Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00631969
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2008-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
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': 'D000069058', 'term': 'Vardenafil Dihydrochloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'In the protocol it is specified that all results are the property of the sponsor. The investigator must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor. The investigator must send a draft publication to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vardenafil ODT (STAXYN, BAY 38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.', 'otherNumAtRisk': 184, 'otherNumAffected': 70, 'seriousNumAtRisk': 184, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.', 'otherNumAtRisk': 174, 'otherNumAffected': 36, 'seriousNumAtRisk': 174, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Salivary gland calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sluggishness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pharmaceutical product complaint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Meniscus removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '9.6', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '7.33', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '7.7', 'spread': '8.19', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '6.42', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '8.6', 'spread': '7.40', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '6.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.109', 'ciLowerLimit': '-8.562', 'ciUpperLimit': '-5.6561', 'groupDescription': 'Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks', 'description': "The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \\<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \\>25 'no ED').", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'PRIMARY', 'title': 'Change in Percentage From Baseline in Success of Penetration at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '35.8', 'spread': '33.63', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '42.82', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '35.2', 'spread': '38.06', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '28.41', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '35.5', 'spread': '35.93', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '35.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-29.027', 'ciLowerLimit': '-35.519', 'ciUpperLimit': '-22.534', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.", 'unitOfMeasure': 'percentage of successful penetrations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Success of Erection Maintenance at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '54.5', 'spread': '32.72', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '31.30', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '49.2', 'spread': '37.28', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '25.72', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '51.7', 'spread': '35.18', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '28.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-38.193', 'ciLowerLimit': '-45.021', 'ciUpperLimit': '-31.366', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.", 'unitOfMeasure': 'percentage of success in maintenance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving "Back to Normal" Erectile Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cochran-Mantel-Haenszel', 'ciPctValue': '95', 'paramValue': '34.778', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks of treatment', 'description': "Responders: percentage of subjects achieving an IIEF-EF score \\> 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \\<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \\>25 'no ED').", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '18.8', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '37.86', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '14.6', 'spread': '33.21', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '37.43', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '16.6', 'spread': '31.54', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '37.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-16.503', 'ciLowerLimit': '-22.424', 'ciUpperLimit': '-10.764', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.", 'unitOfMeasure': 'percentage of successful erections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '51.7', 'spread': '36.10', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '27.69', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '45.3', 'spread': '43.09', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '27.70', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '48.4', 'spread': '39.95', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '27.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-38.167', 'ciLowerLimit': '-45.261', 'ciUpperLimit': '-31.073', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.", 'unitOfMeasure': 'percentage of satisfactory erections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '55.7', 'spread': '36.83', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '30.26', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '45.8', 'spread': '38.43', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '25.74', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '50.5', 'spread': '37.90', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '28.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-36.555', 'ciLowerLimit': '-43.645', 'ciUpperLimit': '-29.465', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.", 'unitOfMeasure': 'percentage of satisfactory attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '34.5', 'spread': '36.19', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '36.86', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '32.7', 'spread': '35.23', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '29.96', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '33.5', 'spread': '35.60', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '33.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-25.193', 'ciLowerLimit': '-31.562', 'ciUpperLimit': '-18.824', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.", 'unitOfMeasure': 'percentage of ejaculation successes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Number of Sexual Attempts Till First Successful Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 weeks of treatment', 'unitOfMeasure': 'Sexual Attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ease With Erection at 12 Weeks or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '28.6', 'spread': '28.02', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '27.92', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '25.0', 'spread': '31.20', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '28.98', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '26.7', 'spread': '29.73', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '28.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-24.703', 'ciLowerLimit': '-30.067', 'ciUpperLimit': '-19.340', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-24.496', 'ciLowerLimit': '-34.865', 'ciUpperLimit': '-24.128', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '28.6', 'spread': '29.34', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '29.06', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '25.3', 'spread': '30.24', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '29.48', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '26.8', 'spread': '29.78', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '29.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-27.775', 'ciLowerLimit': '-33.155', 'ciUpperLimit': '-22.394', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '31.0', 'spread': '29.46', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '32.66', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '26.8', 'spread': '32.29', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '31.80', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '28.8', 'spread': '30.98', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '32.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-23.326', 'ciLowerLimit': '-29.062', 'ciUpperLimit': '-17.598', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Confidence for Completion at 12 Weeks or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '28.7', 'spread': '27.56', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '27.53', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '25.8', 'spread': '30.18', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '26.57', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '27.7', 'spread': '28.94', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '26.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-23.384', 'ciLowerLimit': '-28.594', 'ciUpperLimit': '-18.175', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Medication at Week 12 or LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '57.2', 'spread': '28.09', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '25.58', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '52.3', 'spread': '29.54', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '24.55', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '54.6', 'spread': '28.90', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '24.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-33.076', 'ciLowerLimit': '-38.745', 'ciUpperLimit': '-27.407', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.'}, {'type': 'SECONDARY', 'title': 'Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cochran-Mantel-Haenszel', 'ciPctValue': '95', 'paramValue': '74.449', 'groupDescription': 'Statistical analysis applies to the total population.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks of treatment', 'description': "Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ED Patients Aged < 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged \\< 65 years.'}, {'id': 'OG001', 'title': 'ED Patients Aged ≥ 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.16', 'groupId': 'OG000', 'lowerLimit': '18.97', 'upperLimit': '112.8'}, {'value': '55.37', 'groupId': 'OG001', 'lowerLimit': '21.23', 'upperLimit': '104.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Point estimate of ratio', 'ciPctValue': '90', 'paramValue': '117.42', 'ciLowerLimit': '79.59', 'ciUpperLimit': '173.23', 'groupDescription': 'Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \\< 65 years) were calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}, {'pValue': '0.7064', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.', 'unitOfMeasure': 'μg*h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ED Patients Aged < 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged \\< 65 years.'}, {'id': 'OG001', 'title': 'ED Patients Aged ≥ 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.09', 'groupId': 'OG000', 'lowerLimit': '3.134', 'upperLimit': '19.04'}, {'value': '13.43', 'groupId': 'OG001', 'lowerLimit': '2.913', 'upperLimit': '27.91'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Point estimate of ratio', 'ciPctValue': '90', 'paramValue': '133.07', 'ciLowerLimit': '87.46', 'ciUpperLimit': '202.46', 'groupDescription': 'Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \\< 65 years) were calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}, {'pValue': '0.8749', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ED Patients Aged < 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged \\< 65 years.'}, {'id': 'OG001', 'title': 'ED Patients Aged ≥ 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.36', 'groupId': 'OG000', 'lowerLimit': '10.94', 'upperLimit': '68.46'}, {'value': '41.80', 'groupId': 'OG001', 'lowerLimit': '16.56', 'upperLimit': '148.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Point estimate of ratio', 'ciPctValue': '90', 'paramValue': '125.28', 'ciLowerLimit': '73.65', 'ciUpperLimit': '213.11', 'groupDescription': 'Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \\< 65 years) were calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}, {'pValue': '0.7375', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.', 'unitOfMeasure': 'µg*h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ED Patients Aged < 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged \\< 65 years.'}, {'id': 'OG001', 'title': 'ED Patients Aged ≥ 65 Years', 'description': 'Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.260', 'groupId': 'OG000', 'lowerLimit': '3.756', 'upperLimit': '23.32'}, {'value': '11.47', 'groupId': 'OG001', 'lowerLimit': '5.563', 'upperLimit': '41.17'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Point estimate of ratio', 'ciPctValue': '90', 'paramValue': '123.84', 'ciLowerLimit': '80.12', 'ciUpperLimit': '191.42', 'groupDescription': 'Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \\< 65 years) were calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}, {'pValue': '0.3940', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': 'safety population', 'groupId': 'FG000', 'numSubjects': '184'}, {'comment': 'safety population', 'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Noncompliant With Study Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No Drug Exposure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects recruited to 40 investigational centers in Belgium (4), France (8), Germany (9), Spain (3), Netherlands (5), and South Africa (11). First patient first visit on 25 April 2008, last patient last visit on 19 January 2009.', 'preAssignmentDetails': '409 male subjects screened (\\<65 years: n=185; \\>=65 years: n=224), 362 randomized to treatment (186 to Vardenafil ODT, and 176 to placebo). The main efficacy analysis set was the Intent-to-treat (ITT) population (randomized treated subjects with baseline and post-baseline efficacy and safety assessments); 183 on Vardenafil ODT and 172 on placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'All age groups', 'categories': [{'measurements': [{'value': '27.2', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '27.3', 'spread': '3.7', 'groupId': 'BG002'}]}]}, {'title': '< 65 years', 'categories': [{'measurements': [{'value': '27.5', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '3.9', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '26.9', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '27.0', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'dispFirstSubmitDate': '2010-02-08', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2008-02-29', 'dispFirstSubmitQcDate': '2010-02-08', 'resultsFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2008-02-29', 'dispFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-21', 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF', 'timeFrame': 'from baseline up to 12 weeks', 'description': "The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \\<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \\>25 'no ED')."}, {'measure': 'Change in Percentage From Baseline in Success of Penetration at 12 Weeks', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner."}, {'measure': 'Change From Baseline in Success of Erection Maintenance at 12 Weeks', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration."}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving "Back to Normal" Erectile Function', 'timeFrame': 'up to 12 weeks of treatment', 'description': "Responders: percentage of subjects achieving an IIEF-EF score \\> 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \\<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \\>25 'no ED')."}, {'measure': 'Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections."}, {'measure': 'Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections."}, {'measure': 'Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts."}, {'measure': 'Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks', 'timeFrame': 'from baseline up to 12 weeks of treatment', 'description': "SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations."}, {'measure': 'Number of Sexual Attempts Till First Successful Attempt', 'timeFrame': 'up to 12 weeks of treatment'}, {'measure': 'Change From Baseline in Ease With Erection at 12 Weeks or LOCF', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.'}, {'measure': 'Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.'}, {'measure': 'Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.'}, {'measure': 'Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.'}, {'measure': 'Change From Baseline in Confidence for Completion at 12 Weeks or LOCF', 'timeFrame': 'from baseline up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.'}, {'measure': 'Satisfaction With Medication at Week 12 or LOCF', 'timeFrame': 'up to 12 weeks', 'description': 'Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of \'ease with erection\', \'erectile functioning satisfaction\', \'pleasure of sexual activity\', \'satisfaction with orgasm\', \'confidence for completion\', and \'satisfaction with medication\') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.'}, {'measure': 'Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale', 'timeFrame': 'up to 12 weeks of treatment', 'description': "Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)"}, {'measure': 'Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.'}, {'measure': 'Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.'}, {'measure': 'Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.'}, {'measure': 'Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma', 'timeFrame': 'Visit 5 after 12 weeks of treatment', 'description': 'Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '21883954', 'type': 'RESULT', 'citation': 'Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.'}, {'pmid': '20233275', 'type': 'RESULT', 'citation': 'Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.'}, {'pmid': '20925442', 'type': 'RESULT', 'citation': 'Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.'}, {'pmid': '20807322', 'type': 'RESULT', 'citation': 'Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for information of Bayer products for Europe'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males 18 years-of-age or older\n* Stable, heterosexual relationship for at least 6 months\n* A history of erectile dysfunction (ED) for at least 6 months\n\nExclusion Criteria:\n\n* Any underlying cardiovascular condition, including unstable angina pectoris\n* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1\n* Uncontrolled atrial fibrillation / flutter at screening\n* History of surgical prostatectomy for prostate cancer\n* Hereditary degenerative retinal disorders\n* History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision\n* Presence of penile anatomical abnormalities\n* Subjects who have been confirmed with phenylketonuria (PKU)\n* Spinal cord injury\n* Resting or postural hypotension or hypertension\n* Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin\n* Use of any treatment for ED within 7 days of Visit 1\n* History of congenital QT prolongation\n* History of syncope within the last 6 months prior to entry into the study'}, 'identificationModule': {'nctId': 'NCT00631969', 'briefTitle': 'Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I', 'orgStudyIdInfo': {'id': '12093'}, 'secondaryIdInfos': [{'id': '2008-000536-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'description': 'Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.', 'interventionNames': ['Drug: Vardenafil ODT (STAXYN, BAY38-9456)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vardenafil ODT (STAXYN, BAY38-9456)', 'type': 'DRUG', 'description': 'Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)', 'armGroupLabels': ['Vardenafil ODT (STAXYN, BAY38-9456)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1000', 'city': 'Bruxelles - Brussel', 'country': 'Belgium'}, {'zip': '1070', 'city': 'Bruxelles - Brussel', 'country': 'Belgium'}, {'zip': '1200', 'city': 'Bruxelles - Brussel', 'country': 'Belgium'}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13006', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '40000', 'city': 'Mont-de-Marsan', 'country': 'France', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '75008', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '81925', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '92637', 'city': 'Weiden', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 49.67682, 'lon': 12.15613}}, {'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20354', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '49076', 'city': 'Osnabrück', 'state': 'Lower Saxony', 'country': 'Germany', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '41063', 'city': 'Mönchengladbach', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '45468', 'city': 'Mülheim', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.43218, 'lon': 6.87967}}, {'zip': '02625', 'city': 'Bautzen', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '04109', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '01662', 'city': 'Meissen', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.16158, 'lon': 13.4737}}, {'zip': '6836 BH', 'city': 'Arnhem', 'country': 'Netherlands', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '5751 XJ', 'city': 'Deurne', 'country': 'Netherlands', 'geoPoint': {'lat': 51.46, 'lon': 5.79722}}, {'zip': '2316 ZL', 'city': 'Leiden', 'country': 'Netherlands', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '7581 BV', 'city': 'Losser', 'country': 'Netherlands', 'geoPoint': {'lat': 52.26083, 'lon': 7.00417}}, {'zip': '6212 XN', 'city': 'Maastricht', 'country': 'Netherlands', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '7442 LS', 'city': 'Nijverdal', 'country': 'Netherlands', 'geoPoint': {'lat': 52.36, 'lon': 6.46806}}, {'zip': '0140', 'city': 'Centurion', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -25.85891, 'lon': 28.18577}}, {'zip': '1818', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2198', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '1739', 'city': 'Krugersdorp', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -26.08577, 'lon': 27.77515}}, {'zip': '0001', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0083', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4037', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4091', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '7463', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7530', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08034', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'La Laguna', 'country': 'Spain', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '36211', 'city': 'Vigo', 'state': 'Vigo', 'country': 'Spain', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Schering-Plough', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}