Trial Outcomes & Findings for Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB) (NCT NCT00444925)

Last Updated: 2015-03-24

Results Overview

UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1712 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2015-03-24

Participant Flow

Participants with urgency incontinence Overactive Bladder (OAB) symptoms who met all entrance criteria were randomized to the double-blind treatment period.

Participant milestones

Participant milestones
Measure	Placebo Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Single-blind Placebo Run-In Period STARTED	2446	0	0
Single-blind Placebo Run-In Period COMPLETED	1712	0	0
Single-blind Placebo Run-In Period NOT COMPLETED	734	0	0
Randomized to Double-blind Treatment STARTED	337	690	685
Randomized to Double-blind Treatment COMPLETED	334	684	679
Randomized to Double-blind Treatment NOT COMPLETED	3	6	6
Double-blind Treatment Period STARTED	334	684	679
Double-blind Treatment Period COMPLETED	304	628	598
Double-blind Treatment Period NOT COMPLETED	30	56	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Randomized to Double-blind Treatment Never returned after randomization	3	6	6
Double-blind Treatment Period Death	2	0	0
Double-blind Treatment Period Adverse Event	6	28	44
Double-blind Treatment Period Lack of Efficacy	5	5	13
Double-blind Treatment Period Lost to Follow-up	4	8	5
Double-blind Treatment Period Withdrawal by Subject	6	8	7
Double-blind Treatment Period Other	7	7	12

Baseline Characteristics

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)	Total n=1697 Participants Total of all reporting groups
Age, Customized 18 - 44 years	55 participants n=5 Participants	103 participants n=7 Participants	96 participants n=5 Participants	254 participants n=4 Participants
Age, Customized 45 - 64 years	167 participants n=5 Participants	349 participants n=7 Participants	367 participants n=5 Participants	883 participants n=4 Participants
Age, Customized >= 65 years	112 participants n=5 Participants	232 participants n=7 Participants	216 participants n=5 Participants	560 participants n=4 Participants
Sex: Female, Male Female	269 Participants n=5 Participants	564 Participants n=7 Participants	558 Participants n=5 Participants	1391 Participants n=4 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	120 Participants n=7 Participants	121 Participants n=5 Participants	306 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still blinded.

Outcome measures

Outcome measures
Measure	Placebo n=307 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=626 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=619 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).	-1.46 number of episodes per 24 hours Standard Error 0.10	-1.61 number of episodes per 24 hours Standard Error 0.06	-1.72 number of episodes per 24 hours Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4

Population: FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI\>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 \[Last Observation Carried Forward (LOCF)\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4. Week 1 (n=302, 614, 612)	-0.54 number of episodes per 24 hours Standard Error 0.09	-0.92 number of episodes per 24 hours Standard Error 0.06	-0.95 number of episodes per 24 hours Standard Error 0.06
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4. Week 4 [LOCF] (n=307, 626, 618)	-1.06 number of episodes per 24 hours Standard Error 0.10	-1.40 number of episodes per 24 hours Standard Error 0.06	-1.52 number of episodes per 24 hours Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Population: FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI\>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Percent Change From Baseline of UUI Episodes Per 24 Hours. Week 1 (n=302, 614, 612)	-28.6 percent change Interval -100.0 to 300.0	-55.1 percent change Interval -100.0 to 537.5	-53.6 percent change Interval -100.0 to 525.0
Percent Change From Baseline of UUI Episodes Per 24 Hours. Week 4 [LOCF] (n=307, 626, 618)	-60.0 percent change Interval -100.0 to 300.0	-85.7 percent change Interval -100.0 to 650.0	-93.2 percent change Interval -100.0 to 450.0
Percent Change From Baseline of UUI Episodes Per 24 Hours. Week 12 [LOCF] (n=307, 626, 619)	-82.1 percent change Interval -100.0 to 300.0	-100.0 percent change Interval -100.0 to 450.0	-100.0 percent change Interval -100.0 to 400.0

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Population: FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Voided Volume Per Micturition. Week 1 (n=306, 622, 623)	11.0 voided volume per micturition Standard Error 3.2 • Interval 5.0 to 14.5	19.2 voided volume per micturition Standard Error 2.5 • Interval 13.6 to 21.3	18.7 voided volume per micturition Standard Error 2.5 • Interval 12.6 to 20.9
Change From Baseline in Mean Voided Volume Per Micturition. Week 4 [LOCF] (n=313, 633, 625)	14.0 voided volume per micturition Standard Error 3.8 • Interval 6.9 to 18.9	25.7 voided volume per micturition Standard Error 3.0 • Interval 19.4 to 29.0	30.5 voided volume per micturition Standard Error 3.0 • Interval 24.0 to 33.3
Change From Baseline in Mean Voided Volume Per Micturition. Week 12 [LOCF] (n=313, 633, 626)	16.8 voided volume per micturition Standard Error 3.9 • Interval 9.9 to 22.7	23.5 voided volume per micturition Standard Error 3.0 • Interval 17.1 to 26.9	32.9 voided volume per micturition Standard Error 3.1 • Interval 26.1 to 35.8

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Number of Micturitions Per 24 Hours. Week 4 [LOCF] (n= 313, 634, 627)	-1.2 number of micturitions per 24 hours Standard Error 0.2	-1.8 number of micturitions per 24 hours Standard Error 0.1	-1.9 number of micturitions per 24 hours Standard Error 0.1
Change From Baseline in Mean Number of Micturitions Per 24 Hours. Week 12 [LOCF] (n= 313, 634, 628)	-1.5 number of micturitions per 24 hours Standard Error 0.2	-2.1 number of micturitions per 24 hours Standard Error 0.1	-2.2 number of micturitions per 24 hours Standard Error 0.1
Change From Baseline in Mean Number of Micturitions Per 24 Hours. Week 1 (n=307, 622, 623)	-0.5 number of micturitions per 24 hours Standard Error 0.1	-1.0 number of micturitions per 24 hours Standard Error 0.1	-1.0 number of micturitions per 24 hours Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Population: FAS; (n)=number of subjects with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

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 (ie, 100% \*(Week 12 or 4 - baseline)/baseline).

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Percent Change From Baseline of Micturitions Per 24 Hours. Week 1 (n=307, 622, 623)	-2.7 percent change Interval -48.5 to 68.3	-7.7 percent change Interval -68.2 to 70.0	-7.9 percent change Interval -66.0 to 184.0
Percent Change From Baseline of Micturitions Per 24 Hours. Week 4 [LOCF] (n=313, 634, 627)	-10.3 percent change Interval -67.4 to 75.0	-15.0 percent change Interval -66.2 to 82.9	-14.8 percent change Interval -67.6 to 135.7
Percent Change From Baseline of Micturitions Per 24 Hours. Week 12 [LOCF] (n=313, 634, 628)	-12.1 percent change Interval -69.6 to 73.0	-16.2 percent change Interval -69.6 to 55.6	-18.9 percent change Interval -66.7 to 185.7

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Population: FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions \>0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. Week 1 (n=288, 584, 596)	-0.1 nocturnal micturitions per 24 hours Standard Error 0.1	-0.3 nocturnal micturitions per 24 hours Standard Error 0.0	-0.2 nocturnal micturitions per 24 hours Standard Error 0.0
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. Week 4 [LOCF] (n=293, 596, 600)	-0.4 nocturnal micturitions per 24 hours Standard Error 0.1	-0.5 nocturnal micturitions per 24 hours Standard Error 0.0	-0.5 nocturnal micturitions per 24 hours Standard Error 0.1
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. Week 12 [LOCF] (n=293, 596, 601)	-0.5 nocturnal micturitions per 24 hours Standard Error 0.1	-0.6 nocturnal micturitions per 24 hours Standard Error 0.1	-0.6 nocturnal micturitions per 24 hours Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Percent change of nocturnal 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 (ie, 100% \*(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. Week 1 (n=288, 584, 596)	-10.0 percent change Interval -100.0 to 500.0	-12.5 percent change Interval -100.0 to 350.0	0.0 percent change Interval -100.0 to 800.0
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. Week 4 [LOCF] (n=293, 596, 600)	-22.2 percent change Interval -100.0 to 600.0	-25.0 percent change Interval -100.0 to 400.0	-20.0 percent change Interval -100.0 to 900.0
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. Week 12 [LOCF] (n=293, 596, 601)	-25.0 percent change Interval -100.0 to 600.0	-27.9 percent change Interval -100.0 to 500.0	-28.6 percent change Interval -100.0 to 400.0

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Population: FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes \>0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

Mean number urgency episodes (USS rating \>= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. Week 1 (n=306, 619, 621)	-0.4 urgency episodes per 24 hours Standard Error 0.2	-1.3 urgency episodes per 24 hours Standard Error 0.2	-1.1 urgency episodes per 24 hours Standard Error 0.2
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. Week 4 [LOCF] (n=311, 631, 627)	-1.2 urgency episodes per 24 hours Standard Error 0.2	-2.4 urgency episodes per 24 hours Standard Error 0.2	-2.6 urgency episodes per 24 hours Standard Error 0.2
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. Week 12 [LOCF] (n=311, 631, 628)	-2.0 urgency episodes per 24 hours Standard Error 0.3	-3.1 urgency episodes per 24 hours Standard Error 0.2	-3.5 urgency episodes per 24 hours Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Percent change of urgency episodes (USS rating \>= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Percent Change From Baseline of Urgency Episodes Per 24 Hours. Week 1 (n=306, 619, 621)	-5.6 percent change Interval -100.0 to 271.4	-12.5 percent change Interval -100.0 to 400.0	-9.7 percent change Interval -100.0 to 485.7
Percent Change From Baseline of Urgency Episodes Per 24 Hours. Week 4 [LOCF] (n=311,631, 627)	-11.4 percent change Interval -100.0 to 560.0	-23.1 percent change Interval -100.0 to 233.3	-26.9 percent change Interval -100.0 to 385.7
Percent Change From Baseline of Urgency Episodes Per 24 Hours. Week 12 [LOCF] (n=311, 631, 628)	-17.6 percent change Interval -100.0 to 560.0	-30.8 percent change Interval -100.0 to 372.7	-37.9 percent change Interval -100.0 to 385.7

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Population: FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes \>0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, Tolterodine ER, and Fesoterodine, respectively.

Mean number of severe urgency episodes (USS rating \>= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. Week 1 (n=306, 618, 618)	-0.4 severe urgency episodes per 24 hours Standard Error 0.2	-1.3 severe urgency episodes per 24 hours Standard Error 0.2	-1.2 severe urgency episodes per 24 hours Standard Error 0.2
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. Week 4 [LOCF] (n=311, 630, 624)	-1.2 severe urgency episodes per 24 hours Standard Error 0.2	-2.2 severe urgency episodes per 24 hours Standard Error 0.2	-2.4 severe urgency episodes per 24 hours Standard Error 0.2
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. Week 12 [LOCF] (n=311, 630, 625)	-1.9 severe urgency episodes per 24 hours Standard Error 0.2	-2.8 severe urgency episodes per 24 hours Standard Error 0.2	-3.0 severe urgency episodes per 24 hours Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Percent change calculated as change in severe urgency episodes (USS rating \>= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. Week 1 (n=306, 618, 618)	-9.4 percent change Interval -100.0 to 500.0	-25.0 percent change Interval -100.0 to 775.0	-25.0 percent change Interval -100.0 to 680.0
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. Week 4 [LOCF] (n=311, 630, 624)	-25.0 percent change Interval -100.0 to 866.7	-45.8 percent change Interval -100.0 to 460.0	-54.5 percent change Interval -100.0 to 550.0
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. Week 12 [LOCF] (n=311, 630, 625)	-48.0 percent change Interval -100.0 to 733.3	-63.4 percent change Interval -100.0 to 412.5	-71.4 percent change Interval -100.0 to 585.7

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. Week 1 (n=306, 619, 621)	-0.1 score on scale Standard Error 0.0	-0.2 score on scale Standard Error 0.0	-0.2 score on scale Standard Error 0.0
Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. Week 4 [LOCF] (n=311, 631, 627)	-0.2 score on scale Standard Error 0.0	-0.4 score on scale Standard Error 0.0	-0.5 score on scale Standard Error 0.0
Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. Week 12 [LOCF] (n=311, 631, 628)	-0.4 score on scale Standard Error 0.0	-0.6 score on scale Standard Error 0.0	-0.7 score on scale Standard Error 0.0

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. Week 4 [LOCF] (n=311,631, 627)	-5.7 score on scale Standard Error 0.8	-9.7 score on scale Standard Error 0.6	-10.5 score on scale Standard Error 0.6
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. Week 1 (n=306, 619, 621)	-2.4 score on scale Standard Error 0.7	-5.7 score on scale Standard Error 0.5	-5.5 score on scale Standard Error 0.5
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. Week 12 [LOCF] (n=311, 631, 628)	-8.2 score on scale Standard Error 0.8	-12.1 score on scale Standard Error 0.6	-13.2 score on scale Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline, Week 1, Week, 4, Week 12

Number of subjects in 4-point category: \>= to 2 points improvement \[major improvement\]; 1 point improvement \[minor improvement\]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 1 (n=309, 625, 623), >=2 points improvement	32 participants	79 participants	102 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 1, 1-point improvement	94 participants	181 participants	186 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 1, no change	147 participants	306 participants	286 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 1, deterioration	36 participants	59 participants	49 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 4 (n=313, 632, 629), >=2 points improvement	57 participants	169 participants	196 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 4, 1-point improvement	95 participants	201 participants	224 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 4, no change	127 participants	203 participants	176 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 4, deterioration	34 participants	59 participants	33 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 12 (n=313, 632, 630), >=2 points improvement	67 participants	210 participants	254 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 12, 1-point improvement	102 participants	189 participants	198 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 12, no change	111 participants	171 participants	148 participants
Change From Baseline in Patient Perception of Bladder Condition (PPBC). Week 12, deterioration	33 participants	62 participants	30 participants

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, Week 12

Number of subjects in 3-point category: improvement \[\>=1-point improvement\]; no change; deterioration \[\>=1-point decrease\], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 1, no change	218 participants	438 participants	413 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 1, deterioration	23 participants	27 participants	40 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 12 (n=313, 633, 630), improvement	112 participants	254 participants	291 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 1 (n=309, 627, 624), improvement	68 participants	162 participants	171 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 4 (n=313, 633, 629), improvement	98 participants	238 participants	256 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 4, no change	194 participants	362 participants	348 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 4, deterioration	21 participants	33 participants	25 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 12, no change	181 participants	344 participants	314 participants
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. Week 12, deterioration	20 participants	35 participants	25 participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.

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 \[(Actual total raw score - lowest possible value of raw score)/by raw score range \* 100\]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).	-16.3 score on scale Standard Error 1.4	-22.5 score on scale Standard Error 1.1	-27.1 score on scale Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo, Tolterodine ER, and Fesoterodine, respectively.

HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=\[(Highest possible raw score-Actual total raw score)/Raw score range\]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). HRQL scale score total (n=289, 588, 572)	12.0 score on scale Standard Error 1.3	16.3 score on scale Standard Error 1.0	19.3 score on scale Standard Error 1.0
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). HRQL concern domain (n=289, 589, 572)	13.4 score on scale Standard Error 1.5	19.3 score on scale Standard Error 1.1	22.6 score on scale Standard Error 1.2
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). HRQL coping domain (n=289, 589, 572)	14.0 score on scale Standard Error 1.5	18.5 score on scale Standard Error 1.2	22.6 score on scale Standard Error 1.2
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). HRQL sleep domain (n=289, 589, 572)	12.2 score on scale Standard Error 1.4	15.1 score on scale Standard Error 1.1	17.3 score on scale Standard Error 1.1
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). HRQL social interaction domain (n=289, 588, 572)	6.8 score on scale Standard Error 1.1	9.4 score on scale Standard Error 0.9	11.6 score on scale Standard Error 0.9

POST_HOC outcome

Timeframe: Week 1, Week 4, Week 12

Population: FAS; only subjects with baseline urgency urinary incontinence \>0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).

Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Outcome measures

Outcome measures
Measure	Placebo n=334 Participants Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER n=684 Participants Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine n=679 Participants Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Diary Dry Rates Week 1	54 participants	153 participants	159 participants
Diary Dry Rates Week 4	97 participants	290 participants	306 participants
Diary Dry Rates Week 12	138 participants	358 participants	396 participants

Adverse Events

Placebo

Serious events: 8 serious events

Other events: 76 other events

Deaths: 0 deaths

Tolterodine ER

Serious events: 9 serious events

Other events: 213 other events

Deaths: 0 deaths

Fesoterodine

Serious events: 15 serious events

Other events: 290 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/334	0.00% 0/684	0.15% 1/679
Cardiac disorders Hypertensive heart disease	0.00% 0/334	0.00% 0/684	0.15% 1/679
Cardiac disorders Myocardial ischaemia	0.00% 0/334	0.00% 0/684	0.15% 1/679
Gastrointestinal disorders Abdominal pain	0.00% 0/334	0.00% 0/684	0.15% 1/679
Gastrointestinal disorders Appendicitis perforated	0.00% 0/334	0.00% 0/684	0.15% 1/679
Gastrointestinal disorders Nausea	0.30% 1/334	0.00% 0/684	0.00% 0/679
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/334	0.00% 0/684	0.15% 1/679
Gastrointestinal disorders Vomiting	0.30% 1/334	0.00% 0/684	0.00% 0/679
General disorders Chest pain	0.00% 0/334	0.15% 1/684	0.00% 0/679
Hepatobiliary disorders Biliary colic	0.00% 0/334	0.15% 1/684	0.00% 0/679
Infections and infestations Abdominal wall abscess	0.30% 1/334	0.00% 0/684	0.00% 0/679
Infections and infestations Bronchiectasis	0.00% 0/334	0.00% 0/684	0.15% 1/679
Infections and infestations Cystitis	0.00% 0/334	0.15% 1/684	0.00% 0/679
Infections and infestations Herpes zoster	0.00% 0/334	0.15% 1/684	0.00% 0/679
Injury, poisoning and procedural complications Hand fracture	0.30% 1/334	0.00% 0/684	0.00% 0/679
Injury, poisoning and procedural complications Head injury	0.00% 0/334	0.15% 1/684	0.00% 0/679
Injury, poisoning and procedural complications Seroma	0.30% 1/334	0.00% 0/684	0.00% 0/679
Injury, poisoning and procedural complications Traumatic brain injury	0.00% 0/334	0.00% 0/684	0.15% 1/679
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/334	0.00% 0/684	0.15% 1/679
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.30% 1/334	0.00% 0/684	0.00% 0/679
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/334	0.15% 1/684	0.15% 1/679
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.30% 1/334	0.00% 0/684	0.00% 0/679
Musculoskeletal and connective tissue disorders Pain in extremity	0.30% 1/334	0.00% 0/684	0.00% 0/679
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.30% 1/334	0.00% 0/684	0.00% 0/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/334	0.15% 1/684	0.00% 0/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/334	0.00% 0/684	0.15% 1/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.30% 1/334	0.00% 0/684	0.00% 0/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/334	0.15% 1/684	0.00% 0/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.30% 1/334	0.00% 0/684	0.00% 0/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/334	0.00% 0/684	0.15% 1/679
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.30% 1/334	0.00% 0/684	0.00% 0/679
Nervous system disorders Dizziness	0.30% 1/334	0.00% 0/684	0.00% 0/679
Nervous system disorders Haemorrhage intracranial	0.00% 0/334	0.00% 0/684	0.15% 1/679
Nervous system disorders Vertebrobasilar insufficiency	0.30% 1/334	0.00% 0/684	0.00% 0/679
Psychiatric disorders Mental status changes	0.30% 1/334	0.00% 0/684	0.00% 0/679
Psychiatric disorders Suicidal behaviour	0.00% 0/334	0.00% 0/684	0.15% 1/679
Renal and urinary disorders Urinary incontinence	0.00% 0/334	0.00% 0/684	0.15% 1/679
Reproductive system and breast disorders Breast mass	0.00% 0/334	0.15% 1/684	0.00% 0/679
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/334	0.00% 0/684	0.15% 1/679
Respiratory, thoracic and mediastinal disorders Asthma	0.30% 1/334	0.00% 0/684	0.00% 0/679
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/334	0.15% 1/684	0.00% 0/679
Vascular disorders Arteriosclerosis	0.30% 1/334	0.00% 0/684	0.00% 0/679

Other adverse events

Other adverse events
Measure	Placebo Tablets (4 milligrams \[mg\] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks	Tolterodine ER Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)	Fesoterodine Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Eye disorders Dry eye	1.8% 6/334	1.2% 8/684	1.3% 9/679
Eye disorders Vision blurred	0.30% 1/334	1.2% 8/684	1.8% 12/679
Gastrointestinal disorders Abdominal pain	1.2% 4/334	0.58% 4/684	1.5% 10/679
Gastrointestinal disorders Abdominal pain upper	0.90% 3/334	0.88% 6/684	1.3% 9/679
Gastrointestinal disorders Constipation	3.0% 10/334	4.1% 28/684	5.4% 37/679
Gastrointestinal disorders Diarrhoea	1.2% 4/334	2.2% 15/684	2.1% 14/679
Gastrointestinal disorders Dry mouth	6.0% 20/334	16.4% 112/684	27.8% 189/679
Gastrointestinal disorders Dyspepsia	0.30% 1/334	1.2% 8/684	1.8% 12/679
Gastrointestinal disorders Nausea	1.8% 6/334	1.0% 7/684	1.8% 12/679
Gastrointestinal disorders Vomiting	0.60% 2/334	0.29% 2/684	1.0% 7/679
General disorders Fatigue	0.00% 0/334	0.58% 4/684	1.8% 12/679
Infections and infestations Influenza	1.2% 4/334	1.2% 8/684	1.0% 7/679
Infections and infestations Nasopharyngitis	3.0% 10/334	1.9% 13/684	1.9% 13/679
Infections and infestations Sinusitis	0.90% 3/334	1.2% 8/684	0.44% 3/679
Infections and infestations Upper respiratory tract infection	1.2% 4/334	1.3% 9/684	0.29% 2/679
Infections and infestations Urinary tract infection	0.60% 2/334	1.5% 10/684	2.2% 15/679
Musculoskeletal and connective tissue disorders Back pain	3.0% 10/334	1.0% 7/684	1.5% 10/679
Nervous system disorders Dizziness	0.90% 3/334	1.5% 10/684	1.2% 8/679
Nervous system disorders Headache	2.4% 8/334	3.4% 23/684	5.6% 38/679
Renal and urinary disorders Dysuria	0.30% 1/334	1.0% 7/684	0.59% 4/679
Respiratory, thoracic and mediastinal disorders Cough	0.30% 1/334	0.58% 4/684	1.2% 8/679
Vascular disorders Hypertension	0.90% 3/334	0.44% 3/684	1.2% 8/679

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 \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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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