Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-13 @ 7:49 AM
Study NCT ID:
NCT01655069
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2012-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'India', 'Netherlands', 'Russia']}, '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': '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': 'Astellas.resultsdisclosure@astellas.com', 'phone': '+31 (0) 71 5455 050', 'title': 'Medical Director', 'organization': 'Astellas Pharma Europe B.V.'}, '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 at least 90 days prior to publication for review and comment. Sponsor may delay the publication temporarily to seek patent protection or permanently withhold the publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).', 'description': '(1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.', 'eventGroups': [{'id': 'EG000', 'title': 'Children (Aged 5 to Less Than 12 Years', 'description': 'Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 70, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 16, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA v13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (Aged 5 to Less Than 12 Years)', 'description': 'Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}, {'id': 'OG001', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}], 'classes': [{'title': 'TEAE - Mild', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'TEAE - Moderate', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'TEAE - Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to discontinuation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Drug related TEAEs leading to permanent discont.', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).', 'description': 'The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows:\n\nMild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (Aged 5 to Less Than 12 Years)', 'description': 'Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults'}, {'id': 'OG001', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}], 'classes': [{'title': '3 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': '6 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': '9 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': '12 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': '24 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.61', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': '40 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.66', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': '52 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '-0.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.26', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '-1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-1.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.54', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '-1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-1.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.93', 'ciLowerLimit': '-2.19', 'ciUpperLimit': '-1.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-2.09', 'ciUpperLimit': '-0.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.40', 'ciLowerLimit': '-2.09', 'ciUpperLimit': '-0.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-2.27', 'ciUpperLimit': '-0.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-2.50', 'ciUpperLimit': '-1.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.00', 'ciLowerLimit': '-2.83', 'ciUpperLimit': '-1.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.', 'unitOfMeasure': 'incontinence episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (Aged 5 to Less Than 12 Years)', 'description': 'Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}, {'id': 'OG001', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}], 'classes': [{'title': '3 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': '6 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': '9 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.59', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': '12 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': '24 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': '40 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': '52 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '1.27', 'ciUpperLimit': '2.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '1.36', 'ciUpperLimit': '2.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.74', 'ciUpperLimit': '2.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.28', 'ciLowerLimit': '1.79', 'ciUpperLimit': '2.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84', 'ciLowerLimit': '2.19', 'ciUpperLimit': '3.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.17', 'ciUpperLimit': '2.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '0.52', 'ciUpperLimit': '3.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '0.39', 'ciUpperLimit': '3.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.69', 'ciLowerLimit': '1.34', 'ciUpperLimit': '4.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.07', 'ciLowerLimit': '1.70', 'ciUpperLimit': '4.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.45', 'ciLowerLimit': '1.05', 'ciUpperLimit': '3.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.71', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.93', 'ciLowerLimit': '2.34', 'ciUpperLimit': '5.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (Aged 5 to Less Than 12 Years)', 'description': 'Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}, {'id': 'OG001', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}], 'classes': [{'title': '3 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': '6 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.96', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': '9 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': '12 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': '24 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': '40 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.43', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': '52 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.80', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '-0.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-1.60', 'ciUpperLimit': '-1.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '-1.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '-1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.83', 'ciLowerLimit': '-2.22', 'ciUpperLimit': '-1.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '-0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '-0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-1.92', 'ciUpperLimit': '-0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG001'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.79', 'ciLowerLimit': '-2.59', 'ciUpperLimit': '-1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}], 'classes': [{'title': '3 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': '6 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': '9 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': '12 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '0.38', 'groupId': 'OG000'}]}]}, {'title': '24weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.47', 'groupId': 'OG000'}]}]}, {'title': '40 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': '52 weeks solifenacin treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.87', 'spread': '0.44', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 3 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '-0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 6 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '-0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 9 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.28', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '-0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 12 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '-0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 24 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.96', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '-1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 40 weeks'}, {'groupIds': ['OG000'], 'paramType': 'Adjusted change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.20', 'ciLowerLimit': '-3.48', 'ciUpperLimit': '-0.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.65', 'groupDescription': 'Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and "duration" repeated within participant.', 'statisticalMethod': 'Repeated Measures ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Duration of solifenacin treatment: 52 weeks'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.', 'unitOfMeasure': 'urgency episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (Aged 5 to Less Than 12 Years)', 'description': 'Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}, {'id': 'OG001', 'title': 'Adolescents (Aged 12 to Less Than 18 Years)', 'description': 'Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)', 'description': 'PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children Treated With Placebo in 905-CL-076', 'description': 'Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.'}, {'id': 'FG001', 'title': 'Children Treated With Solifenacin in 905-CL-076', 'description': 'Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.'}, {'id': 'FG002', 'title': 'Adolescents Treated With Placebo in 905-CL-076', 'description': 'Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.'}, {'id': 'FG003', 'title': 'Adolescents Treated With Solifenacin in 905-CL-076', 'description': 'Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Safety Analysis Set (SAF)', 'comment': 'SAF consisted of all participants with at least 1 dose of open-label solifenacin and safety data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Full Analysis Set (FAS)', 'comment': 'FAS consisted of all participants with at least 1 dose of open-label solifenacin and efficacy data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'No Treatment Needed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants recruited for this study were children (5 to less than 12 years old) and adolescents (12 to less than 18 years old) with overactive bladder (OAB), who completed the 2-week placebo run-in period and 12-week treatment period of Study 905-CL-076 (NCT01565707).', 'preAssignmentDetails': 'Children and adolescents with OAB, who completed study 905-CL-076, consented to enter this study and fulfilled all the eligibility criteria were enrolled at Week 12/13 (2-3 days after last dose was received during the 905-CL-076 study). The age of participant at informed consent signing in 905-CL-076 determined the age group in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Children Treated With Placebo in 905-CL-076', 'description': 'Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.'}, {'id': 'BG001', 'title': 'Children Treated With Solifenacin in 905-CL-076', 'description': 'Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.'}, {'id': 'BG002', 'title': 'Adolescents Treated With Placebo in 905-CL-076', 'description': 'Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.'}, {'id': 'BG003', 'title': 'Adolescents Treated With Solifenacin in 905-CL-076', 'description': 'Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '1.6', 'groupId': 'BG004'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '14.5', 'spread': '1.8', 'groupId': 'BG003'}, {'value': '14.2', 'spread': '1.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The row for children only includes data for children. The row for adolescents only includes data for adolescents.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population is Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of open-label solifenacin and had any safety data reported after the first dose of open-label solifenacin. The baseline values measured for study 905-CL-076 were used as the baseline values for the present study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2015-07-23', 'completionDateStruct': {'date': '2014-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-20', 'studyFirstSubmitDate': '2012-07-30', 'dispFirstSubmitQcDate': '2015-07-23', 'resultsFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2012-07-30', 'dispFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-07', 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).', 'description': 'The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows:\n\nMild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.'}, {'measure': 'Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.'}, {'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.'}, {'measure': 'Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents', 'timeFrame': 'Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment', 'description': 'Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.'}, {'measure': 'Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume', 'timeFrame': 'Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)', 'description': 'PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overactive bladder (OAB)', 'Solifenacin succinate suspension', 'Phase 3', 'Pediatric'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-002047-10/results', 'label': 'Link to results on EudraCT'}, {'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=244', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).', 'detailedDescription': 'There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076\n\nExclusion Criteria:\n\n* Subject has failed the exclusion criteria of study 905-CL-076'}, 'identificationModule': {'nctId': 'NCT01655069', 'acronym': 'LEOPARD', 'briefTitle': 'A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)', 'orgStudyIdInfo': {'id': '905-CL-077'}, 'secondaryIdInfos': [{'id': '2011-002047-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children Treated with Placebo in 905-CL-076', 'description': 'Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.', 'interventionNames': ['Drug: Solifenacin succinate suspension']}, {'type': 'EXPERIMENTAL', 'label': 'Children Treated with Solifenacin in 905-CL-076', 'description': 'Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.', 'interventionNames': ['Drug: Solifenacin succinate suspension']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescents Treated with Placebo in 905-CL-076', 'description': 'Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.', 'interventionNames': ['Drug: Solifenacin succinate suspension']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescents Treated with Solifenacin in 905-CL-076', 'description': 'Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.', 'interventionNames': ['Drug: Solifenacin succinate suspension']}], 'interventions': [{'name': 'Solifenacin succinate suspension', 'type': 'DRUG', 'otherNames': ['YM905', 'solifenacin succinate'], 'description': 'Oral suspension', 'armGroupLabels': ['Adolescents Treated with Placebo in 905-CL-076', 'Adolescents Treated with Solifenacin in 905-CL-076', 'Children Treated with Placebo in 905-CL-076', 'Children Treated with Solifenacin in 905-CL-076']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Site: 1006', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Site: 3202', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Site: 3209', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Site: 3208', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Site: 3201', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Site: 3203', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'Site: 3204', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Site: 3205', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '13087-567', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'Site: 5507', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '80240-060', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Site: 5506', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Site: 1001', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'DK-9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Site: 4503', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Site: 4501', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Site: 4502', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Site: 4504', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '4530', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Site: 5202', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': 'C.P.06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Site: 5205', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Site: 4701', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '1108', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Site: 6301', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '80-803', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Site: 4805', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Site: 4803', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '20-093', 'city': 'Lubin', 'country': 'Poland', 'facility': 'Site: 4804', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '04-736', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Site: 4801', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '11 000', 'city': 'Belgrade', 'country': 'Serbia and Montenegro', 'facility': 'Site: 3810'}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia and Montenegro', 'facility': 'Site: 3812'}, {'zip': '7700', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Site: 2703', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '705717', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Site: 8203', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Site: 8206', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site: 8207', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site: 8202', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41685', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Site: 4606', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '54185', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'Site: 4603', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Site: 4602', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '90185', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Site: 4605', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '6100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Site: 9001', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Site: 9002', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Site: 3854', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Site: 4403', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Site: 4401', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Clinical Study Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}