Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 4:02 AM
Study NCT ID:
NCT00806494
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2008-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
UK Study Assessing Flexible Dose Fesoterodine in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': 'This was a single arm, non-comparative study. Hence no formal hypothesis testing was performed, and assessment of efficacy was based on changes from baseline in efficacy endpoints.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.', 'otherNumAtRisk': 331, 'otherNumAffected': 177, 'seriousNumAtRisk': 331, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.26', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '-2.91'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.', 'unitOfMeasure': 'Number of Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.55', 'groupId': 'OG000', 'lowerLimit': '-2.87', 'upperLimit': '-2.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.', 'unitOfMeasure': 'Number of Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=305)', 'categories': [{'measurements': [{'value': '-18.69', 'groupId': 'OG000', 'lowerLimit': '-20.86', 'upperLimit': '-16.51'}]}]}, {'title': 'Week 12 (n=317)', 'categories': [{'measurements': [{'value': '-23.61', 'groupId': 'OG000', 'lowerLimit': '-25.86', 'upperLimit': '-21.36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=297)', 'categories': [{'measurements': [{'value': '-0.61', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '-0.48'}]}]}, {'title': 'Week 12 (n=309)', 'categories': [{'measurements': [{'value': '-0.78', 'groupId': 'OG000', 'lowerLimit': '-0.91', 'upperLimit': '-0.64'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.', 'unitOfMeasure': 'Number of episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with nocturnal \\>0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=297)', 'categories': [{'measurements': [{'value': '-15.18', 'groupId': 'OG000', 'lowerLimit': '-21.24', 'upperLimit': '-9.13'}]}]}, {'title': 'Week 12 (n=309)', 'categories': [{'measurements': [{'value': '-23.35', 'groupId': 'OG000', 'lowerLimit': '-29.72', 'upperLimit': '-16.98'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with nocturnal \\>0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=125)', 'categories': [{'measurements': [{'value': '-1.19', 'groupId': 'OG000', 'lowerLimit': '-1.52', 'upperLimit': '-0.86'}]}]}, {'title': 'Week 12 (n=127)', 'categories': [{'measurements': [{'value': '-1.64', 'groupId': 'OG000', 'lowerLimit': '-2.02', 'upperLimit': '-1.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).\n\nMean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.', 'unitOfMeasure': 'Number of Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (number of participants with UUI episodes \\>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=125)', 'categories': [{'measurements': [{'value': '-59.11', 'groupId': 'OG000', 'lowerLimit': '-70.61', 'upperLimit': '-47.60'}]}]}, {'title': 'Week 12 (n=127)', 'categories': [{'measurements': [{'value': '-79.30', 'groupId': 'OG000', 'lowerLimit': '-88.51', 'upperLimit': '-70.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (number of participants with UUI episodes \\>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=303)', 'categories': [{'measurements': [{'value': '-3.94', 'groupId': 'OG000', 'lowerLimit': '-4.43', 'upperLimit': '-3.44'}]}]}, {'title': 'Week 12 (n=317)', 'categories': [{'measurements': [{'value': '-5.10', 'groupId': 'OG000', 'lowerLimit': '-5.62', 'upperLimit': '-4.58'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Urgency episodes were defined as those with a USS rating of \\>=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.', 'unitOfMeasure': 'Number of Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (number of participants with urgency episodes \\>=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=303)', 'categories': [{'measurements': [{'value': '-40.69', 'groupId': 'OG000', 'lowerLimit': '-46.11', 'upperLimit': '-35.27'}]}]}, {'title': 'Week 12 (n=317)', 'categories': [{'measurements': [{'value': '-51.75', 'groupId': 'OG000', 'lowerLimit': '-57.26', 'upperLimit': '-46.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with urgency episodes \\>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=284)', 'categories': [{'measurements': [{'value': '-0.95', 'groupId': 'OG000', 'lowerLimit': '-1.10', 'upperLimit': '-0.80'}]}]}, {'title': 'Week 12 (n=297)', 'categories': [{'measurements': [{'value': '-1.16', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '-1.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'NUEs were defined as those with a USS rating of \\>=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).\n\nMean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.', 'unitOfMeasure': 'Number of Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with NUEs \\>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=284)', 'categories': [{'measurements': [{'value': '-38.71', 'groupId': 'OG000', 'lowerLimit': '-45.07', 'upperLimit': '-32.35'}]}]}, {'title': 'Week 12 (n=297)', 'categories': [{'measurements': [{'value': '-44.78', 'groupId': 'OG000', 'lowerLimit': '-53.41', 'upperLimit': '-36.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with NUEs \\>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=268)', 'categories': [{'measurements': [{'value': '-2.31', 'groupId': 'OG000', 'lowerLimit': '-2.72', 'upperLimit': '-1.90'}]}]}, {'title': 'Week 12 (n=278)', 'categories': [{'measurements': [{'value': '-2.93', 'groupId': 'OG000', 'lowerLimit': '-3.36', 'upperLimit': '-2.50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'SUEs were defined as those with a USS rating of \\>=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.', 'unitOfMeasure': 'Number of Episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with SUEs \\>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=268)', 'categories': [{'measurements': [{'value': '-57.37', 'groupId': 'OG000', 'lowerLimit': '-65.20', 'upperLimit': '-49.55'}]}]}, {'title': 'Week 12 (n=278)', 'categories': [{'measurements': [{'value': '-69.14', 'groupId': 'OG000', 'lowerLimit': '-77.12', 'upperLimit': '-61.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; participants reporting this symptom at baseline (participants with SUEs \\>0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=304)', 'categories': [{'measurements': [{'value': '-0.49', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '-0.35'}]}]}, {'title': 'Week 12 (n=316)', 'categories': [{'measurements': [{'value': '-0.64', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '-0.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.', 'unitOfMeasure': 'Number of Incontinence Pads', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Major Improvement (Week 4), n=307', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Minor Improvement (Week 4), n=307', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'No Change (Week 4), n=307', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Deterioration (Week 4), n=307', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Major Improvement (Week 12), n=322', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}]}]}, {'title': 'Minor Improvement (Week 12), n=322', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'No Change (Week 12), n=322', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Deterioration (Week 12), n=322', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement \\[score difference \\<=-2\\]; minor improvement \\[score difference =-1\\]; no change \\[score difference = 0\\]; deterioration \\[score difference \\>=1\\]), based on PPBC score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Improvement (Week 4), n=307', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'No Change (Week 4), n=307', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}]}]}, {'title': 'Deterioration (Week 4), n=307', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Improvement (Week 12), n=321', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'No Change (Week 12), n=321', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}, {'title': 'Deterioration (Week 12), n=321', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': "UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement \\[Increase of 1 or more points in difference of scores\\]; no change \\[score difference=0\\]; deterioration \\[Negative difference of scores\\], based on UPS score, with number of participants in each of the 3-point categories.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoteridine', 'description': 'Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Week 4 (n=300)', 'categories': [{'measurements': [{'value': '-27.95', 'groupId': 'OG000', 'lowerLimit': '-30.41', 'upperLimit': '-25.50'}]}]}, {'title': 'Week 12 (n=319)', 'categories': [{'measurements': [{'value': '-37.25', 'groupId': 'OG000', 'lowerLimit': '-39.83', 'upperLimit': '-34.66'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range \\* 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.', 'unitOfMeasure': 'Score on Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'groupId': 'OG000', 'lowerLimit': '-5.72', 'upperLimit': '-4.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.', 'unitOfMeasure': 'Score on Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'Benefit from Treatment - Much Benefit', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'Benefit from Treatment - Little Benefit', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Benefit from Treatment - No', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with Treatment - Yes', 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with Treatment - No', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with Treatment - Yes (Very Satisfied)', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with Treatment - Yes (Little Satisfied)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with Treatment - No(Little Dissatisfied)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with Treatment - No (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Willingness to Continue - Yes', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}]}]}, {'title': 'Willingness to Continue - No', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Willingness to Continue - Yes (Very Willing)', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}]}]}, {'title': 'Willingness to Continue - Yes (Little Bit Willing)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Willingness to Continue - No (Little Unwilling)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Willingness to Continue - No (Very Unwilling)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 (or Early Withdrawal)', 'description': 'BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 (or Early Withdrawal)', 'description': "TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with analyzable data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'classes': [{'title': 'General Health Perception (n=311)', 'categories': [{'measurements': [{'value': '-2.57', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-0.34'}]}]}, {'title': 'Incontinence Impact (n=309)', 'categories': [{'measurements': [{'value': '-29.69', 'groupId': 'OG000', 'lowerLimit': '-32.22', 'upperLimit': '-27.17'}]}]}, {'title': 'Role Limitations (n=311)', 'categories': [{'measurements': [{'value': '-41.16', 'groupId': 'OG000', 'lowerLimit': '-44.57', 'upperLimit': '-37.75'}]}]}, {'title': 'Physical Limitations (n=311)', 'categories': [{'measurements': [{'value': '-36.60', 'groupId': 'OG000', 'lowerLimit': '-40.10', 'upperLimit': '-33.10'}]}]}, {'title': 'Social Limitations (n=310)', 'categories': [{'measurements': [{'value': '-25.22', 'groupId': 'OG000', 'lowerLimit': '-28.38', 'upperLimit': '-22.05'}]}]}, {'title': 'Personal Relationships (n=220)', 'categories': [{'measurements': [{'value': '-15.23', 'groupId': 'OG000', 'lowerLimit': '-18.77', 'upperLimit': '-11.69'}]}]}, {'title': 'Emotions (n=308)', 'categories': [{'measurements': [{'value': '-25.78', 'groupId': 'OG000', 'lowerLimit': '-28.91', 'upperLimit': '-22.64'}]}]}, {'title': 'Sleep/Energy (n=311)', 'categories': [{'measurements': [{'value': '-21.38', 'groupId': 'OG000', 'lowerLimit': '-24.30', 'upperLimit': '-18.47'}]}]}, {'title': 'Severity of Urinary Symptoms (n=311)', 'categories': [{'measurements': [{'value': '-21.92', 'groupId': 'OG000', 'lowerLimit': '-24.49', 'upperLimit': '-19.34'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'KHQ: Self-administered questionnaire containing 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). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.', 'unitOfMeasure': 'Score on Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants with analyzable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '331'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 18 to 44 Years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Between 45 to 64 Years', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}, {'title': '>= 65 Years', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '263', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-04', 'studyFirstSubmitDate': '2008-12-09', 'resultsFirstSubmitDate': '2011-01-04', 'studyFirstSubmitQcDate': '2008-12-09', 'lastUpdatePostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-04', 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.'}, {'measure': 'Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.'}, {'measure': 'Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.'}, {'measure': 'Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.'}, {'measure': 'Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).\n\nMean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.'}, {'measure': 'Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.'}, {'measure': 'Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Urgency episodes were defined as those with a USS rating of \\>=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.'}, {'measure': 'Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.'}, {'measure': 'Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'NUEs were defined as those with a USS rating of \\>=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).\n\nMean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.'}, {'measure': 'Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.'}, {'measure': 'Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'SUEs were defined as those with a USS rating of \\>=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.'}, {'measure': 'Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.'}, {'measure': 'Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.'}, {'measure': 'Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement \\[score difference \\<=-2\\]; minor improvement \\[score difference =-1\\]; no change \\[score difference = 0\\]; deterioration \\[score difference \\>=1\\]), based on PPBC score.'}, {'measure': 'Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': "UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement \\[Increase of 1 or more points in difference of scores\\]; no change \\[score difference=0\\]; deterioration \\[Negative difference of scores\\], based on UPS score, with number of participants in each of the 3-point categories."}, {'measure': 'Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12', 'timeFrame': 'Baseline, Week 4 and Week 12', 'description': 'OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range \\* 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.'}, {'measure': 'Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.'}, {'measure': 'Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire', 'timeFrame': 'Week 12 (or Early Withdrawal)', 'description': 'BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).'}, {'measure': 'Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12', 'timeFrame': 'Week 12 (or Early Withdrawal)', 'description': "TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'."}, {'measure': "Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12", 'timeFrame': 'Baseline, Week 12', 'description': 'KHQ: Self-administered questionnaire containing 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). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fesoterodine', 'Open Label', 'Flexible Dose', 'OAB'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221058&StudyName=UK%20Study%20Assessing%20Flexible%20Dose%20Fesoterodine%20in%20Adults%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To explore the effects of fesoterodine when used in a flexible dose manner'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female \\>18 years old\n* OAB for \\>3 months\n\nExclusion Criteria:\n\n* Patients with conditions that would contraindicate for fesoterodine use\n* Patients with significant hepatic and renal disease or other significant unstable diseases.\n* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.'}, 'identificationModule': {'nctId': 'NCT00806494', 'acronym': 'SAFINA', 'briefTitle': 'UK Study Assessing Flexible Dose Fesoterodine in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 12 Week, Multi-centre, Open Label Study To Evaluate The Efficacy, Tolerability And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.', 'orgStudyIdInfo': {'id': 'A0221058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Fesoterodine 4mg, escalating to 8mg as required', 'interventionNames': ['Drug: Fesoterodine']}], 'interventions': [{'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB7 5JD', 'city': 'Ely', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.39964, 'lon': 0.26196}}, {'zip': 'CW1 4QJ', 'city': 'Crewe', 'state': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.09787, 'lon': -2.44161}}, {'zip': 'PL23 1DT', 'city': 'Fowey', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.33634, 'lon': -4.6386}}, {'zip': 'TR18 4JH', 'city': 'Penzance', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.11861, 'lon': -5.53715}}, {'zip': 'S40 4TF', 'city': 'Chesterfield', 'state': 'Derbyshire', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.25, 'lon': -1.41667}}, 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{'zip': 'W1P 9LL', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NN8 4RW', 'city': 'Northants', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site'}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'SA6 6NL', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'SN25 4YZ', 'city': 'Swindon', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}