Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
Study NCT ID:
NCT00970632
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2009-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
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'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], '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'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks', 'otherNumAtRisk': 171, 'otherNumAffected': 39, 'seriousNumAtRisk': 171, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks', 'otherNumAtRisk': 168, 'otherNumAffected': 40, 'seriousNumAtRisk': 168, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks', 'otherNumAtRisk': 172, 'otherNumAffected': 35, 'seriousNumAtRisk': 172, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ill-defined disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Allergy to arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Multiple allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Semen volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-2.1', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-1.5', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-2.2', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-2.3', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.6', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.055', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.6', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-1.5', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-1.0', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.2', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.118', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.2', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.3', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.546', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.1', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-1.5', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-1.5', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1 week', 'description': 'The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.8', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.9', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.8', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '-0.6', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Improvement (PGI-I) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'title': 'Very much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'A little better', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'Very much better', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \\[total IPSS \\<20\\]; severe \\[total IPSS ≥20\\]).', 'testedNonInferiority': False}, {'pValue': '0.114', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \\[total IPSS \\<20\\]; severe \\[total IPSS ≥20\\]).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant\'s symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data.'}, {'type': 'SECONDARY', 'title': 'Clinician Global Impression of Improvement (CGI-I) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'title': 'Very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'A little better', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Very much better', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate \\[total IPSS \\<20\\]; severe \\[total IPSS ≥20\\]).', 'testedNonInferiority': False}, {'pValue': '0.452', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \\[total IPSS \\<20\\]; severe \\[total IPSS ≥20\\]).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant\'s symptoms based on a 7-point scale. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '17.50', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '17.74', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '16.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median of Treatment Group Differences', 'paramValue': '-4.4', 'pValueComment': 'The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'Van Elteren Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.', 'testedNonInferiority': False}, {'pValue': '0.457', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median of Treatment Group Differences', 'paramValue': '-2.2', 'pValueComment': 'The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.', 'statisticalMethod': 'Van Elteren Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'paramValue': '4.0', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.699', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'paramValue': '-0.4', 'pValueComment': 'The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized sexually active participants with erectile dysfunction who started study medication, and had baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '4.84', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '3.1'}, {'value': '1.6', 'spread': '5.49', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '5.2'}, {'value': '1.6', 'spread': '4.06', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) using rank transformed data.', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA using rank transformed data.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.', 'unitOfMeasure': 'milliliters per second (mL/sec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '2.72', 'groupId': 'OG000', 'lowerLimit': '-0.90', 'upperLimit': '1.80'}, {'value': '1.25', 'spread': '3.24', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '3.25'}, {'value': '0.70', 'spread': '3.03', 'groupId': 'OG002', 'lowerLimit': '-0.40', 'upperLimit': '2.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was \\>=125 mL.', 'unitOfMeasure': 'milliliters per second (mL/sec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '110.92', 'groupId': 'OG000', 'lowerLimit': '-61.00', 'upperLimit': '69.00'}, {'value': '11.0', 'spread': '101.45', 'groupId': 'OG001', 'lowerLimit': '-64.00', 'upperLimit': '70.50'}, {'value': '16.0', 'spread': '109.30', 'groupId': 'OG002', 'lowerLimit': '-38.00', 'upperLimit': '79.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'OG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'OG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '56.48', 'groupId': 'OG000', 'lowerLimit': '-20.0', 'upperLimit': '23.0'}, {'value': '-1.0', 'spread': '46.97', 'groupId': 'OG001', 'lowerLimit': '-28.0', 'upperLimit': '18.0'}, {'value': '-5.5', 'spread': '59.21', 'groupId': 'OG002', 'lowerLimit': '-23.5', 'upperLimit': '17.0'}]}]}], 'analyses': [{'pValue': '0.303', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) using rank transformed data.', 'testedNonInferiority': False}, {'pValue': '0.146', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA using rank transformed data.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'PVR was the amount of urine remaining in the bladder after void completion.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'FG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'FG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Period 1: Screening and 4-week washout of benign prostatic hyperplasia (BPH), overactive bladder (OAB), and/or erectile dysfunction (ED) treatments. Period 2: 4-week, single-blind, placebo lead-in to assess compliance and establish baseline levels. Period 3: Randomization to treatment (placebo, tadalafil 5 mg, or tamsulosin 0.4 mg for 12 weeks).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '511', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks'}, {'id': 'BG001', 'title': 'Tadalafil 5 mg', 'description': 'Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks'}, {'id': 'BG002', 'title': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '8.65', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '8.08', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '7.76', 'groupId': 'BG002'}, {'value': '63.6', 'spread': '8.16', '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': '172', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '511', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '372', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '4.09', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '4.03', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '3.73', 'groupId': 'BG002'}, {'value': '27.7', 'spread': '3.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "BMI measured the participant's body weight divided by the square of his or her height.", 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lower Urinary Tract Symptom (LUTS) Severity', 'classes': [{'title': 'Moderate (IPSS <20)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}]}, {'title': 'Severe (IPSS ≥20)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The total International Prostate Symptom Score (IPSS) was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms.', 'unitOfMeasure': 'participants'}, {'title': 'Peak Urine Flow Rate (Qmax) Category', 'classes': [{'title': '<10 mL/sec', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}]}, {'title': '10-15 mL/sec', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}, {'title': '>15 mL/sec', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Qmax is a uroflowmetry parameter used to measure peak urine flow rate with a standard calibrated flowmeter in milliliters per second (mL/sec) at Visit 3 (Week 0). Percentages were based on the prevoid number of randomized participants with valid uroflowmetry data (N=498 participants). The uroflowmetry assessment was considered valid and data were included in this summary only if total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and voided volume (V-Comp) was ≥125 mL.', 'unitOfMeasure': 'participants'}, {'title': 'Postvoid Residual Volume (PVR)', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '51.14', 'groupId': 'BG000'}, {'value': '54.6', 'spread': '52.29', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '57.99', 'groupId': 'BG002'}, {'value': '55.1', 'spread': '53.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "PVR was determined by ultrasound at baseline. Urine volume was measured after complete emptying of the participant's bladder.", 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.69', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.83', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '1.57', 'groupId': 'BG002'}, {'value': '2.0', 'spread': '1.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate disorders, such as prostate cancer.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Erectile Dysfunction (ED)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ED was defined as a consistent change in the quality of erection adversely affecting participant satisfaction with sexual intercourse.', 'unitOfMeasure': 'participants'}, {'title': 'Erectile Dysfunction (ED) Severity', 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ED was defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse. Severity was based on investigator opinion. The participant population included 357 randomized subjects with ED.', 'unitOfMeasure': 'participants'}, {'title': 'Erectile Dysfunction (ED) Duration', 'classes': [{'title': '<1 year', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}, {'title': '≥1 year', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ED was defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse. The participant population included 357 randomized subjects with ED.', 'unitOfMeasure': 'participants'}, {'title': 'Sexually Active with a Female Partner', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '427', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Expect to Remain Sexually Active', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The participant population was based on 427 randomized subjects who reported being sexually active with a female partner.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2009-09-01', 'resultsFirstSubmitDate': '2011-11-21', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-21', 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week', 'timeFrame': 'Baseline, 1 week', 'description': 'The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks', 'timeFrame': 'Baseline, 4 weeks', 'description': 'BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Patient Global Impression of Improvement (PGI-I) at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant\'s symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".'}, {'measure': 'Clinician Global Impression of Improvement (CGI-I) at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant\'s symptoms based on a 7-point scale. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".'}, {'measure': 'Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall', 'timeFrame': '12 weeks', 'description': 'The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.'}, {'measure': 'Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.'}, {'measure': 'Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.'}, {'measure': 'Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was \\>=125 mL.'}, {'measure': 'Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.'}, {'measure': 'Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'PVR was the amount of urine remaining in the bladder after void completion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia (BPH)']}, 'referencesModule': {'references': [{'pmid': '26299520', 'type': 'DERIVED', 'citation': 'Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.'}, {'pmid': '23346990', 'type': 'DERIVED', 'citation': 'Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.'}, {'pmid': '22297243', 'type': 'DERIVED', 'citation': 'Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study.\n* Provide signed informed consent at the start of the study.\n* Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.\n* Have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed.\n* Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.\n* Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.\n* Have reduced urine flow (measured by special toilet equipment).\n* Demonstrate compliance with study drug administration requirements.\n\nExclusion Criteria:\n\n* Treated with nitrates\n* Have unstable angina or angina that requires treatment.\n* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).\n* Have very high or very low blood pressure.\n* Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.\n* Have uncontrolled diabetes.\n* Have prostate cancer, are being treated for cancer.\n* Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.'}, 'identificationModule': {'nctId': 'NCT00970632', 'briefTitle': 'A Study of Tadalafil in Men With Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '12932'}, 'secondaryIdInfos': [{'id': 'H6D-MC-LVID', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks', 'interventionNames': ['Drug: Placebo tablet', 'Drug: Placebo capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil 5 milligram (mg)', 'description': 'Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks', 'interventionNames': ['Drug: Tadalafil 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin 0.4 mg', 'description': 'Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Tadalafil 5 mg', 'type': 'DRUG', 'otherNames': ['Cialis', 'LY450190'], 'description': 'Tadalafil 5 mg po QD for 12 weeks', 'armGroupLabels': ['Tadalafil 5 milligram (mg)']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'Placebo tablet po QD for 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Tamsulosin 0.4 mg po QD for 12 weeks', 'armGroupLabels': ['Tamsulosin 0.4 mg']}, {'name': 'Placebo capsule', 'type': 'DRUG', 'description': 'Placebo capsule po QD for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', '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': -34.92866, 'lon': 138.59863}}, {'zip': '3165', 'city': 'Bentleigh East', 'state': 'Victoria', 'country': 'Australia', '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': -37.91928, 'lon': 145.05301}}, {'zip': '6230', 'city': 'Bunbury', 'state': 'Western Australia', 'country': 'Australia', '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': -33.32711, 'lon': 115.64137}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', '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': -31.98184, 'lon': 115.8073}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', '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': 47.79941, 'lon': 13.04399}}, {'zip': '1220', 'city': 'Vienna', 'country': 'Austria', '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': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', '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': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', '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': 51.05, 'lon': 3.71667}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', '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': 50.63373, 'lon': 5.56749}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', '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': 48.84226, 'lon': 2.18232}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', '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': 43.70313, 'lon': 7.26608}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', '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': 47.90248, 'lon': 1.90407}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', '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': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', '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': 45.70359, 'lon': 4.82424}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', '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': 48.87143, 'lon': 2.22929}}, {'zip': '74906', 'city': 'Bad Rappenau', 'country': 'Germany', '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': 49.23848, 'lon': 9.1018}}, {'zip': 'D-83707', 'city': 'Bad Wiessee', 'country': 'Germany', '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': 47.71667, 'lon': 11.71667}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', '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': 52.37052, 'lon': 9.73322}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', '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': 51.33962, 'lon': 12.37129}}, {'zip': '35039', 'city': 'Marburg', 'country': 'Germany', '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': 50.80904, 'lon': 8.77069}}, {'zip': 'D-75417', 'city': 'Mühlacker', 'country': 'Germany', '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': 48.94754, 'lon': 8.83675}}, {'zip': 'D-16515', 'city': 'Oranienburg', 'country': 'Germany', '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': 52.75577, 'lon': 13.24197}}, {'zip': '71110', 'city': 'Heraklion', 'country': 'Greece', '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': 35.32787, 'lon': 25.14341}}, {'zip': '45500', 'city': 'Ioannina', 'country': 'Greece', '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': 39.66341, 'lon': 20.85187}}, {'zip': '41221', 'city': 'Larissa', 'country': 'Greece', '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': 39.62847, 'lon': 22.42112}}, {'zip': '26500', 'city': 'Pátrai', 'country': 'Greece', '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': 38.2462, 'lon': 21.73508}}, {'zip': '56429', 'city': 'Thessaloniki', 'country': 'Greece', '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': 40.64072, 'lon': 22.93493}}, {'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.23064, 'lon': 19.36409}}, {'zip': '02-005', 'city': 'Warsaw', 'country': 'Poland', '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': 52.22977, 'lon': 21.01178}}], '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', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}