Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT00689104
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2008-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.Disclosure@us.astellas.com', 'title': 'Director Medical Science', 'organization': 'Astellas Pharma Europe B.V.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Primary publication of the multi-center data. Sponsor must receive a site's manuscript at least 45 days prior to planned submission to ensure that no confidential information of Sponsor is included in the document. Sponsor will respond within 30 days and may request changes or delay the publication to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.', 'otherNumAtRisk': 494, 'otherNumAffected': 49, 'seriousNumAtRisk': 494, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.', 'otherNumAtRisk': 493, 'otherNumAffected': 42, 'seriousNumAtRisk': 493, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.', 'otherNumAtRisk': 496, 'otherNumAffected': 41, 'seriousNumAtRisk': 496, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.', 'otherNumAtRisk': 495, 'otherNumAffected': 86, 'seriousNumAtRisk': 495, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}], 'seriousEvents': [{'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Postoperative infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Open wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Gas poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Enterocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Cardiovascular evaluation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Ruptured cerebral aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Bunion operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Papilloma excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Retinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Sympathetic posterior cervical syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Vaginal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 496, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 495, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.17', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-1.46', 'spread': '0.115', 'groupId': 'OG002'}, {'value': '-1.27', 'spread': '0.112', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '-0.09', 'pValueComment': 'The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.', 'statisticalMethod': 'Stratified rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.03', 'pValueComment': 'The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.', 'statisticalMethod': 'Stratified rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.21', 'pValueComment': 'The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.', 'groupDescription': 'Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.', 'statisticalMethod': 'Stratified rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12 (final visit)', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Incontinence episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '-1.77', 'spread': '0.110', 'groupId': 'OG002'}, {'value': '-1.59', 'spread': '0.111', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.29', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.13', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.06', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in Mean Volume Voided Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '2.00', 'groupId': 'OG002'}, {'value': '25.0', 'spread': '2.00', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '6.3', 'ciUpperLimit': '17.4', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '7.7', 'ciUpperLimit': '18.7', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.6', 'ciLowerLimit': '7.1', 'ciUpperLimit': '18.2', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.118', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '0.120', 'groupId': 'OG002'}, {'value': '-1.00', 'spread': '0.117', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.06', 'pValueComment': 'The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.', 'statisticalMethod': 'Stratified rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.05', 'pValueComment': 'The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.', 'statisticalMethod': 'Stratified rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.03', 'pValueComment': 'The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.', 'groupDescription': 'Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.', 'statisticalMethod': 'Stratified rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Incontinence episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '477', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-1.29', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '-1.10', 'spread': '0.096', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.13', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '-0.26', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.06', 'pValueComment': 'LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'groupDescription': 'Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 8 [N=280; 277; 268; 292]', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.128', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': '0.130', 'groupId': 'OG002'}, {'value': '-1.02', 'spread': '0.125', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=275; 272; 262; 276]', 'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '0.117', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '-1.27', 'spread': '0.116', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 8 and 12', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Incontinence episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as "N". LOCF was not utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 8 [N=463; 450; 455; 461]', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-1.66', 'spread': '0.106', 'groupId': 'OG002'}, {'value': '-1.43', 'spread': '0.106', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=452; 437; 447; 438]', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '0.115', 'groupId': 'OG001'}, {'value': '-1.78', 'spread': '0.113', 'groupId': 'OG002'}, {'value': '-1.60', 'spread': '0.114', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 8 and 12', 'description': 'The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as "N". LOCF was not used in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=479; 470; 477; 474]', 'categories': [{'measurements': [{'value': '9.8', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '20.3', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '21.4', 'spread': '1.74', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=463; 449; 455; 461]', 'categories': [{'measurements': [{'value': '11.7', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '25.3', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '25.9', 'spread': '1.97', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=452; 437; 447; 438]', 'categories': [{'measurements': [{'value': '11.9', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '25.8', 'spread': '2.10', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as "N".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=283; 286; 276; 288]', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '-1.01', 'spread': '0.107', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=273; 272; 263; 281]', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '0.118', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '0.120', 'groupId': 'OG002'}, {'value': '-0.99', 'spread': '0.116', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=269; 267; 257; 265]', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '0.114', 'groupId': 'OG002'}, {'value': '-1.19', 'spread': '0.122', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=283; 286; 276; 289]', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '0.111', 'groupId': 'OG002'}, {'value': '-1.18', 'spread': '0.109', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Urgency incontinence episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 post baseline micturition measurement in the visit diary \\& at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=475; 469; 471; 470]', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '0.138', 'groupId': 'OG002'}, {'value': '-1.63', 'spread': '0.139', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=460; 446; 450; 456]', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '0.155', 'groupId': 'OG001'}, {'value': '-1.90', 'spread': '0.154', 'groupId': 'OG002'}, {'value': '-1.91', 'spread': '0.153', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=450; 433; 441; 434]', 'categories': [{'measurements': [{'value': '-1.65', 'spread': '0.154', 'groupId': 'OG000'}, {'value': '-2.35', 'spread': '0.157', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '0.155', 'groupId': 'OG002'}, {'value': '-2.16', 'spread': '0.156', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=479; 470; 474; 472]', 'categories': [{'measurements': [{'value': '-1.65', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '0.152', 'groupId': 'OG001'}, {'value': '-1.96', 'spread': '0.151', 'groupId': 'OG002'}, {'value': '-2.07', 'spread': '0.152', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Urgency episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=476; 469; 472; 471]', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '-0.21', 'spread': '0.023', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=460; 447; 451; 456]', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.027', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '0.027', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=450; 434; 442; 434]', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '0.029', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=480; 472; 475; 473]', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.028', 'groupId': 'OG002'}, {'value': '-0.29', 'spread': '0.028', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': "Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=428; 422; 422; 432]', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.045', 'groupId': 'OG002'}, {'value': '-0.29', 'spread': '0.045', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=414; 404; 403; 419]', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.048', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.048', 'groupId': 'OG002'}, {'value': '-0.39', 'spread': '0.047', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=404; 393; 395; 399]', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.049', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '0.048', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=428; 423; 422; 433]', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.047', 'groupId': 'OG002'}, {'value': '-0.45', 'spread': '0.047', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'nocturia episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=209; 183; 195; 181]', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.110', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-0.67', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=204; 176; 183; 177]', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '0.125', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '0.122', 'groupId': 'OG002'}, {'value': '-0.77', 'spread': '0.124', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=200; 172; 181; 165]', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.117', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '0.123', 'groupId': 'OG002'}, {'value': '-0.95', 'spread': '0.128', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=209; 183; 195; 181]', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.123', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '-0.95', 'spread': '0.123', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The average number of times a patient records a new pad used per day during the 3-day micturition diary period.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'pads', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=291; 293; 281; 299]', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}, {'value': '32.0', 'groupId': 'OG002'}, {'value': '33.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=280; 277; 268; 292]', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}, {'value': '45.1', 'groupId': 'OG002'}, {'value': '41.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=275; 272; 262; 276]', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}, {'value': '43.9', 'groupId': 'OG002'}, {'value': '48.6', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=291; 293; 281; 300]', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}, {'value': '43.8', 'groupId': 'OG002'}, {'value': '47.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8 and 12', 'description': 'The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 postbaseline micturition measurement in the visit diary \\& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=291; 293; 281; 299]', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '57.3', 'groupId': 'OG001'}, {'value': '54.4', 'groupId': 'OG002'}, {'value': '56.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=280; 277; 268; 292]', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}, {'value': '68.3', 'groupId': 'OG002'}, {'value': '64.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=275; 272; 262; 276]', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '73.5', 'groupId': 'OG001'}, {'value': '67.9', 'groupId': 'OG002'}, {'value': '69.6', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=291; 293; 281; 300]', 'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000'}, {'value': '72.2', 'groupId': 'OG001'}, {'value': '67.6', 'groupId': 'OG002'}, {'value': '68.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 postbaseline micturition measurement in the visit diary \\& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=472; 460; 470; 467]', 'categories': [{'measurements': [{'value': '-9.7', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-13.8', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '-13.8', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=455; 441; 450; 451]', 'categories': [{'measurements': [{'value': '-13.3', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-17.8', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-17.6', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '-17.1', 'spread': '0.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=445; 424; 435; 433]', 'categories': [{'measurements': [{'value': '-15.3', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-20.3', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-20.0', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-18.5', 'spread': '0.88', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=475; 465; 473; 469]', 'categories': [{'measurements': [{'value': '-14.9', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-19.9', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '-18.4', 'spread': '0.85', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. 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 in symptom bother score indicates improvements.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=471; 463; 469; 467]', 'categories': [{'measurements': [{'value': '8.8', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '9.4', 'spread': '0.68', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=454; 446; 450; 453]', 'categories': [{'measurements': [{'value': '11.9', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=445; 426; 435; 432]', 'categories': [{'measurements': [{'value': '14.1', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '15.1', 'spread': '0.80', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=473; 468; 472; 470]', 'categories': [{'measurements': [{'value': '13.7', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '14.8', 'spread': '0.77', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 12 [N=111; 120; 109; 113]', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '7.31', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '13.42', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '18.83', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '12.68', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=113; 122; 110; 114]', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '13.31', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '18.74', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '12.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'percent work time missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 12 [N=116; 128; 104; 114]', 'categories': [{'measurements': [{'value': '-8.3', 'spread': '24.50', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '23.24', 'groupId': 'OG001'}, {'value': '-10.8', 'spread': '25.19', 'groupId': 'OG002'}, {'value': '-6.7', 'spread': '28.40', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=118; 130; 106; 115]', 'categories': [{'measurements': [{'value': '-8.1', 'spread': '24.43', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '23.24', 'groupId': 'OG001'}, {'value': '-10.8', 'spread': '25.04', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '28.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'percent impairment while working', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 12 [N=104; 117; 98; 104]', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '23.86', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '25.70', 'groupId': 'OG001'}, {'value': '-11.6', 'spread': '27.09', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '28.32', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=106; 119; 99; 105]', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '23.79', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '25.64', 'groupId': 'OG001'}, {'value': '-11.5', 'spread': '26.97', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '28.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'percent overall work impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 12 [N=409; 395; 409; 400]', 'categories': [{'measurements': [{'value': '-11.2', 'spread': '27.73', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': '27.93', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '28.67', 'groupId': 'OG002'}, {'value': '-14.7', 'spread': '29.50', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=419; 400; 417; 409]', 'categories': [{'measurements': [{'value': '-11.0', 'spread': '27.78', 'groupId': 'OG000'}, {'value': '-14.9', 'spread': '27.84', 'groupId': 'OG001'}, {'value': '-14.4', 'spread': '28.70', 'groupId': 'OG002'}, {'value': '-14.3', 'spread': '29.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'percent activity impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'No problem -> No problem', 'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}, {'value': '330', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Some problems', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Missing data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> No problems', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Some problems', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Confined -> No problems', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Confined -> Some problems', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Confined -> Confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Confined -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> No problem', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Some problems', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Confined to bed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI have no problems in walking about; I have some problems in walking about; I am confined to bed.\n\nIn the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'No problem -> No problem', 'categories': [{'measurements': [{'value': '437', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '439', 'groupId': 'OG002'}, {'value': '432', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Some problems', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Unable to wash or dress myself', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Missing data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> No problems', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Some problems', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Unable to wash or dress myself', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unable to wash or dress myself -> No problems', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unable to wash or dress myself -> Some problems', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unable to wash or dress -> Unable to wash or dress', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unable to wash or dress myself -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> No problem', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Some problems', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Unable to wash or dress myself', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'No problem -> No problem', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Some problems', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Unable to perform usual activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'No problem -> Missing data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> No problems', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Some problems', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Some problems-> Unable to perform usual activities', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Some problems -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unable to perform usual activities -> No problems', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Unable to perform usual activities-> Some problems', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Unable to perform -> Unable to perform', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Unable to perform usual activities -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> No problem', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Some problems', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Unable to perform usual activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'No pain -> No pain', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}]}, {'title': 'No pain -> Moderate pain', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'No pain -> Extreme pain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'No pain -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Moderate pain -> No pain', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'Moderate pain -> Moderate pain', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}]}, {'title': 'Moderate pain -> Extreme pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Moderate pain ->Missing data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Extreme pain -> No pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Extreme pain -> Moderate pain', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Extreme pain -> Extreme pain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Extreme pain -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> No pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Moderate pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Extreme pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Not anxious -> Not anxious', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '217', 'groupId': 'OG003'}]}]}, {'title': 'Not anxious -> Moderately anxious', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Not anxious -> Extremely anxious', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Not anxious -> Missing data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Moderately anxious -> Not anxious', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}]}, {'title': 'Moderately anxious -> Moderately anxious', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}]}, {'title': 'Moderately anxious -> Extremely anxious', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Moderately anxious -> Missing data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Extremely anxious -> Not anxious', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Extremely anxious -> Moderately anxious', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Extremely anxious -> Extremely anxious', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Extremely anxious -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Not anxious', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Moderately anxious', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Extremely anxious', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing data -> Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=466; 459; 468; 461]', 'categories': [{'measurements': [{'value': '3.1', 'spread': '15.64', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '15.74', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '16.75', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '17.68', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=451; 443; 447; 447]', 'categories': [{'measurements': [{'value': '4.5', 'spread': '16.81', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '16.79', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '17.42', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '17.31', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=443; 423; 437; 429]', 'categories': [{'measurements': [{'value': '6.7', 'spread': '19.01', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '18.89', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '17.56', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '17.62', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=470; 466; 472; 467]', 'categories': [{'measurements': [{'value': '6.4', 'spread': '19.03', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '18.67', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '17.74', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '18.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': "The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug \\& had a baseline \\& at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 12 [N=425; 410; 421; 417]', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.06', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=433; 416; 429; 426]', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 12 [N=421; 410; 420; 416]', 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.147', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.149', 'groupId': 'OG001'}, {'value': '2.67', 'spread': '0.147', 'groupId': 'OG002'}, {'value': '2.44', 'spread': '0.148', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=428; 414; 427; 425]', 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '0.149', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.146', 'groupId': 'OG002'}, {'value': '2.44', 'spread': '0.147', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Week 4 [N=477; 467; 473; 474]', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.23', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 [N=462; 448; 453; 460]', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 [N=451; 435; 443; 439]', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': 'Final Visit (LOCF) [N=478; 469; 475; 474]', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': "The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.", 'unitOfMeasure': 'Physician visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'OG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'classes': [{'title': 'Improvement: Week 12 [N=425; 410;421; 417]', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}, {'value': '65.2', 'groupId': 'OG003'}]}]}, {'title': 'Improvement: Final Visit [N=433; 416; 429; 426]', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000'}, {'value': '61.3', 'groupId': 'OG001'}, {'value': '62.2', 'groupId': 'OG002'}, {'value': '65.0', 'groupId': 'OG003'}]}]}, {'title': 'Major Improvement: Week 12 [N=425; 410; 421; 417]', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}, {'value': '34.0', 'groupId': 'OG002'}, {'value': '31.7', 'groupId': 'OG003'}]}]}, {'title': 'Major Improvement: Final Visit [N=433;416;429;426]', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}, {'value': '33.6', 'groupId': 'OG002'}, {'value': '31.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'FG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'FG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'FG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '497'}, {'groupId': 'FG001', 'numSubjects': '497'}, {'groupId': 'FG002', 'numSubjects': '498'}, {'groupId': 'FG003', 'numSubjects': '495'}]}, {'type': 'Safety Analysis Set (SAF)', 'achievements': [{'comment': 'All randomized patients who took at least 1 dose of double-blind study drug.', 'groupId': 'FG000', 'numSubjects': '494'}, {'comment': 'All randomized patients who took at least 1 dose of double-blind study drug.', 'groupId': 'FG001', 'numSubjects': '493'}, {'comment': 'All randomized patients who took at least 1 dose of double-blind study drug.', 'groupId': 'FG002', 'numSubjects': '496'}, {'comment': 'All randomized patients who took at least 1 dose of double-blind study drug.', 'groupId': 'FG003', 'numSubjects': '495'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'comment': 'Treated patients with a baseline and at least 1 postbaseline micturition measurement.', 'groupId': 'FG000', 'numSubjects': '480'}, {'comment': 'Treated patients with a baseline and at least 1 postbaseline micturition measurement.', 'groupId': 'FG001', 'numSubjects': '473'}, {'comment': 'Treated patients with a baseline and at least 1 postbaseline micturition measurement.', 'groupId': 'FG002', 'numSubjects': '478'}, {'comment': 'Treated patients with a baseline and at least 1 postbaseline micturition measurement.', 'groupId': 'FG003', 'numSubjects': '475'}]}, {'type': 'Full Analysis Set Incontinence (FAS-I)', 'achievements': [{'comment': 'Full analysis set patients who had at least 1 incontinence episode at baseline.', 'groupId': 'FG000', 'numSubjects': '291'}, {'comment': 'Full analysis set patients who had at least 1 incontinence episode at baseline.', 'groupId': 'FG001', 'numSubjects': '293'}, {'comment': 'Full analysis set patients who had at least 1 incontinence episode at baseline.', 'groupId': 'FG002', 'numSubjects': '281'}, {'comment': 'Full analysis set patients who had at least 1 incontinence episode at baseline.', 'groupId': 'FG003', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '453'}, {'groupId': 'FG001', 'numSubjects': '440'}, {'groupId': 'FG002', 'numSubjects': '453'}, {'groupId': 'FG003', 'numSubjects': '445'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Eligibility criterion not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Randomized but never received study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After screening, 2336 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1987 eligible patients were randomly assigned to receive placebo, mirabegron 50 mg, mirabegron 100 mg or tolterodine 4 mg for 12 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}, {'value': '495', 'groupId': 'BG003'}, {'value': '1978', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.'}, {'id': 'BG001', 'title': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'BG002', 'title': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.'}, {'id': 'BG003', 'title': 'Tolterodine SR 4 mg', 'description': 'Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '12.30', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '12.36', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '12.71', 'groupId': 'BG002'}, {'value': '59.1', 'spread': '12.89', 'groupId': 'BG003'}, {'value': '59.1', 'spread': '12.56', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Measure data are provided for all randomized patients who took at least 1 dose of double-blind study drug (Safety Analysis Set).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '356', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}, {'value': '361', 'groupId': 'BG003'}, {'value': '1429', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '549', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '490', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}, {'value': '490', 'groupId': 'BG003'}, {'value': '1960', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of overactive bladder (OAB)', 'classes': [{'title': 'Urge Incontinence', 'categories': [{'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '782', 'groupId': 'BG004'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}, {'value': '449', 'groupId': 'BG004'}]}]}, {'title': 'Frequency', 'categories': [{'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}, {'value': '747', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of OAB symptoms', 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'spread': '91.38', 'groupId': 'BG000'}, {'value': '79.6', 'spread': '87.14', 'groupId': 'BG001'}, {'value': '84.8', 'spread': '94.12', 'groupId': 'BG002'}, {'value': '75.5', 'spread': '92.20', 'groupId': 'BG003'}, {'value': '79.0', 'spread': '91.25', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of micturitions per 24 Hours', 'classes': [{'categories': [{'measurements': [{'value': '11.72', 'spread': '3.122', 'groupId': 'BG000'}, {'value': '11.64', 'spread': '2.967', 'groupId': 'BG001'}, {'value': '11.49', 'spread': '2.720', 'groupId': 'BG002'}, {'value': '11.53', 'spread': '2.773', 'groupId': 'BG003'}, {'value': '11.59', 'spread': '2.899', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The average number of micturitions (urinations) recorded by the patient in a micturition diary for 3 days prior to the Baseline visit.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean volume voided per micturition', 'classes': [{'categories': [{'measurements': [{'value': '156.8', 'spread': '52.73', 'groupId': 'BG000'}, {'value': '160.3', 'spread': '57.85', 'groupId': 'BG001'}, {'value': '158.9', 'spread': '53.95', 'groupId': 'BG002'}, {'value': '157.4', 'spread': '54.23', 'groupId': 'BG003'}, {'value': '158.3', 'spread': '54.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded by the patient in a micturition diary for 3 days prior to the Baseline visit.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of urgency episodes (grade 3 or 4) per 24 hours', 'classes': [{'categories': [{'measurements': [{'value': '5.72', 'spread': '3.972', 'groupId': 'BG000'}, {'value': '5.68', 'spread': '3.679', 'groupId': 'BG001'}, {'value': '5.95', 'spread': '3.699', 'groupId': 'BG002'}, {'value': '5.79', 'spread': '3.494', 'groupId': 'BG003'}, {'value': '5.79', 'spread': '3.713', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Urgency episodes were those classified by the patient in a 3-day micturition diary as 3 or 4 on the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.', 'unitOfMeasure': 'urgency episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean level of urgency', 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '0.563', 'groupId': 'BG000'}, {'value': '2.40', 'spread': '0.547', 'groupId': 'BG001'}, {'value': '2.46', 'spread': '0.528', 'groupId': 'BG002'}, {'value': '2.41', 'spread': '0.561', 'groupId': 'BG003'}, {'value': '2.41', 'spread': '0.551', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of nocturia episodes per 24 hours', 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '1.405', 'groupId': 'BG000'}, {'value': '1.87', 'spread': '1.294', 'groupId': 'BG001'}, {'value': '1.91', 'spread': '1.374', 'groupId': 'BG002'}, {'value': '1.93', 'spread': '1.417', 'groupId': 'BG003'}, {'value': '1.92', 'spread': '1.373', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The average number of times a patient waked at night to urinate (excluding incontinence only episodes) recorded for 3 days prior to the Baseline visit in the patient micturition diary.', 'unitOfMeasure': 'nocturia episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of pads used per 24 hours', 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '1.812', 'groupId': 'BG000'}, {'value': '1.12', 'spread': '1.941', 'groupId': 'BG001'}, {'value': '1.25', 'spread': '2.020', 'groupId': 'BG002'}, {'value': '1.04', 'spread': '1.752', 'groupId': 'BG003'}, {'value': '1.13', 'spread': '1.884', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded by the patient in a micturition diary for 3 days prior to the Baseline visit.', 'unitOfMeasure': 'pads', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2010-03-23', 'completionDateStruct': {'date': '2009-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2008-05-29', 'dispFirstSubmitQcDate': '2010-03-23', 'resultsFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2008-06-02', 'dispFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-09-17', 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and Week 12 (final visit)', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Final Visit in Mean Volume Voided Per Micturition', 'timeFrame': 'Baseline and Week 12', 'description': 'The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and Week 4', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline and Week 4', 'description': 'The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and Weeks 8 and 12', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline and Weeks 8 and 12', 'description': 'The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': "Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The average number of times a patient records a new pad used per day during the 3-day micturition diary period.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit', 'timeFrame': 'Weeks 4, 8 and 12', 'description': 'The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.'}, {'measure': 'Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. 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 in symptom bother score indicates improvements.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.\n\nLS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed', 'timeFrame': 'Baseline and Week 12', 'description': 'The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working', 'timeFrame': 'Baseline and Week 12', 'description': "The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment', 'timeFrame': 'Baseline and Week 12', 'description': "The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment', 'timeFrame': 'Baseline and Week 12', 'description': "The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI have no problems in walking about; I have some problems in walking about; I am confined to bed.\n\nIn the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.'}, {'measure': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.'}, {'measure': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.'}, {'measure': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.'}, {'measure': 'Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:\n\nI am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.'}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': "The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement."}, {'measure': 'Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement."}, {'measure': 'Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)', 'timeFrame': 'Baseline and Week 12', 'description': "The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement."}, {'measure': 'Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': "The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition."}, {'measure': 'Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Micturition', 'Urinary incontinence', 'Urinary urge incontinence', 'Overactive bladder (OAB)', 'Urgency', 'YM178', 'Frequency'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '23182126', 'type': 'BACKGROUND', 'citation': 'Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.'}, {'pmid': '37160401', 'type': 'DERIVED', 'citation': 'Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.'}, {'pmid': '24246044', 'type': 'DERIVED', 'citation': 'Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=35', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is willing and able to complete the micturition diary and questionnaires correctly\n* Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months\n* Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period\n* Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period\n\nExclusion Criteria:\n\n* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control\n* Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor\n* Subject has an indwelling catheter or practices intermittent self-catheterization\n* Subject has diabetic neuropathy\n* Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs\n* Subject receives non-drug treatment including electro-stimulation therapy\n* Subject has severe hypertension\n* Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients\n* Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)\n* Subject had an average total daily urine volume \\> 3000 mL as recorded in the 3-day micturition diary period\n* Subject has serum creatinine \\>150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) \\> 3x ULN\n* Subject has a clinically significant abnormal electrocardiogram (ECG)'}, 'identificationModule': {'nctId': 'NCT00689104', 'acronym': 'SCORPIO', 'briefTitle': 'Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder', 'orgStudyIdInfo': {'id': '178-CL-046'}, 'secondaryIdInfos': [{'id': '2007-001451-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.', 'interventionNames': ['Drug: Placebo to Mirabegron', 'Drug: Placebo to Tolterodine']}, {'type': 'EXPERIMENTAL', 'label': 'Mirabegron 50 mg', 'description': 'Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.', 'interventionNames': ['Drug: Mirabegron', 'Drug: Placebo to Tolterodine']}, {'type': 'EXPERIMENTAL', 'label': 'Mirabegron 100 mg', 'description': 'Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.', 'interventionNames': ['Drug: Mirabegron', 'Drug: Placebo to Tolterodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tolterodine SR 4 mg', 'description': 'Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.', 'interventionNames': ['Drug: Tolterodine', 'Drug: Placebo to Mirabegron']}], 'interventions': [{'name': 'Mirabegron', 'type': 'DRUG', 'otherNames': ['Myrbetriq', 'YM178'], 'description': 'Tablets', 'armGroupLabels': ['Mirabegron 100 mg', 'Mirabegron 50 mg']}, {'name': 'Tolterodine', 'type': 'DRUG', 'description': 'Capsules', 'armGroupLabels': ['Tolterodine SR 4 mg']}, {'name': 'Placebo to Mirabegron', 'type': 'DRUG', 'description': 'Matching mirabegron placebo tablets.', 'armGroupLabels': ['Placebo', 'Tolterodine SR 4 mg']}, {'name': 'Placebo to Tolterodine', 'type': 'DRUG', 'description': 'Matching tolterodine placebo capsules.', 'armGroupLabels': ['Mirabegron 100 mg', 'Mirabegron 50 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auchenflower', 'country': 'Australia', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'city': 'Clayton', 'country': 'Australia', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Kogarah', 'country': 'Australia', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'city': 'Randwick', 'country': 'Australia', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'Woolloongabba', 'country': 'Australia', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'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': '223041', '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': '2030', 'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'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': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '8900', 'city': 'Leper', 'country': 'Belgium'}, {'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': '3800', 'city': 'Sint-Truiden', 'country': 'Belgium', 'geoPoint': {'lat': 50.81679, 'lon': 5.18647}}, {'city': 'Pleven', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '60200', 'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '27601', 'city': 'Mělník', 'country': 'Czechia', 'geoPoint': {'lat': 50.3505, 'lon': 14.47411}}, {'zip': '77200', 'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '70853', 'city': 'Ostrava-Poruba', 'country': 'Czechia'}, {'zip': '30599', 'city': 'Pilsen', 'country': 'Czechia', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '12851', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '14056', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '18081', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '41108', 'city': 'Štětí', 'country': 'Czechia', 'geoPoint': {'lat': 50.45298, 'lon': 14.37421}}, {'zip': '40001', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'zip': '9100', 'city': 'Aalborg', 'country': 'Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'city': 'Roskilde', 'country': 'Denmark', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '68070', 'city': 'Mulhouse', 'country': 'France', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '45035', 'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '86551', 'city': 'Aichach', 'country': 'Germany', 'geoPoint': {'lat': 48.45755, 'lon': 11.13413}}, {'zip': '56130', 'city': 'Bad Ems', 'country': 'Germany', 'geoPoint': {'lat': 50.33544, 'lon': 7.71369}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '47051', 'city': 'Duisburg', 'country': 'Germany', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'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': '81925', 'city': 'Muenchen-Bogenhausen', 'country': 'Germany'}, {'zip': '01844', 'city': 'Neustadt in Sachsen', 'country': 'Germany', 'geoPoint': {'lat': 51.02844, 'lon': 14.21785}}, {'zip': '16151', 'city': 'Oranienburg', 'country': 'Germany', 'geoPoint': {'lat': 52.75577, 'lon': 13.24197}}, {'zip': '01445', 'city': 'Radebeul', 'country': 'Germany', 'geoPoint': {'lat': 51.10654, 'lon': 13.66047}}, {'zip': '06526', 'city': 'Sangerhausen', 'country': 'Germany', 'geoPoint': {'lat': 51.47221, 'lon': 11.29533}}, {'zip': '54290', 'city': 'Trier', 'country': 'Germany', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '25436', 'city': 'Uetersen', 'country': 'Germany', 'geoPoint': {'lat': 53.68878, 'lon': 9.66197}}, {'city': 'Athens', 'country': 'Greece', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Nikaias-Piraeus', 'country': 'Greece'}, {'city': 'Pátrai', 'country': 'Greece', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Thessaloniki', 'country': 'Greece', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '1047', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1076', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1204', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4043', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3300', 'city': 'Eger', 'country': 'Hungary', 'geoPoint': {'lat': 47.90265, 'lon': 20.37329}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'city': 'Pápa', 'country': 'Hungary', 'geoPoint': {'lat': 47.33004, 'lon': 17.4674}}, {'city': 'Sopron', 'country': 'Hungary', 'geoPoint': {'lat': 47.68501, 'lon': 16.59049}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '7100', 'city': 'Szekszárd', 'country': 'Hungary', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '2800', 'city': 'Tatabánya', 'country': 'Hungary', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}, {'zip': '8200', 'city': 'Veszprém', 'country': 'Hungary', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '101', 'city': 'Reykjavik', 'country': 'Iceland', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}, {'city': 'Cork', 'country': 'Ireland', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'country': 'Ireland', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Mullingar', 'country': 'Ireland', 'geoPoint': {'lat': 53.52466, 'lon': -7.3385}}, {'city': 'Tralee', 'country': 'Ireland', 'geoPoint': {'lat': 52.27042, 'lon': -9.70264}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '59129', 'city': 'Florence', 'country': 'Italy', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16128', 'city': 'Genoa', 'country': 'Italy', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '04100', 'city': 'Latina', 'country': 'Italy', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '20013', 'city': 'Magenta', 'country': 'Italy', 'geoPoint': {'lat': 45.46456, 'lon': 8.88453}}, {'zip': '20142', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20153', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '06122', 'city': 'Perugia', 'country': 'Italy', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '64100', 'city': 'Teramo', 'country': 'Italy', 'geoPoint': {'lat': 42.66123, 'lon': 13.69901}}, {'zip': '24047', 'city': 'Treviglio', 'country': 'Italy', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Liepāja', 'country': 'Latvia', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'city': 'Riga', 'country': 'Latvia', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Kaunas', 'country': 'Lithuania', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7334 DZ', 'city': 'Apeldoorn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '7511 JX', 'city': 'Enschede', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '2334 CK', 'city': 'Leiden', 'country': 'Netherlands', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '8600 BA', 'city': 'Sneek', 'country': 'Netherlands', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '5022 GC', 'city': 'Tilburg', 'country': 'Netherlands', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '7101 BN', 'city': 'Winterswijk', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9725, 'lon': 6.71944}}, {'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '3016', 'city': 'Drammen', 'country': 'Norway', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'zip': '2317', 'city': 'Hamar', 'country': 'Norway', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'zip': '0257', 'city': 'Oslo', 'country': 'Norway', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '3103', 'city': 'Tønsberg', 'country': 'Norway', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'zip': '15-278', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '93-513', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-954', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '00-846', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-005', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '2700', 'city': 'Amadora', 'country': 'Portugal', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '4099-005', 'city': 'Porto', 'country': 'Portugal', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '2304-909', 'city': 'Tomar', 'country': 'Portugal', 'geoPoint': {'lat': 39.60199, 'lon': -8.40924}}, {'zip': '4900-858', 'city': 'Viana do Castelo', 'country': 'Portugal', 'geoPoint': {'lat': 41.69323, 'lon': -8.83287}}, {'zip': '22328', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Lasi', 'country': 'Romania'}, {'city': 'Oradea', 'country': 'Romania', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'city': 'Timișoara', 'country': 'Romania', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '101000', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '105425', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '111020', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '111123', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115516', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117049', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117815', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123836', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125206', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '197089', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198013', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '03659', 'city': 'Martin', 'country': 'Slovakia', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '05801', 'city': 'Poprad', 'country': 'Slovakia', 'geoPoint': {'lat': 49.06144, 'lon': 20.29798}}, {'zip': '90982', 'city': 'Skalica', 'country': 'Slovakia', 'geoPoint': {'lat': 48.8449, 'lon': 17.22635}}, {'zip': '91101', 'city': 'Trenčín', 'country': 'Slovakia', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}, {'zip': '01207', 'city': 'Žilina', 'country': 'Slovakia', 'geoPoint': {'lat': 49.22315, 'lon': 18.73941}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Hatfield', 'country': 'South Africa', 'geoPoint': {'lat': -25.74973, 'lon': 28.24314}}, {'city': 'Lyttelton', 'country': 'South Africa', 'geoPoint': {'lat': -25.82988, 'lon': 28.2012}}, {'city': 'Paarl', 'country': 'South Africa', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'city': 'Pietermaritzburg', 'country': 'South Africa', 'geoPoint': {'lat': -29.61679, 'lon': 30.39278}}, {'zip': '08020', 'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '08950', 'city': 'Esplugues de Llobregat-Barcelo', 'country': 'Spain'}, {'zip': '28942', 'city': 'Fuenlabrada', 'country': 'Spain', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'zip': '28905', 'city': 'Getafe', 'country': 'Spain', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28016', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '8304', 'city': 'Mataró', 'country': 'Spain', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '09200', 'city': 'Miranda de Ebro', 'country': 'Spain', 'geoPoint': {'lat': 42.6865, 'lon': -2.94695}}, {'zip': '07014', 'city': 'Palma de Mallorca', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '45071', 'city': 'Toledo', 'country': 'Spain', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '12540', 'city': 'Villarreal de Huerva', 'country': 'Spain', 'geoPoint': {'lat': 41.19034, 'lon': -1.28983}}, {'zip': '50182', 'city': 'Borås', 'country': 'Sweden', 'geoPoint': {'lat': 57.72101, 'lon': 12.9401}}, {'zip': '25187', 'city': 'Helsingborg', 'country': 'Sweden', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '54130', 'city': 'Skövde', 'country': 'Sweden', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '90185', 'city': 'Umeå', 'country': 'Sweden', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '8501', 'city': 'Frauenfeld', 'country': 'Switzerland', 'geoPoint': {'lat': 47.55776, 'lon': 8.89893}}, {'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '01023', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04053', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': 'B15 2TG', 'city': 'Birmingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'PR7 7NA', 'city': 'Chorley', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.65, 'lon': -2.61667}}, {'zip': 'CR7 7YE', 'city': 'Croydon', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.38333, 'lon': -0.1}}, {'zip': 'L22 OLG', 'city': 'Liverpool', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 2YP', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M15 6SX', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'RG2 7AG', 'city': 'Reading', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'S10 2JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SA6 6NL', 'city': 'Swansea', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}