Trial Outcomes & Findings for Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. (NCT NCT00658684)

NCT ID: NCT00658684

Last Updated: 2010-10-13

Results Overview

The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 153 participants
• Primary outcome timeframe: 52 Weeks
• Results posted on: 2010-10-13

Participant Flow

Subjects were screened at 12 centers in Japan.

After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation.

Participant milestones

Measure	Total All subjects	4 mg Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Study STARTED	152	99	25	28
Overall Study COMPLETED	133	84	22	27
Overall Study NOT COMPLETED	19	15	3	1

Reasons for withdrawal

Measure	Total All subjects	4 mg Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Study Adverse Event	10	8	2	0
Overall Study Withdrawal by Subject	6	4	1	1
Overall Study Lack of Efficacy	1	1	0	0
Overall Study Protocol Violation	1	1	0	0
Overall Study Pregnancy	1	1	0	0

Baseline Characteristics

Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

Baseline characteristics by cohort

Measure	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg n=99 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)	Total n=152 Participants Total of all reporting groups
Age Continuous	54.7 years STANDARD_DEVIATION 10.5 • n=4 Participants	51.0 years STANDARD_DEVIATION 13.1 • n=93 Participants	57.0 years STANDARD_DEVIATION 11.7 • n=27 Participants	52.7 years STANDARD_DEVIATION 12.6 • n=483 Participants
Sex: Female, Male Female	21 Participants n=4 Participants	88 Participants n=93 Participants	24 Participants n=27 Participants	133 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	11 Participants n=93 Participants	4 Participants n=27 Participants	19 Participants n=483 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Population: The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.

The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.

Outcome measures

Measure	Total n=152 Participants All subjects	4 mg n=99 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume All-causality AEs	138 Number of subjects	91 Number of subjects	25 Number of subjects	22 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume Treatment-related AEs	102 Number of subjects	61 Number of subjects	25 Number of subjects	16 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume Serious AEs	1 Number of subjects	1 Number of subjects	0 Number of subjects	0 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume Severe AEs	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume Discontinuations due to all-causlity AEs	10 Number of subjects	8 Number of subjects	2 Number of subjects	0 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume Discontinuations due to treatment-related AEs	7 Number of subjects	6 Number of subjects	1 Number of subjects	0 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume DR/TD due to all-causality AEs	30 Number of subjects	6 Number of subjects	23 Number of subjects	1 Number of subjects
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume DR/TD due to treatment-related AEs	23 Number of subjects	0 Number of subjects	23 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: Week 4, 8, 28 and 52

Population: Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)

The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=101 Participants All subjects	4 mg n=60 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=17 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=24 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 Baseline (n=101, 60, 17, 24)	1.6 Number of episodes Standard Deviation 1.48	1.4 Number of episodes Standard Deviation 1.23	1.7 Number of episodes Standard Deviation 1.24	2.1 Number of episodes Standard Deviation 2.04
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 4 (n=101, 60, 17, 24)	-0.86 Number of episodes Standard Deviation 1.104	-0.99 Number of episodes Standard Deviation 1.117	-0.73 Number of episodes Standard Deviation 1.281	-0.63 Number of episodes Standard Deviation 0.918
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 8 (n=100, 59, 17, 24)	-1.15 Number of episodes Standard Deviation 1.293	-1.16 Number of episodes Standard Deviation 1.173	-1.31 Number of episodes Standard Deviation 1.450	-1.00 Number of episodes Standard Deviation 1.491
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 28 (n=95, 56, 16, 23)	-1.28 Number of episodes Standard Deviation 1.282	-1.24 Number of episodes Standard Deviation 1.185	-1.25 Number of episodes Standard Deviation 1.518	-1.41 Number of episodes Standard Deviation 1.385
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (n= 92, 54, 15, 23)	-1.34 Number of episodes Standard Deviation 1.553	-1.23 Number of episodes Standard Deviation 1.228	-1.18 Number of episodes Standard Deviation 1.661	-1.71 Number of episodes Standard Deviation 2.097
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (LOCF) (n=101, 60, 17, 24)	-1.35 Number of episodes Standard Deviation 1.521	-1.19 Number of episodes Standard Deviation 1.176	-1.22 Number of episodes Standard Deviation 1.568	-1.82 Number of episodes Standard Deviation 2.120

SECONDARY outcome

Timeframe: Week 4, 8, 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)

The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 Baseline (n=150, 97, 25, 28)	11.3 Number of micturitions Standard Deviation 2.85	11.0 Number of micturitions Standard Deviation 2.69	11.2 Number of micturitions Standard Deviation 2.71	12.3 Number of micturitions Standard Deviation 3.31
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 Week 4 (n=150, 97, 25, 28)	-1.42 Number of micturitions Standard Deviation 1.855	-1.73 Number of micturitions Standard Deviation 1.899	-1.28 Number of micturitions Standard Deviation 1.403	-0.45 Number of micturitions Standard Deviation 1.757
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 Week 8 (n=148, 95, 25, 28)	-2.11 Number of micturitions Standard Deviation 1.946	-2.03 Number of micturitions Standard Deviation 1.897	-1.81 Number of micturitions Standard Deviation 2.035	-2.63 Number of micturitions Standard Deviation 2.005
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 Week 28 (n=137, 87, 23, 27)	-2.33 Number of micturitions Standard Deviation 2.338	-2.18 Number of micturitions Standard Deviation 2.351	-2.06 Number of micturitions Standard Deviation 2.260	-3.02 Number of micturitions Standard Deviation 2.315
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 Week 52 (n=133, 84, 22, 27)	-2.63 Number of micturitions Standard Deviation 2.220	-2.48 Number of micturitions Standard Deviation 2.02	-2.21 Number of micturitions Standard Deviation 2.196	-3.44 Number of micturitions Standard Deviation 2.683
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 Week 52 (LOCF) (n=150, 97, 25, 28)	-2.49 Number of micturitions Standard Deviation 2.172	-2.35 Number of micturitions Standard Deviation 1.970	-2.04 Number of micturitions Standard Deviation 2.135	-3.36 Number of micturitions Standard Deviation 2.673

SECONDARY outcome

Timeframe: Week 4, 8, 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)

The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 Baseline (n=150, 97, 25, 28)	4.5 Number of episodes Standard Deviation 3.40	3.9 Number of episodes Standard Deviation 3.31	6.2 Number of episodes Standard Deviation 3.72	5.1 Number of episodes Standard Deviation 2.87
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 4 (n=150, 97, 25, 28)	-1.69 Number of episodes Standard Deviation 2.009	-1.77 Number of episodes Standard Deviation 1.856	-1.75 Number of episodes Standard Deviation 2.572	-1.37 Number of episodes Standard Deviation 2.001
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 8 (n=148, 95, 25, 28)	-2.44 Number of episodes Standard Deviation 2.194	-2.32 Number of episodes Standard Deviation 1.881	-2.59 Number of episodes Standard Deviation 2.940	-2.70 Number of episodes Standard Deviation 2.463
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 28 (n=137, 87, 23, 27)	-2.54 Number of episodes Standard Deviation 2.597	-2.41 Number of episodes Standard Deviation 1.855	-3.12 Number of episodes Standard Deviation 3.304	-2.46 Number of episodes Standard Deviation 3.780
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (n=133, 84, 22, 27)	-2.76 Number of episodes Standard Deviation 2.901	-2.55 Number of episodes Standard Deviation 2.579	-2.80 Number of episodes Standard Deviation 3.193	-3.37 Number of episodes Standard Deviation 3.565
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (LOCF) (n=150, 97, 25, 28)	-2.61 Number of episodes Standard Deviation 2.885	-2.30 Number of episodes Standard Deviation 2.531	-2.93 Number of episodes Standard Deviation 3.319	-3.40 Number of episodes Standard Deviation 3.504

SECONDARY outcome

Timeframe: Week 4, 8, 28 and 52

Population: Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)

The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=103 Participants All subjects	4 mg n=62 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=17 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=24 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 Baseilne (n=103, 62, 17,24)	1.8 Number of episodes Standard Deviation 1.74	1.6 Number of episodes Standard Deviation 1.34	1.8 Number of episodes Standard Deviation 1.33	2.5 Number of episodes Standard Deviation 2.63
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 4 (n=103, 62, 17,24)	-0.84 Number of episodes Standard Deviation 1.140	-0.99 Number of episodes Standard Deviation 1.166	-0.80 Number of episodes Standard Deviation 1.225	-0.49 Number of episodes Standard Deviation 0.963
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 8 (n=102, 61, 17, 24)	-1.23 Number of episodes Standard Deviation 1.354	-1.16 Number of episodes Standard Deviation 1.272	-1.43 Number of episodes Standard Deviation 1.504	-1.28 Number of episodes Standard Deviation 1.486
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 28 (n= 97, 58, 16, 23)	-1.39 Number of episodes Standard Deviation 1.476	-1.26 Number of episodes Standard Deviation 1.322	-1.31 Number of episodes Standard Deviation 1.542	-1.77 Number of episodes Standard Deviation 1.779
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (n=94, 56, 15, 23)	-1.37 Number of episodes Standard Deviation 1.589	-1.26 Number of episodes Standard Deviation 1.331	-1.16 Number of episodes Standard Deviation 1.847	-1.75 Number of episodes Standard Deviation 1.962
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (LOCF) (n=103, 62, 17,24)	-1.38 Number of episodes Standard Deviation 1.557	-1.24 Number of episodes Standard Deviation 1.282	-1.20 Number of episodes Standard Deviation 1.740	-1.86 Number of episodes Standard Deviation 1.990

SECONDARY outcome

Timeframe: Week 4, 8, 28 and 52

Population: Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)

The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=116 Participants All subjects	4 mg n=69 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=23 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=24 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 Baseline (n=116, 69, 23, 24)	1.4 Number of micturitions Standard Deviation 1.04	1.2 Number of micturitions Standard Deviation 1.04	1.6 Number of micturitions Standard Deviation 0.93	1.6 Number of micturitions Standard Deviation 1.05
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 Week 4 (n=116, 69, 23, 24)	-0.31 Number of micturitions Standard Deviation 0.727	-0.34 Number of micturitions Standard Deviation 0.752	-0.45 Number of micturitions Standard Deviation 0.556	-0.08 Number of micturitions Standard Deviation 0.776
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 Week 8 (n=115, 68, 23, 24)	-0.43 Number of micturitions Standard Deviation 0.797	-0.33 Number of micturitions Standard Deviation 0.812	-0.55 Number of micturitions Standard Deviation 0.845	-0.60 Number of micturitions Standard Deviation 0.688
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 Week 28 (n=106, 62, 21, 23)	-0.47 Number of micturitions Standard Deviation 0.752	-0.36 Number of micturitions Standard Deviation 0.788	-0.56 Number of micturitions Standard Deviation 0.694	-0.71 Number of micturitions Standard Deviation 0.661
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (n=103, 60, 20, 23)	-0.57 Number of micturitions Standard Deviation 0.807	-0.46 Number of micturitions Standard Deviation 0.904	-0.68 Number of micturitions Standard Deviation 0.546	-0.75 Number of micturitions Standard Deviation 0.698
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 Week 52 (LOCF) (n=116, 69, 23, 24)	-0.50 Number of micturitions Standard Deviation 0.826	-0.38 Number of micturitions Standard Deviation 0.908	-0.62 Number of micturitions Standard Deviation 0.614	-0.71 Number of micturitions Standard Deviation 0.718

SECONDARY outcome

Timeframe: Week 4, 8, 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)

Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 Baseline (n=150, 97, 25, 28)	158.1 mL Standard Deviation 48.09	162.8 mL Standard Deviation 48.78	156.1 mL Standard Deviation 42.75	143.6 mL Standard Deviation 48.73
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 Week 4 (n=150, 97, 25, 28)	16.67 mL Standard Deviation 41.908	20.58 mL Standard Deviation 44.357	12.18 mL Standard Deviation 43.399	7.16 mL Standard Deviation 29.231
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 Week 8 (n=148, 95, 25, 28)	22.34 mL Standard Deviation 51.339	21.86 mL Standard Deviation 58.194	23.00 mL Standard Deviation 35.061	23.37 mL Standard Deviation 38.273
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 Week 28 (n=137, 87, 23, 27)	32.59 mL Standard Deviation 46.389	31.98 mL Standard Deviation 50.365	40.20 mL Standard Deviation 41.613	28.10 mL Standard Deviation 36.431
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 Week 52 (n=133, 84, 22, 27)	35.92 mL Standard Deviation 44.007	40.21 mL Standard Deviation 47.646	33.02 mL Standard Deviation 40.772	24.95 mL Standard Deviation 32.414
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 Week 52 (LOCF) (n=150, 97, 25, 28)	33.42 mL Standard Deviation 45.175	37.08 mL Standard Deviation 49.276	28.22 mL Standard Deviation 40.693	25.38 mL Standard Deviation 31.890

SECONDARY outcome

Timeframe: Week 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)

KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.

KHQ consists of the following domains:

• General health perceptions (GHP)
• Impact on life
• Role limitations
• Physical limitations
• Social limitations
• Personal relationships (PR)
• Emotions
• Sleep/energy
• Incontinence severity measures (ISM)

Change: mean at Week 28 and 52 minus mean at Baseline

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Emotions: Baseline (n=150, 97, 25, 28)	51.2 Scores on a ascle Standard Deviation 28.38	49.1 Scores on a ascle Standard Deviation 27.49	52.0 Scores on a ascle Standard Deviation 32.19	57.5 Scores on a ascle Standard Deviation 27.89
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Emotions: Week 28 (n=137, 87, 23, 27)	-27.49 Scores on a ascle Standard Deviation 24.219	-27.84 Scores on a ascle Standard Deviation 23.163	-27.54 Scores on a ascle Standard Deviation 26.137	-26.34 Scores on a ascle Standard Deviation 26.714
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 GHP: Baseline (n=150, 97, 25, 28)	37.5 Scores on a ascle Standard Deviation 21.63	37.1 Scores on a ascle Standard Deviation 21.38	37.0 Scores on a ascle Standard Deviation 24.07	39.3 Scores on a ascle Standard Deviation 20.89
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 GHP: Week 28 (n=137, 87, 23, 27)	-2.19 Scores on a ascle Standard Deviation 24.903	-0.57 Scores on a ascle Standard Deviation 26.131	0.00 Scores on a ascle Standard Deviation 22.613	-9.26 Scores on a ascle Standard Deviation 22.088
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 GHP: Week 52 (n=134, 85, 22, 27)	-5.22 Scores on a ascle Standard Deviation 22.751	-5.88 Scores on a ascle Standard Deviation 23.981	-5.68 Scores on a ascle Standard Deviation 21.729	-2.78 Scores on a ascle Standard Deviation 20.016
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Impact on life: Baseline (n=150, 97, 25, 28)	64.0 Scores on a ascle Standard Deviation 23.97	61.2 Scores on a ascle Standard Deviation 21.88	68.0 Scores on a ascle Standard Deviation 31.15	70.2 Scores on a ascle Standard Deviation 22.84
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Impact on life: Week 28 (n=137, 87, 23, 27)	-32.85 Scores on a ascle Standard Deviation 27.112	-32.18 Scores on a ascle Standard Deviation 24.084	-37.68 Scores on a ascle Standard Deviation 33.791	-30.86 Scores on a ascle Standard Deviation 30.559
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Impact on life: Week 52 (n=134, 85, 22, 27)	-33.08 Scores on a ascle Standard Deviation 29.333	-32.94 Scores on a ascle Standard Deviation 26.970	-31.82 Scores on a ascle Standard Deviation 33.297	-34.57 Scores on a ascle Standard Deviation 33.945
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Role limitations: Baseline (n=150, 97, 25, 28)	47.9 Scores on a ascle Standard Deviation 24.75	46.0 Scores on a ascle Standard Deviation 23.05	52.0 Scores on a ascle Standard Deviation 30.55	50.6 Scores on a ascle Standard Deviation 25.04
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Role limitations: Week 28 (n=137, 87, 23, 27)	-28.10 Scores on a ascle Standard Deviation 24.733	-28.16 Scores on a ascle Standard Deviation 22.777	-33.33 Scores on a ascle Standard Deviation 28.427	-23.46 Scores on a ascle Standard Deviation 27.448
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Role limitations: Week 52 (n=134, 85, 22, 27)	-29.85 Scores on a ascle Standard Deviation 26.732	-30.98 Scores on a ascle Standard Deviation 26.371	-31.06 Scores on a ascle Standard Deviation 28.310	-25.31 Scores on a ascle Standard Deviation 27.100
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Physical limitations: Baseline (n=150, 97, 25, 28	51.9 Scores on a ascle Standard Deviation 26.93	49.8 Scores on a ascle Standard Deviation 26.73	54.0 Scores on a ascle Standard Deviation 29.38	57.1 Scores on a ascle Standard Deviation 25.43
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Physical limitations: Week 28 (n=137, 87, 23, 27)	-27.25 Scores on a ascle Standard Deviation 26.031	-26.63 Scores on a ascle Standard Deviation 25.727	-31.16 Scores on a ascle Standard Deviation 29.432	-25.93 Scores on a ascle Standard Deviation 24.605
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Physical limitations: Week 52 (n=134, 85, 22, 27)	-30.10 Scores on a ascle Standard Deviation 25.071	-32.16 Scores on a ascle Standard Deviation 24.504	-28.03 Scores on a ascle Standard Deviation 25.915	-25.31 Scores on a ascle Standard Deviation 26.300
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Social limitations: Baseline (n=150, 97, 25, 28)	30.3 Scores on a ascle Standard Deviation 24.36	27.5 Scores on a ascle Standard Deviation 23.38	31.1 Scores on a ascle Standard Deviation 25.86	39.3 Scores on a ascle Standard Deviation 25.03
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Social limitations: Week 28 (n=137, 87, 23, 27)	-19.63 Scores on a ascle Standard Deviation 19.410	-17.37 Scores on a ascle Standard Deviation 19.241	-22.71 Scores on a ascle Standard Deviation 19.955	-24.28 Scores on a ascle Standard Deviation 19.006
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Social limitations: Week 52 (n=134, 85, 22, 27)	-22.35 Scores on a ascle Standard Deviation 22.661	-20.72 Scores on a ascle Standard Deviation 22.245	-24.75 Scores on a ascle Standard Deviation 21.668	-25.51 Scores on a ascle Standard Deviation 25.000
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 PR: Baseline (n=124, 82, 18, 24)	19.5 Scores on a ascle Standard Deviation 22.46	17.3 Scores on a ascle Standard Deviation 20.86	16.7 Scores on a ascle Standard Deviation 22.87	29.2 Scores on a ascle Standard Deviation 25.66
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 PR: Week 28 (n=110, 71, 16, 23)	-13.18 Scores on a ascle Standard Deviation 18.354	-11.74 Scores on a ascle Standard Deviation 18.558	-10.42 Scores on a ascle Standard Deviation 17.078	-19.57 Scores on a ascle Standard Deviation 17.875
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 PR: Week 52 (n=109, 70, 16, 23)	-14.68 Scores on a ascle Standard Deviation 19.342	-13.57 Scores on a ascle Standard Deviation 19.514	-12.50 Scores on a ascle Standard Deviation 17.743	-19.57 Scores on a ascle Standard Deviation 19.881
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Emotions: Week 52 (n=134, 85, 22, 27)	-30.27 Scores on a ascle Standard Deviation 26.434	-32.42 Scores on a ascle Standard Deviation 24.799	-26.26 Scores on a ascle Standard Deviation 28.595	-26.75 Scores on a ascle Standard Deviation 29.760
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Sleep/energy: Baseline (n=150, 97, 25, 28)	37.0 Scores on a ascle Standard Deviation 27.44	33.2 Scores on a ascle Standard Deviation 24.00	37.3 Scores on a ascle Standard Deviation 29.77	50.0 Scores on a ascle Standard Deviation 33.02
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Sleep/energy: Week 28 (n=137, 87, 23, 27)	-18.61 Scores on a ascle Standard Deviation 21.586	-17.43 Scores on a ascle Standard Deviation 19.998	-18.12 Scores on a ascle Standard Deviation 26.070	-22.84 Scores on a ascle Standard Deviation 22.715
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 Sleep/energy: Week 52 (n=134, 85, 22, 27)	-21.27 Scores on a ascle Standard Deviation 23.338	-20.59 Scores on a ascle Standard Deviation 22.219	-15.91 Scores on a ascle Standard Deviation 22.700	-27.78 Scores on a ascle Standard Deviation 26.554
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 ISM: Baseline (n=150, 97, 25, 28)	34.8 Scores on a ascle Standard Deviation 20.39	32.6 Scores on a ascle Standard Deviation 18.83	31.5 Scores on a ascle Standard Deviation 18.51	45.7 Scores on a ascle Standard Deviation 24.05
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 ISM: Week 28 (n=137, 87, 23, 27)	-16.25 Scores on a ascle Standard Deviation 17.223	-14.87 Scores on a ascle Standard Deviation 16.541	-16.81 Scores on a ascle Standard Deviation 17.623	-20.25 Scores on a ascle Standard Deviation 18.990
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 ISM: Week 52 (n=134, 85, 22, 27)	-19.00 Scores on a ascle Standard Deviation 19.199	-18.43 Scores on a ascle Standard Deviation 18.392	-14.55 Scores on a ascle Standard Deviation 19.370	-24.44 Scores on a ascle Standard Deviation 21.001

SECONDARY outcome

Timeframe: Week 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)

OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).

Change: mean at Week 28 and 52 minus mean at baseline

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 SBS: Baseline (n=150, 97, 25, 28)	42.7 Scores on a scale Standard Deviation 22.53	37.4 Scores on a scale Standard Deviation 19.74	45.2 Scores on a scale Standard Deviation 21.04	58.7 Scores on a scale Standard Deviation 25.55
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 SBS: Week 28 (n=137, 87, 23, 27)	-25.13 Scores on a scale Standard Deviation 19.835	-22.30 Scores on a scale Standard Deviation 18.588	-27.07 Scores on a scale Standard Deviation 16.231	-32.59 Scores on a scale Standard Deviation 24.578
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 SBS: Week 52 (n=134, 85, 22, 27)	-25.24 Scores on a scale Standard Deviation 20.287	-22.41 Scores on a scale Standard Deviation 17.616	-21.25 Scores on a scale Standard Deviation 16.597	-37.41 Scores on a scale Standard Deviation 26.206
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Total: Baseline (n=150, 97, 25, 28)	70.7 Scores on a scale Standard Deviation 18.31	73.9 Scores on a scale Standard Deviation 16.66	72.2 Scores on a scale Standard Deviation 18.97	58.4 Scores on a scale Standard Deviation 18.64
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Total: Week 28 (n=137, 87, 23, 27)	15.66 Scores on a scale Standard Deviation 14.711	14.26 Scores on a scale Standard Deviation 13.366	16.00 Scores on a scale Standard Deviation 14.787	19.88 Scores on a scale Standard Deviation 18.191
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Total: Week 52 (n=134, 85, 22, 27)	16.92 Scores on a scale Standard Deviation 16.461	15.99 Scores on a scale Standard Deviation 14.717	13.35 Scores on a scale Standard Deviation 14.961	22.76 Scores on a scale Standard Deviation 21.365
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Coping: Baseline (n=150, 97, 25, 28)	61.6 Scores on a scale Standard Deviation 26.07	65.6 Scores on a scale Standard Deviation 24.59	64.6 Scores on a scale Standard Deviation 26.49	45.1 Scores on a scale Standard Deviation 25.04
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Coping: Week 28 (n=137, 87, 23, 27)	20.86 Scores on a scale Standard Deviation 20.008	19.66 Scores on a scale Standard Deviation 17.871	18.15 Scores on a scale Standard Deviation 18.605	27.04 Scores on a scale Standard Deviation 26.339
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Coping: Week 52 (n=134, 85, 22, 27)	21.75 Scores on a scale Standard Deviation 23.773	20.91 Scores on a scale Standard Deviation 21.821	15.00 Scores on a scale Standard Deviation 18.127	29.91 Scores on a scale Standard Deviation 31.259
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Concern: Baseline (n=150, 97, 25, 28)	71.0 Scores on a scale Standard Deviation 21.54	73.9 Scores on a scale Standard Deviation 19.70	72.5 Scores on a scale Standard Deviation 20.90	59.5 Scores on a scale Standard Deviation 24.98
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Concern: Week 28 (n=137, 87, 23, 27)	18.48 Scores on a scale Standard Deviation 18.180	16.95 Scores on a scale Standard Deviation 17.142	21.24 Scores on a scale Standard Deviation 17.943	21.06 Scores on a scale Standard Deviation 21.515
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Concern: Week 52 (n=134, 85, 22, 27)	19.77 Scores on a scale Standard Deviation 18.400	19.23 Scores on a scale Standard Deviation 16.946	16.49 Scores on a scale Standard Deviation 17.961	24.13 Scores on a scale Standard Deviation 22.669
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Sleep: Baseline (n=150, 97, 25, 28)	66.5 Scores on a scale Standard Deviation 23.95	69.9 Scores on a scale Standard Deviation 22.30	65.8 Scores on a scale Standard Deviation 25.61	55.6 Scores on a scale Standard Deviation 25.45
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Sleep: Week 28 (n=137, 87, 23, 27)	12.41 Scores on a scale Standard Deviation 21.808	11.13 Scores on a scale Standard Deviation 21.579	13.22 Scores on a scale Standard Deviation 19.313	15.85 Scores on a scale Standard Deviation 24.769
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Sleep: Week 52 (n=134, 85, 22, 27)	14.90 Scores on a scale Standard Deviation 21.467	13.32 Scores on a scale Standard Deviation 19.629	13.09 Scores on a scale Standard Deviation 19.873	21.33 Scores on a scale Standard Deviation 27.197
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Social: Baseline (n=150, 97, 25, 28)	89.2 Scores on a scale Standard Deviation 14.17	91.2 Scores on a scale Standard Deviation 12.31	90.6 Scores on a scale Standard Deviation 13.71	81.0 Scores on a scale Standard Deviation 17.81
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQ- Social: Week 28 (n=137, 87, 23, 27)	6.66 Scores on a scale Standard Deviation 11.461	5.01 Scores on a scale Standard Deviation 10.064	8.00 Scores on a scale Standard Deviation 13.156	10.81 Scores on a scale Standard Deviation 13.304
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 HRQL-Social: Week 52 (n=134, 85, 22, 27)	7.22 Scores on a scale Standard Deviation 12.277	6.26 Scores on a scale Standard Deviation 10.537	6.55 Scores on a scale Standard Deviation 12.802	10.81 Scores on a scale Standard Deviation 16.222

SECONDARY outcome

Timeframe: Week 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)

The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:

1. no problems at all

2. some very minor problems

3. some minor problems

4. some moderate problems

5. severe problems

6. many severe problems

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage Week 28 (n=137, 87, 23, 27)	115 Number of subjects	75 Number of subjects	21 Number of subjects	19 Number of subjects
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage Week 52 (n=134, 85, 22, 27)	116 Number of subjects	75 Number of subjects	18 Number of subjects	23 Number of subjects

SECONDARY outcome

Timeframe: Week 28 and 52

Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)

The PPBC assessment was rated on a 6-point scale as follows:

1. no problems at all

2. some very minor problems

3. some minor problems

4. some moderate problems

5. severe problems

6. many severe problems

Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.

Outcome measures

Measure	Total n=150 Participants All subjects	4 mg n=97 Participants Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 Participants Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 Participants Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Change From Baseline in Grade of PPBC at Week 28 and 52 Baseline (n=150, 97, 25, 28)	4.3 Scores on a scale Standard Deviation 0.51	4.2 Scores on a scale Standard Deviation 0.43	4.5 Scores on a scale Standard Deviation 0.65	4.4 Scores on a scale Standard Deviation 0.56
Change From Baseline in Grade of PPBC at Week 28 and 52 Week 28 (n=137, 87, 23, 27)	-1.66 Scores on a scale Standard Deviation 1.166	-1.74 Scores on a scale Standard Deviation 1.094	-1.83 Scores on a scale Standard Deviation 0.937	-1.26 Scores on a scale Standard Deviation 1.483
Change From Baseline in Grade of PPBC at Week 28 and 52 Week 52 (n=134, 85, 22, 27)	-1.78 Scores on a scale Standard Deviation 1.141	-1.85 Scores on a scale Standard Deviation 1.139	-1.59 Scores on a scale Standard Deviation 1.054	-1.70 Scores on a scale Standard Deviation 1.235

Adverse Events

Total

Serious events: 1 serious events

Other events: 138 other events

Deaths: 0 deaths

4 mg

Serious events: 1 serious events

Other events: 91 other events

Deaths: 0 deaths

4 mg > 8 mg > 4 mg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

4 mg > 8 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total n=152 participants at risk All subjects	4 mg n=99 participants at risk Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 participants at risk Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 participants at risk Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.66% 1/152 • 52 Weeks 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.	1.0% 1/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.

Other adverse events

Measure	Total n=152 participants at risk All subjects	4 mg n=99 participants at risk Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)	4 mg > 8 mg > 4 mg n=25 participants at risk Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)	4 mg > 8 mg n=28 participants at risk Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Ear and labyrinth disorders Vertigo	2.0% 3/152 • 52 Weeks 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.	2.0% 2/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Eye disorders Vision blurred	2.0% 3/152 • 52 Weeks 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.	2.0% 2/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Gastrointestinal disorders Abdominal pain upper	3.3% 5/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Gastrointestinal disorders Constipation	13.2% 20/152 • 52 Weeks 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.	11.1% 11/99 • 52 Weeks 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.	28.0% 7/25 • 52 Weeks 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.	7.1% 2/28 • 52 Weeks 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.
Gastrointestinal disorders Diarrhoea	7.2% 11/152 • 52 Weeks 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.	5.1% 5/99 • 52 Weeks 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.	12.0% 3/25 • 52 Weeks 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.	10.7% 3/28 • 52 Weeks 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.
Gastrointestinal disorders Dry mouth	50.7% 77/152 • 52 Weeks 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.	43.4% 43/99 • 52 Weeks 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.	84.0% 21/25 • 52 Weeks 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.	46.4% 13/28 • 52 Weeks 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.
Gastrointestinal disorders Gastritis	5.9% 9/152 • 52 Weeks 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.	8.1% 8/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Gastrointestinal disorders Nausea	2.6% 4/152 • 52 Weeks 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.	1.0% 1/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Gastrointestinal disorders Periodontitis	2.0% 3/152 • 52 Weeks 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.	0.00% 0/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	7.1% 2/28 • 52 Weeks 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.
Gastrointestinal disorders Stomatitis	2.6% 4/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Infections and infestations Cystitis	7.9% 12/152 • 52 Weeks 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.	8.1% 8/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	10.7% 3/28 • 52 Weeks 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.
Infections and infestations Gastroenteritis	2.0% 3/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Infections and infestations Nasopharyngitis	32.9% 50/152 • 52 Weeks 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.	35.4% 35/99 • 52 Weeks 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.	28.0% 7/25 • 52 Weeks 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.	28.6% 8/28 • 52 Weeks 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.
Infections and infestations Upper respiratory tract infection	7.9% 12/152 • 52 Weeks 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.	8.1% 8/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	7.1% 2/28 • 52 Weeks 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.
Injury, poisoning and procedural complications Contusion	2.0% 3/152 • 52 Weeks 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.	1.0% 1/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Injury, poisoning and procedural complications Joint sprain	2.0% 3/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Investigations Alanine aminotransferase increased	2.6% 4/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Investigations Aspartate aminotransferase increased	2.6% 4/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 6/152 • 52 Weeks 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.	5.1% 5/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Musculoskeletal and connective tissue disorders Back pain	10.5% 16/152 • 52 Weeks 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.	12.1% 12/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	10.7% 3/28 • 52 Weeks 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.
Nervous system disorders Dizziness	3.9% 6/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Nervous system disorders Headache	3.3% 5/152 • 52 Weeks 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.	5.1% 5/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Nervous system disorders Somnolence	3.3% 5/152 • 52 Weeks 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.	1.0% 1/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	7.1% 2/28 • 52 Weeks 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.
Psychiatric disorders Insomnia	2.0% 3/152 • 52 Weeks 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.	2.0% 2/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Renal and urinary disorders Dysuria	3.9% 6/152 • 52 Weeks 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.	2.0% 2/99 • 52 Weeks 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.	12.0% 3/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Renal and urinary disorders Residual urine	2.0% 3/152 • 52 Weeks 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.	1.0% 1/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	0.00% 0/28 • 52 Weeks 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.
Renal and urinary disorders Urine flow decreased	2.6% 4/152 • 52 Weeks 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.	1.0% 1/99 • 52 Weeks 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.	8.0% 2/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	4.6% 7/152 • 52 Weeks 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.	4.0% 4/99 • 52 Weeks 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.	4.0% 1/25 • 52 Weeks 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.	7.1% 2/28 • 52 Weeks 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.
Skin and subcutaneous tissue disorders Eczema	2.6% 4/152 • 52 Weeks 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.	3.0% 3/99 • 52 Weeks 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.	0.00% 0/25 • 52 Weeks 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.	3.6% 1/28 • 52 Weeks 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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