Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT00861757
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2009-03-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, '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': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks', 'otherNumAtRisk': 154, 'otherNumAffected': 24, 'seriousNumAtRisk': 154, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks', 'otherNumAtRisk': 151, 'otherNumAffected': 38, 'seriousNumAtRisk': 151, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks', 'otherNumAtRisk': 155, 'otherNumAffected': 42, 'seriousNumAtRisk': 155, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks', 'otherNumAtRisk': 152, 'otherNumAffected': 35, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Adenoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper airway obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Colon polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo PO, QD (30min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '-5.5', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '-1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.\n\nLeast Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'title': 'Voiding (Obstructive) Score (N = 154,151,155,152)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.3', 'groupId': 'OG003'}]}]}, {'title': 'Storage (Irritative) Score (N = 154,151,155,152)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.6', 'pValueComment': 'This is the p value for the Voiding (Obstructive) Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.3', 'pValueComment': 'This is the p value for the Voiding (Obstructive) Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-1.1', 'pValueComment': 'This is the p value for the Voiding (Obstructive) Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'pValueComment': 'This is the p value for the Storage (Irritative) Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'pValueComment': 'This is the p value for the Storage (Irritative) Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'pValueComment': 'This is the p value for the Storage (Irritative) Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).\n\nLeast Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.393', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '148', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.331', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.140', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.940', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'Qmax: defined as the peak urine flow rate (measured in milliliters per second \\[mL/second\\] using standard calibrated flowmeter).\n\nLeast Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.', 'unitOfMeasure': 'milliliter per second (mL/sec)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Improvement (PGI-I) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'A Little Worse', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'A Little Better', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}, {'title': 'Much Better', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Very Much Better', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': "The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Clinician Global Impression of Improvement (CGI-I) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'A Little Worse', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'A Little Better', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}, {'title': 'Much Better', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Very Much Better', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': "The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-0.06', 'spread': '0.61', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.412', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.083', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.456', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'Nanograms of PSA per milliliter (ng/mL) of blood.', 'unitOfMeasure': 'microgram/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'spread': '45.35', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '45.21', 'groupId': 'OG001'}, {'value': '-2.90', 'spread': '48.84', 'groupId': 'OG002'}, {'value': '-5.67', 'spread': '34.38', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.688', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.510', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure (Sitting) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.9', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '12.4', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '12.2', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '8.1', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '7.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.274', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.538', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.216', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.524', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure (Standing) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.8', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '11.6', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '13.7', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.4', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '8.2', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '8.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.723', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.273', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for systolic blood pressure.', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'This is the p value for diastolic blood pressure.', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'OG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'OG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '8.3', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '7.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.330', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.838', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.409', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 weeks', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'FG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'FG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'FG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '137'}, {'groupId': 'FG003', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}, {'value': '612', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks'}, {'id': 'BG001', 'title': '2.5 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'BG002', 'title': '5.0 mg Tadalafil', 'description': 'Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks'}, {'id': 'BG003', 'title': '0.2 mg Tamsulosin', 'description': 'Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '62.6', 'spread': '7.9', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '7.8', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}, {'value': '612', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}, {'value': '612', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '342', 'groupId': 'BG004'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '2.8', 'groupId': 'BG002'}, {'value': '24.4', 'spread': '2.9', 'groupId': 'BG003'}, {'value': '24.2', 'spread': '2.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms/square meters (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Tobacco Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}, {'value': '496', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Alcohol Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '326', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Benign Prostatic Hyperplasia (BPH) Severity', 'classes': [{'title': 'Moderate (IPSS<20)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '408', 'groupId': 'BG004'}]}]}, {'title': 'Severe (IPSS>=20)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '204', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'The International Prostate Symptom Score (IPSS) Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.', 'unitOfMeasure': 'participants'}, {'title': 'Duration of BPH', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '2.9', 'groupId': 'BG002'}, {'value': '3.7', 'spread': '3.2', 'groupId': 'BG003'}, {'value': '3.7', 'spread': '3.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Global Impressions of Severity Scale (PGI-S)', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '168', 'groupId': 'BG004'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': "The Patient Global Impressions of Severity Scale (PGI-S) measures patient's perception of severity of illness prior to clinical assessments during study visits. Scores range from 1 (Normal) to 4 (Severe) where 1=Normal, 2=Mild, 3=Moderate, and 4=Severe.", 'unitOfMeasure': 'participants'}, {'title': 'Clinical Global Impressions of Severity Scale (CGI-S)', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '371', 'groupId': 'BG004'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': "The Clinical Global Impressions of Severity Scale (CGI-S) measures clinician's perception of severity of illness prior to assessments during study visits. Scores range from 1 (Normal) to 4 (Severe) where 1=Normal, 2=Mild, 3=Moderate, and 4=Severe.", 'unitOfMeasure': 'participants'}, {'title': 'Previous Alpha-Blocker Therapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '335', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '277', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous BPH Therapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}, {'value': '493', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Postvoid Residual Volume (PVR)', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '47.7', 'groupId': 'BG000'}, {'value': '37.7', 'spread': '40.3', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '51.2', 'groupId': 'BG002'}, {'value': '32.7', 'spread': '37.1', 'groupId': 'BG003'}, {'value': '37.7', 'spread': '44.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Postvoid residual volume (PVR) is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.', 'unitOfMeasure': 'milliliters (mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prostate Volume', 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '35.3', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '13.7', 'groupId': 'BG002'}, {'value': '33.9', 'spread': '11.1', 'groupId': 'BG003'}, {'value': '34.8', 'spread': '13.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Prostate volume is defined as the volume of prostate estimated by transabdominal or transrectal ultrasound.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-23', 'studyFirstSubmitDate': '2009-03-12', 'resultsFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-10', 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.\n\nLeast Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])', 'timeFrame': 'baseline, 12 weeks', 'description': 'IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).\n\nLeast Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.'}, {'measure': 'Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.'}, {'measure': 'Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Qmax: defined as the peak urine flow rate (measured in milliliters per second \\[mL/second\\] using standard calibrated flowmeter).\n\nLeast Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.'}, {'measure': 'Patient Global Impression of Improvement (PGI-I) at Week 12', 'timeFrame': '12 weeks', 'description': "The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7)."}, {'measure': 'Clinician Global Impression of Improvement (CGI-I) at Week 12', 'timeFrame': '12 weeks', 'description': "The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7)."}, {'measure': 'Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Nanograms of PSA per milliliter (ng/mL) of blood.'}, {'measure': 'Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.'}, {'measure': 'Change From Baseline in Blood Pressure (Sitting) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks'}, {'measure': 'Change From Baseline in Blood Pressure (Standing) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks'}, {'measure': 'Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks', 'timeFrame': 'baseline, 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment\n* Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.\n* Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment\n\nExclusion Criteria:\n\n* Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation\n* History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation\n* History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation\n* Clinical evidence of prostate cancer at initiation\n* Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation\n* History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study\n* History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)\n* Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation'}, 'identificationModule': {'nctId': 'NCT00861757', 'briefTitle': 'Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Double Blind, Placebo and Tamsulosin Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil Once a Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '10487'}, 'secondaryIdInfos': [{'id': 'H6D-MC-LVHB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2.5 mg Tadalafil', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'EXPERIMENTAL', 'label': '5.0 mg Tadalafil', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.2 mg Tamsulosin', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Tadalafil', 'type': 'DRUG', 'otherNames': ['LY450190, Cialis'], 'description': 'by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks', 'armGroupLabels': ['2.5 mg Tadalafil', '5.0 mg Tadalafil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'PO, QD (30 min after meal) for 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'PO, QD (30 min after meal) for 12 weeks', 'armGroupLabels': ['0.2 mg Tamsulosin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '663-8006', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '565-0854', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '130-0026', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', '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': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', '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': 24.9896, 'lon': 121.3187}}], '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': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}