Trial Outcomes & Findings for 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. (NCT NCT00798434)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

794 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2011-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo/Fesoterodine 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).	Fesoterodine/Fesoterodine 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).
Double-Blind STARTED	396	398
Double-Blind Received Treatment	393	392
Double-Blind COMPLETED	341	314
Double-Blind NOT COMPLETED	55	84
Open-Label STARTED	341	314
Open-Label Received Treatment	341	313
Open-Label COMPLETED	299	282
Open-Label NOT COMPLETED	42	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Fesoterodine 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).	Fesoterodine/Fesoterodine 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).
Double-Blind Adverse Event	22	46
Double-Blind Death	0	1
Double-Blind Lost to Follow-up	1	0
Double-Blind Lack of Efficacy	8	12
Double-Blind Withdrawal by Subject	17	14
Double-Blind Protocol Violation	1	4
Double-Blind Did Not Meet Entrance Criteria	2	1
Double-Blind Other	1	0
Double-Blind Not Treated	3	6
Open-Label Adverse Event	33	11
Open-Label Lack of Efficacy	5	11
Open-Label Withdrawal by Subject	2	7
Open-Label Protocol Violation	1	0
Open-Label Other	1	2
Open-Label Not Treated	0	1

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Fesoterodine n=393 Participants 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).	Fesoterodine/Fesoterodine n=392 Participants 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).	Total n=785 Participants Total of all reporting groups
Age, Customized 65-75 years	267 participants n=5 Participants	264 participants n=7 Participants	531 participants n=5 Participants
Age, Customized 76-84 years	114 participants n=5 Participants	116 participants n=7 Participants	230 participants n=5 Participants
Age, Customized greater than or equal to 85 years	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Sex: Female, Male Female	205 Participants n=5 Participants	213 Participants n=7 Participants	418 Participants n=5 Participants
Sex: Female, Male Male	188 Participants n=5 Participants	179 Participants n=7 Participants	367 Participants n=5 Participants
Patient Perception of Bladder Condition (PPBC) at Baseline no problems at all	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Patient Perception of Bladder Condition (PPBC) at Baseline some very minor problems	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Patient Perception of Bladder Condition (PPBC) at Baseline some minor problems	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Patient Perception of Bladder Condition (PPBC) at Baseline some moderate problems	185 Participants n=5 Participants	190 Participants n=7 Participants	375 Participants n=5 Participants
Patient Perception of Bladder Condition (PPBC) at Baseline severe problems	157 Participants n=5 Participants	158 Participants n=7 Participants	315 Participants n=5 Participants
Patient Perception of Bladder Condition (PPBC) at Baseline many severe problems	37 Participants n=5 Participants	23 Participants n=7 Participants	60 Participants n=5 Participants
Micturition-Related Urgency Episodes per 24 Hours	8.7 Episodes per 24 hours n=5 Participants	8.5 Episodes per 24 hours n=7 Participants	8.7 Episodes per 24 hours n=5 Participants
Severe Micturition-Related Urgency Episodes per 24 Hours	3.0 Episodes per 24 hours n=5 Participants	2.7 Episodes per 24 hours n=7 Participants	2.7 Episodes per 24 hours n=5 Participants
Micturitions per 24 Hours	11.5 Episodes per 24 hours n=5 Participants	11.3 Episodes per 24 hours n=7 Participants	11.3 Episodes per 24 hours n=5 Participants
Nocturnal Micturitions per 24 Hours	2.7 Episodes per 24 hours n=5 Participants	2.7 Episodes per 24 hours n=7 Participants	2.7 Episodes per 24 hours n=5 Participants
UUI Episodes per 24 Hours	0.0 Episodes per 24 hours n=5 Participants	0.0 Episodes per 24 hours n=7 Participants	0.0 Episodes per 24 hours n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=381 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 Baseline (n=381, 374)	8.80 Episodes per 24 hours Standard Deviation 3.97	8.48 Episodes per 24 hours Standard Deviation 3.62
Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 Change at Week 12 (n=356, 338)	-2.48 Episodes per 24 hours Standard Deviation 4.53	-3.84 Episodes per 24 hours Standard Deviation 4.10

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=365, 356)	6.7 Percent change Interval 0.0 to 29.0	5.3 Percent change Interval 0.0 to 20.7
Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	5.7 Percent change Interval 0.0 to 26.0	4.3 Percent change Interval 0.0 to 18.7
Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=356, 338)	5.3 Percent change Interval 0.0 to 27.3	3.7 Percent change Interval 0.0 to 21.7

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=381 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-1.53 Episodes per 24 hours Standard Deviation 3.79	-2.12 Episodes per 24 hours Standard Deviation 3.07
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=356, 338)	-1.78 Episodes per 24 hours Standard Deviation 3.85	-2.43 Episodes per 24 hours Standard Deviation 3.14
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Baseline (n=381, 374)	4.11 Episodes per 24 hours Standard Deviation 4.24	3.53 Episodes per 24 hours Standard Deviation 3.40
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=365, 356)	-0.96 Episodes per 24 hours Standard Deviation 3.39	-1.81 Episodes per 24 hours Standard Deviation 2.96

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=365, 356)	-0.7 Percent change Interval -16.7 to 14.7	-1.3 Percent change Interval -16.0 to 11.3
Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-1.0 Percent change Interval -23.3 to 15.3	-1.7 Percent change Interval -17.3 to 6.3
Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=356, 338)	-1.3 Percent change Interval -23.3 to 17.3	-2.0 Percent change Interval -17.3 to 7.7

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 Baseline (n=382, 374)	12.10 Micturitions per 24 hours Standard Deviation 3.12	11.89 Micturitions per 24 hours Standard Deviation 2.90
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=366, 356)	-0.69 Micturitions per 24 hours Standard Deviation 2.26	-1.47 Micturitions per 24 hours Standard Deviation 2.19
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-1.11 Micturitions per 24 hours Standard Deviation 2.37	-1.95 Micturitions per 24 hours Standard Deviation 2.33
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=359, 338)	-1.15 Micturitions per 24 hours Standard Deviation 2.56	-2.09 Micturitions per 24 hours Standard Deviation 2.33

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=366, 356)	-0.7 Percent change Interval -7.7 to 9.7	-1.3 Percent change Interval -11.7 to 11.7
Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-1.0 Percent change Interval -7.3 to 10.3	-1.7 Percent change Interval -12.3 to 9.3
Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=359, 338)	-1.3 Percent change Interval -7.7 to 10.0	-2.0 Percent change Interval -12.7 to 7.0

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Baseline (n=382, 374)	2.92 Micturitions per 24 hours Standard Deviation 1.46	2.80 Micturitions per 24 hours Standard Deviation 1.47
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=366, 356)	-0.22 Micturitions per 24 hours Standard Deviation 1.15	-0.38 Micturitions per 24 hours Standard Deviation 0.99
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-0.30 Micturitions per 24 hours Standard Deviation 1.13	-0.51 Micturitions per 24 hours Standard Deviation 1.03
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=359, 338)	-0.33 Micturitions per 24 hours Standard Deviation 1.15	-0.55 Micturitions per 24 hours Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=366, 356)	-0.3 Percent change Interval -5.0 to 8.3	-0.3 Percent change Interval -4.7 to 3.7
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-0.3 Percent change Interval -4.0 to 6.7	-0.7 Percent change Interval -4.3 to 4.0
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=359, 338)	-0.3 Percent change Interval -4.0 to 6.3	-0.7 Percent change Interval -5.3 to 3.0

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=381 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	0.0 Episodes per 24 hours Interval -12.3 to 22.0	0.0 Episodes per 24 hours Interval -14.3 to 2.7
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=356, 338)	0.0 Episodes per 24 hours Interval -14.0 to 22.3	0.0 Episodes per 24 hours Interval -10.3 to 7.7
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 Baseline (n=381, 374)	0.0 Episodes per 24 hours Interval 0.0 to 26.7	0.0 Episodes per 24 hours Interval 0.0 to 14.3
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=365, 356)	0.0 Episodes per 24 hours Interval -14.3 to 22.3	0.0 Episodes per 24 hours Interval -13.7 to 8.3

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 4 (n=365, 356)	0.0 Percent change Interval 0.0 to 22.7	0.0 Percent change Interval 0.0 to 9.3
Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	0.0 Percent change Interval 0.0 to 23.3	0.0 Percent change Interval 0.0 to 5.7
Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 Change at Week 12 (n=356, 338)	0.0 Percent change Interval 0.0 to 22.7	0.0 Percent change Interval 0.0 to 14.7

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=381 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 Baseline (n=381, 374)	37.55 Scores on a scale Standard Deviation 13.95	36.07 Scores on a scale Standard Deviation 11.16
Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 Change at Week 4 (n=365, 356)	-4.35 Scores on a scale Standard Deviation 11.7	-8.52 Scores on a scale Standard Deviation 10.0
Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 Change at Week 8 (n=349, 331)	-6.53 Scores on a scale Standard Deviation 12.5	-10.81 Scores on a scale Standard Deviation 10.7
Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 Change at Week 12 (n=356, 338)	-7.33 Scores on a scale Standard Deviation 12.7	-11.59 Scores on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: Weeks 8 to 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants 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).	Fesoterodine n=158 Participants 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).
Percentage of Participants Who Were Incontinent at Baseline and Became Dry	45.0 Percentage of participants	53.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=374 Participants 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).	Fesoterodine n=369 Participants 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).
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Creams Change at Week 4 (n=360, 349)	-0.01 Skin protective agents Standard Deviation 0.55	-0.02 Skin protective agents Standard Deviation 0.39
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Creams Change at Week 8 (n=342, 325)	0.06 Skin protective agents Standard Deviation 0.60	-0.03 Skin protective agents Standard Deviation 0.47
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Incontinence pads at Baseline (n=374, 369)	1.49 Skin protective agents Standard Deviation 2.70	1.35 Skin protective agents Standard Deviation 2.01
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Incontinence pads Change at Week 4 (n=360, 350)	-0.20 Skin protective agents Standard Deviation 1.97	-0.27 Skin protective agents Standard Deviation 1.33
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Incontinence pads Change at Week 8 (n=342, 326)	-0.15 Skin protective agents Standard Deviation 2.01	-0.38 Skin protective agents Standard Deviation 1.57
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Incontinence pads Change at Week 12 (n=350, 332)	-0.16 Skin protective agents Standard Deviation 1.98	-0.50 Skin protective agents Standard Deviation 1.35
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Creams at Baseline (n=374, 368)	0.12 Skin protective agents Standard Deviation 0.72	0.16 Skin protective agents Standard Deviation 0.68
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Creams Change at Week 12 (n=350, 331)	0.04 Skin protective agents Standard Deviation 0.41	-0.03 Skin protective agents Standard Deviation 0.54
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Powder at Baseline (n=374, 368)	0.03 Skin protective agents Standard Deviation 0.29	0.02 Skin protective agents Standard Deviation 0.23
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Powder Change at Week 4 (n=360, 349)	0.03 Skin protective agents Standard Deviation 0.27	-0.02 Skin protective agents Standard Deviation 0.24
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Powder Change at Week 8 (n=342, 325)	0.03 Skin protective agents Standard Deviation 0.39	-0.01 Skin protective agents Standard Deviation 0.29
Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 Powder Change at Week 12 (n=350, 331)	0.03 Skin protective agents Standard Deviation 0.44	-0.02 Skin protective agents Standard Deviation 0.22

SECONDARY outcome

Timeframe: Week 12

Population: FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).

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.

Outcome measures

Outcome measures
Measure	Placebo n=340 Participants 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).	Fesoterodine n=334 Participants 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).
Percentage of Participants With Improvement at Week 12	42.9 Percentage of participants	67.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: FAS; N=participants with evaluable data

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).

Outcome measures

Outcome measures
Measure	Placebo n=370 Participants 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).	Fesoterodine n=360 Participants 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).
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 Improvement	168 Participants	192 Participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 No Change	202 Participants	168 Participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 Deterioration	40 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: FAS; N=participants with evaluable data

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).

Outcome measures

Outcome measures
Measure	Placebo n=351 Participants 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).	Fesoterodine n=329 Participants 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).
Change From Baseline in PPBC at Week 8 Improvement	185 Participants	210 Participants
Change From Baseline in PPBC at Week 8 No Change	166 Participants	119 Participants
Change From Baseline in PPBC at Week 8 Deterioration	22 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).

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).

Outcome measures

Outcome measures
Measure	Placebo n=368 Participants 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).	Fesoterodine n=360 Participants 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).
Change From Baseline in PPBC at Week 12 Improvement	204 Participants	256 Participants
Change From Baseline in PPBC at Week 12 No Change	164 Participants	104 Participants
Change From Baseline in PPBC at Week 12 Deterioration	33 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Not analyzed

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Weeks 4

Population: FAS; N=participants with evaluable data

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.

Outcome measures

Outcome measures
Measure	Placebo n=370 Participants 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).	Fesoterodine n=361 Participants 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).
Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 No Change	263 Participants	250 Participants
Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 Deterioration	33 Participants	21 Participants
Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 Improvement	74 Participants	90 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: FAS; N=participants with evaluable data

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.

Outcome measures

Outcome measures
Measure	Placebo n=351 Participants 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).	Fesoterodine n=330 Participants 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).
Change From Baseline in PPUS at Week 8 No Change	224 Participants	194 Participants
Change From Baseline in PPUS at Week 8 Deterioration	32 Participants	25 Participants
Change From Baseline in PPUS at Week 8 Improvement	95 Participants	111 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).

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.

Outcome measures

Outcome measures
Measure	Placebo n=367 Participants 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).	Fesoterodine n=361 Participants 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).
Change From Baseline in PPUS at Week 12 Improvement	109 Participants	133 Participants
Change From Baseline in PPUS at Week 12 No Change	226 Participants	200 Participants
Change From Baseline in PPUS at Week 12 Deterioration	32 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Not analyzed

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, and 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants 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).	Fesoterodine n=382 Participants 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).
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 Baseline (n=381, 373)	52.90 Scores on a scale Standard Deviation 18.75	50.58 Scores on a scale Standard Deviation 19.35
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 Change at Week 4 (n=369, 358)	-9.03 Scores on a scale Standard Deviation 17.74	-14.05 Scores on a scale Standard Deviation 18.37
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 Change at Week 8 (n=349, 328)	-12.86 Scores on a scale Standard Deviation 18.95	-18.03 Scores on a scale Standard Deviation 19.25
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 Change at Week 12 (n=366, 357)	-12.16 Scores on a scale Standard Deviation 20.19	-18.37 Scores on a scale Standard Deviation 21.38
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 Change at Week 24	NA Scores on a scale Standard Deviation NA Not Applicable (NA); Week 24 data collected change from baseline not calculated	NA Scores on a scale Standard Deviation NA Week 24 data collected change from baseline not calculated

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, and 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants 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).	Fesoterodine n=379 Participants 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).
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 Change at Week 12 (n=363, 357)	9.56 Scores on a scale Standard Deviation 18.75	13.19 Scores on a scale Standard Deviation 17.49
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 Baseline (n=373, 379)	62.45 Scores on a scale Standard Deviation 20.20	64.42 Scores on a scale Standard Deviation 19.82
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 Change at Week 4 (n=367, 354)	7.28 Scores on a scale Standard Deviation 15.48	10.24 Scores on a scale Standard Deviation 14.92
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 Change at Week 8 (n=348, 328)	9.36 Scores on a scale Standard Deviation 17.98	12.96 Scores on a scale Standard Deviation 16.76
Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 Change at Week 24	NA Scores on a scale Standard Deviation NA Change from Week 12 to Week 24 calculated instead of change from baseline to Week 24	NA Scores on a scale Standard Deviation NA Change from Week 12 to Week 24 calculated instead of change from baseline to Week 24

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, and 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=380 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Concern Change at Week 24	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Sleep at Baseline (n=380, 374)	53.79 Scores on a scale Standard Deviation 23.69	57.52 Scores on a scale Standard Deviation 23.83
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Sleep Change at Week 4 (n=368, 358)	7.31 Scores on a scale Standard Deviation 20.13	9.07 Scores on a scale Standard Deviation 18.61
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Sleep Change at Week 8 (n=348, 329)	9.01 Scores on a scale Standard Deviation 21.42	10.87 Scores on a scale Standard Deviation 20.07
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Sleep Change at Week 12 (n=365, 358)	9.36 Scores on a scale Standard Deviation 22.08	11.99 Scores on a scale Standard Deviation 21.33
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Sleep Change at Week 24	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Social at Baseline (n=380, 374)	79.10 Scores on a scale Standard Deviation 21.84	81.02 Scores on a scale Standard Deviation 20.43
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Social Change at Week 4 (n=368, 355)	4.41 Scores on a scale Standard Deviation 16.01	6.25 Scores on a scale Standard Deviation 14.27
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Social Change at Week 8 (n=349, 328)	5.84 Scores on a scale Standard Deviation 18.58	8.17 Scores on a scale Standard Deviation 17.24
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Social Change at Week 12 (n=364, 357)	5.29 Scores on a scale Standard Deviation 18.56	7.02 Scores on a scale Standard Deviation 17.40
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Social Change at Week 24	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Coping at Baseline (n=380, 374)	57.52 Scores on a scale Standard Deviation 24.36	58.31 Scores on a scale Standard Deviation 24.05
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Coping Change at Week 4 (n=368, 358)	8.35 Scores on a scale Standard Deviation 19.28	11.90 Scores on a scale Standard Deviation 17.98
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Coping Change at Week 8 (n=348, 329)	10.46 Scores on a scale Standard Deviation 20.96	14.98 Scores on a scale Standard Deviation 20.48
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Coping Change at Week 12 (n=365, 358)	10.60 Scores on a scale Standard Deviation 22.78	15.65 Scores on a scale Standard Deviation 21.52
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Coping Change at Week 24	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.	NA Scores on a scale Standard Deviation NA Week 24 data collected, change from baseline not analyzed.
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Concern at Baseline (n=380, 374)	62.10 Scores on a scale Standard Deviation 23.32	64.67 Scores on a scale Standard Deviation 22.47
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Concern Change at Week 4 (n=368, 358)	7.96 Scores on a scale Standard Deviation 17.80	11.88 Scores on a scale Standard Deviation 18.20
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Concern Change at Week 8 (n=348, 329)	10.88 Scores on a scale Standard Deviation 21.23	15.39 Scores on a scale Standard Deviation 19.77
Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 Concern Change at Week 12 (n=365, 358)	11.25 Scores on a scale Standard Deviation 21.39	15.48 Scores on a scale Standard Deviation 20.23

SECONDARY outcome

Timeframe: Weeks 12 and 24

Population: FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).

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.

Outcome measures

Outcome measures
Measure	Placebo n=330 Participants 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).	Fesoterodine n=301 Participants 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).
Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 Week 12	44.97 Scores on a scale Standard Deviation 28.42	63.01 Scores on a scale Standard Deviation 24.16
Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 Change at Week 24	21.22 Scores on a scale Standard Deviation 28.47	3.58 Scores on a scale Standard Deviation 20.27

SECONDARY outcome

Timeframe: Weeks 12 and 24

Population: FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).

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.

Outcome measures

Outcome measures
Measure	Placebo n=330 Participants 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).	Fesoterodine n=301 Participants 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).
Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 Week 12	2.21 Scores on a scale Standard Deviation 1.07	2.85 Scores on a scale Standard Deviation 1.10
Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 Change at Week 24	0.74 Scores on a scale Standard Deviation 1.22	0.17 Scores on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants 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).	Fesoterodine n=32 Participants 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).
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline General Health Perception (n=23, 32)	35.87 Scores on a scale Standard Deviation 19.69	25.00 Scores on a scale Standard Deviation 17.96
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 General Hlth Perception n=21, 29	-2.38 Scores on a scale Standard Deviation 15.62	2.59 Scores on a scale Standard Deviation 13.93
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Incontinence Impact (n=23, 32)	75.36 Scores on a scale Standard Deviation 25.06	73.96 Scores on a scale Standard Deviation 29.00
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Incontinence Impact (n=21, 29)	-12.70 Scores on a scale Standard Deviation 32.45	-16.09 Scores on a scale Standard Deviation 34.06
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Role Limitations (n=22, 32)	48.48 Scores on a scale Standard Deviation 34.85	46.35 Scores on a scale Standard Deviation 30.15
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Role Limitations (n=20, 29)	-10.83 Scores on a scale Standard Deviation 45.33	-12.64 Scores on a scale Standard Deviation 25.45
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Physical Limitations (n=22, 32)	50.76 Scores on a scale Standard Deviation 31.49	44.79 Scores on a scale Standard Deviation 32.91
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Physical Limitations (n=20, 29)	-13.33 Scores on a scale Standard Deviation 30.40	-13.79 Scores on a scale Standard Deviation 28.20
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Social Limitations (n=22, 32)	24.75 Scores on a scale Standard Deviation 23.43	29.86 Scores on a scale Standard Deviation 33.89
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Social Limitations (n=20, 29)	-7.50 Scores on a scale Standard Deviation 23.17	-8.62 Scores on a scale Standard Deviation 24.20
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Personal Relationships (n=16,17)	15.63 Scores on a scale Standard Deviation 28.85	19.61 Scores on a scale Standard Deviation 27.15
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Personal Relationship (n=11, 14)	4.55 Scores on a scale Standard Deviation 18.40	-5.95 Scores on a scale Standard Deviation 18.03
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Emotions (n=22, 32)	32.32 Scores on a scale Standard Deviation 25.64	32.64 Scores on a scale Standard Deviation 29.18
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Emotions (n=20, 29)	-2.78 Scores on a scale Standard Deviation 28.58	-6.51 Scores on a scale Standard Deviation 25.63
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Sleep/Energy (n=22, 32)	46.97 Scores on a scale Standard Deviation 27.04	57.29 Scores on a scale Standard Deviation 27.74
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Sleep/Energy (n=20, 29)	-8.33 Scores on a scale Standard Deviation 26.21	-11.49 Scores on a scale Standard Deviation 23.61
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Baseline Severity USS (n=22, 32)	43.94 Scores on a scale Standard Deviation 22.69	44.38 Scores on a scale Standard Deviation 25.99
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 Change at Week 12 Severity USS (n=20, 29)	-2.00 Scores on a scale Standard Deviation 18.99	-8.51 Scores on a scale Standard Deviation 16.70

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.

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.

Outcome measures

Outcome measures
Measure	Placebo n=381 Participants 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).	Fesoterodine n=373 Participants 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).
Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 Baseline (n=381, 373)	0.7825 Scores on a scale Standard Deviation 0.2246	0.8092 Scores on a scale Standard Deviation 0.2068
Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 Change at Week 12 (n=362, 346)	0.0230 Scores on a scale Standard Deviation 0.1963	0.0064 Scores on a scale Standard Deviation 0.1854

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Not analyzed

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS

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.

Outcome measures

Outcome measures
Measure	Placebo n=382 Participants 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).	Fesoterodine n=374 Participants 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).
Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 Baseline	28.09 Scores on a scale Standard Deviation 1.98	28.20 Scores on a scale Standard Deviation 1.94
Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 Change at Week 12	0.23 Scores on a scale Standard Deviation 1.82	0.24 Scores on a scale Standard Deviation 1.76

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-baseline and Week 24

Population: Not analyzed

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 24

Population: FAS; N=participants with evaluable data.

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.

Outcome measures

Outcome measures
Measure	Placebo n=332 Participants 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).	Fesoterodine n=305 Participants 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).
Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24	-4.24 Episodes per 24 hours Standard Deviation 4.62	-4.07 Episodes per 24 hours Standard Deviation 4.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 24

Population: FAS; N=participants with evaluable data.

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.

Outcome measures

Outcome measures
Measure	Placebo n=332 Participants 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).	Fesoterodine n=305 Participants 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).
Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24	-2.57 Episodes per 24 hours Standard Deviation 4.37	-2.41 Episodes per 24 hours Standard Deviation 3.30

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 24

Population: FAS; N=participants with evaluable data.

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.

Outcome measures

Outcome measures
Measure	Placebo n=332 Participants 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).	Fesoterodine n=305 Participants 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).
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24	-0.60 Micturitions per 24 hours Standard Deviation 1.24	-0.67 Micturitions per 24 hours Standard Deviation 1.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 24

Population: FAS; N=participants with evaluable data.

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.

Outcome measures

Outcome measures
Measure	Placebo n=333 Participants 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).	Fesoterodine n=305 Participants 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).
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24	-2.28 Micturitions per 24 hours Standard Deviation 2.89	-2.36 Micturitions per 24 hours Standard Deviation 2.57

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 24

Population: FAS; N=participants with evaluable data.

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.

Outcome measures

Outcome measures
Measure	Placebo n=333 Participants 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).	Fesoterodine n=305 Participants 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).
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24	0.0 Episodes per 24 hours Interval -26.7 to 13.7	0.0 Episodes per 24 hours Interval -14.3 to 4.0

Adverse Events

Placebo Double-Blind

Serious events: 9 serious events

Other events: 71 other events

Deaths: 0 deaths

Fesoterodine Double-Blind

Serious events: 14 serious events

Other events: 187 other events

Deaths: 0 deaths

Festerodine/Fesoterodine Open-Label

Serious events: 11 serious events

Other events: 49 other events

Deaths: 0 deaths

Placebo/Fesoterodine Open-label

Serious events: 7 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo Double-Blind n=393 participants at risk Participants received matched placebo once daily from baseline to Week 12 (double-blinded)	Fesoterodine Double-Blind n=392 participants at risk Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)	Festerodine/Fesoterodine Open-Label n=313 participants at risk 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.	Placebo/Fesoterodine Open-label n=341 participants at risk 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.
Gastrointestinal disorders Constipation	2.5% 10/393 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.	8.9% 35/392 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.	1.6% 5/313 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.	6.2% 21/341 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.
Gastrointestinal disorders Diarrhoea	1.3% 5/393 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.	2.6% 10/392 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.	0.64% 2/313 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.	1.5% 5/341 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.
Gastrointestinal disorders Dry mouth	5.3% 21/393 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.	33.9% 133/392 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.	6.7% 21/313 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.	27.9% 95/341 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.
Gastrointestinal disorders Dyspepsia	0.51% 2/393 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.	2.3% 9/392 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.	0.96% 3/313 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.	1.2% 4/341 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.
Gastrointestinal disorders Nausea	1.0% 4/393 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.	2.3% 9/392 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.	0.64% 2/313 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.	0.29% 1/341 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.
General disorders Fatigue	2.5% 10/393 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.	2.3% 9/392 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.	0.00% 0/313 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.	1.2% 4/341 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.
Infections and infestations Nasopharyngitis	2.3% 9/393 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.	3.1% 12/392 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.	1.9% 6/313 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.	0.59% 2/341 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.
Infections and infestations Urinary tract infection	1.8% 7/393 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.	2.6% 10/392 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.	4.5% 14/313 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.	1.2% 4/341 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.
Musculoskeletal and connective tissue disorders Back pain	2.0% 8/393 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.	0.51% 2/392 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.	1.3% 4/313 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.	0.88% 3/341 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.
Nervous system disorders Dizziness	1.0% 4/393 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.	3.6% 14/392 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.	0.64% 2/313 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.	1.8% 6/341 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.
Nervous system disorders Headache	1.3% 5/393 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.	2.8% 11/392 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.	0.00% 0/313 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.	2.1% 7/341 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.
Vascular disorders Hypertension	2.0% 8/393 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.	1.8% 7/392 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.	0.64% 2/313 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.	2.1% 7/341 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.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER