Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01510158
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2012-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combining Lesinurad With Allopurinol in Inadequate Responders
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': 'C000593471', 'term': 'lesinurad'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nbhakta@ardeabio.com', 'phone': '1-858-652-6671', 'title': 'Nihar Bhakta, MD', 'organization': 'Ardea Biosciences, MD'}, 'certainAgreement': {'otherDetails': "PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Overall number of baseline participants used to determine number of participants at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'Lesinurad 200 mg + Allopurinol', 'description': 'lesinurad 200 mg qd plus allopurinol', 'otherNumAtRisk': 201, 'otherNumAffected': 147, 'seriousNumAtRisk': 201, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Lesinurad 400 mg + Allopurinol', 'description': 'lesinurad 400 mg qd plus allopurinol', 'otherNumAtRisk': 201, 'otherNumAffected': 156, 'seriousNumAtRisk': 201, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Placebo + Allopurinol', 'description': 'placebo qd plus allopurinol', 'otherNumAtRisk': 201, 'otherNumAffected': 138, 'seriousNumAtRisk': 201, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Deafness transitory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Inner ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Androgen deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperparathyroidism primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypogonadism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Astigmatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Presbyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vascular dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stag horn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With an sUA Level That is < 6.0 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Allopurinol', 'description': 'lesinurad 200 mg qd plus allopurinol'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Allopurinol', 'description': 'lesinurad 400 mg qd plus allopurinol'}, {'id': 'OG002', 'title': 'Placebo + Allopurinol', 'description': 'placebo qd plus allopurinol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.542', 'groupId': 'OG000'}, {'value': '0.592', 'groupId': 'OG001'}, {'value': '0.279', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 Months, analysis after all subjects complete 12 months', 'unitOfMeasure': 'Proportion of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Gout Flares', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Allopurinol', 'description': 'lesinurad 200 mg qd plus allopurinol'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Allopurinol', 'description': 'lesinurad 400 mg qd plus allopurinol'}, {'id': 'OG002', 'title': 'Placebo + Allopurinol', 'description': 'placebo qd plus allopurinol'}], 'classes': [{'categories': [{'measurements': [{'value': '.60', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '.50', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '.60', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9796', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6125', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.43', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12', 'unitOfMeasure': 'Gout Flares', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tophus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Allopurinol', 'description': 'lesinurad 200 mg qd plus allopurinol'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Allopurinol', 'description': 'lesinurad 400 mg qd plus allopurinol'}, {'id': 'OG002', 'title': 'Placebo + Allopurinol', 'description': 'placebo qd plus allopurinol'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.211', 'groupId': 'OG001'}, {'value': '0.294', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0183', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.08', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5974', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12', 'unitOfMeasure': 'Proportion of Subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lesinurad 200 mg + Allopurinol', 'description': 'lesinurad 200 mg qd plus allopurinol'}, {'id': 'FG001', 'title': 'Lesinurad 400 mg + Allopurinol', 'description': 'lesinurad 400 mg qd plus allopurinol'}, {'id': 'FG002', 'title': 'Placebo + Allopurinol', 'description': 'placebo qd plus allopurinol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Gout flare', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'Sponsor terminated study.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '603', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lesinurad 200 mg + Allopurinol', 'description': 'lesinurad 200 mg qd plus allopurinol'}, {'id': 'BG001', 'title': 'Lesinurad 400 mg + Allopurinol', 'description': 'lesinurad 400 mg qd plus allopurinol'}, {'id': 'BG002', 'title': 'Placebo + Allopurinol', 'description': 'placebo qd plus allopurinol'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '51.9', 'spread': '11.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '518', 'groupId': 'BG003'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '567', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '603', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2015-04-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2012-01-11', 'dispFirstSubmitQcDate': '2015-04-30', 'resultsFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2012-01-11', 'dispFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-11', 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With an sUA Level That is < 6.0 mg/dL', 'timeFrame': '6 Months, analysis after all subjects complete 12 months'}], 'secondaryOutcomes': [{'measure': 'Gout Flares', 'timeFrame': '12 Months', 'description': 'Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12'}, {'measure': 'Tophus', 'timeFrame': '12 Months', 'description': 'Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gout']}, 'referencesModule': {'references': [{'pmid': '35835008', 'type': 'DERIVED', 'citation': 'Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.'}, {'pmid': '27564409', 'type': 'DERIVED', 'citation': 'Saag KG, Fitz-Patrick D, Kopicko J, Fung M, Bhakta N, Adler S, Storgard C, Baumgartner S, Becker MA. Lesinurad Combined With Allopurinol: A Randomized, Double-Blind, Placebo-Controlled Study in Gout Patients With an Inadequate Response to Standard-of-Care Allopurinol (a US-Based Study). Arthritis Rheumatol. 2017 Jan;69(1):203-212. doi: 10.1002/art.39840.'}], 'seeAlsoLinks': [{'url': 'http://www.gouttrial.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.', 'detailedDescription': 'Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended serum urate (sUA) target of \\< 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are uric acid transporter 1 (URAT1) inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.\n* Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.\n* Subject has been taking allopurinol as the sole urate-lowering therapy indicated for the treatment of gout for at least 8 weeks prior to the Screening Visit at a stable, medically appropriate dose, as determined by the investigator, of at least 300 mg per day (at least 200 mg for subjects with moderate renal impairment).\n* Subject must be able to take gout flare prophylaxis with colchicine or an Nonsteroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.\n* Subject has an sUA level ≥ 6.5 mg/dL at the Screening Visit and ≥ 6.0 mg/dL at Day -7 Visit.\n* Subject has reported at least 2 gout flares in the prior 12 months.\n* Body mass index (BMI) \\< 45 kg/m2\n\nExclusion Criteria:\n\n* Subject with known hypersensitivity or allergy to allopurinol.\n* Subject who is taking any other approved urate-lowering medication that is indicated for the treatment of gout other than allopurinol within 8 weeks of the Screening Visit.\n* Subject who is pregnant or breastfeeding.\n* Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \\[150 mL\\] of wine, 12 oz \\[360 mL\\] of beer, or 1.5 oz \\[45 mL\\] of hard liquor).\n* Subject with a history or suspicion of drug abuse within the past 5 years.\n* Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.\n* Subject with known or suspected human immunodeficiency virus (HIV) infection.\n* Subject with a positive test for active hepatitis B or hepatitis C infection.\n* Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.\n* Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.\n* Subject with uncontrolled hypertension.\n* Subject with an estimated creatinine clearance \\< 30 mL/min.\n* Subject with active peptic ulcer disease requiring treatment.\n* Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.\n* Subject receiving chronic treatment with more than 325 mg of salicylates per day.\n* Subject taking valpromide, progabide, or valproic acid.\n* Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.\n* Subject with any other medical or psychological condition, which might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study."}, 'identificationModule': {'nctId': 'NCT01510158', 'acronym': 'CLEAR 1', 'briefTitle': 'Combining Lesinurad With Allopurinol in Inadequate Responders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardea Biosciences, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol.', 'orgStudyIdInfo': {'id': 'RDEA594-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lesinurad 200 mg + allopurinol', 'interventionNames': ['Drug: Lesinurad', 'Drug: Allopurinol']}, {'type': 'EXPERIMENTAL', 'label': 'lesinurad 400 mg + allopurinol', 'interventionNames': ['Drug: Lesinurad', 'Drug: Allopurinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + allopurinol', 'interventionNames': ['Drug: Placebo', 'Drug: Allopurinol']}], 'interventions': [{'name': 'Lesinurad', 'type': 'DRUG', 'description': 'Tablets, 200 mg once daily (qd)', 'armGroupLabels': ['lesinurad 200 mg + allopurinol']}, {'name': 'Lesinurad', 'type': 'DRUG', 'description': 'Tablets, 400 mg qd', 'armGroupLabels': ['lesinurad 400 mg + allopurinol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Placebo qd', 'armGroupLabels': ['Placebo + allopurinol']}, {'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)', 'armGroupLabels': ['lesinurad 200 mg + allopurinol']}, {'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)', 'armGroupLabels': ['lesinurad 400 mg + allopurinol']}, {'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)', 'armGroupLabels': ['Placebo + allopurinol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.80243, 'lon': -86.97219}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': 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