Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 3:40 PM
Study NCT ID:
NCT00734604
Status:
COMPLETED
Last Update Posted:
2010-11-18
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D006301', 'term': 'Health Services Needs and Demand'}], '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': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]', 'otherNumAtRisk': 378, 'otherNumAffected': 66, 'seriousNumAtRisk': 378, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Sildenafil Citrate as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]', 'otherNumAtRisk': 378, 'otherNumAffected': 73, 'seriousNumAtRisk': 378, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]', 'otherNumAtRisk': 378, 'otherNumAffected': 70, 'seriousNumAtRisk': 378, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypogonadism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cyanopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metamorphopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Visual brightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ear infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 18, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Balanitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ejaculation failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Perineal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 26, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Elbow operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.24', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.57'}, {'value': '0.39', 'spread': '0.67', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '0.45'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.19', 'pValueComment': 'p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.24', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.872', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.08', 'pValueComment': 'p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'estimateComment': 'LS Mean difference = Tadalafil OaD-Tadalafil PRN', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.06', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '3.07', 'spread': '0.48', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.20', 'pValueComment': 'p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '0.395', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.07', 'pValueComment': 'p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '2.42', 'spread': '0.53', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '-0.25', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '-0.08', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.60', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '15.40', 'spread': '6.27', 'groupId': 'OG001'}, {'value': '15.55', 'spread': '6.23', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '8.68', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '9.70', 'spread': '7.01', 'groupId': 'OG001'}, {'value': '9.54', 'spread': '7.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '-0.27', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '-0.22', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'tadalafil 20 mg as needed \\[T(PRN)\\]'}, {'id': 'OG002', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.26', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.09', 'pValueComment': 'p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.12', 'pValueComment': 'p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.35', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '8.34', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '8.37', 'spread': '2.73', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '3.33', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '3.17', 'groupId': 'OG001'}, {'value': '3.83', 'spread': '3.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.36', 'pValueComment': 'p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '-0.23', 'pValueComment': 'p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.26', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '5.27', 'spread': '2.34', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '2.60', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '2.84', 'spread': '2.58', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.00', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '0.046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.00', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '75.81', 'spread': '22.36', 'groupId': 'OG000'}, {'value': '75.68', 'spread': '19.58', 'groupId': 'OG001'}, {'value': '79.50', 'spread': '19.56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.66', 'ciLowerLimit': '1.16', 'ciUpperLimit': '6.17', 'pValueComment': 'p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.27', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.55', 'ciLowerLimit': '-6.05', 'ciUpperLimit': '-1.04', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.27', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of each treatment', 'description': "EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '378', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline through 26 weeks (including two washout periods of 1 week each)', 'description': 'Serious adverse events are listed in the Reported Adverse Event module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '50.28', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '50.50', 'spread': '21.58', 'groupId': 'OG001'}, {'value': '50.69', 'spread': '21.32', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '22.94', 'spread': '24.86', 'groupId': 'OG000'}, {'value': '22.87', 'spread': '24.43', 'groupId': 'OG001'}, {'value': '24.13', 'spread': '24.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '2.17', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-3.35', 'ciUpperLimit': '0.74', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '1.83', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '1.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.22', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.367', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.23', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 1 range from 0 (not at all) to 4 (extremely).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '2.36', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.32', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.722', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.10', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 2 range from 0 (not at all) to 4 (extremely).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '1.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.37', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.16', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 3 range from 0 (not at all) to 4 (extremely).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil Once a Day [T(OaD)]', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\]'}, {'id': 'OG001', 'title': 'Sildenafil as Needed [S(PRN)]', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\]'}, {'id': 'OG002', 'title': 'Tadalafil as Needed [T(PRN)]', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '2.44', 'spread': '0.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.22', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.637', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.09', 'pValueComment': 'p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 4 range from 0 (not at all) to 4 (extremely).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T(OaD)/S(PRN)/T(PRN)', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks'}, {'id': 'FG001', 'title': 'T(OaD)/T(PRN)/S(PRN)', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks'}, {'id': 'FG002', 'title': 'S(PRN)/T(OaD)/T(PRN)', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks'}, {'id': 'FG003', 'title': 'S(PRN)/T(PRN)/T(OaD)', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks'}, {'id': 'FG004', 'title': 'T(PRN)/T(OaD)/S(PRN)', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks'}, {'id': 'FG005', 'title': 'T(PRN)/S(PRN)/T(OaD)', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '63'}, {'groupId': 'FG005', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '378', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'T(OaD)/S(PRN)/T(PRN)', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks'}, {'id': 'BG001', 'title': 'T(OaD)/T(PRN)/S(PRN)', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks'}, {'id': 'BG002', 'title': 'S(PRN)/T(OaD)/T(PRN)', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks'}, {'id': 'BG003', 'title': 'S(PRN)/T(PRN)/T(OaD)', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks'}, {'id': 'BG004', 'title': 'T(PRN)/T(OaD)/S(PRN)', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks'}, {'id': 'BG005', 'title': 'T(PRN)/S(PRN)/T(OaD)', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.53', 'spread': '11.62', 'groupId': 'BG000'}, {'value': '55.12', 'spread': '8.89', 'groupId': 'BG001'}, {'value': '55.40', 'spread': '11.70', 'groupId': 'BG002'}, {'value': '54.87', 'spread': '12.04', 'groupId': 'BG003'}, {'value': '59.04', 'spread': '10.56', 'groupId': 'BG004'}, {'value': '54.36', 'spread': '10.28', 'groupId': 'BG005'}, {'value': '56.21', 'spread': '10.98', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '378', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '255', 'groupId': 'BG006'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '105', 'groupId': 'BG006'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'West Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '84', 'groupId': 'BG006'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '100', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.35', 'spread': '4.18', 'groupId': 'BG000'}, {'value': '27.62', 'spread': '2.65', 'groupId': 'BG001'}, {'value': '27.77', 'spread': '3.71', 'groupId': 'BG002'}, {'value': '28.68', 'spread': '4.74', 'groupId': 'BG003'}, {'value': '27.80', 'spread': '3.51', 'groupId': 'BG004'}, {'value': '29.08', 'spread': '4.26', 'groupId': 'BG005'}, {'value': '28.22', 'spread': '3.91', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Erectile Dysfunction (ED) Duration', 'classes': [{'title': '=> 1 year', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '356', 'groupId': 'BG006'}]}]}, {'title': '=> than 6 months through <1 year', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ED Etiology', 'classes': [{'title': 'Mixed', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '146', 'groupId': 'BG006'}]}]}, {'title': 'Organic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '163', 'groupId': 'BG006'}]}]}, {'title': 'Psychogenic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior sildenafil citrate use as needed (PRN)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '229', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '149', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Vardenafil HCl use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '104', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '274', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2008-08-12', 'resultsFirstSubmitDate': '2010-09-20', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-10-21', 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.'}, {'measure': 'Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.'}, {'measure': 'Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.'}, {'measure': 'Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.'}, {'measure': 'Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection', 'timeFrame': 'baseline, 8 weeks of each treatment'}, {'measure': 'Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.'}, {'measure': 'Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.'}, {'measure': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint', 'timeFrame': '8 weeks of each treatment', 'description': "EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction)."}, {'measure': 'Number of Participants With at Least One Serious Adverse Event', 'timeFrame': 'baseline through 26 weeks (including two washout periods of 1 week each)', 'description': 'Serious adverse events are listed in the Reported Adverse Event module.'}, {'measure': 'Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score', 'timeFrame': 'baseline, 8 weeks of each treatment', 'description': 'Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.'}, {'measure': 'Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 1 range from 0 (not at all) to 4 (extremely).'}, {'measure': 'Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 2 range from 0 (not at all) to 4 (extremely).'}, {'measure': 'Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 3 range from 0 (not at all) to 4 (extremely).'}, {'measure': 'Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint', 'timeFrame': '8 weeks of each treatment', 'description': 'Scores for Question 4 range from 0 (not at all) to 4 (extremely).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '22429760', 'type': 'DERIVED', 'citation': 'Rubio-Aurioles E, Porst H, Kim ED, Montorsi F, Hackett G, Morales AM, Stuckey B, Buttner H, West TM, Huynh NN, Lenero E, Burns P, Kopernicky V. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. J Sex Med. 2012 May;9(5):1418-29. doi: 10.1111/j.1743-6109.2012.02667.x. Epub 2012 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of erectile dysfunction (ED).\n* Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.\n* Have never used tadalafil 5 mg or 2.5 mg once a day therapy.\n* Anticipate having the same adult female sexual partner willing to participate during the study.\n* Agree to make at least four sexual intercourse attempts during the first four weeks of the study.\n* Agree not to use any other treatment for ED (even herbal treatments) during the study.\n* Agree to follow the directions given by the study doctor and staff about using the study drug.\n\nExclusion Criteria:\n\n* Have any other primary sexual disorders present or penile deformity.\n* Have history of radical prostatectomy or penile implant.\n* Have problems with your kidneys, liver, or nervous system.\n* Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.\n* Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).\n* Have chest pain (called unstable angina or angina) that requires treatment.\n* Have heart disease that causes symptoms after you exert yourself.\n* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).\n* Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).\n* Have retinitis pigmentosa.\n* Have history of human immunodeficiency virus (HIV).\n* Have very high or very low blood pressure (your study doctor will discuss the limits with you).\n* Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.\n* Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.\n* Have a scheduled or planned surgery requiring anaesthesia during the course of the study.\n* Have a scheduled cataract surgery during the curse of the study.'}, 'identificationModule': {'nctId': 'NCT00734604', 'briefTitle': 'A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.', 'orgStudyIdInfo': {'id': '12313'}, 'secondaryIdInfos': [{'id': 'H6D-CR-S024', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T(OaD)/S(PRN)/T(PRN)', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks', 'interventionNames': ['Drug: tadalafil once a day [T(OaD)]', 'Drug: sildenafil citrate as needed [S(PRN)]', 'Drug: tadalafil as needed [T(PRN)]']}, {'type': 'EXPERIMENTAL', 'label': 'T(OaD)/T(PRN)/S(PRN)', 'description': 'Tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks', 'interventionNames': ['Drug: tadalafil once a day [T(OaD)]', 'Drug: sildenafil citrate as needed [S(PRN)]', 'Drug: tadalafil as needed [T(PRN)]']}, {'type': 'EXPERIMENTAL', 'label': 'S(PRN)/T(OaD)/T(PRN)', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks', 'interventionNames': ['Drug: tadalafil once a day [T(OaD)]', 'Drug: sildenafil citrate as needed [S(PRN)]', 'Drug: tadalafil as needed [T(PRN)]']}, {'type': 'EXPERIMENTAL', 'label': 'S(PRN)/T(PRN)/T(OaD)', 'description': 'Sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks', 'interventionNames': ['Drug: tadalafil once a day [T(OaD)]', 'Drug: sildenafil citrate as needed [S(PRN)]', 'Drug: tadalafil as needed [T(PRN)]']}, {'type': 'EXPERIMENTAL', 'label': 'T(PRN)/T(OaD)/S(PRN)', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks', 'interventionNames': ['Drug: tadalafil once a day [T(OaD)]', 'Drug: sildenafil citrate as needed [S(PRN)]', 'Drug: tadalafil as needed [T(PRN)]']}, {'type': 'EXPERIMENTAL', 'label': 'T(PRN)/S(PRN)/T(OaD)', 'description': 'Tadalafil 20 mg as needed \\[T(PRN)\\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \\[S(PRN)\\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \\[T(OaD)\\] for 8 weeks', 'interventionNames': ['Drug: tadalafil once a day [T(OaD)]', 'Drug: sildenafil citrate as needed [S(PRN)]', 'Drug: tadalafil as needed [T(PRN)]']}], 'interventions': [{'name': 'tadalafil once a day [T(OaD)]', 'type': 'DRUG', 'otherNames': ['Cialis', 'LY450190'], 'description': '5 mg tablet taken once a day (OaD) by mouth for 8 weeks', 'armGroupLabels': ['S(PRN)/T(OaD)/T(PRN)', 'S(PRN)/T(PRN)/T(OaD)', 'T(OaD)/S(PRN)/T(PRN)', 'T(OaD)/T(PRN)/S(PRN)', 'T(PRN)/S(PRN)/T(OaD)', 'T(PRN)/T(OaD)/S(PRN)']}, {'name': 'sildenafil citrate as needed [S(PRN)]', 'type': 'DRUG', 'description': '100 mg tablet taken as needed (PRN) by mouth for 8 weeks', 'armGroupLabels': ['S(PRN)/T(OaD)/T(PRN)', 'S(PRN)/T(PRN)/T(OaD)', 'T(OaD)/S(PRN)/T(PRN)', 'T(OaD)/T(PRN)/S(PRN)', 'T(PRN)/S(PRN)/T(OaD)', 'T(PRN)/T(OaD)/S(PRN)']}, {'name': 'tadalafil as needed [T(PRN)]', 'type': 'DRUG', 'otherNames': ['Cialis', 'LY450190'], 'description': '20 mg tablet taken as needed (PRN) by mouth for 8 weeks', 'armGroupLabels': ['S(PRN)/T(OaD)/T(PRN)', 'S(PRN)/T(PRN)/T(OaD)', 'T(OaD)/S(PRN)/T(PRN)', 'T(OaD)/T(PRN)/S(PRN)', 'T(PRN)/S(PRN)/T(OaD)', 'T(PRN)/T(OaD)/S(PRN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', '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': 34.7304, 'lon': -86.58594}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '06762', 'city': 'Middlebury', 'state': 'Connecticut', 'country': 'United States', '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': 41.52787, 'lon': -73.12761}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', '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': 26.13421, 'lon': -80.23184}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', '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': 35.96064, 'lon': -83.92074}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', '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': 29.42412, 'lon': -98.49363}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3144', 'city': 'Malvern', 'state': 'Victoria', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '74110-020', 'city': 'Goiânia', 'country': 'Brazil', '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': -16.67861, 'lon': -49.25389}}, {'zip': '13500-020', 'city': 'Rio Claro', 'country': 'Brazil', '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': -22.41139, 'lon': -47.56139}}, {'zip': '20725-090', 'city': 'Rio de Janeiro', 'country': 'Brazil', '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': -22.90642, 'lon': -43.18223}}, {'zip': '15090-000', 'city': 'Sao Jose Rio Preto', 'country': 'Brazil', '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.'}, {'zip': '04044-060', 'city': 'São Paulo', 'country': 'Brazil', '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': -23.5475, 'lon': -46.63611}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '13465', 'city': 'Berlin', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20354', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '07100', 'city': 'Sassari', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '14000', 'city': 'La Joya', 'country': 'Mexico', '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': 32.44363, 'lon': -117.00371}}, {'zip': '10700', 'city': 'Mexico City', 'country': 'Mexico', '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': 19.42847, 'lon': -99.12766}}, {'zip': '64040', 'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '00912', 'city': 'San Juan', 'country': 'Puerto Rico', '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': 18.46633, 'lon': -66.10572}}, {'zip': '00907', 'city': 'Santurce', 'country': 'Puerto Rico', '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': 18.19523, 'lon': -67.14018}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', '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': 43.37135, 'lon': -8.396}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', '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': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29007', 'city': 'Málaga', 'country': 'Spain', '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': 36.72016, 'lon': -4.42034}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '36211', 'city': 'Vigo', 'country': 'Spain', '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': 42.23282, 'lon': -8.72264}}, {'zip': 'DH1 2QW', 'city': 'Durham', 'state': 'County Durham', 'country': 'United Kingdom', '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': 54.77676, 'lon': -1.57566}}, {'zip': 'PL6 8BX', 'city': 'Plymouth', 'state': 'Devonshire', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'WS14 9JL', 'city': 'Lichfield', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.68154, 'lon': -1.82549}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', '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': 53.79648, 'lon': -1.54785}}, {'zip': 'NW8 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Easter 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'}}}}