Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-28 @ 12:30 AM
Study NCT ID:
NCT01021332
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'title': 'Medical Director, Global Medical Science', 'organization': 'Astellas Pharma Europe B.V.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principle Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 90 days prior to publication for review and comment. Sponsor may delay the publication to seek patent approval.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment', 'otherNumAtRisk': 1066, 'otherNumAffected': 180, 'seriousNumAtRisk': 1066, 'seriousNumAffected': 64}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numEvents': 61, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numEvents': 138, 'numAffected': 132}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neuroendocrine tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atrial fibillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cerebral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lateral medullary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Post procedural haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bronchietasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lobar pnemonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Iliac artery occulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1066, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment'}], 'classes': [{'title': 'Participants With Treatment-Emergent Adverse Event', 'categories': [{'measurements': [{'value': '499', 'groupId': 'OG000'}]}]}, {'title': 'Drug-related AEs', 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}]}]}, {'title': 'Drug-related SAEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAE causing discontinuation of study drug.', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)', 'description': 'Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1056', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '49.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF population with at least one baseline and one post-baseline PVR volume measured.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1047', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4.54', 'spread': '5.927', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'Qmax during a micturition (urination) was recorded using uroflowmetry.', 'unitOfMeasure': 'ml/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF population with at least one baseine and one post-baseline micturition episode.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment in Average Flow Rate (Qmean)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1047', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'spread': '2.884', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'Qmean during a micturition (urination) was recorded using uroflowmetry.', 'unitOfMeasure': 'ml/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF population with at least one baseline and one post-baseline micturition episode.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1004', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.0', 'spread': '5.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1008', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1008', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '47.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1008', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '101.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1006', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '3.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'urgency episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with at least 1 urgency episode at baseline. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'urgency incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'nocturia episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'pads', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1005', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.1', 'spread': '9.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in IPSS Voiding Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1004', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '4.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in IPSS Storage Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1004', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '2.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Individual IPSS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1004', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'title': 'Incomplete emptying of the bladder', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.49', 'groupId': 'OG000'}]}]}, {'title': 'Frequency', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Intermittency', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Urgency', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Weak stream', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.62', 'groupId': 'OG000'}]}]}, {'title': 'Hesitancy', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': 'Nocturia', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Symptom Bother Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.6', 'spread': '17.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '18.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '18.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '19.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1002', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '15.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '15.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Number of OAB-q Responders Based on Health-related Quality of Life: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in EQ-5D Mobility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'title': 'No problem -> No problem', 'categories': [{'measurements': [{'value': '775', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> Some problem', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> confined to bed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> No problem', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> Some problem', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> No data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Confined to bed -> no problem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Confined to bed -> some problem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Confined to bed -> confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Confined to bed -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no problem', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No data -> some problem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in EQ-5D Self-care Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'title': 'No problem -> No problem', 'categories': [{'measurements': [{'value': '934', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> Some problem', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> Unable to wash/dress', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> No data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> no problem', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> some problem', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> unable to wash/dress', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to wash/dress -> no problem', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unable to wash/dress -> some problem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to wash/dress -> unable to wash/dress', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to wash/dress -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no problem', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'No data -> some problem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> unable to wash/dress', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in EQ-5D Usual Activities Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'title': 'No problem -> No problem', 'categories': [{'measurements': [{'value': '805', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> Some problem', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> unable to perform usual activities', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No problem -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> no problem', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> some problem', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> unable to perform usual activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Some problem -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to perform usual activities -> no problem', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unable to perform usual activities -> some problem', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unable to perform usual activities -> same status', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to perform usual activities -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no problem', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No data -> some problem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> unable to perform usual activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1002', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'title': 'No pain -> no pain', 'categories': [{'measurements': [{'value': '499', 'groupId': 'OG000'}]}]}, {'title': 'No pain -> moderate pain', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'No pain -> extreme pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No pain -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Moderate pain -> no pain', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}]}]}, {'title': 'Moderate pain -> moderate pain', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}, {'title': 'Moderate pain -> extreme pain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Moderate pain -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Extreme pain -> no pain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Extreme pain -> moderate pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Extreme pain -> extreme pain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Extreme pain -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No data -> moderate pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> extreme pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'title': 'Not anxious -> Not anxious', 'categories': [{'measurements': [{'value': '737', 'groupId': 'OG000'}]}]}, {'title': 'Not anxious -> moderately anxious', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Not anxious -> extremely anxious', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not anxious -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Moderately anxious -> not anxious', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Moderately anxious -> moderately anxious', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Moderately anxious -> extremely anxious', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Moderately anxious -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Extremely anxious -> not anxious', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Extremely anxious -> moderately anxious', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Extremely anxious -> extremely anxious', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Extremely anxious -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> not anxious', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No data -> moderately anxious', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> extremely anxious', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No data -> no data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Group', 'description': 'Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '17.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Took ≥ 1 dose of FDC open-label study drug', 'groupId': 'FG000', 'numSubjects': '1066'}]}, {'type': 'Safety Analysis Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1066'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1009'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '960'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Not fulfilling incl./excl.criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were eligible for Study 905-CL-057 if they completed 12 weeks of double-blind treatment in Study 905-CL-055, complied with inclusion criteria and did not meet any exclusion criteria. Participants treated with the FDC 0.4 mg/6 mg or 0.4 mg/9 mg for maximally 40 weeks.', 'preAssignmentDetails': 'All eligible participants started with 4 weeks of open-label FDC 0.4 mg/6 mg and were given the opportunity to adjust their dose at 3 monthly intervals thereafter if desired.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Group', 'description': 'Participants who received at least one dose of open-label FDC treatment'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '540', 'groupId': 'BG000'}]}]}, {'title': '>65 and < 75 years', 'categories': [{'measurements': [{'value': '417', 'groupId': 'BG000'}]}]}, {'title': '> 75 years', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1066', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1060', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total International Prostate Symptom Score (IPSS)', 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'spread': '4.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population excluding 5 patients with invalid questionnaires. The IPSS is a validated global questionnaire to assess the degree of "bother" from urinary symptoms, based on answers to 7questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total International Prostate Symptom Score (IPSS) voiding score', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '3.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population excluding 5 patients with invalid questionnaires. The IPSS is a validated global questionnaire to assess the degree of "bother" from urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total International Prostate Symptom Score (IPSS) storage score', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '2.37', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population excluding 5 patients with invalid questionnaires.The IPSS is a validated global questionnaire to assess the degree of "bother" from urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IPSS Quality of Life Score(Qol) score', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population excluding 5 patients with invalid questionnaires. The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Urgency Frequency Score (TUFS) (previous known as Total Urgency Score (TUS)', 'classes': [{'categories': [{'measurements': [{'value': '27.18', 'spread': '8.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population.The Participant Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: 0.No urgency; 1.Mild urgency; 2.Moderate urgency; 3.Severe urgency; 4.Urgency incontinence. TUFS/TUS was the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Micturitions/24 hour', 'classes': [{'categories': [{'measurements': [{'value': '11.44', 'spread': '2.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population. A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Volume voided/micturition', 'classes': [{'categories': [{'measurements': [{'value': '162.81', 'spread': '47.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population. A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Incontinence episodes/24 hour', 'classes': [{'categories': [{'measurements': [{'value': '1.77', 'spread': '2.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population. An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'incontinence episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urgency incontinence episodes /24 hour', 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '1.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population. An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'urgency incontinence episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nocturia episodes/ 24 hour', 'classes': [{'categories': [{'measurements': [{'value': '2.40', 'spread': '1.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FAS population. A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.', 'unitOfMeasure': 'nocturia episodes', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'SAF and FAS (study-specific)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1067}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2011-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2009-11-24', 'resultsFirstSubmitDate': '2015-10-14', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-16', 'studyFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)', 'description': 'Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).'}, {'measure': 'Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.'}, {'measure': 'Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'Qmax during a micturition (urination) was recorded using uroflowmetry.'}, {'measure': 'Change From Baseline to End of Treatment in Average Flow Rate (Qmean)', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'Qmean during a micturition (urination) was recorded using uroflowmetry.'}, {'measure': 'Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).'}, {'measure': 'Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.'}, {'measure': 'Change From Baseline to End of Treatment in IPSS Voiding Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).'}, {'measure': 'Change From Baseline to End of Treatment in IPSS Storage Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).'}, {'measure': 'Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).'}, {'measure': 'Change From Baseline to End of Treatment in Individual IPSS Scores', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.'}, {'measure': 'Change From Baseline to End of Treatment in Symptom Bother Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.'}, {'measure': 'Number of OAB-q Responders Based on Health-related Quality of Life: Total Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.'}, {'measure': 'Change From Baseline to End of Treatment in EQ-5D Mobility Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).'}, {'measure': 'Change From Baseline to End of Treatment in EQ-5D Self-care Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).'}, {'measure': 'Change From Baseline to End of Treatment in EQ-5D Usual Activities Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).'}, {'measure': 'Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).'}, {'measure': 'Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).'}, {'measure': 'Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score', 'timeFrame': 'Baseline and up to 52 weeks of FDC treatment', 'description': 'Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vesomni', 'Solifenacin succinate', 'EC905', 'Tamsulosin hydrochloride OCAS', 'Treatment', 'Lower Urinary Tract Symptoms', 'Benign Prostatic Hyperplasia'], 'conditions': ['Lower Urinary Tract Symptoms', 'Benign Prostatic Hyperplasia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=39', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.', 'detailedDescription': 'This is an open-label extension study following the double blind 905-CL-055 study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of 12 weeks double-blind treatment in Study 905-CL-055\n\nExclusion Criteria:\n\n* Any significant PVR volume (\\>150 mL)'}, 'identificationModule': {'nctId': 'NCT01021332', 'acronym': 'Neptune II', 'briefTitle': 'Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component', 'orgStudyIdInfo': {'id': '905-CL-057'}, 'secondaryIdInfos': [{'id': '2008-001212-20', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total Group', 'description': 'Participants who received at least one dose of open-label fixed dose combination (FDC) treatment', 'interventionNames': ['Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)', 'Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)']}], 'interventions': [{'name': 'tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)', 'type': 'DRUG', 'otherNames': ['EC905', 'Vesomni'], 'description': 'oral', 'armGroupLabels': ['Total Group']}, {'name': 'tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)', 'type': 'DRUG', 'otherNames': ['EC905'], 'description': 'oral', 'armGroupLabels': ['Total Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '220036', 'city': 'Minsk', 'country': 'Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '220119', 'city': 'Minsk', 'country': 'Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '223040', 'city': 'Minsk', 'country': 'Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '500 02', 'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '700 30', 'city': 'Ostrava', 'country': 'Czechia', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '301 24', 'city': 'Pilsen', 'country': 'Czechia', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '413 01', 'city': 'Roudnice nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.42528, 'lon': 14.26175}}, {'zip': '686 08', 'city': 'Uherské Hradiště', 'country': 'Czechia', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'zip': '400 01', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'zip': '591 01', 'city': "Zd'ar Nad Sazavou", 'country': 'Czechia'}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '03100', 'city': 'Montluçon', 'country': 'France', 'geoPoint': {'lat': 46.34015, 'lon': 2.60254}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '06295', 'city': 'Eisleben Lutherstadt', 'country': 'Germany', 'geoPoint': {'lat': 51.52754, 'lon': 11.54835}}, {'zip': '65933', 'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '27777', 'city': 'Ganderkesee', 'country': 'Germany', 'geoPoint': {'lat': 53.03616, 'lon': 8.54514}}, {'zip': '19230', 'city': 'Hagenow', 'country': 'Germany', 'geoPoint': {'lat': 53.43203, 'lon': 11.19165}}, {'zip': '06132', 'city': 'Halle', 'country': 'Germany', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20253', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '16761', 'city': 'Henningsdorf', 'country': 'Germany'}, {'zip': '06333', 'city': 'Hettstedt', 'country': 'Germany', 'geoPoint': {'lat': 51.6503, 'lon': 11.51146}}, {'zip': '56068', 'city': 'Koblenz', 'country': 'Germany', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '04105', 'city': 'Leipzig', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '01844', 'city': 'Neustadt in Sachsen', 'country': 'Germany', 'geoPoint': {'lat': 51.02844, 'lon': 14.21785}}, {'zip': '01445', 'city': 'Radebeul', 'country': 'Germany', 'geoPoint': {'lat': 51.10654, 'lon': 13.66047}}, 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