Trial Outcomes & Findings for A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder (NCT NCT00928070)

Last Updated: 2013-01-17

Results Overview

UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

566 participants

Primary outcome timeframe

Baseline

Results posted on

2013-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Overall Study STARTED	283	283
Overall Study Treated	281	281
Overall Study COMPLETED	220	226
Overall Study NOT COMPLETED	63	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	10	3
Overall Study Adverse Event	14	26
Overall Study Lack of Efficacy	9	5
Overall Study Did not meet entrance criteria	16	9
Overall Study Protocol Violation	6	5
Overall Study Randomized but not treated	2	2
Overall Study Other	5	5

Baseline Characteristics

A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=281 Participants Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=281 Participants Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.	Total n=562 Participants Total of all reporting groups
Age, Customized 65 to 74 years	134 participants n=93 Participants	145 participants n=4 Participants	279 participants n=27 Participants
Age, Customized 75 to 84 years	118 participants n=93 Participants	106 participants n=4 Participants	224 participants n=27 Participants
Age, Customized At least 85 years	29 participants n=93 Participants	30 participants n=4 Participants	59 participants n=27 Participants
Sex: Female, Male Female	236 Participants n=93 Participants	225 Participants n=4 Participants	461 Participants n=27 Participants
Sex: Female, Male Male	45 Participants n=93 Participants	56 Participants n=4 Participants	101 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Full analysis set (FAS) population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=250 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours	3.93 episodes per 24 hours Standard Deviation 2.16	4.07 episodes per 24 hours Standard Deviation 2.33

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: FAS population. Last observation carried forward (LOCF) method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Outcome measures

Outcome measures
Measure	Placebo n=250 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12	-2.20 episodes per 24 hours Standard Error 0.15	-2.84 episodes per 24 hours Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.

Outcome measures

Outcome measures
Measure	Placebo n=248 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=255 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4	-1.54 episodes per 24 hours Standard Error 0.16	-2.36 episodes per 24 hours Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100\*(Week 4 or 12 - baseline)/baseline).

Outcome measures

Outcome measures
Measure	Placebo n=250 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 Change at Week 4	-39.2 percent change Standard Deviation 65.7	-57.2 percent change Standard Deviation 54.4
Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 Change at Week 12	-55.4 percent change Standard Deviation 63.1	-71.2 percent change Standard Deviation 51.4

SECONDARY outcome

Timeframe: Baseline

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=258 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Mean Number of Micturitions Per 24 Hours	12.22 micturitions per 24 hours Standard Deviation 3.21	12.11 micturitions per 24 hours Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=258 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 Change at Week 4	-0.77 micturitions per 24 hours Standard Error 0.17	-1.64 micturitions per 24 hours Standard Error 0.17
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 Change at Week 12	-1.50 micturitions per 24 hours Standard Error 0.16	-2.34 micturitions per 24 hours Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100\*(Week 4 or 12 - baseline)/baseline).

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=258 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Change at Week 4	-5.1 percent change Standard Deviation 24.4	-12.7 percent change Standard Deviation 19.1
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Change at Week 12	-10.4 percent change Standard Deviation 22.4	-17.8 percent change Standard Deviation 19.6

SECONDARY outcome

Timeframe: Baseline

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Mean Number of Micturition-related Urgency Episodes Per 24 Hours	10.30 episodes per 24 hours Standard Deviation 3.67	10.02 episodes per 24 hours Standard Deviation 3.54

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 4	-1.64 episodes per 24 hours Standard Error 0.24	-2.74 episodes per 24 hours Standard Error 0.24
Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 12	-2.75 episodes per 24 hours Standard Error 0.25	-4.15 episodes per 24 hours Standard Error 0.25

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100\*(Week 4 or 12 - baseline)/baseline).

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 4	-12.7 percent change Standard Deviation 45.0	-26.2 percent change Standard Deviation 39.4
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 12	-23.9 percent change Standard Deviation 46.4	-39.7 percent change Standard Deviation 45.0

SECONDARY outcome

Timeframe: Baseline

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=254 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours	2.87 episodes per 24 hours Standard Deviation 1.51	2.69 episodes per 24 hours Standard Deviation 1.38

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=254 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 4	-0.44 episodes per 24 hours Standard Error 0.09	-0.58 episodes per 24 hours Standard Error 0.09
Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 12	-0.68 episodes per 24 hours Standard Error 0.09	-0.97 episodes per 24 hours Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100\*(Week 4 or 12 - baseline)/baseline).

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=254 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 4	-4.9 percent change Standard Deviation 68.2	-18.0 percent change Standard Deviation 62.6
Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 Change at Week 12	-15.5 percent change Standard Deviation 63.6	-31.2 percent change Standard Deviation 59.5

SECONDARY outcome

Timeframe: Baseline

Population: FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Frequency-Urgency Sum Rating Per 24 Hours	45.33 units on a scale Standard Deviation 13.20	44.92 units on a scale Standard Deviation 13.45

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=256 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12 Change at Week 4	-6.95 units on a scale Standard Error 0.86	-11.62 units on a scale Standard Error 0.86
Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12 Change at Week 12	-11.53 units on a scale Standard Error 0.84	-16.50 units on a scale Standard Error 0.84

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'n' is signifying those participants of the population subsets who were evaluated for this measure at the time point for each group respectively.

Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=\<) 3.5 and more than (\>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =\< 2.5 and \> 2.5 undergarments/day.

Outcome measures

Outcome measures
Measure	Placebo n=281 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=281 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Baseline: =<3.5 undergarments (n=193,184)	1.41 undergarments Standard Deviation 0.84	1.49 undergarments Standard Deviation 0.74
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Baseline: >3.5 undergarments (n=12,19)	4.97 undergarments Standard Deviation 1.84	4.81 undergarments Standard Deviation 0.92
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Baseline: =<2.5 undergarments (n=172,169)	1.21 undergarments Standard Deviation 0.63	1.35 undergarments Standard Deviation 0.62
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Baseline: >2.5 undergarments (n=35,35)	3.71 undergarments Standard Deviation 1.42	3.94 undergarments Standard Deviation 1.18
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Change at Week 4: =<3.5 undergarments(n=193,184)	-0.27 undergarments Standard Deviation 1.13	-0.61 undergarments Standard Deviation 1.09
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Change at Week 4: >3.5 undergarments(n=12,19)	-2.56 undergarments Standard Deviation 3.07	-2.11 undergarments Standard Deviation 3.38
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Change at Week 12: =<2.5 undergarments(n=172,169)	-0.31 undergarments Standard Deviation 1.06	-0.72 undergarments Standard Deviation 0.82
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 Change at Week 12: >2.5 undergarments(n=35,35)	-2.14 undergarments Standard Deviation 2.06	-1.98 undergarments Standard Deviation 1.86

SECONDARY outcome

Timeframe: Screening, Week 4, 12

PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.

Outcome measures

Outcome measures
Measure	Placebo n=264 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=265 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Baseline: No problems at all	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Baseline: Some very minor problems	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Baseline: Some minor problems	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Baseline: Moderate problems	44.7 percentage of participants	44.5 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Baseline: Severe problems	43.9 percentage of participants	44.2 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Baseline: Many severe problems	11.4 percentage of participants	11.3 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 4: Deterioration	12.3 percentage of participants	9.5 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 4: No change	42.5 percentage of participants	29.8 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 4: Minor improvement	25.3 percentage of participants	27.5 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 4: Major improvement	19.9 percentage of participants	33.2 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 12: Deterioration	12.1 percentage of participants	7.2 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 12: No change	33.7 percentage of participants	27.2 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 12: Minor improvement	25.0 percentage of participants	26.8 percentage of participants
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 Change at Week 12: Major improvement	29.2 percentage of participants	38.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.

OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother.

Outcome measures

Outcome measures
Measure	Placebo n=267 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=269 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	67.67 units on a scale Standard Deviation 18.59	67.25 units on a scale Standard Deviation 19.04

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.

Outcome measures

Outcome measures
Measure	Placebo n=267 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=269 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 Change at Week 4	-13.81 units on a scale Standard Error 1.46	-22.96 units on a scale Standard Error 1.46
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 Change at Week 12	-20.48 units on a scale Standard Error 1.58	-28.08 units on a scale Standard Error 1.58

SECONDARY outcome

Timeframe: Baseline

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.

OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicative of better HRQL.

Outcome measures

Outcome measures
Measure	Placebo n=267 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=269 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) Concern domain	45.89 units on a scale Standard Deviation 25.38	46.57 units on a scale Standard Deviation 25.88
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) Coping domain	44.72 units on a scale Standard Deviation 26.12	44.74 units on a scale Standard Deviation 26.76
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) Sleep domain	40.19 units on a scale Standard Deviation 26.51	43.41 units on a scale Standard Deviation 25.76
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) Social interaction domain	72.05 units on a scale Standard Deviation 25.35	72.70 units on a scale Standard Deviation 25.45
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) Total	49.61 units on a scale Standard Deviation 22.35	50.58 units on a scale Standard Deviation 22.87

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Population: FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. LOCF method was used to impute Week 12 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.

Outcome measures

Outcome measures
Measure	Placebo n=267 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=269 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 4: concern domain	12.35 units on a scale Standard Error 1.61	20.51 units on a scale Standard Error 1.61
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 4: coping domain	12.90 units on a scale Standard Error 1.65	19.86 units on a scale Standard Error 1.66
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 4: sleeping domain	13.33 units on a scale Standard Error 1.56	17.33 units on a scale Standard Error 1.56
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 4: social interaction domain	8.77 units on a scale Standard Error 1.19	11.22 units on a scale Standard Error 1.19
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 4: total	12.00 units on a scale Standard Error 1.37	17.80 units on a scale Standard Error 1.38
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 12: concern domain	17.20 units on a scale Standard Error 1.70	26.24 units on a scale Standard Error 1.70
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 12: coping domain	20.34 units on a scale Standard Error 1.72	25.66 units on a scale Standard Error 1.72
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 12: sleeping domain	19.05 units on a scale Standard Error 1.63	23.10 units on a scale Standard Error 1.63
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 12: social interaction domain	12.12 units on a scale Standard Error 1.26	14.47 units on a scale Standard Error 1.26
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 Change at Week 12: total	17.55 units on a scale Standard Error 1.46	23.08 units on a scale Standard Error 1.46

SECONDARY outcome

Timeframe: Week 12

OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=228 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control	52.98 units on a scale Standard Deviation 33.82	68.89 units on a scale Standard Deviation 28.89

SECONDARY outcome

Timeframe: Week 12

Participant's response to question, "overall, how satisfied are you with your OAB medication?" was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into "satisfied", and 4 and 5 were combined into "dissatisfied".

Outcome measures

Outcome measures
Measure	Placebo n=224 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=227 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response Not satisfied	37.5 percentage of participants	18.9 percentage of participants
Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response Neither dissatisfied nor satisfied	15.2 percentage of participants	9.3 percentage of participants
Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response Satisfied	47.3 percentage of participants	71.8 percentage of participants

SECONDARY outcome

Timeframe: Screening

MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.

Outcome measures

Outcome measures
Measure	Placebo n=220 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=223 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Mini Mental State Examination (MMSE)	28.04 units on a scale Standard Deviation 2.05	28.16 units on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Screening, Week 12

Outcome measures

Outcome measures
Measure	Placebo n=220 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=223 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12	0.33 units on a scale Standard Error 0.12	0.15 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

PVR volume is defined as volume of urine remaining in the bladder immediately after urination.

Outcome measures

Outcome measures
Measure	Placebo n=266 Participants Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=271 Participants Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12 Baseline	26.51 mL Standard Deviation 35.36	25.69 mL Standard Deviation 34.28
Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12 Change at Week 4	1.83 mL Standard Deviation 41.30	13.43 mL Standard Deviation 57.70
Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12 Change at Week 12	-2.98 mL Standard Deviation 35.95	13.58 mL Standard Deviation 60.22

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 120 other events

Deaths: 0 deaths

Fesoterodine

Serious events: 8 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=281 participants at risk Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine n=281 participants at risk Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Cardiac disorders Cardiac failure congestive	0.36% 1/281 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% 0/281 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.
Cardiac disorders Coronary artery occlusion	0.00% 0/281 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.	0.36% 1/281 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 Rectal haemorrhage	0.36% 1/281 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% 0/281 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 Influenza	0.00% 0/281 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.	0.36% 1/281 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 Urosepsis	0.00% 0/281 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.	0.36% 1/281 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 Fall	0.00% 0/281 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.	0.36% 1/281 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 Femur fracture	0.00% 0/281 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.	0.36% 1/281 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 Hip fracture	0.36% 1/281 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.	0.36% 1/281 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 dislocation	0.36% 1/281 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% 0/281 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 Arthritis	0.36% 1/281 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% 0/281 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 Haemarthrosis	0.00% 0/281 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.	0.36% 1/281 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 Muscular weakness	0.00% 0/281 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.	0.36% 1/281 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 Osteoarthritis	0.00% 0/281 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.	0.36% 1/281 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 Chronic obstructive pulmonary disease	0.36% 1/281 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% 0/281 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

Additional Information

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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.
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Restriction type: OTHER