Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 1:06 AM
Study NCT ID:
NCT00798434
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2008-11-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, '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}, 'limitationsAndCaveats': {'description': 'The descriptive statistics and analyses of outcome measure 12 as defined in the protocol are not presented. Results are presented as defined in the statistical analysis plan.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Double-Blind', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded)', 'otherNumAtRisk': 393, 'otherNumAffected': 71, 'seriousNumAtRisk': 393, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Fesoterodine Double-Blind', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)', 'otherNumAtRisk': 392, 'otherNumAffected': 187, 'seriousNumAtRisk': 392, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Festerodine/Fesoterodine Open-Label', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). Serious adverse events (SAEs) and non-serious adverse events (AEs) reported reported for these participants only during the open-label phase.', 'otherNumAtRisk': 313, 'otherNumAffected': 49, 'seriousNumAtRisk': 313, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Placebo/Fesoterodine Open-label', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). SAEs and non-serious AEs reported for these participants only during the open-label phase.', 'otherNumAtRisk': 341, 'otherNumAffected': 119, 'seriousNumAtRisk': 341, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 133}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 95}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Optic nerve infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ovarian fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urethral polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aneurysm ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=381, 374)', 'categories': [{'measurements': [{'value': '8.80', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '3.62', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '-2.48', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '-3.84', 'spread': '4.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.54', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 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). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)=randomized participants who took at least 1 dose of double-blind (DB) treatment, had baseline and post-baseline efficacy data for at least 1 endpoint and at least 1 time point during DB treatment; number of participants analyzed (n)=participants with evaluable data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Change at Week 4 (n=365, 356)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '29.0'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '20.7'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '26.0'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '18.7'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '27.3'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '21.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.44', 'ciLowerLimit': '-14.67', 'ciUpperLimit': '-14.25', 'estimateComment': 'Hodges-Lehman estimate of median treatment difference and confidence interval (CI)', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': "2-sided Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of \\>=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100\\* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS;N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=381, 374)', 'categories': [{'measurements': [{'value': '4.11', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=365, 356)', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-1.53', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '3.07', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '-1.78', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '-2.43', 'spread': '3.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '-0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Severe micturition-related urgency episodes defined as those with the USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Change at Week 4 (n=365, 356)', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-16.7', 'upperLimit': '14.7'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '11.3'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-23.3', 'upperLimit': '15.3'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-17.3', 'upperLimit': '6.3'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-23.3', 'upperLimit': '17.3'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-17.3', 'upperLimit': '7.7'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.00', 'estimateComment': 'Hodges-Lehman estimate of median treatment difference and CI', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': "2-sided Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Severe micturition-related urgency episodes defined as those with USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=382, 374)', 'categories': [{'measurements': [{'value': '12.10', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '11.89', 'spread': '2.90', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=366, 356)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-1.95', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=359, 338)', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-2.09', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.', 'unitOfMeasure': 'Micturitions per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Change at Week 4 (n=366, 356)', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-7.7', 'upperLimit': '9.7'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-11.7', 'upperLimit': '11.7'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-7.3', 'upperLimit': '10.3'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-12.3', 'upperLimit': '9.3'}]}]}, {'title': 'Change at Week 12 (n=359, 338)', 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-7.7', 'upperLimit': '10.0'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-12.7', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.31', 'ciLowerLimit': '-7.40', 'ciUpperLimit': '-7.19', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': "2-sided Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=382, 374)', 'categories': [{'measurements': [{'value': '2.92', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=366, 356)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=359, 338)', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.', 'unitOfMeasure': 'Micturitions per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Change at Week 4 (n=366, 356)', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '8.3'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '3.7'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '6.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '4.0'}]}]}, {'title': 'Change at Week 12 (n=359, 338)', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '6.3'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.52', 'ciLowerLimit': '-9.52', 'ciUpperLimit': '-9.09', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': "2-sided Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 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. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=381, 374)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '26.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '14.3'}]}]}, {'title': 'Change at Week 4 (n=365, 356)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-14.3', 'upperLimit': '22.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-13.7', 'upperLimit': '8.3'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-12.3', 'upperLimit': '22.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-14.3', 'upperLimit': '2.7'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '22.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-10.3', 'upperLimit': '7.7'}]}]}], 'analyses': [{'pValue': '0.1005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehman estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.00', 'pValueComment': "The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.", 'estimateComment': 'Hodges-Lehman estimate of median treatment difference and CI', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': "Van-Elteren's Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Change at Week 4 (n=365, 356)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '22.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.3'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '23.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '22.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '14.7'}]}]}], 'analyses': [{'pValue': '0.0218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.00', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': "2-sided Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=381, 374)', 'categories': [{'measurements': [{'value': '37.55', 'spread': '13.95', 'groupId': 'OG000'}, {'value': '36.07', 'spread': '11.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=365, 356)', 'categories': [{'measurements': [{'value': '-4.35', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '-8.52', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=349, 331)', 'categories': [{'measurements': [{'value': '-6.53', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '-10.81', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=356, 338)', 'categories': [{'measurements': [{'value': '-7.33', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-11.59', 'spread': '10.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.70', 'ciLowerLimit': '-6.30', 'ciUpperLimit': '-3.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': '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). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Incontinent at Baseline and Became Dry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}, {'value': '53.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.515', 'ciLowerLimit': '0.909', 'ciUpperLimit': '2.528', 'pValueComment': 'Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.', 'groupDescription': 'LOCF', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, and age category', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8 to 12', 'description': 'Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. 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': 'FAS; N=number of participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Incontinence pads at Baseline (n=374, 369)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Incontinence pads Change at Week 4 (n=360, 350)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Incontinence pads Change at Week 8 (n=342, 326)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Incontinence pads Change at Week 12 (n=350, 332)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Creams at Baseline (n=374, 368)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Creams Change at Week 4 (n=360, 349)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Creams Change at Week 8 (n=342, 325)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Creams Change at Week 12 (n=350, 331)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Powder at Baseline (n=374, 368)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Powder Change at Week 4 (n=360, 349)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Powder Change at Week 8 (n=342, 325)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Powder Change at Week 12 (n=350, 331)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0230', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Incontinence pads at Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours', 'testedNonInferiority': False}, {'pValue': '0.0909', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'groupDescription': 'Creams at Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours', 'testedNonInferiority': False}, {'pValue': '0.2039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'groupDescription': 'Powder at Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.', 'unitOfMeasure': 'Skin protective agents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '67.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.096', 'ciLowerLimit': '2.181', 'ciUpperLimit': '4.395', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, and age category', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: "My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment." Improvement was defined as a rating of 1 or 2.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than \\[\\<\\]0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PPBC at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference \\<0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PPBC at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.506', 'ciLowerLimit': '1.767', 'ciUpperLimit': '3.556', 'pValueComment': 'Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline PPBC category', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference \\<0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PPBC at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference \\<0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PPUS at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PPUS at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.916', 'ciLowerLimit': '1.305', 'ciUpperLimit': '2.811', 'pValueComment': 'Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.', 'groupDescription': 'LOCF', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline PPUS category', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PPUS at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=381, 373)', 'categories': [{'measurements': [{'value': '52.90', 'spread': '18.75', 'groupId': 'OG000'}, {'value': '50.58', 'spread': '19.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=369, 358)', 'categories': [{'measurements': [{'value': '-9.03', 'spread': '17.74', 'groupId': 'OG000'}, {'value': '-14.05', 'spread': '18.37', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=349, 328)', 'categories': [{'measurements': [{'value': '-12.86', 'spread': '18.95', 'groupId': 'OG000'}, {'value': '-18.03', 'spread': '19.25', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=366, 357)', 'categories': [{'measurements': [{'value': '-12.16', 'spread': '20.19', 'groupId': 'OG000'}, {'value': '-18.37', 'spread': '21.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not Applicable (NA); Week 24 data collected change from baseline not calculated', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected change from baseline not calculated', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.12', 'ciLowerLimit': '-9.65', 'ciUpperLimit': '-4.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, and 24', 'description': 'OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=373, 379)', 'categories': [{'measurements': [{'value': '62.45', 'spread': '20.20', 'groupId': 'OG000'}, {'value': '64.42', 'spread': '19.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=367, 354)', 'categories': [{'measurements': [{'value': '7.28', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '10.24', 'spread': '14.92', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=348, 328)', 'categories': [{'measurements': [{'value': '9.36', 'spread': '17.98', 'groupId': 'OG000'}, {'value': '12.96', 'spread': '16.76', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=363, 357)', 'categories': [{'measurements': [{'value': '9.56', 'spread': '18.75', 'groupId': 'OG000'}, {'value': '13.19', 'spread': '17.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Change from Week 12 to Week 24 calculated instead of change from baseline to Week 24', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Change from Week 12 to Week 24 calculated instead of change from baseline to Week 24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.48', 'ciLowerLimit': '2.24', 'ciUpperLimit': '6.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'groupDescription': 'Week 12 LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, and 24', 'description': 'OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Coping at Baseline (n=380, 374)', 'categories': [{'measurements': [{'value': '57.52', 'spread': '24.36', 'groupId': 'OG000'}, {'value': '58.31', 'spread': '24.05', 'groupId': 'OG001'}]}]}, {'title': 'Coping Change at Week 4 (n=368, 358)', 'categories': [{'measurements': [{'value': '8.35', 'spread': '19.28', 'groupId': 'OG000'}, {'value': '11.90', 'spread': '17.98', 'groupId': 'OG001'}]}]}, {'title': 'Coping Change at Week 8 (n=348, 329)', 'categories': [{'measurements': [{'value': '10.46', 'spread': '20.96', 'groupId': 'OG000'}, {'value': '14.98', 'spread': '20.48', 'groupId': 'OG001'}]}]}, {'title': 'Coping Change at Week 12 (n=365, 358)', 'categories': [{'measurements': [{'value': '10.60', 'spread': '22.78', 'groupId': 'OG000'}, {'value': '15.65', 'spread': '21.52', 'groupId': 'OG001'}]}]}, {'title': 'Coping Change at Week 24', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Concern at Baseline (n=380, 374)', 'categories': [{'measurements': [{'value': '62.10', 'spread': '23.32', 'groupId': 'OG000'}, {'value': '64.67', 'spread': '22.47', 'groupId': 'OG001'}]}]}, {'title': 'Concern Change at Week 4 (n=368, 358)', 'categories': [{'measurements': [{'value': '7.96', 'spread': '17.80', 'groupId': 'OG000'}, {'value': '11.88', 'spread': '18.20', 'groupId': 'OG001'}]}]}, {'title': 'Concern Change at Week 8 (n=348, 329)', 'categories': [{'measurements': [{'value': '10.88', 'spread': '21.23', 'groupId': 'OG000'}, {'value': '15.39', 'spread': '19.77', 'groupId': 'OG001'}]}]}, {'title': 'Concern Change at Week 12 (n=365, 358)', 'categories': [{'measurements': [{'value': '11.25', 'spread': '21.39', 'groupId': 'OG000'}, {'value': '15.48', 'spread': '20.23', 'groupId': 'OG001'}]}]}, {'title': 'Concern Change at Week 24', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Sleep at Baseline (n=380, 374)', 'categories': [{'measurements': [{'value': '53.79', 'spread': '23.69', 'groupId': 'OG000'}, {'value': '57.52', 'spread': '23.83', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Change at Week 4 (n=368, 358)', 'categories': [{'measurements': [{'value': '7.31', 'spread': '20.13', 'groupId': 'OG000'}, {'value': '9.07', 'spread': '18.61', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Change at Week 8 (n=348, 329)', 'categories': [{'measurements': [{'value': '9.01', 'spread': '21.42', 'groupId': 'OG000'}, {'value': '10.87', 'spread': '20.07', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Change at Week 12 (n=365, 358)', 'categories': [{'measurements': [{'value': '9.36', 'spread': '22.08', 'groupId': 'OG000'}, {'value': '11.99', 'spread': '21.33', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Change at Week 24', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Social at Baseline (n=380, 374)', 'categories': [{'measurements': [{'value': '79.10', 'spread': '21.84', 'groupId': 'OG000'}, {'value': '81.02', 'spread': '20.43', 'groupId': 'OG001'}]}]}, {'title': 'Social Change at Week 4 (n=368, 355)', 'categories': [{'measurements': [{'value': '4.41', 'spread': '16.01', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '14.27', 'groupId': 'OG001'}]}]}, {'title': 'Social Change at Week 8 (n=349, 328)', 'categories': [{'measurements': [{'value': '5.84', 'spread': '18.58', 'groupId': 'OG000'}, {'value': '8.17', 'spread': '17.24', 'groupId': 'OG001'}]}]}, {'title': 'Social Change at Week 12 (n=364, 357)', 'categories': [{'measurements': [{'value': '5.29', 'spread': '18.56', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '17.40', 'groupId': 'OG001'}]}]}, {'title': 'Social Change at Week 24', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 data collected, change from baseline not analyzed.', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.39', 'ciLowerLimit': '2.57', 'ciUpperLimit': '8.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44', 'groupDescription': 'Coping Subscale at Week 12; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.39', 'ciLowerLimit': '2.84', 'ciUpperLimit': '7.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'groupDescription': 'Concern Subscale at Week 12; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score', 'testedNonInferiority': False}, {'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.09', 'ciLowerLimit': '1.38', 'ciUpperLimit': '6.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': 'Sleep Subscale at Week 12; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score', 'testedNonInferiority': False}, {'pValue': '0.0152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '0.49', 'ciUpperLimit': '4.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'groupDescription': 'Social Subscale at Week 12; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, and 24', 'description': 'OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '44.97', 'spread': '28.42', 'groupId': 'OG000'}, {'value': '63.01', 'spread': '24.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '21.22', 'spread': '28.47', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '20.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.537', 'ciLowerLimit': '2.281', 'ciUpperLimit': '5.484', 'pValueComment': "Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.", 'groupDescription': 'LOCF', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time and age category', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12 and 24', 'description': 'OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.21', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '0.74', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.881', 'ciLowerLimit': '2.045', 'ciUpperLimit': '4.058', 'pValueComment': "Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.", 'groupDescription': 'LOCF', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time and age category', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12 and 24', 'description': 'OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline General Health Perception (n=23, 32)', 'categories': [{'measurements': [{'value': '35.87', 'spread': '19.69', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '17.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 General Hlth Perception n=21, 29', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '15.62', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '13.93', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Incontinence Impact (n=23, 32)', 'categories': [{'measurements': [{'value': '75.36', 'spread': '25.06', 'groupId': 'OG000'}, {'value': '73.96', 'spread': '29.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Incontinence Impact (n=21, 29)', 'categories': [{'measurements': [{'value': '-12.70', 'spread': '32.45', 'groupId': 'OG000'}, {'value': '-16.09', 'spread': '34.06', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Role Limitations (n=22, 32)', 'categories': [{'measurements': [{'value': '48.48', 'spread': '34.85', 'groupId': 'OG000'}, {'value': '46.35', 'spread': '30.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Role Limitations (n=20, 29)', 'categories': [{'measurements': [{'value': '-10.83', 'spread': '45.33', 'groupId': 'OG000'}, {'value': '-12.64', 'spread': '25.45', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Physical Limitations (n=22, 32)', 'categories': [{'measurements': [{'value': '50.76', 'spread': '31.49', 'groupId': 'OG000'}, {'value': '44.79', 'spread': '32.91', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Physical Limitations (n=20, 29)', 'categories': [{'measurements': [{'value': '-13.33', 'spread': '30.40', 'groupId': 'OG000'}, {'value': '-13.79', 'spread': '28.20', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Social Limitations (n=22, 32)', 'categories': [{'measurements': [{'value': '24.75', 'spread': '23.43', 'groupId': 'OG000'}, {'value': '29.86', 'spread': '33.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Social Limitations (n=20, 29)', 'categories': [{'measurements': [{'value': '-7.50', 'spread': '23.17', 'groupId': 'OG000'}, {'value': '-8.62', 'spread': '24.20', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Personal Relationships (n=16,17)', 'categories': [{'measurements': [{'value': '15.63', 'spread': '28.85', 'groupId': 'OG000'}, {'value': '19.61', 'spread': '27.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Personal Relationship (n=11, 14)', 'categories': [{'measurements': [{'value': '4.55', 'spread': '18.40', 'groupId': 'OG000'}, {'value': '-5.95', 'spread': '18.03', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Emotions (n=22, 32)', 'categories': [{'measurements': [{'value': '32.32', 'spread': '25.64', 'groupId': 'OG000'}, {'value': '32.64', 'spread': '29.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Emotions (n=20, 29)', 'categories': [{'measurements': [{'value': '-2.78', 'spread': '28.58', 'groupId': 'OG000'}, {'value': '-6.51', 'spread': '25.63', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Sleep/Energy (n=22, 32)', 'categories': [{'measurements': [{'value': '46.97', 'spread': '27.04', 'groupId': 'OG000'}, {'value': '57.29', 'spread': '27.74', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Sleep/Energy (n=20, 29)', 'categories': [{'measurements': [{'value': '-8.33', 'spread': '26.21', 'groupId': 'OG000'}, {'value': '-11.49', 'spread': '23.61', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Severity USS (n=22, 32)', 'categories': [{'measurements': [{'value': '43.94', 'spread': '22.69', 'groupId': 'OG000'}, {'value': '44.38', 'spread': '25.99', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 Severity USS (n=20, 29)', 'categories': [{'measurements': [{'value': '-2.00', 'spread': '18.99', 'groupId': 'OG000'}, {'value': '-8.51', 'spread': '16.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3163', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.18', 'ciLowerLimit': '-4.13', 'ciUpperLimit': '12.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.12', 'groupDescription': 'General Health Perception; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.4698', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.29', 'ciLowerLimit': '-23.70', 'ciUpperLimit': '11.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.63', 'groupDescription': 'Incontinence Impact; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.5321', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.85', 'ciLowerLimit': '-24.58', 'ciUpperLimit': '12.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.28', 'groupDescription': 'Role Limitations; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.6523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.81', 'ciLowerLimit': '-20.74', 'ciUpperLimit': '13.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.39', 'groupDescription': 'Physical Limitations; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.6344', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.26', 'ciLowerLimit': '-10.47', 'ciUpperLimit': '16.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.80', 'groupDescription': 'Social Limitations; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.2013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.11', 'ciLowerLimit': '-28.71', 'ciUpperLimit': '6.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.38', 'groupDescription': 'Personal Relationships; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.3831', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.07', 'ciLowerLimit': '-19.96', 'ciUpperLimit': '7.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.88', 'groupDescription': 'Emotions; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.5167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.46', 'ciLowerLimit': '-9.30', 'ciUpperLimit': '18.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.82', 'groupDescription': 'Sleep/Energy; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}, {'pValue': '0.0532', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.19', 'ciLowerLimit': '-20.53', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.12', 'groupDescription': 'Severity of Urinary Symptoms; LOCF', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline total domain score', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data at sites in the United Kingdom only; n=participants with evaluable data for specific KHQ category. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline (n=381, 373)', 'categories': [{'measurements': [{'value': '0.7825', 'spread': '0.2246', 'groupId': 'OG000'}, {'value': '0.8092', 'spread': '0.2068', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=362, 346)', 'categories': [{'measurements': [{'value': '0.0230', 'spread': '0.1963', 'groupId': 'OG000'}, {'value': '0.0064', 'spread': '0.1854', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8959', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0016', 'ciLowerLimit': '-0.0229', 'ciUpperLimit': '0.0262', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0125', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates were treatment, study center, dosing time, age category, and baseline single utility score', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D- Each Dimension Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini Mental State Examination (MMSE) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine', 'description': 'Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28.09', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '28.20', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Improvement at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-baseline and Week 24', 'description': 'Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: "My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment." Treatment Response was set to "Yes" if the first 2 categories (1 or 2) of the scale selected and "No" if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.24', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '-4.07', 'spread': '4.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of \\>=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.57', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '-2.41', 'spread': '3.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Severe micturition-related urgency episodes defined as those with the USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.', 'unitOfMeasure': 'Micturitions per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.28', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '2.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.', 'unitOfMeasure': 'Micturitions per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'OG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-26.7', 'upperLimit': '13.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-14.3', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 milligrams (mg) once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'FG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}], 'periods': [{'title': 'Double-Blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '396'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}, {'groupId': 'FG001', 'numSubjects': '392'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '84'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Open-Label', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '785', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Fesoterodine', 'description': 'Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'BG001', 'title': 'Fesoterodine/Fesoterodine', 'description': 'Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '65-75 years', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}]}, {'title': '76-84 years', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'greater than or equal to 85 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '418', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient Perception of Bladder Condition (PPBC) at Baseline', 'classes': [{'title': 'no problems at all', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'some very minor problems', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'some minor problems', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'some moderate problems', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}, {'title': 'severe problems', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}, {'title': 'many severe problems', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants who contributed to baseline score; PPBC: self-administered, single-item, questionnaire asked participants to describe their perception of their bladder-related problems; 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', 'unitOfMeasure': 'Participants'}, {'title': 'Micturition-Related Urgency Episodes per 24 Hours', 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '28.7'}, {'value': '8.5', 'groupId': 'BG001', 'lowerLimit': '1.3', 'upperLimit': '21.0'}, {'value': '8.7', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '28.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Micturition-related urgency episodes per 24 hours defined as those with Urinary Sensation Scale (USS) rating of \\>=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'FULL_RANGE'}, {'title': 'Severe Micturition-Related Urgency Episodes per 24 Hours', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '28.7'}, {'value': '2.7', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '19.0'}, {'value': '2.7', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '28.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Severe micturition-related urgency episodes defined as those with USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'FULL_RANGE'}, {'title': 'Micturitions per 24 Hours', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '28.7'}, {'value': '11.3', 'groupId': 'BG001', 'lowerLimit': '7.5', 'upperLimit': '25.7'}, {'value': '11.3', 'groupId': 'BG002', 'lowerLimit': '7.0', 'upperLimit': '28.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Micturitions included episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI).', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'FULL_RANGE'}, {'title': 'Nocturnal Micturitions per 24 Hours', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '2.7', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '12.3'}, {'value': '2.7', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '12.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 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'}, {'title': 'UUI Episodes per 24 Hours', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '26.7'}, {'value': '0.0', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '14.3'}, {'value': '0.0', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '26.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine) in the diary.', 'unitOfMeasure': 'Episodes per 24 hours', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 794}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2008-11-25', 'resultsFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-08', 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Improvement at Week 24', 'timeFrame': 'Pre-baseline and Week 24', 'description': 'Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: "My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment." Treatment Response was set to "Yes" if the first 2 categories (1 or 2) of the scale selected and "No" if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2.'}, {'measure': 'Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of \\>=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.'}, {'measure': 'Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Severe micturition-related urgency episodes defined as those with the USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.'}, {'measure': 'Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.'}, {'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.'}, {'measure': 'Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (\\>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 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). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of \\>=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100\\* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.'}, {'measure': 'Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Severe micturition-related urgency episodes defined as those with the USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.'}, {'measure': 'Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Severe micturition-related urgency episodes defined as those with USS rating \\>=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.'}, {'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.'}, {'measure': 'Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.'}, {'measure': 'Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 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. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.'}, {'measure': 'Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 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. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.'}, {'measure': 'Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.'}, {'measure': 'Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.'}, {'measure': 'Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': '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). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.'}, {'measure': 'Percentage of Participants Who Were Incontinent at Baseline and Became Dry', 'timeFrame': 'Weeks 8 to 12', 'description': 'Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.'}, {'measure': 'Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12', 'timeFrame': 'Baseline and Weeks 4, 8, and 12', 'description': 'Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.'}, {'measure': 'Percentage of Participants With Improvement at Week 12', 'timeFrame': 'Week 12', 'description': 'Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: "My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment." Improvement was defined as a rating of 1 or 2.'}, {'measure': 'Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than \\[\\<\\]0).'}, {'measure': 'Change From Baseline in PPBC at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference \\<0).'}, {'measure': 'Change From Baseline in PPBC at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference \\<0).'}, {'measure': 'Change From Baseline in PPBC at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference \\<0).'}, {'measure': 'Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4', 'timeFrame': 'Baseline and Weeks 4', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline."}, {'measure': 'Change From Baseline in PPUS at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline."}, {'measure': 'Change From Baseline in PPUS at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline."}, {'measure': 'Change From Baseline in PPUS at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \\[without leaking\\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \\[without leaking\\]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline."}, {'measure': 'Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24', 'timeFrame': 'Baseline and Weeks 4, 8, 12, and 24', 'description': 'OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.'}, {'measure': 'Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24', 'timeFrame': 'Baseline and Weeks 4, 8, 12, and 24', 'description': 'OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.'}, {'measure': 'Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24', 'timeFrame': 'Baseline and Weeks 4, 8, 12, and 24', 'description': 'OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.'}, {'measure': 'Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24', 'timeFrame': 'Weeks 12 and 24', 'description': 'OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.'}, {'measure': 'Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24', 'timeFrame': 'Weeks 12 and 24', 'description': 'OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.'}, {'measure': "Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12", 'timeFrame': 'Baseline and Week 12', 'description': 'KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.'}, {'measure': 'Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.'}, {'measure': 'Change From Baseline in EQ-5D- Each Dimension Score at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.'}, {'measure': 'Change From Baseline in Mini Mental State Examination (MMSE) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive bladder syndrome', 'fesoterodine', 'elderly', 'flexible dose regimen', 'urgency', 'frequency', 'urge urinary incontinence', 'anticholinergic', 'antimuscarinic'], 'conditions': ['Urinary Bladder, Overactive']}, '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': '23460503', 'type': 'DERIVED', 'citation': 'Wagg A, Khullar V, Michel MC, Oelke M, Darekar A, Bitoun CE. Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: open-label extension of the SOFIA trial. Neurourol Urodyn. 2014 Jan;33(1):106-14. doi: 10.1002/nau.22383. Epub 2013 Mar 4.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221045&StudyName=A%20study%20to%20compare%20the%20effectiveness%20and%20safety%20of%20fesoterodine%20and%20placebo%20in%20an%20elderly%20population%20of%20patients%20who%20go%20to%20the%20toi', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \\> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥65 years old.\n* Overactive bladder symptoms for at least 3 months prior to study start.\n* Eight or more micturitions per 24 hours as confirmed by diary records\n\nExclusion Criteria:\n\n* Predominant Stress Urinary Incontinence\n* Active or recurrent bladder infections\n* Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.'}, 'identificationModule': {'nctId': 'NCT00798434', 'acronym': 'SOFIA', 'briefTitle': 'A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.', 'orgStudyIdInfo': {'id': 'A0221045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fesoterodine', 'description': 'Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.', 'interventionNames': ['Drug: Fesoterodine fumarate']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo administered orally in the morning or evening.', 'armGroupLabels': ['Placebo']}, {'name': 'Fesoterodine fumarate', 'type': 'DRUG', 'otherNames': ['Toviaz'], 'description': 'Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.', 'armGroupLabels': ['Fesoterodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 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