEL', 'type': 'DRUG', 'otherNames': ['selonsertib', 'GS-4997'], 'description': 'Tablets administered orally once daily', 'armGroupLabels': ['SEL 18 mg', 'SEL 6 mg']}, {'name': 'Placebo to match SEL 6 mg', 'type': 'DRUG', 'description': 'Tablets administered orally once daily', 'armGroupLabels': ['Placebo', 'SEL 18 mg']}, {'name': 'Placebo to match SEL 18 mg', 'type': 'DRUG', 'description': 'Tablets administered orally once daily', 'armGroupLabels': ['Placebo', 'SEL 6 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 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