Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-12 @ 7:23 AM
Study NCT ID:
NCT02267356
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599187', 'term': 'VT-1161'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@viamet.com', 'phone': '(919) 467-8539', 'title': 'Sr Vice President, Clinical Development', 'organization': 'Mycovia Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Neither Institution nor Principal Investigator shall publish the results of the Trial without the prior written consent of Sponsor, which it may withhold in its sole discretion.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows:\n\nLow-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose 12-week', 'description': 'Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks', 'otherNumAtRisk': 53, 'otherNumAffected': 29, 'seriousNumAtRisk': 53, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Low Dose 24-week', 'description': 'Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks', 'otherNumAtRisk': 53, 'otherNumAffected': 26, 'seriousNumAtRisk': 53, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'High Dose 12-week', 'description': 'Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks', 'otherNumAtRisk': 52, 'otherNumAffected': 31, 'seriousNumAtRisk': 52, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'High Dose 24-week', 'description': 'Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks', 'otherNumAtRisk': 54, 'otherNumAffected': 36, 'seriousNumAtRisk': 54, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Matching placebo tablets for 24 weeks', 'otherNumAtRisk': 47, 'otherNumAffected': 26, 'seriousNumAtRisk': 47, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Congenital aural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Meibomian gland dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Duodenogastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 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'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Onychoclasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue 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'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Hemorrhagic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Acoustic neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 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47, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Postmenopausal hemmorage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose 12-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'OG001', 'title': 'Low Dose 24-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'OG002', 'title': 'High Dose 12-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'OG003', 'title': 'High Dose 24-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': '4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture.\n\nInvestigator Global Assessment (IGA) scoring:\n\n0: 0% nail involvement\n\n1. \\>0% to ≤10% nail involvement\n2. \\>10% to \\<25% nail involvement\n3. ≥25% to ≤50% nail involvement\n4. \\>50% to ≤75% nail involvement\n5. \\>75% nail involvement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Initial 60-week study data. Study extension data not applicable.'}, {'type': 'PRIMARY', 'title': 'Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose 12-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'OG001', 'title': 'Low Dose 24-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'OG002', 'title': 'High Dose 12-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'OG003', 'title': 'High Dose 24-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': '4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose 12-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'FG001', 'title': 'Low Dose 24-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'FG002', 'title': 'High Dose 12-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'FG003', 'title': 'High Dose 24-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'FG004', 'title': 'Placebo', 'description': '4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}], 'periods': [{'title': 'Initial Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '5'}]}]}, {'title': 'Study Extension', 'milestones': [{'type': 'STARTED', 'comment': 'Not all subjects completing initial study continued in study extension. Continuation was optional.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '259', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose 12-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'BG001', 'title': 'Low Dose 24-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'BG002', 'title': 'High Dose 12-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks'}, {'id': 'BG003', 'title': 'High Dose 24-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'BG004', 'title': 'Placebo', 'description': '4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '9.41', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '10.28', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '12.79', 'groupId': 'BG002'}, {'value': '49.0', 'spread': '10.45', 'groupId': 'BG003'}, {'value': '52.7', 'spread': '11.69', 'groupId': 'BG004'}, {'value': '50.0', 'spread': '10.96', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '208', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Analysis Population data is for initial 60-week study only.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2014-10-08', 'resultsFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-09', 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48', 'timeFrame': '48 weeks', 'description': 'Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture.\n\nInvestigator Global Assessment (IGA) scoring:\n\n0: 0% nail involvement\n\n1. \\>0% to ≤10% nail involvement\n2. \\>10% to \\<25% nail involvement\n3. ≥25% to ≤50% nail involvement\n4. \\>50% to ≤75% nail involvement\n5. \\>75% nail involvement'}, {'measure': 'Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'referencesModule': {'references': [{'pmid': '32421854', 'type': 'DERIVED', 'citation': 'Elewski B, Brand S, Degenhardt T, Curelop S, Pollak R, Schotzinger R, Tavakkol A. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail. Br J Dermatol. 2021 Feb;184(2):270-280. doi: 10.1111/bjd.19224. Epub 2020 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines.\n\nThis study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months.\n\nThe additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nDistal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.\n\nPositive culture for dermatophytes and positive KOH.\n\nNail ≤ 3 mm thick at the distal end.\n\nAt least ≥ 2 mm of the proximal end of the great toenail must be free of infection.\n\nSubjects must be able to swallow tablets.\n\nWomen of childbearing potential and males must use acceptable birth control methods throughout the study.\n\nKey Exclusion Criteria:\n\nPresence of subungual hematoma or melanonychia.\n\nPresence of dermatophytoma/nail streaks and severe onychorrhexis.\n\nSignificant dystrophy or anatomic abnormalities of the great toenail.\n\nPresence of any other infections of the foot.\n\nEvidence of clinically significant major organ disease.\n\nPoorly controlled diabetes mellitus.\n\nOnychomycosis involving more than 8 toe nails.\n\nRecent use of systemic antifungal therapy.\n\nRecent of any topical antifungal nail therapy.\n\nRecent use of systemic corticosteroid therapy.\n\nRecent use of immunosuppressive medication.\n\nHistory of prolonged QT intervals.\n\nKnown human immunodeficiency virus (HIV) infection.\n\nKnown significant renal or hepatic impairment.\n\nKnown history of intolerance or hypersensitivity to azole antifungal drugs.'}, 'identificationModule': {'nctId': 'NCT02267356', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viamet'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail', 'orgStudyIdInfo': {'id': 'VMT-VT-1161-CL-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose 12-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks', 'interventionNames': ['Drug: VT-1161']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose 24-week', 'description': '2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks', 'interventionNames': ['Drug: VT-1161']}, {'type': 'EXPERIMENTAL', 'label': 'High dose 12-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks', 'interventionNames': ['Drug: VT-1161']}, {'type': 'EXPERIMENTAL', 'label': 'High dose 24-week', 'description': '4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks', 'interventionNames': ['Drug: VT-1161']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VT-1161', 'type': 'DRUG', 'armGroupLabels': ['High dose 12-week', 'High dose 24-week', 'Low dose 12-week', 'Low dose 24-week']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Kirklin Clinic of UAB Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Specialists, Inc', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 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