Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT00783094
Status:
COMPLETED
Last Update Posted:
2011-03-29
First Post:
2008-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.', 'description': 'Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.', 'eventGroups': [{'id': 'EG000', 'title': 'Tadalafil 2.5 mg - Double-Blind Phase', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.', 'otherNumAtRisk': 142, 'otherNumAffected': 52, 'seriousNumAtRisk': 142, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Tadalafil 5 mg - Double-Blind Phase', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.', 'otherNumAtRisk': 140, 'otherNumAffected': 54, 'seriousNumAtRisk': 140, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo - Double-Blind Phase', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.', 'otherNumAtRisk': 140, 'otherNumAffected': 53, 'seriousNumAtRisk': 140, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label', 'description': '5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.', 'otherNumAtRisk': 135, 'otherNumAffected': 81, 'seriousNumAtRisk': 135, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Tadalafil 5 mg: Tadalafil 5 mg Open-Label', 'description': '5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.', 'otherNumAtRisk': 128, 'otherNumAffected': 81, 'seriousNumAtRisk': 128, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Placebo: Tadalafil 5 mg Open-Label', 'description': '5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.', 'otherNumAtRisk': 131, 'otherNumAffected': 94, 'seriousNumAtRisk': 131, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 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'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.201', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, prior alpha blocker use (yes/no), and baseline value.', 'testedNonInferiority': False}, {'pValue': '0.062', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, prior alpha blocker use (yes/no) and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.356', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, prior alpha blocker use (yes/no) and baseline value.', 'testedNonInferiority': False}, {'pValue': '0.487', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, prior alpha blocker use (yes/no) and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.228', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, prior alpha blocker use (yes/no) and baseline value.', 'testedNonInferiority': False}, {'pValue': '0.033', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, prior alpha blocker use (yes/no) and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.249', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.904', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.', 'testedNonInferiority': False}, {'pValue': '0.800', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.147', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.', 'testedNonInferiority': False}, {'pValue': '0.094', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Least Squares Mean Difference = Tadalafil 5 mg - Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).', 'unitOfMeasure': 'milliliters per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'title': '0-6 hours (n=225, 200)', 'categories': [{'measurements': [{'value': '86.0', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '169', 'spread': '41.2', 'groupId': 'OG001'}]}]}, {'title': '6-12 hours (n=72, 72)', 'categories': [{'measurements': [{'value': '68.7', 'spread': '37.6', 'groupId': 'OG000'}, {'value': '140', 'spread': '51.3', 'groupId': 'OG001'}]}]}, {'title': '12-24 hours (n=102, 106)', 'categories': [{'measurements': [{'value': '57.5', 'spread': '49.1', 'groupId': 'OG000'}, {'value': '93.6', 'spread': '55.6', 'groupId': 'OG001'}]}]}, {'title': '24-48 hours (n=11, 8)', 'categories': [{'measurements': [{'value': '43.5', 'spread': '89.7', 'groupId': 'OG000'}, {'value': '75.2', 'spread': '56.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.', 'unitOfMeasure': 'nanogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events During 12 Weeks of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Non-Serious Adverse Events', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 12 weeks', 'description': 'A listing of Adverse Events are reported in the Reported Adverse Event Section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '14.0', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '10.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.342', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-Value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.127', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-Value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxin rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.705', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-Value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.173', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-Value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sitting Heart Rate at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '8.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.606', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.149', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.41', 'spread': '41.43', 'groupId': 'OG000'}, {'value': '-5.15', 'spread': '40.32', 'groupId': 'OG001'}, {'value': '-4.72', 'spread': '36.40', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.428', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.426', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxin rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '2.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxin rank-sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxin rank-sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measurement of nanograms of PSA per milliliter (ng/mL) of blood.', 'unitOfMeasure': 'Micrograms per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '3.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '4.48', 'groupId': 'OG001'}, {'value': '2.01', 'spread': '5.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Non-Serious Adverse Events', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of 12 weeks of double-blind through 54 weeks', 'description': 'A listing of Adverse Events are reported in the Reported Adverse Event Section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure During at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '14.2', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '9.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sitting Heart Rate at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '10.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54-weeks', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Measurement of nanograms of PSA per milliliter (ng/mL) of blood.', 'unitOfMeasure': 'microgram/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'spread': '50.0', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '42.9', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '46.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Post residual volume (PVR) is measured by ultrasound at regular intervals.', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.', 'anticipatedPostingDate': '2011-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'FG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}], 'periods': [{'title': 'Randomized Double-Blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Open-Label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tadalafil 2.5 mg', 'description': '2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'BG001', 'title': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '66.9', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '67.0', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '66.8', 'spread': '7.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline (Visit 3) Benign Prostatic Hyperplasia Severity', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants with BPH were defined as having had signs and symptoms of benign prostatic hyperplasia (BPH) (as diagnosed by a qualified physician) \\>6 months at Visit 1. Signs and symptoms of BPH included those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining)and/or storage (irritative symptoms, such as frequency, urgency, or nocturia).', 'unitOfMeasure': 'participants'}, {'title': 'Current Alcohol Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '281', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Tobacco Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Recorded', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous Alpha-blocker Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Actual use of alpha-blockers within the previous 12 months.', 'unitOfMeasure': 'participants'}, {'title': 'Previous Benign Prostatic Hyperplasia Therapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '339', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Actual benign prostatic hyperplasia (BPH) therapy within the previous 12 months.', 'unitOfMeasure': 'participants'}, {'title': 'Previous Overactive Bladder Therapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '393', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Actual overactive bladder (OAB) therapy within the previous 12 months.', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '23.5', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '23.6', 'spread': '2.9', 'groupId': 'BG002'}, {'value': '23.5', 'spread': '2.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms/meters squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of BPH', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '2.9', 'groupId': 'BG002'}, {'value': '4.2', 'spread': '3.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Participants had signs and symptoms of benign prostatic hyperplasia (BPH) (as diagnosed by a qualified physician) \\>6 months at Visit 1.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.0', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '166.9', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '166.3', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '166.4', 'spread': '6.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Postvoid Residual Volume', 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '46.6', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '36.4', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '42.7', 'groupId': 'BG002'}, {'value': '33.0', 'spread': '42.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Postvoid residual volume (PVR) was measured by ultrasound at regular intervals.', 'unitOfMeasure': 'mililiters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '65.4', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '65.1', 'spread': '9.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-18', 'studyFirstSubmitDate': '2008-10-30', 'resultsFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-25', 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.'}, {'measure': 'Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).'}, {'measure': 'Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.'}, {'measure': 'Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).'}, {'measure': 'Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.'}, {'measure': 'Number of Participants With Adverse Events During 12 Weeks of the Study', 'timeFrame': 'Baseline through 12 weeks', 'description': 'A listing of Adverse Events are reported in the Reported Adverse Event Section.'}, {'measure': 'Change From Baseline in Blood Pressure at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks'}, {'measure': 'Change From Baseline in Sitting Heart Rate at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 Weeks'}, {'measure': 'Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.'}, {'measure': 'Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measurement of nanograms of PSA per milliliter (ng/mL) of blood.'}, {'measure': 'Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.'}, {'measure': 'Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).'}, {'measure': 'Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.'}, {'measure': 'Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).'}, {'measure': 'Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment', 'timeFrame': 'End of 12 weeks of double-blind through 54 weeks', 'description': 'A listing of Adverse Events are reported in the Reported Adverse Event Section.'}, {'measure': 'Change From Baseline in Blood Pressure During at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks'}, {'measure': 'Change From Baseline in Sitting Heart Rate at 54-Week Endpoint', 'timeFrame': 'Baseline, 54-weeks'}, {'measure': 'Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Measurement of nanograms of PSA per milliliter (ng/mL) of blood.'}, {'measure': 'Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint', 'timeFrame': 'Baseline, 54 weeks', 'description': 'Post residual volume (PVR) is measured by ultrasound at regular intervals.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.\n* Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.\n* Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.\n\nExclusion Criteria:\n\n* Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.\n* History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.\n* History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.\n* Clinical evidence of prostate cancer at Visit 1.\n* Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.\n* History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.\n* History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.\n* Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.'}, 'identificationModule': {'nctId': 'NCT00783094', 'briefTitle': 'Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '12757'}, 'secondaryIdInfos': [{'id': 'H6D-JE-LVIA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tadalafil 2.5 milligrams (mg)', 'description': '2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.', 'interventionNames': ['Drug: Tadalafil 2.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil 5 mg', 'description': '5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.', 'interventionNames': ['Drug: Tadalafil 5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 12 weeks.\n\nThen subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil 2.5 mg', 'type': 'DRUG', 'otherNames': ['LY450190', 'Cialis'], 'description': 'oral, daily', 'armGroupLabels': ['Tadalafil 2.5 milligrams (mg)']}, {'name': 'Tadalafil 5 mg', 'type': 'DRUG', 'otherNames': ['LY450190', 'Cialis'], 'description': 'oral, daily', 'armGroupLabels': ['Tadalafil 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral, daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '274-0825', 'city': 'Chiba', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '730-0013', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '226-0025', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '607-8085', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '561-0832', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '150-0002', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 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