Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 4:34 AM
Study NCT ID:
NCT05007392
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706811', 'term': 'dotinurad'}, {'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eisai-chiken_hotline@hhc.eisai.co.jp', 'phone': 'none', 'title': 'Eisai Inquiry Service', 'organization': 'Eisai Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to Week 24', 'description': 'Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 203, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 201, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Monocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Monocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Right ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Xerophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Anal eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Duodenogastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Ileal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Tooth impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 24}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Hepatic lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gallbladder enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 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urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Glomerulonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Renal milk of calcium cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Urate nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Prostatic calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Reflux laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Urticaria papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Phlebolith', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}, {'term': 'Glomerulonephritis membranous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0.'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'OG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '44.5'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '79.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.87', 'ciLowerLimit': '27.36', 'ciUpperLimit': '44.37', 'estimateComment': 'The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'Percentage of participants with SUA level less than or equal to (\\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'OG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '57.1'}, {'value': '55.5', 'groupId': 'OG001', 'lowerLimit': '48.9', 'upperLimit': '62.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.24', 'ciLowerLimit': '-3.69', 'ciUpperLimit': '14.17', 'estimateComment': 'The difference of percentage and stratified 95% CI was based on Mantel-Haenszel method.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The prespecified non-inferiority margin was -10% in the analysis.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'Percentage of participants with SUA level \\<=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'OG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}, {'title': 'Wee 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}, {'value': '84.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}, {'value': '83.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}, {'value': '78.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Percentage of participants with SUA level \\<=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'OG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'classes': [{'title': 'Percent Reduction from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.43', 'spread': '13.200', 'groupId': 'OG000'}, {'value': '27.43', 'spread': '14.754', 'groupId': 'OG001'}]}]}, {'title': 'Percent Reduction from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.06', 'spread': '14.018', 'groupId': 'OG000'}, {'value': '39.10', 'spread': '18.931', 'groupId': 'OG001'}]}]}, {'title': 'Percent Reduction from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.06', 'spread': '15.383', 'groupId': 'OG000'}, {'value': '38.62', 'spread': '17.305', 'groupId': 'OG001'}]}]}, {'title': 'Percent Reduction from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.13', 'spread': '16.016', 'groupId': 'OG000'}, {'value': '51.47', 'spread': '18.542', 'groupId': 'OG001'}]}]}, {'title': 'Percent Reduction from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.71', 'spread': '15.728', 'groupId': 'OG000'}, {'value': '50.22', 'spread': '20.714', 'groupId': 'OG001'}]}]}, {'title': 'Percent Reduction from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.28', 'spread': '16.907', 'groupId': 'OG000'}, {'value': '48.07', 'spread': '23.243', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.', 'unitOfMeasure': 'Percent change in SUA level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'OG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'classes': [{'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.60', 'spread': '1.457', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '1.508', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.62', 'spread': '1.597', 'groupId': 'OG000'}, {'value': '-3.80', 'spread': '1.973', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.52', 'spread': '1.691', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '1.817', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.44', 'spread': '1.731', 'groupId': 'OG000'}, {'value': '-5.05', 'spread': '2.078', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.52', 'spread': '1.757', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '2.201', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.20', 'spread': '1.800', 'groupId': 'OG000'}, {'value': '-4.71', 'spread': '2.415', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'OG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.65', 'spread': '1.426', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '1.451', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.07', 'spread': '1.432', 'groupId': 'OG000'}, {'value': '6.93', 'spread': '1.447', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.01', 'spread': '1.372', 'groupId': 'OG000'}, {'value': '5.80', 'spread': '1.857', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.12', 'spread': '1.546', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '1.708', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.24', 'spread': '1.605', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '1.776', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.14', 'spread': '1.467', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '1.900', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.49', 'spread': '1.575', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '2.296', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "number analyzed" signifies those participants who were evaluable at specified timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 milligrams (mg) tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'FG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'Safety Analysis Set', 'comment': 'Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'Full Analysis Set', 'comment': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '221'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Serum uric acid (SUA) level of <=2.0 milligram per deciliter (mg/dL) for 2 consecutive visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Use of prohibited concomitant drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Inadequate therapeutic effect or progression of disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Participant choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 30 investigative sites in China from 21 December 2021 to 14 June 2023.', 'preAssignmentDetails': 'A total of 604 participants were screened, of which 153 were screen failure. 451 participants were enrolled and randomized and 448 received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Febuxostat', 'description': 'Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.'}, {'id': 'BG001', 'title': 'Dotinurad', 'description': 'Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '10.98', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '11.56', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '11.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-07', 'size': 596615, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-10T06:34', 'hasProtocol': True}, {'date': '2023-08-25', 'size': 269908, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-10T06:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2021-08-11', 'resultsFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-10', 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)', 'timeFrame': 'At Week 24', 'description': 'Percentage of participants with SUA level less than or equal to (\\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)', 'timeFrame': 'At Week 12', 'description': 'Percentage of participants with SUA level \\<=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.'}, {'measure': 'Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24', 'timeFrame': 'At Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Percentage of participants with SUA level \\<=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.'}, {'measure': 'Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.'}, {'measure': 'Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.'}, {'measure': 'Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dotinurad', 'Febuxostat'], 'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (\\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 in Chinese participants with gout.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gout participant (with a history of gout attack or concurrent gouty tophi) with SUA level greater than (\\>) 7.0 mg/dL in the screening phase (within 14 days prior to randomization)\n2. Male or female participant with age greater than or equal to (\\>=) 18 years at the time of informed consent\n3. Provide written informed consent signed by the participant prior to entering the study or undergoing any study procedures, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study\n\nExclusion Criteria:\n\n1. Has gouty arthritis that has not resolved within 14 days prior to randomization\n2. Has secondary hyperuricemia\n3. Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain)\n4. Evidence of clinically significant disease (example, cardiac disease: heart failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant\'s safety or interfere with the study assessments\n5. Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 multiple (\\*) upper limit of normal (ULN) in the screening phase\n6. Estimated glomerular filtration rate (eGFR) of less than (\\<) 30 milliliter per minute/1.73 square meters in the screening phase\n7. Systolic blood pressure of \\>=180 millimetre of mercury (mmHg) or diastolic blood pressure of \\>=110 mmHg in the screening phase\n8. Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of \\>=8.4 percent (%) in the screening phase\n9. Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)'}, 'identificationModule': {'nctId': 'NCT05007392', 'briefTitle': 'A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout', 'orgStudyIdInfo': {'id': 'FYU-981-J086-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: Dotinurad + Febuxostat Matched Placebo', 'description': 'Participants will receive one dotinurad 1 mg tablet and one febuxostat 20 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then one dotinurad 2 mg tablet and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two dotinurad 2 mg tablets and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).', 'interventionNames': ['Drug: Dotinurad', 'Other: Febuxostat Matched Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug: Febuxostat + Dotinurad Matched Placebo', 'description': 'Participants will receive one febuxostat 20 mg tablet and one dotinurad 1 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then two febuxostat 20 mg tablets and one dotinurad 2 mg matched placebo tablet, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two febuxostat 20 mg tablets and two dotinurad 2 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).', 'interventionNames': ['Drug: Febuxostat', 'Other: Dotinurad Matched Placebo']}], 'interventions': [{'name': 'Dotinurad', 'type': 'DRUG', 'otherNames': ['FYU-981'], 'description': 'Dotinurad oral tablets.', 'armGroupLabels': ['Drug: Dotinurad + Febuxostat Matched Placebo']}, {'name': 'Febuxostat', 'type': 'DRUG', 'description': 'Febuxostat oral tablets.', 'armGroupLabels': ['Drug: Febuxostat + Dotinurad Matched Placebo']}, {'name': 'Dotinurad Matched Placebo', 'type': 'OTHER', 'description': 'Dotinurad matched placebo oral tablets.', 'armGroupLabels': ['Drug: Febuxostat + Dotinurad Matched Placebo']}, {'name': 'Febuxostat Matched Placebo', 'type': 'OTHER', 'description': 'Febuxostat matched placebo oral tablets.', 'armGroupLabels': ['Drug: Dotinurad + Febuxostat Matched Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101100', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '528000', 'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': "Foshan First People's Hospital", 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510080', 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