Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT01745094
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2012-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'motoko.ida@astellas.com', 'phone': '+81-3-3244-0512 Ext:', 'title': 'Medical Director', 'organization': 'Astellas Pharma Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi center data. Sponsor must receive a site's manuscript prior to publication for review and comment.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to week 16', 'description': 'Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 23, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 21, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 39, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 67, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood uric acid decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Urinary sediment abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'ECG ST segment depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Drug-related Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to permanent discontinuation (PD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Drug-related TEAEs leading to PD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to weeks 16', 'description': 'TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in OABSS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.52', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '2.32', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '2.90', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '2.90', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '2.86', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '2.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8, 16', 'description': 'The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Normalization for OABSS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8 and 16', 'description': 'Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.46', 'spread': '16.735', 'groupId': 'OG000'}, {'value': '-12.52', 'spread': '20.926', 'groupId': 'OG001'}, {'value': '-15.29', 'spread': '14.348', 'groupId': 'OG002'}, {'value': '-10.39', 'spread': '17.222', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.00', 'spread': '19.557', 'groupId': 'OG000'}, {'value': '-22.25', 'spread': '20.877', 'groupId': 'OG001'}, {'value': '-17.68', 'spread': '15.930', 'groupId': 'OG002'}, {'value': '-16.56', 'spread': '18.171', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.21', 'spread': '18.631', 'groupId': 'OG000'}, {'value': '-22.25', 'spread': '20.877', 'groupId': 'OG001'}, {'value': '-17.55', 'spread': '16.253', 'groupId': 'OG002'}, {'value': '-16.31', 'spread': '18.034', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8, 16', 'description': 'The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in OAB-q SF Total HRQL Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.14', 'spread': '12.786', 'groupId': 'OG000'}, {'value': '9.31', 'spread': '15.559', 'groupId': 'OG001'}, {'value': '12.43', 'spread': '15.449', 'groupId': 'OG002'}, {'value': '6.14', 'spread': '13.797', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.54', 'spread': '13.349', 'groupId': 'OG000'}, {'value': '16.72', 'spread': '16.439', 'groupId': 'OG001'}, {'value': '14.72', 'spread': '16.428', 'groupId': 'OG002'}, {'value': '12.72', 'spread': '17.170', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.34', 'spread': '13.005', 'groupId': 'OG000'}, {'value': '16.72', 'spread': '16.439', 'groupId': 'OG001'}, {'value': '13.88', 'spread': '16.080', 'groupId': 'OG002'}, {'value': '12.56', 'spread': '17.022', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8, 16', 'description': 'The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '1.576', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '1.977', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '1.604', 'groupId': 'OG002'}, {'value': '-1.02', 'spread': '1.666', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.69', 'spread': '1.690', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.862', 'groupId': 'OG001'}, {'value': '-1.74', 'spread': '1.586', 'groupId': 'OG002'}, {'value': '-1.32', 'spread': '1.656', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.98', 'spread': '1.667', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '1.997', 'groupId': 'OG001'}, {'value': '-1.50', 'spread': '1.850', 'groupId': 'OG002'}, {'value': '-1.75', 'spread': '2.136', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.06', 'spread': '1.677', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '2.106', 'groupId': 'OG001'}, {'value': '-1.90', 'spread': '1.920', 'groupId': 'OG002'}, {'value': '-2.13', 'spread': '2.118', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.89', 'spread': '1.789', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '2.106', 'groupId': 'OG001'}, {'value': '-1.94', 'spread': '1.792', 'groupId': 'OG002'}, {'value': '-2.12', 'spread': '2.094', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Normalization for the mean number of micturitions per 24 hours was defined as \\< 8 micturitions per 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Urgency Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.843', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '1.927', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '1.790', 'groupId': 'OG002'}, {'value': '-1.43', 'spread': '2.057', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.77', 'spread': '0.969', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '1.897', 'groupId': 'OG001'}, {'value': '-1.76', 'spread': '1.490', 'groupId': 'OG002'}, {'value': '-1.37', 'spread': '2.189', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.95', 'spread': '1.279', 'groupId': 'OG000'}, {'value': '-2.55', 'spread': '2.162', 'groupId': 'OG001'}, {'value': '-1.89', 'spread': '1.674', 'groupId': 'OG002'}, {'value': '-1.88', 'spread': '2.576', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.77', 'spread': '1.253', 'groupId': 'OG000'}, {'value': '-2.59', 'spread': '2.201', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '1.759', 'groupId': 'OG002'}, {'value': '-2.06', 'spread': '2.419', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.57', 'spread': '1.382', 'groupId': 'OG000'}, {'value': '-2.59', 'spread': '2.201', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '1.877', 'groupId': 'OG002'}, {'value': '-2.02', 'spread': '2.392', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis.', 'unitOfMeasure': 'urgency episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.675', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.787', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '1.141', 'groupId': 'OG002'}, {'value': '-0.64', 'spread': '1.032', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.983', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.842', 'groupId': 'OG001'}, {'value': '-1.26', 'spread': '1.453', 'groupId': 'OG002'}, {'value': '-0.76', 'spread': '1.273', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '1.236', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '1.177', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '1.238', 'groupId': 'OG002'}, {'value': '-0.93', 'spread': '1.248', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '1.076', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '1.168', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '1.517', 'groupId': 'OG002'}, {'value': '-1.08', 'spread': '1.068', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.064', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '1.168', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '1.505', 'groupId': 'OG002'}, {'value': '-1.06', 'spread': '1.055', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence\'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis.', 'unitOfMeasure': 'incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.689', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.756', 'groupId': 'OG001'}, {'value': '-0.77', 'spread': '1.220', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '1.055', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '1.045', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.793', 'groupId': 'OG001'}, {'value': '-1.07', 'spread': '1.068', 'groupId': 'OG002'}, {'value': '-0.72', 'spread': '1.208', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '1.252', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.115', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.996', 'groupId': 'OG002'}, {'value': '-0.91', 'spread': '1.160', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.940', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.089', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '1.089', 'groupId': 'OG002'}, {'value': '-0.96', 'spread': '1.040', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.948', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.089', 'groupId': 'OG001'}, {'value': '-1.04', 'spread': '1.412', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '1.027', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence\'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis.', 'unitOfMeasure': 'urge incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Volume Voided Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.120', 'spread': '26.2220', 'groupId': 'OG000'}, {'value': '19.380', 'spread': '31.5492', 'groupId': 'OG001'}, {'value': '33.781', 'spread': '32.6029', 'groupId': 'OG002'}, {'value': '24.821', 'spread': '35.8941', 'groupId': 'OG003'}]}]}, {'title': 'Week16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.532', 'spread': '32.2243', 'groupId': 'OG000'}, {'value': '33.031', 'spread': '38.2492', 'groupId': 'OG001'}, {'value': '35.780', 'spread': '33.8236', 'groupId': 'OG002'}, {'value': '36.921', 'spread': '43.8896', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.865', 'spread': '32.5400', 'groupId': 'OG000'}, {'value': '33.031', 'spread': '38.2492', 'groupId': 'OG001'}, {'value': '34.118', 'spread': '32.6790', 'groupId': 'OG002'}, {'value': '36.957', 'spread': '43.6344', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was \\> 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was \\> 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was \\> 0 at baseline was included in the analysis.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Nocturia Episodes Per Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Patients received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Patients received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '1,122', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.787', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.709', 'groupId': 'OG002'}, {'value': '-0.27', 'spread': '0.738', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.681', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.688', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '0.682', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '0.825', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.704', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.796', 'groupId': 'OG001'}, {'value': '-0.29', 'spread': '0.829', 'groupId': 'OG002'}, {'value': '-0.58', 'spread': '0.916', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.881', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.674', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.813', 'groupId': 'OG002'}, {'value': '-0.61', 'spread': '0.992', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.847', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.674', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.812', 'groupId': 'OG002'}, {'value': '-0.60', 'spread': '0.982', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis.', 'unitOfMeasure': 'nocturia episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Postvoid Residual (PVR) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'OG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'OG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg."'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.95', 'spread': '18.078', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '17.709', 'groupId': 'OG001'}, {'value': '13.78', 'spread': '35.702', 'groupId': 'OG002'}, {'value': '4.36', 'spread': '20.797', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.83', 'spread': '19.442', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '19.512', 'groupId': 'OG001'}, {'value': '11.05', 'spread': '32.310', 'groupId': 'OG002'}, {'value': '1.87', 'spread': '13.428', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.53', 'spread': '21.047', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '22.163', 'groupId': 'OG001'}, {'value': '6.51', 'spread': '22.067', 'groupId': 'OG002'}, {'value': '1.17', 'spread': '17.997', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '24.102', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '14.897', 'groupId': 'OG001'}, {'value': '7.31', 'spread': '22.754', 'groupId': 'OG002'}, {'value': '3.60', 'spread': '24.223', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '23.576', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '14.897', 'groupId': 'OG001'}, {'value': '8.00', 'spread': '28.833', 'groupId': 'OG002'}, {'value': '3.17', 'spread': '24.144', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'FG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'FG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'FG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Not Meeting the Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Need Further Examinations Due to Biopsy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Show no Stable Solifenacin Intake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Untenable Due to Recurrent Cystitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with overactive bladder (OAB) were enrolled in 29 sites in Japan.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Solifenacin 2.5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'BG001', 'title': 'Solifenacin 2.5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'BG002', 'title': 'Solifenacin 5 mg + Mirabegron 25 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.'}, {'id': 'BG003', 'title': 'Solifenacin 5 mg + Mirabegron 50 mg', 'description': 'Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '65.6', 'spread': '8.71', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '10.27', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '9.47', 'groupId': 'BG002'}, {'value': '63.8', 'spread': '10.34', 'groupId': 'BG003'}, {'value': '64.7', 'spread': '9.92', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Overactive Bladder Symptom Score (OABSS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.31', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '2.36', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '2.67', 'groupId': 'BG002'}, {'value': '8.1', 'spread': '2.45', 'groupId': 'BG003'}, {'value': '7.8', 'spread': '2.49', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS). The FAS consisted of participants who received at least 1 dose of the study drug for the treatment period, and who provided evaluable patient diary data for at least 1 efficacy variable, before and after the start of the treatment period. Participants with available data are included in the analysis.'}, {'title': 'Overactive Bladder questionnaire Short Form (OAB-q SF) Score: Symptom Severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '33.94', 'spread': '20.386', 'groupId': 'BG000'}, {'value': '39.37', 'spread': '20.470', 'groupId': 'BG001'}, {'value': '32.12', 'spread': '17.701', 'groupId': 'BG002'}, {'value': '31.29', 'spread': '19.205', 'groupId': 'BG003'}, {'value': '33.27', 'spread': '19.328', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'OAB-q SF Score: Total Health-Related Quality of Life (HRQOL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '73.71', 'spread': '18.662', 'groupId': 'BG000'}, {'value': '70.31', 'spread': '18.873', 'groupId': 'BG001'}, {'value': '75.10', 'spread': '17.708', 'groupId': 'BG002'}, {'value': '76.06', 'spread': '19.341', 'groupId': 'BG003'}, {'value': '74.49', 'spread': '18.743', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Number of Micturitions per 24 Hours', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10.38', 'spread': '2.128', 'groupId': 'BG000'}, {'value': '11.12', 'spread': '2.722', 'groupId': 'BG001'}, {'value': '9.81', 'spread': '1.918', 'groupId': 'BG002'}, {'value': '10.15', 'spread': '2.331', 'groupId': 'BG003'}, {'value': '10.26', 'spread': '2.302', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Number of Urgency Episodes per 24 Hours', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2.86', 'spread': '2.433', 'groupId': 'BG000'}, {'value': '4.12', 'spread': '2.586', 'groupId': 'BG001'}, {'value': '2.86', 'spread': '1.997', 'groupId': 'BG002'}, {'value': '3.63', 'spread': '2.846', 'groupId': 'BG003'}, {'value': '3.42', 'spread': '2.586', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis.', 'unitOfMeasure': 'urgency episodes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Number of Incontinence Episodes per 24 Hours', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '1.454', 'groupId': 'BG000'}, {'value': '1.54', 'spread': '1.248', 'groupId': 'BG001'}, {'value': '2.09', 'spread': '2.121', 'groupId': 'BG002'}, {'value': '1.51', 'spread': '1.520', 'groupId': 'BG003'}, {'value': '1.64', 'spread': '1.616', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence\'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis.', 'unitOfMeasure': 'incontinence episodes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Number of Urge Incontinence Episodes per 24 Hours', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '1.506', 'groupId': 'BG000'}, {'value': '1.42', 'spread': '1.243', 'groupId': 'BG001'}, {'value': '1.69', 'spread': '1.366', 'groupId': 'BG002'}, {'value': '1.30', 'spread': '1.138', 'groupId': 'BG003'}, {'value': '1.43', 'spread': '1.245', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence\'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis.', 'unitOfMeasure': 'urge incontinence episodes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Volume Voided per Micturition', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '158.627', 'spread': '47.0511', 'groupId': 'BG000'}, {'value': '158.633', 'spread': '43.6678', 'groupId': 'BG001'}, {'value': '182.362', 'spread': '56.3405', 'groupId': 'BG002'}, {'value': '173.658', 'spread': '47.5973', 'groupId': 'BG003'}, {'value': '171.029', 'spread': '49.7826', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was \\> 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was \\> 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was \\> 0 at baseline was included in the analysis.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Number of Nocturia Episodes per Night', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.79', 'spread': '1.075', 'groupId': 'BG000'}, {'value': '1.55', 'spread': '0.783', 'groupId': 'BG001'}, {'value': '1.85', 'spread': '1.006', 'groupId': 'BG002'}, {'value': '1.72', 'spread': '1.084', 'groupId': 'BG003'}, {'value': '1.74', 'spread': '1.018', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis.', 'unitOfMeasure': 'nocturia episodes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS participants with available data are included in the analysis.'}, {'title': 'Postvoid Residual (PVR) Volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14.95', 'spread': '23.214', 'groupId': 'BG000'}, {'value': '10.51', 'spread': '16.066', 'groupId': 'BG001'}, {'value': '13.93', 'spread': '17.188', 'groupId': 'BG002'}, {'value': '12.11', 'spread': '20.199', 'groupId': 'BG003'}, {'value': '12.76', 'spread': '19.273', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2013-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2012-12-06', 'resultsFirstSubmitDate': '2017-12-10', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-31', 'studyFirstPostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug up to weeks 16', 'description': 'TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in OABSS Total Score', 'timeFrame': 'Baseline and week 8, 16', 'description': 'The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.'}, {'measure': 'Number of Participants Who Achieved Normalization for OABSS Total Score', 'timeFrame': 'Week 8 and 16', 'description': 'Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.'}, {'measure': 'Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score', 'timeFrame': 'Baseline and week 8, 16', 'description': 'The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.'}, {'measure': 'Change From Baseline in OAB-q SF Total HRQL Score', 'timeFrame': 'Baseline and week 8, 16', 'description': 'The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.'}, {'measure': 'Change From Baseline in the Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded.'}, {'measure': 'Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours', 'timeFrame': 'Week 16', 'description': 'Normalization for the mean number of micturitions per 24 hours was defined as \\< 8 micturitions per 24 hours.'}, {'measure': 'Change From Baseline in the Number of Urgency Episodes Per 24 Hours', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis.'}, {'measure': 'Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours', 'timeFrame': 'Week 16', 'description': 'Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.'}, {'measure': 'Change From Baseline in the Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence\'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis.'}, {'measure': 'Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Week 16', 'description': 'Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.'}, {'measure': 'Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence\'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis.'}, {'measure': 'Change From Baseline in the Volume Voided Per Micturition', 'timeFrame': 'Baseline and week 8, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was \\> 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was \\> 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was \\> 0 at baseline was included in the analysis.'}, {'measure': 'Change From Baseline in the Number of Nocturia Episodes Per Night', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis.'}, {'measure': 'Change From Baseline in Postvoid Residual (PVR) Volume', 'timeFrame': 'Baseline and week 4, 8, 12, 16', 'description': 'Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mirabegron', 'solifenacin'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=169', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.', 'detailedDescription': 'The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female: postmenopausal OAB outpatient\n* Male: OAB outpatient who did not wish to have children at all\n* Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study\n* Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points\n\nExclusion Criteria:\n\n* Patient had a residual urine volume of ≥100 mL or a maximum flow rate \\<5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction\n* Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)\n* Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period'}, 'identificationModule': {'nctId': 'NCT01745094', 'briefTitle': 'A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan', 'orgStudyIdInfo': {'id': '178-CL-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concomitant Group', 'description': 'concomitant administration of mirabegron to solifenacin treated patients', 'interventionNames': ['Drug: mirabegron', 'Drug: solifenacin']}], 'interventions': [{'name': 'mirabegron', 'type': 'DRUG', 'otherNames': ['YM178', 'Betanis'], 'description': 'oral', 'armGroupLabels': ['Concomitant Group']}, {'name': 'solifenacin', 'type': 'DRUG', 'otherNames': ['Vesicare', 'YM905'], 'description': 'oral', 'armGroupLabels': ['Concomitant Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}