Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT01302067
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2011-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, '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': 'C526675', 'term': 'fesoterodine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 28 days after the last dose of the study drug', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.', 'otherNumAtRisk': 790, 'otherNumAffected': 297, 'seriousNumAtRisk': 790, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.', 'otherNumAtRisk': 386, 'otherNumAffected': 103, 'seriousNumAtRisk': 386, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.', 'otherNumAtRisk': 779, 'otherNumAffected': 349, 'seriousNumAtRisk': 779, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Eustachian tube obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Conjunctival irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Eye allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Scintillating scotoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 203}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Palatal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Peptic ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Adverse 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'MedDRAv15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Tongue dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Herpes simplex ophthalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Post procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Benign ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Uterine hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 790, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 386, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 779, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAv15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '718', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.85', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-3.12', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.66', 'pValueComment': 'Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.', 'testedNonInferiority': False}, {'pValue': '0.0109', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.06', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'Treatment comparisons were performed with a two-sided test at the 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.39', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'Treatment comparisons were performed with a two-sided test at the 5% significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI \\>0 per 24 hours \\& non-missing change from BL to Week 12 were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '705', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.95', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.79', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0082', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.10', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '-0.41', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency \\>0 per 24 hours and non-missing change from BL to Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '719', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.45', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-2.97', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.40', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '-1.03', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '-0.23', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '-0.51', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency \\>0 per 24 hours and non-missing change from BL to Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '705', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.58', 'groupId': 'OG000', 'lowerLimit': '-65.71', 'upperLimit': '96.30'}, {'value': '-9.01', 'groupId': 'OG001', 'lowerLimit': '-60.94', 'upperLimit': '95.00'}, {'value': '-17.24', 'groupId': 'OG002', 'lowerLimit': '-70.91', 'upperLimit': '117.65'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '0.0040', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency \\>0 per 24 hours and non-missing change from BL to Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '719', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.74', 'groupId': 'OG000', 'lowerLimit': '-64.58', 'upperLimit': '92.59'}, {'value': '-12.16', 'groupId': 'OG001', 'lowerLimit': '-64.04', 'upperLimit': '95.00'}, {'value': '-24.14', 'groupId': 'OG002', 'lowerLimit': '-76.74', 'upperLimit': '78.26'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency \\>0 per 24 hours and non-missing change from BL to Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '704', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.55', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-2.75', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '-0.50', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0662', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.01', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.30', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': 'UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI \\>0 per 24 hours and non-missing change from BL to Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '704', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-77.78', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '244.44'}, {'value': '-60.50', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '283.33'}, {'value': '-82.48', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '500.00'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4', 'description': 'UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI \\>0 per 24 hours and non-missing change from BL to Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '718', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-93.75', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '437.50'}, {'value': '-78.89', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '350.00'}, {'value': '-100.00', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '325.00'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI \\>0 per 24 hours and non-missing change from BL to Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '705', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.89', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.85', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-3.40', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.55', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '-1.06', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0121', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.11', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '-0.55', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes \\>0 per 24 hours and non-missing change from BL to Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '719', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.23', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-2.99', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-5.01', 'spread': '0.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.02', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '-1.49', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '-0.34', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '-0.71', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes \\>0 per 24 hours and non-missing change from BL to Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '705', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.26', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '280.00'}, {'value': '-14.70', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '716.67'}, {'value': '-27.27', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '150.00'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '0.0348', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes \\>0 per 24 hours and non-missing change from BL to Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '719', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.88', 'groupId': 'OG000', 'lowerLimit': '-100.00', 'upperLimit': '310.00'}, {'value': '-22.73', 'groupId': 'OG001', 'lowerLimit': '-100.00', 'upperLimit': '716.67'}, {'value': '-44.29', 'groupId': 'OG002', 'lowerLimit': '-100.00', 'upperLimit': '233.33'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.', 'unitOfMeasure': 'Participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes \\>0 per 24 hours and non-missing change from BL to Week 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'title': 'Deterioration', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}]}, {'title': 'Minor improvement', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': 'Major improvement', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0057', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'title': 'Deterioration', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}]}]}, {'title': 'Improvement', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0091', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3901', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '678', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.19', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-22.41', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-34.88', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.47', 'ciLowerLimit': '-15.49', 'ciUpperLimit': '-9.45', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.54', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.69', 'ciLowerLimit': '-7.15', 'ciUpperLimit': '-2.22', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.78', 'ciLowerLimit': '-10.78', 'ciUpperLimit': '-4.78', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.53', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \\[(Actual total raw score - lowest possible value of raw score)/range\\]\\*100. Higher scores values indicative of greater symptom bother.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.69', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '20.91', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '31.38', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.46', 'ciLowerLimit': '7.20', 'ciUpperLimit': '13.73', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.68', 'ciLowerLimit': '2.01', 'ciUpperLimit': '7.36', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.78', 'ciLowerLimit': '2.53', 'ciUpperLimit': '9.03', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.66', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.82', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '20.27', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '31.18', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.91', 'ciLowerLimit': '7.73', 'ciUpperLimit': '14.09', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.62', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.36', 'ciLowerLimit': '1.76', 'ciUpperLimit': '6.96', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.33', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.55', 'ciLowerLimit': '3.39', 'ciUpperLimit': '9.72', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.61', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.97', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '18.25', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '25.71', 'spread': '1.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.46', 'ciLowerLimit': '4.40', 'ciUpperLimit': '10.51', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.56', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.74', 'ciLowerLimit': '1.24', 'ciUpperLimit': '6.23', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.27', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0164', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.72', 'ciLowerLimit': '0.68', 'ciUpperLimit': '6.76', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.43', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '12.61', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '20.11', 'spread': '0.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.50', 'ciLowerLimit': '5.03', 'ciUpperLimit': '9.97', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.68', 'ciLowerLimit': '1.65', 'ciUpperLimit': '5.70', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.82', 'ciLowerLimit': '1.36', 'ciUpperLimit': '6.28', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.25', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.70', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '18.57', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '27.94', 'spread': '1.03', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.37', 'ciLowerLimit': '6.56', 'ciUpperLimit': '12.18', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.23', 'ciLowerLimit': '1.93', 'ciUpperLimit': '6.53', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.17', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.14', 'ciLowerLimit': '2.34', 'ciUpperLimit': '7.94', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43', 'estimateComment': 'Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.', 'groupDescription': 'P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Became Dry at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '704', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '26.4', 'groupId': 'OG001'}, {'value': '36.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8121', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI\\>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI \\>0 per 24 hours and non-missing change from baseline to Week 4.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Became Dry at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '718', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'OG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '39.5', 'groupId': 'OG001'}, {'value': '57.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A closed-testing procedure was used for the treatment comparison.', 'groupDescription': 'P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI \\>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI \\>0 per 24 hours and non-missing change from baseline to Week 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'FG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '790'}, {'groupId': 'FG001', 'numSubjects': '386'}, {'groupId': 'FG002', 'numSubjects': '779'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '712'}, {'groupId': 'FG001', 'numSubjects': '352'}, {'groupId': 'FG002', 'numSubjects': '681'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '98'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '45'}]}]}], 'recruitmentDetails': 'This report presents results of a 12-week study conducted at 241 centers across 27 countries.', 'preAssignmentDetails': 'Participants ≥18 years of age with overactive bladder (OAB) symptoms for ≥6 months prior to screening were enrolled. After screening eligible participants were enrolled into the run-in period and received placebo for 2 weeks in a single-blind manner. Participants completed a 3-day bladder diary for 3 days in the week prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'BG000'}, {'value': '386', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}, {'value': '1955', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Fesoterodine 4 Milligram (mg)', 'description': 'Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received one tablet of placebo per day for 12 weeks.'}, {'id': 'BG002', 'title': 'Fesoterodine 8 mg', 'description': 'Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '18 to 44', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '262', 'groupId': 'BG003'}]}]}, {'title': '45 to 64', 'categories': [{'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}, {'value': '950', 'groupId': 'BG003'}]}]}, {'title': '>= 65', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}, {'value': '743', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '647', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '627', 'groupId': 'BG002'}, {'value': '1590', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '365', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2012}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-25', 'studyFirstSubmitDate': '2011-02-18', 'resultsFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-01', 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Week 12', 'description': 'UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.', 'timeFrame': 'Week 4', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.'}, {'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.', 'timeFrame': 'Week 12', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.'}, {'measure': 'Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.', 'timeFrame': 'Week 4', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.'}, {'measure': 'Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.', 'timeFrame': 'Week 12', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI.'}, {'measure': 'Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.', 'timeFrame': 'Week 4', 'description': 'UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.', 'timeFrame': 'Week 4', 'description': 'UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Week 12', 'description': 'UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.', 'timeFrame': 'Week 4', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Week 12', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.', 'timeFrame': 'Week 4', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.', 'timeFrame': 'Week 12', 'description': 'The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.'}, {'measure': 'Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.', 'timeFrame': 'Week 12', 'description': 'PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.'}, {'measure': 'Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.', 'timeFrame': 'Week 12', 'description': 'UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).'}, {'measure': 'Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.', 'timeFrame': 'Week 12', 'description': 'OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \\[(Actual total raw score - lowest possible value of raw score)/range\\]\\*100. Higher scores values indicative of greater symptom bother.'}, {'measure': 'Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.'}, {'measure': 'Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.'}, {'measure': 'Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.'}, {'measure': 'Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.'}, {'measure': 'Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.', 'timeFrame': 'Week 12', 'description': 'OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \\[(Highest possible raw score-Actual total raw score)/Raw score range\\]\\*100. Higher transformed scores indicative of better HRQL.'}, {'measure': 'Percentage of Participants Who Became Dry at Week 4.', 'timeFrame': 'Week 4', 'description': 'Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI\\>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary'}, {'measure': 'Percentage of Participants Who Became Dry at Week 12.', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI \\>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '37160401', 'type': 'DERIVED', 'citation': 'Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.'}, {'pmid': '35881009', 'type': 'DERIVED', 'citation': 'Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.'}, {'pmid': '24552358', 'type': 'DERIVED', 'citation': 'Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221095&StudyName=A%2012%20week%20study%20to%20confirm%20the%20effectiveness%20of%208mg%20of%20fesoterodine%20compared%20to%204mg%20of%20fesoterodine', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. 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