Clinical Trial to Evaluate the Efficacy and Safety of Fes... | NCT00611026

Label	Type	Intervention Names
1	Active Comparator	Drug: Tolterodine ER
2	Placebo Comparator	Drug: Placebo
3	Experimental	Drug: Fesoterodine

Name	Type	Description	Arm Group Labels	Other Names
Tolterodine ER	Drug	The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.	1

Measure	Description	Time Frame
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12	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).	Baseline, Week 12

Measure	Description	Time Frame
Change From Baseline in Mean Voided Volume Per Micturition	Mean voided volume in milliliters (mL) 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.	Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Enterprise	Alabama	36330	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
37160401	Derived	Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
35881009	Derived	Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	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 matching to treatment.
FG001	Tolterodine ER

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12

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).

Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded.

Posted

Mean

Standard Error

episodes per 24 hours

Baseline, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Units	Counts
Participants	OG000448 OG001926 OG002908

Title

Denominators

Categories

Title	Measurements
	OG000-1.62± 0.07 OG001-1.74± 0.06 OG002-1.95± 0.05

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively). If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed.	Van Elteren's Test	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.	<0.0001	Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.					2-Sided

Secondary

Change From Baseline in Mean Voided Volume Per Micturition

Mean voided volume in milliliters (mL) 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.

FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (LOCF)], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Posted

Mean

Standard Error

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Mean Number of Micturitions Per 24 Hours

The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.

FAS; (n)=number of participants 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.

Posted

Least Squares Mean

Standard Error

micturitions per 24 hours

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Percent Change From Baseline of Micturitions Per 24 Hours

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 1 or 4 or 12 - baseline)/baseline).

FAS; (n)=number of participants 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.

Posted

Median

Full Range

percent change

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours

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

FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and 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.

Posted

Least Squares Mean

Standard Error

nocturnal micturitions per 24 hours

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours

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 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.

Posted

Median

Full Range

percent change

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4

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).

FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [LOCF] for placebo, tolterodine ER, and fesoterodine, respectively.

Posted

Mean

Standard Error

episodes per 24 hours

Baseline, Week 1, Week 4

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Percent Change From Baseline of UUI Episodes Per 24 Hours

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.

FAS; (n)=number of participants with baseline UUI >0 per 24 hours and 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.

Posted

Median

Full Range

percent change

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 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).

FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and 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.

Posted

Least Squares Mean

Standard Error

episodes per 24 hours

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.

Posted

Median

Full Range

percent change

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours

Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 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).

FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and 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.

Posted

Mean

Standard Error

severe urgency episodes per 24 hours

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours

Percent change calculated as change in severe urgency episodes (USS rating ≥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).

Posted

Median

Full Range

percent change

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.

Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating 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).

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)

Frequency-Urgency Sum 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).

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary

Diary dry rate: percentage of participants 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).

FAS; (n)=number of participants with non-missing baseline and respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Posted

Number

percentage of participants

Week 1, Week 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Patient Perception of Bladder Condition (PPBC)

Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), 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.

Posted

Number

participants

Baseline, Week 1, Week, 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.

Number of participants 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.

Posted

Number

participants

Baseline, Week 1, Week, 4, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12

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. Negative change in Symptom Bother Score indicates improvement.

FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Secondary

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12

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] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.

FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 12

ID	Title	Description
OG000	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 matching to treatment.
OG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Post-Hoc

Post-hoc Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage.

Safety population included all participants who were randomized and received at least 1 dose of study treatment. N=number of participants with AEs noted in other unreviewed medical chart records as performed at other departments during the clinical trial but were not included as AEs in Case Report Forms; reported post-hoc.

Posted

Number

events

Baseline up to Week 12

ID	Title	Description
OG000	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
OG001	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Bronchopneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0020 affected960 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0020 affected960 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0020 affected960 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0020 affected960 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0021 affected960 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0020 affected960 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk
Balance disorder	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0022 affected960 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Mania	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Allergic respiratory disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0011 affected973 at risk EG0020 affected960 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0010 affected973 at risk EG0021 affected960 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG0010 affected973 at risk EG0020 affected960 at risk

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010665	Phenylpropanolamine
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D020005	Propanols
D000588	Amines
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D003408	Cresols
D010636	Phenols

ID	Title	Description
BG000	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 matching to treatment.
BG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
BG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 matching to treatment.	8	478	83	478
EG001	Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	6	973	261	973
EG002	Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.	13	960	375	960

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected478 at risk EG00130 affected973 at risk EG00242 affected960 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected478 at risk EG00111 affected973 at risk EG00211 affected960 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00026 affected478 at risk EG001130 affected973 at risk EG002265 affected960 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected478 at risk EG00110 affected973 at risk EG00221 affected960 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected478 at risk EG00113 affected973 at risk EG00211 affected960 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected478 at risk EG00114 affected973 at risk EG0024 affected960 at risk
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 affected478 at risk EG00110 affected973 at risk EG0023 affected960 at risk
Influenza	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected478 at risk EG00112 affected973 at risk EG0025 affected960 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 affected478 at risk EG0019 affected973 at risk EG0028 affected960 at risk
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected478 at risk EG00111 affected973 at risk EG0024 affected960 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0005 affected478 at risk EG00112 affected973 at risk EG00214 affected960 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected478 at risk EG0019 affected973 at risk EG0028 affected960 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected478 at risk EG00120 affected973 at risk EG00227 affected960 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected478 at risk EG0018 affected973 at risk EG00210 affected960 at risk
Polyuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG00010 affected478 at risk EG00124 affected973 at risk EG00229 affected960 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected478 at risk EG0014 affected973 at risk EG00212 affected960 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected478 at risk EG0012 affected973 at risk EG00211 affected960 at risk