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Clinical Trial Results:
Long-term Extension Study to Evaluate the Safety of Fesoterodine in Japanese Pediatric Subjects With Symptoms of Detrusor Overactivity Associated With a Neurological Condition (Neurogenic Detrusor Overactivity) who Have Completed 24 Weeks Treatment in Study A0221047

Summary
EudraCT number	2020-004192-41
Trial protocol	Outside EU/EEA
Global end of trial date	01 Apr 2020

Results information
Results version number	v1(current)
This version publication date	11 Oct 2020
First version publication date	11 Oct 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

A0221109

ISRCTN number

US NCT number

NCT02501928

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

13 Aug 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Apr 2020

Was the trial ended prematurely?

Main objective of the trial

To investigate the safety and tolerability of fesoterodine following once daily longterm treatment in Japanese pediatric subjects.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Jun 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 12

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This (A0221109) was a long term extension (LTE) study only among Japanese subjects who participated and completed the precedent study A0221047 (NCT01557244). Per plan, efficacy outcome measures and treatment-emergent adverse events were reported using merged data of studies A0221047 and A0221109.

Screening details

A0221047 had 2 cohorts. Cohort 1 had an active comparator phase and Cohort 2 had an efficacy phase followed by a safety extension phase for each cohort. Japanese subjects from both cohorts, if consented continued in this LTE study and received the same treatment as in A0221047, per investigator judgment on safety and tolerance of subjects.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Fesoterodine 8 mg Tablet

Arm description

In precedent study A0221047, subject of cohort 1, with body weight greater than (>) 25 kilogram (kg), received fesoterodine 4 milligram (mg) prolonged release (PR) tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and 12 weeks in safety extension phase. Only Japanese subject who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received Fesoterodine 8 mg PR tablet orally once daily for 28 weeks in this study.

Fesoterodine 2 mg Capsule

Arm description

In precedent study A0220147, subjects of cohort 2, with body weight less than or equal to (<=) 25 kg, received fesoterodine 2 mg beads-in-capsule (BIC) capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase). Only Japanese subjects who consented to continue in this LTE study, were to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks in precedent study A0221047 and received fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this study.

Fesoterodine 4 mg Capsule

Arm description

In precedent study A0221047, subjects of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase. Only Japanese subjects who consented to continue in this LTE study, were to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks (in active comparator phase) and 12 weeks (in safety extension phase) in precedent study A0220147 and received fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.

Number of subjects in period 1	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Started	2	7	3
Completed	2	6	3
Not completed	0	1	0
Withdrawal By Parent/Guardian	-	1	-

Baseline characteristics

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Reporting group title

Fesoterodine 8 mg Tablet

Reporting group description

Reporting group title

Fesoterodine 2 mg Capsule

Reporting group description

Reporting group title

Fesoterodine 4 mg Capsule

Reporting group description

Reporting group values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Total
Number of subjects	2	7	3	12
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	7	3	10
Adolescents (12-17 years)	2	0	0	2
Adults (18-64 years)	0	0	0	0
From 65-84 years	0	0	0	0
85 years and over	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	13.50 ± 0.71	7.86 ± 1.68	7.33 ± 0.58	-
Sex: Female, Male
Units: subjects
Female	2	0	1	3
Male	0	7	2	9
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0
Asian	2	7	3	12
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	0	0	0	0
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	2	7	3	12
Unknown or Not Reported	0	0	0	0

End points

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Reporting group title

Fesoterodine 8 mg Tablet

Reporting group description

Reporting group title

Fesoterodine 2 mg Capsule

Reporting group description

Reporting group title

Fesoterodine 4 mg Capsule

Reporting group description

Subject analysis set title

Cohort 1

Subject analysis set type

Full analysis

Subject analysis set description

Subjects of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (12 weeks in each active comparator and safety extension phase) in precedent study A0221047 and then continued same dose and dosage form of fesoterodine for 28 weeks in this LTE study.

Subject analysis set title

Cohort 2

Subject analysis set type

Full analysis

Subject analysis set description

Subjects of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily in efficacy and safety phase in precedent study A0221047 and then continued same dose and dosage form of fesoterodine for 28 weeks in this LTE study.

Subject analysis set title

Total of Treatment Groups

Subject analysis set type

Full analysis

Subject analysis set description

Total Subjects who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive same treatment respectively, in this LTE study.

Primary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109

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End point title

Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109 ^[1]

End point description

An AE was any untoward medical occurrence in subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. AEs included both serious and non-serious adverse events. TEAEs were summarized for each cohort (Cohort 1 and Cohort 2, irrespective of treatment received), each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Safety analysis set was analyzed.

End point type

Primary

End point timeframe

Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: subjects
Subjects with AEs	2	6	3	2	9	11
Subjects with SAEs	0	1	0	0	1	1

No statistical analyses for this end point

Primary: Change From Baseline in Visual Acuity at Week 12: Study A0221109

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End point title

Change From Baseline in Visual Acuity at Week 12: Study A0221109 ^[2]

End point description

Visual acuity (VA) was assessed for each eye using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and subject, divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint, data have been reported for right and left eye separately. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: LogMAR
arithmetic mean (standard deviation)
Right Eye: Baseline	0.27 ± 0.376	0.04 ± 0.137	0.28 ± 0.334
Right Eye: Change at Week 12	0.14 ± 0.204	-0.03 ± 0.083	0.04 ± 0.067
Left Eye: Baseline	0.45 ± 0.350	0.04 ± 0.183	0.63 ± 0.663
Left Eye: Change at Week 12	0.03 ± 0.126	0.03 ± 0.116	0.07 ± 0.122

No statistical analyses for this end point

Primary: Change From Baseline in Visual Acuity at Week 28: Study A0221109

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End point title

Change From Baseline in Visual Acuity at Week 28: Study A0221109 ^[3]

End point description

VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and subject, divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint, data have been reported for right and left eye separately. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	6	3
Units: LogMAR
arithmetic mean (standard deviation)
Right Eye	0.00 ± 0.000	0.03 ± 0.118	0.02 ± 0.142
Left Eye	0.31 ± 0.681	0.05 ± 0.057	0.16 ± 0.208

No statistical analyses for this end point

Primary: Change From Baseline in Visual Acuity at Final Visit: Study A0221109

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End point title

Change From Baseline in Visual Acuity at Final Visit: Study A0221109 ^[4]

End point description

VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and subject, divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint, data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: LogMAR
arithmetic mean (standard deviation)
Right Eye	0.00 ± 0.000	0.02 ± 0.108	0.02 ± 0.142
Left Eye	0.31 ± 0.681	0.04 ± 0.055	0.16 ± 0.208

No statistical analyses for this end point

Primary: Change From Baseline in Visual Accommodation at Week 12: Study A0221109

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End point title

Change From Baseline in Visual Accommodation at Week 12: Study A0221109 ^[5]

End point description

The visual accommodation was the minimum focusing distance for each eye at which vision became blurred – the mean of triplicate measurements. The subjects focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: centimeter
arithmetic mean (standard deviation)
Right Eye: Baseline (n =2, 7, 3)	9.33 ± 8.014	8.62 ± 10.938	5.56 ± 4.857
Right Eye: Change at Week 12 (n =2, 7, 3)	2.50 ± 2.593	5.86 ± 13.287	6.67 ± 10.990
Left Eye: Baseline (n =2, 7, 2)	14.00 ± 13.199	9.86 ± 13.685	4.83 ± 6.835
Left Eye: Change at Week 12 (n =2, 7, 2)	-1.83 ± 2.593	3.24 ± 13.662	16.17 ± 23.806

No statistical analyses for this end point

Primary: Change From Baseline in Visual Accommodation at Week 28: Study A0221109

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End point title

Change From Baseline in Visual Accommodation at Week 28: Study A0221109 ^[6]

End point description

The visual accommodation was the minimum focusing distance for each eye at which vision became blurred – the mean of triplicate measurements. The subject focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	6	3
Units: centimeter
arithmetic mean (standard deviation)
Right Eye (n =2, 6, 3)	5.17 ± 7.307	0.78 ± 2.639	-0.11 ± 1.836
Left Eye (n =2, 6, 2)	3.17 ± 5.421	-0.39 ± 3.803	0.50 ± 0.707

No statistical analyses for this end point

Primary: Change From Baseline in Visual Accommodation at Final Visit: Study A0221109

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End point title

Change From Baseline in Visual Accommodation at Final Visit: Study A0221109 ^[7]

End point description

The visual accommodation was the minimum focusing distance for each eye at which vision became blurred – the mean of triplicate measurements. The subject focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: centimeter
arithmetic mean (standard deviation)
Right Eye (n =2, 7, 3)	5.17 ± 7.307	4.38 ± 9.833	-0.11 ± 1.836
Left Eye (n =2, 7, 2)	3.17 ± 5.421	2.86 ± 9.263	0.50 ± 0.707

No statistical analyses for this end point

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109

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End point title

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109 ^[8]

End point description

CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behavior: Baseline	50.0 ± 0.00	52.6 ± 3.82	50.7 ± 1.15
Aggressive behavior: Change at Week 12	0.0 ± 0.00	-0.1 ± 3.53	0.0 ± 0.00
Anxious/depressed: Baseline	50.0 ± 0.00	52.1 ± 3.34	50.7 ± 0.58
Anxious/depressed: Change at Week 12	0.0 ± 0.00	0.7 ± 4.11	-0.7 ± 0.58
Attention problems: Baseline	50.0 ± 0.00	53.6 ± 3.55	53.3 ± 4.93
Attention problems: Change at week 12	0.0 ± 0.00	-1.1 ± 2.34	0.0 ± 0.00
Rule-breaking behavior: Baseline	50.5 ± 0.71	52.4 ± 3.60	53.3 ± 5.77
Rule-breaking behavior: Change at Week 12	0.0 ± 0.00	-0.3 ± 4.11	0.0 ± 0.00
Social problems: Baseline	50.0 ± 0.00	52.4 ± 2.70	54.3 ± 6.66
Social problems: Change at Week 12	0.0 ± 0.00	0.0 ± 3.65	0.7 ± 1.15
Somatic complaints: Baseline	51.5 ± 2.12	53.4 ± 5.35	55.7 ± 4.62
Somatic complaints: Change at Week 12	1.5 ± 2.12	0.9 ± 1.46	-2.3 ± 2.08
Thought problems: Baseline	50.0 ± 0.00	50.9 ± 1.46	53.0 ± 4.36
Thought problems: Change at Week 12	0.0 ± 0.00	0.3 ± 1.70	0.0 ± 0.00
Withdrawn: Baseline	50.0 ± 0.00	53.4 ± 4.86	52.7 ± 4.62
Withdrawn: Change at Week 12	0.0 ± 0.00	-1.7 ± 4.54	0.0 ± 0.00
Externalizing problems: Baseline	37.0 ± 4.24	47.6 ± 8.79	44.0 ± 10.00
Externalizing problems: Change at Week 12	0.0 ± 0.00	-0.3 ± 6.07	0.0 ± 0.00
Internalizing problems: Baseline	36.0 ± 4.24	49.0 ± 3.79	47.7 ± 7.51
Internalizing problems: Change at Week 12	3.0 ± 4.24	0.4 ± 5.00	-4.0 ± 2.00
Total problems: Baseline	30.5 ± 2.12	49.1 ± 3.67	46.7 ± 11.59
Total problems: Change at Week 12	3.0 ± 4.24	-1.1 ± 2.12	0.3 ± 1.53

No statistical analyses for this end point

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109

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End point title

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109 ^[9]

End point description

CBCL:assessed child's behavioral and emotional problems(pbl). Parent/caregiver of child answered 120 items,each on scale:0=not true,1=somewhat/sometimes true,2=very/often true.103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70;internalizing pbl combined anxious/depressed,withdrawn and somatic complaints,TSR=0-64.Total pbl combined 8 domains and 17 remaining items,TSR=0-240.TSR for each domain,summary and total pbl was sum of scores of related items respectively.Lower scores for each domain, summary,total pbl=better outcomes.Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety set. Number of subjects analysed=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	6	3
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behavior	0.0 ± 0.00	-2.2 ± 3.76	-0.3 ± 0.58
Anxious/depressed	0.0 ± 0.00	-0.7 ± 4.13	0.3 ± 1.53
Attention problems	0.0 ± 0.00	-1.0 ± 2.45	0.0 ± 0.00
Rule-breaking behavior	-0.5 ± 0.71	-1.0 ± 2.97	1.3 ± 2.31
Social problems	0.0 ± 0.00	0.3 ± 1.63	1.0 ± 1.73
Somatic complaints	0.0 ± 0.00	1.2 ± 1.83	-2.3 ± 2.08
Thought problems	0.0 ± 0.00	-0.2 ± 0.41	-0.3 ± 0.58
Withdrawn	0.0 ± 0.00	-2.0 ± 7.04	0.0 ± 0.00
Externalizing problems	-3.0 ± 4.24	-3.5 ± 5.92	0.0 ± 0.00
Internalizing problems	0.0 ± 0.00	-2.5 ± 6.83	-2.7 ± 3.06
Total problems	-2.5 ± 3.54	-1.7 ± 2.94	1.0 ± 1.00

No statistical analyses for this end point

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109

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End point title

Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109 ^[10]

End point description

CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behavior	0.0 ± 0.00	-1.9 ± 3.53	-0.3 ± 0.58
Anxious/depressed	0.0 ± 0.00	-0.6 ± 3.78	0.3 ± 1.53
Attention problems	0.0 ± 0.00	-0.9 ± 2.27	0.0 ± 0.00
Rule-breaking behavior	-0.5 ± 0.71	-0.9 ± 2.73	1.3 ± 2.31
Social problems	0.0 ± 0.00	0.3 ± 1.50	1.0 ± 1.73
Somatic complaints	0.0 ± 0.00	1.0 ± 1.73	-2.3 ± 2.08
Thought problems	0.0 ± 0.00	-0.1 ± 0.38	-0.3 ± 0.58
Withdrawn	0.0 ± 0.00	-1.7 ± 6.47	0.0 ± 0.00
Externalizing problems	-3.0 ± 4.24	-3.0 ± 5.57	0.0 ± 0.00
Internalizing problems	0.0 ± 0.00	-2.1 ± 6.31	-2.7 ± 3.06
Total problems	-2.5 ± 3.54	-1.4 ± 2.76	1.0 ± 1.00

No statistical analyses for this end point

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109

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End point title

Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109 ^[11]

End point description

CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behavior: Baseline	0.0 ± 0.00	3.4 ± 3.05	2.0 ± 2.00
Aggressive behavior: Change at Week 12	0.0 ± 0.00	-0.1 ± 2.97	0.0 ± 0.00
Anxious/depressed: Baseline	0.0 ± 0.00	1.9 ± 1.57	1.3 ± 1.15
Anxious/depressed: Change at Week 12	0.0 ± 0.00	0.3 ± 1.60	-0.7 ± 0.58
Attention problems: Baseline	0.0 ± 0.00	3.6 ± 2.64	3.0 ± 3.46
Attention problems: Change at week 12	0.0 ± 0.00	-0.6 ± 1.27	0.0 ± 0.00
Rule-breaking behavior: Baseline	0.5 ± 0.71	1.3 ± 1.50	1.3 ± 2.31
Rule-breaking behavior: Change at Week 12	0.0 ± 0.00	-0.1 ± 1.21	0.0 ± 0.00
Social problems: Baseline	0.0 ± 0.00	1.6 ± 1.27	2.3 ± 3.21
Social problems: Change at Week 12	0.0 ± 0.00	0.0 ± 1.63	0.3 ± 0.58
Somatic complaints: Baseline	0.5 ± 0.71	1.0 ± 1.53	1.7 ± 1.15
Somatic complaints: Change at Week 12	0.5 ± 0.71	0.3 ± 0.49	-0.7 ± 0.58
Thought problems: Baseline	0.0 ± 0.00	0.6 ± 0.79	1.3 ± 1.53
Thought problems: Change at Week 12	0.0 ± 0.00	-0.1 ± 0.69	0.0 ± 0.00
Withdrawn: Baseline	0.0 ± 0.00	0.9 ± 1.21	0.7 ± 1.15
Withdrawn: Change at Week 12	0.0 ± 0.00	-0.4 ± 1.13	0.0 ± 0.00
Externalizing: Baseline	0.5 ± 0.71	4.7 ± 4.27	3.3 ± 4.16
Externalizing: Change at Week 12	0.0 ± 0.00	-0.3 ± 3.59	0.0 ± 0.00
Internalizing: Baseline	0.5 ± 0.71	3.7 ± 1.38	3.7 ± 2.31
Internalizing: Change at Week 12	0.5 ± 0.71	0.1 ± 2.19	-1.3 ± 0.58
Total problems: Baseline	1.5 ± 0.71	19.1 ± 5.79	18.0 ± 17.78
Total problems: Change at Week 12	1.0 ± 1.41	-1.3 ± 4.07	-0.3 ± 1.15

No statistical analyses for this end point

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109

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End point title

Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109 ^[12]

End point description

CBCL: assessed child's behavioral and emotional (pbl).Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior,TSR =0-36;anxious/depressed,TSR=0-26;attention pbl,TSR=0-20;rule-breaking behavior,TSR=0-34;social pbl,TSR=0-22;somatic complaints,TSR=0-22;thought pbl,TSR=0-30;withdrawn,TSR=0-16.Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set. Number of subjects analysed=subjects evaluable for the endpoint

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	6	3
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behavior	0.0 ± 0.00	-1.8 ± 3.06	-0.3 ± 0.58
Anxious/depressed	0.0 ± 0.00	-0.3 ± 1.37	0.0 ± 1.00
Attention problems	0.0 ± 0.00	-0.5 ± 1.22	0.0 ± 0.00
Rule-breaking behavior	-0.5 ± 0.71	-0.2 ± 0.98	0.3 ± 0.58
Social problems	0.0 ± 0.00	0.2 ± 0.98	0.3 ± 0.58
Somatic complaints	0.0 ± 0.00	0.3 ± 0.52	-0.7 ± 0.58
Thought problems	0.0 ± 0.00	-0.2 ± 0.41	-0.3 ± 0.58
Withdrawn	0.0 ± 0.00	-0.5 ± 1.76	0.0 ± 0.00
Externalizing	-0.5 ± 0.71	-2.0 ± 3.58	0.0 ± 0.00
Internalizing	0.0 ± 0.00	-0.5 ± 2.88	-0.7 ± 0.58
Total problems	-0.5 ± 0.71	-2.7 ± 4.63	0.7 ± 0.58

No statistical analyses for this end point

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109

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End point title

Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109 ^[13]

End point description

CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behavior	0.0 ± 0.00	-1.6 ± 2.88	-0.3 ± 0.58
Anxious/depressed	0.0 ± 0.00	-0.3 ± 1.25	0.0 ± 1.00
Attention problems	0.0 ± 0.00	-0.4 ± 1.13	0.0 ± 0.00
Rule-breaking behavior	-0.5 ± 0.71	-0.1 ± 0.90	0.3 ± 0.58
Social problems	0.0 ± 0.00	0.1 ± 0.90	0.3 ± 0.58
Somatic complaints	0.0 ± 0.00	0.3 ± 0.49	-0.7 ± 0.58
Thought problems	0.0 ± 0.00	-0.1 ± 0.38	-0.3 ± 0.58
Withdrawn	0.0 ± 0.00	-0.4 ± 1.62	0.0 ± 0.00
Externalizing	-0.5 ± 0.71	-1.7 ± 3.35	0.0 ± 0.00
Internalizing	0.0 ± 0.00	-0.4 ± 2.64	-0.7 ± 0.58
Total problems	-0.5 ± 0.71	-2.3 ± 4.35	0.7 ± 0.58

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109 ^[14]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[15]	5	3
Units: seconds
arithmetic mean (standard deviation)
Dominant hand: Baseline	±	43.0 ± 23.44	39.3 ± 15.18
Dominant hand: Change at Week 12	±	0.8 ± 6.72	-0.3 ± 15.28
Non-dominant hand: Baseline	±	33.4 ± 10.74	52.0 ± 19.67
Non-dominant hand: Change at Week 12	±	8.2 ± 19.93	-1.3 ± 9.45

Notes
[15] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109 ^[16]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[17]	4	3
Units: seconds
arithmetic mean (standard deviation)
Dominant hand	±	4.5 ± 2.38	3.7 ± 4.04
Non-dominant hand	±	6.3 ± 7.37	-7.7 ± 10.26

Notes
[17] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109 ^[18]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[19]	5	3
Units: seconds
arithmetic mean (standard deviation)
Dominant hand	±	0.8 ± 8.53	3.7 ± 4.04
Non-dominant hand	±	4.4 ± 7.60	-7.7 ± 10.26

Notes
[19] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109 ^[20]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[21]
Units: seconds
arithmetic mean (standard deviation)
Dominant hand: Baseline	59.5 ± 6.36	107.5 ± 75.66	±
Dominant hand: Change at Week 12	0.0 ± 2.83	-11.5 ± 13.44	±
Non-dominant hand: Baseline	60.5 ± 6.36	145.5 ± 132.23	±
Non-dominant hand: Change at Week 12	-0.5 ± 4.95	-2.0 ± 9.90	±

Notes
[21] - No subjects were of age >=9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109 ^[22]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[23]
Units: seconds
arithmetic mean (standard deviation)
Dominant hand	2.0 ± 7.07	-14.0 ± 24.04	±
Non-dominant hand	-1.0 ± 2.83	-35.0 ± 48.08	±

Notes
[23] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109 ^[24]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[25]
Units: seconds
arithmetic mean (standard deviation)
Dominant hand	2.08 ± 7.07	-14.0 ± 24.04	±
Non-dominant hand	-1.0 ± 2.83	-35.0 ± 48.08	±

Notes
[25] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109 ^[26]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[27]	5	3
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline	±	0.2 ± 0.45	0.0 ± 0.00
Dominant hand: Change at Week 12	±	0.2 ± 0.45	0.0 ± 0.00
Non-dominant hand: Baseline	±	0.0 ± 0.00	0.0 ± 0.00
Non-dominant hand: Change at Week 12	±	0.6 ± 1.34	0.0 ± 0.00

Notes
[27] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109 ^[28]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[29]	4	3
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	±	0.3 ± 0.96	0.0 ± 0.00
Non-dominant hand	±	0.0 ± 0.00	0.0 ± 0.00

Notes
[29] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109 ^[30]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[31]	5	3
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	±	0.2 ± 0.84	0.0 ± 0.00
Non-dominant hand	±	0.0 ± 0.00	0.0 ± 0.00

Notes
[31] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109 ^[32]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[33]
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline	0.0 ± 0.00	0.5 ± 0.71	±
Dominant hand: Change at Week 12	0.0 ± 0.00	-0.5 ± 0.71	±
Non-dominant hand: Baseline	0.0 ± 0.00	0.5 ± 0.71	±
Non-dominant hand: Change at Week 12	0.0 ± 0.00	-0.5 ± 0.71	±

Notes
[33] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109 ^[34]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[35]
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	0.0 ± 0.00	0.0 ± 1.41	±
Non-dominant hand	0.0 ± 0.00	-0.5 ± 0.71	±

Notes
[35] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109 ^[36]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[37]
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	0.0 ± 0.00	0.0 ± 1.41	±
Non-dominant hand	0.0 ± 0.00	-0.5 ± 0.71	±

Notes
[37] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109 ^[38]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[39]	5	3
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline	±	10.0 ± 0.00	10.0 ± 0.00
Dominant hand: Change at Week 12	±	0.0 ± 0.00	0.0 ± 0.00
Non-dominant hand: Baseline	±	10.0 ± 0.00	10.0 ± 0.00
Non-dominant hand: Change at Week 12	±	0.0 ± 0.00	0.0 ± 0.00

Notes
[39] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

Top of page

End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109 ^[40]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[41]	4	3
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	±	0.0 ± 0.00	0.0 ± 0.00
Non-dominant hand	±	0.0 ± 0.00	0.0 ± 0.00

Notes
[41] - No subject was of age below 9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109 ^[42]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[43]	5	3
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	±	0.0 ± 0.00	0.0 ± 0.00
Non-dominant hand	±	0.0 ± 0.00	0.0 ± 0.00

Notes
[43] - No subjects were of age <9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109 ^[44]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[45]
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline	25.0 ± 0.00	25.0 ± 0.00	±
Dominant hand: Change at Week 12	0.0 ± 0.00	0.0 ± 0.00	±
Non-dominant hand: Baseline	25.0 ± 0.00	25.0 ± 0.00	±
Non-dominant hand: Change at Week 12	0.0 ± 0.00	0.0 ± 0.00	±

Notes
[45] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

Top of page

End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109 ^[46]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[47]
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	0.0 ± 0.00	0.0 ± 0.00	±
Non-dominant hand	0.0 ± 0.00	0.0 ± 0.00	±

Notes
[47] - No subject was of age 9 years and above.

No statistical analyses for this end point

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109 ^[48]

End point description

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	2	0 ^[49]
Units: pegs
arithmetic mean (standard deviation)
Dominant hand	0.0 ± 0.00	0.0 ± 0.00	±
Non-dominant hand	0.0 ± 0.00	0.0 ± 0.00	±

Notes
[49] - No subjects were of age >=9 years.

No statistical analyses for this end point

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109

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End point title

Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109 ^[50]

End point description

Systolic blood and diastolic blood pressure were evaluated for examination of vital signs. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: millimeter of mercury
arithmetic mean (standard deviation)
Systolic blood pressure	6.0 ± 4.24	2.1 ± 9.65	5.0 ± 14.11
Diastolic blood pressure	10.5 ± 4.95	-0.9 ± 8.90	6.3 ± 15.31

No statistical analyses for this end point

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109

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End point title

Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109 ^[51]

End point description

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	6	3
Units: millimeter of mercury
arithmetic mean (standard deviation)
Systolic blood pressure	8.5 ± 16.26	5.7 ± 11.18	9.7 ± 2.52
Diastolic blood pressure	12.0 ± 4.24	5.3 ± 9.03	10.7 ± 2.52

No statistical analyses for this end point

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109

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End point title

Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109 ^[52]

End point description

Systolic blood and diastolic blood pressure were evaluated for examination of vital sign. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: millimeter of mercury
arithmetic mean (standard deviation)
Systolic blood pressure	8.5 ± 16.26	5.1 ± 10.30	9.7 ± 2.52
Diastolic blood pressure	12.0 ± 4.24	4.6 ± 8.48	10.7 ± 2.52

No statistical analyses for this end point

Primary: Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109

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End point title

Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109 ^[53]

End point description

Pulse rate was evaluated for examination of vital sign. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: beats per minute
arithmetic mean (standard deviation)	0.0 ± 18.38	2.4 ± 12.53	-8.0 ± 2.00

No statistical analyses for this end point

Primary: Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109

Top of page

End point title

Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109 ^[54]

End point description

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	6	3
Units: beats per minute
arithmetic mean (standard deviation)	-3.5 ± 6.36	-2.7 ± 8.82	-3.7 ± 9.61

No statistical analyses for this end point

Primary: Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109

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End point title

Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109 ^[55]

End point description

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: beats per minute
arithmetic mean (standard deviation)	-3.5 ± 6.36	-1.4 ± 8.70	-3.7 ± 9.61

No statistical analyses for this end point

Primary: Number of Subjects With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109

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End point title

Number of Subjects With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109 ^[56]

End point description

UTI data were summarized for each cohort, each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109.

End point type

Primary

End point timeframe

Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)

Notes
[56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: subjects	0	1	0	0	1	1

No statistical analyses for this end point

Primary: Number of Subjects With Clinical Laboratory Abnormalities

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End point title

Number of Subjects With Clinical Laboratory Abnormalities ^[57]

End point description

Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN); platelets<0.5*LLN>1.75*upper limit of normal (ULN); leukocytes <0.6*LLN>1.5*ULN; lymphocytes, neutrophils <0.8*LLN >1.2*UL; basophils, eosinophils, monocytes >1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin >1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein, albumin <0.8*LLN >1.2*ULN; blood urea nitrogen, creatinine >1.3*ULN; urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN; potassium, chloride, bicarbonate <0.9*LLN>1.1*ULN; glucose <0.6*LLN>1.5*ULN; creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, glucose, ketones, protein, hemoglobin, nitrite, leukocyte esterase >=1; erythrocytes, leukocytes >=20; epithelial cells >=6, bacteria >20, hyaline casts >1. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set analyzed.

End point type

Primary

End point timeframe

Baseline to 28 weeks of treatment in A0221109

Notes
[57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	2	7	3
Units: subjects	2	6	2

No statistical analyses for this end point

Primary: Change From Baseline in Post-Void Residual (PVR) Volume at Week 12: Study A0221109

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End point title

Change From Baseline in Post-Void Residual (PVR) Volume at Week 12: Study A0221109 ^[58]

End point description

Post-void residual volume was assessed by an ultrasound. PVR volume was assessed only in subjects who did not perform clean intermittent catheterization or in any subjects who had >1 UTI during the study. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. All subjects performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 12

Notes
[58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[59]	0 ^[60]	0 ^[61]
Units: milliliter
arithmetic mean (standard deviation)	±	±	±

Notes
[59] - No subject was eligible for post-void residual volume assessment.
[60] - No subject was eligible for post-void residual volume assessment.
[61] - No subject was eligible for post-void residual volume assessment.

No statistical analyses for this end point

Primary: Change From Baseline in Post-Void Residual (PVR) Volume at Week 28: Study A0221109

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End point title

Change From Baseline in Post-Void Residual (PVR) Volume at Week 28: Study A0221109 ^[62]

End point description

Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for subjects who did not perform clean intermittent catheterization or in any subjects who had >1 UTI during the study. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. All subjects performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.

End point type

Primary

End point timeframe

A0221109: Baseline, Week 28

Notes
[62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[63]	0 ^[64]	0 ^[65]
Units: milliliter
arithmetic mean (standard deviation)	±	±	±

Notes
[63] - No subject was eligible for post-void residual volume assessment.
[64] - No subject was eligible for post-void residual volume assessment.
[65] - No subject was eligible for post-void residual volume assessment.

No statistical analyses for this end point

Primary: Change From Baseline in Post-Void Residual (PVR) Volume at Final Visit: Study A0221109

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End point title

Change From Baseline in Post-Void Residual (PVR) Volume at Final Visit: Study A0221109 ^[66]

End point description

End point type

Primary

End point timeframe

A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Notes
[66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule
Number of subjects analysed	0 ^[67]	0 ^[68]	0 ^[69]
Units: milliliter
arithmetic mean (standard deviation)	±	±	±

Notes
[67] - No subject was eligible for post-void residual volume assessment.
[68] - No subject was eligible for post-void residual volume assessment.
[69] - No subject was eligible for post-void residual volume assessment.

No statistical analyses for this end point

Secondary: Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

Maximum cystometric bladder capacity was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O). Maximum cystometric bladder capacity was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Full analysis set (FAS) included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: milliliter
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	181.0 ± 28.28	149.7 ± 38.49	102.3 ± 48.95	181.0 ± 28.28	135.5 ± 45.21	143.1 ± 45.37
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	153.0 ± 56.57	37.6 ± 28.83	55.3 ± 38.76	153.0 ± 56.57	42.9 ± 31.01	61.3 ± 53.98
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	121.5 ± 30.41	32.8 ± 52.42	48.0 ± 67.55	121.5 ± 30.41	37.9 ± 53.99	53.1 ± 59.74
Change at Final Visit (n =2, 6, 3, 2, 9, 11)	121.5 ± 30.41	32.8 ± 52.42	48.0 ± 67.55	121.5 ± 30.41	37.9 ± 53.99	53.1 ± 59.74

No statistical analyses for this end point

Secondary: Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

Detrusor pressure (cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing. Detrusor pressure was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: cm H2O
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	29.0 ± 8.49	32.4 ± 11.57	58.3 ± 57.55	29.0 ± 8.49	40.2 ± 31.34	38.3 ± 28.79
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	-5.5 ± 0.71	-6.0 ± 7.85	-31.7 ± 43.73	-5.5 ± 0.71	-13.7 ± 24.90	-12.3 ± 22.74
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	-7.0 ± 0.00	-2.8 ± 2.86	-7.3 ± 47.44	-7.0 ± 0.00	-4.3 ± 23.93	-4.8 ± 21.43
Change at Final Visit (n =2, 6, 3, 2, 9, 11)	-7.0 ± 0.00	-2.8 ± 2.86	-7.3 ± 47.44	-7.0 ± 0.00	-4.3 ± 23.93	-4.8 ± 21.43

No statistical analyses for this end point

Secondary: Number of Subjects With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Number of Subjects With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

Subjects with presence of IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: subjects
Baseline	1	7	3	1	10	11
Week 12	0	4	3	0	7	7
Week 28	0	5	3	0	8	8
Final Visit	0	5	3	0	8	8

No statistical analyses for this end point

Secondary: Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

Bladder volume at first IDC was measured using urodynamic testing. Bladder volume at first IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. 9999 =standard deviation was not estimable since only 1 subjects was analysed. 99999 =Arithmetic mean and SD were not estimable since no subjects were analysed. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	1	7	3	1	10	11
Units: milliliter
arithmetic mean (standard deviation)
Baseline (n =1, 7, 3, 1, 10, 11)	175.0 ± 9999	48.1 ± 36.57	50.3 ± 22.14	175.0 ± 9999	48.8 ± 31.65	60.3 ± 48.47
Change at Week 12 (n =0, 4, 3, 0, 7, 7)	99999 ± 99999	113.8 ± 68.55	70.0 ± 4.58	99999 ± 99999	95.0 ± 53.88	95.0 ± 53.88
Change at Week 28 (n =0, 5, 3, 0, 8, 8)	99999 ± 99999	38.6 ± 24.46	70.0 ± 50.11	99999 ± 99999	50.4 ± 36.38	50.4 ± 36.38
Change at Final Visit (n =0, 5, 3, 8, 0, 8, )	99999 ± 99999	38.6 ± 24.46	70.0 ± 50.11	99999 ± 99999	50.4 ± 36.38	50.4 ± 36.38

No statistical analyses for this end point

Secondary: Change From Baseline in Bladder Compliance at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Bladder Compliance at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). Bladder Compliance was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: milliliter per cm H2O
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	7.00 ± 2.828	8.16 ± 5.668	4.20 ± 2.307	7.00 ± 2.828	6.97 ± 5.124	6.98 ± 4.712
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	9.00 ± 7.071	23.34 ± 55.493	12.40 ± 14.855	9.00 ± 7.071	20.06 ± 46.151	18.22 ± 42.021
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	8.65 ± 6.152	13.18 ± 18.628	13.30 ± 15.836	8.65 ± 6.152	13.22 ± 16.721	12.39 ± 15.194
Change at Final Visit (n =2, 6, 3, 2, 9, 11)	8.65 ± 6.152	13.18 ± 18.628	13.30 ± 15.836	8.65 ± 6.152	13.22 ± 16.721	12.39 ± 15.194

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 micturitions at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. No subject in reporting arms “Cohort 1”, “Fesoterodine 8 mg Tablet” and “Fesoterodine 4 mg Capsule” had >0 micturitions at baseline.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	0 ^[70]	4	0 ^[71]	0 ^[72]	4	4
Units: micturitions per 24 hours
arithmetic mean (standard deviation)
Baseline	±	4.58 ± 4.541	±	±	4.58 ± 4.541	4.58 ± 4.541
Change at Week 12	±	-1.50 ± 1.036	±	±	-1.50 ± 1.036	-1.50 ± 1.036
Change at Week 28	±	-1.08 ± 0.631	±	±	-1.08 ± 0.631	-1.08 ± 0.631
Change at Final Visit	±	-1.08 ± 0.631	±	±	-1.08 ± 0.631	-1.08 ± 0.631

Notes
[70] - No subjects had >0 micturitions at baseline.
[71] - No subjects had >0 micturitions at baseline.
[72] - No subjects had >0 micturitions at baseline.

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Number of Catheterizations per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Number of Catheterizations per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: catheterizations per 24 hours
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	5.33 ± 0.943	4.24 ± 1.641	5.00 ± 0.000	5.33 ± 0.943	4.47 ± 1.390	4.61 ± 1.332
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	0.00 ± 0.471	0.03 ± 0.420	0.11 ± 0.192	0.00 ± 0.471	0.05 ± 0.357	0.04 ± 0.353
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	0.33 ± 0.000	-0.19 ± 0.267	0.11 ± 0.192	0.33 ± 0.000	-0.09 ± 0.278	-0.02 ± 0.302
Change at Final Visit (n =2, 7, 3, 2, 10, 12)	0.33 ± 0.000	-0.21 ± 0.249	0.11 ± 0.192	0.33 ± 0.000	-0.12 ± 0.273	-0.04 ± 0.303

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Number of Micturitions or Catheterizations Combined per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Number of Micturitions or Catheterizations Combined per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean number of micturitions and catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hr) period. This endpoint was only calculated for subjects with >0 micturitions or catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: micturitions or catheterizations/24 hr
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	5.33 ± 0.943	6.86 ± 3.259	5.00 ± 0.000	5.33 ± 0.943	6.30 ± 2.808	6.14 ± 2.584
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	0.00 ± 0.471	-0.83 ± 1.264	0.11 ± 0.192	0.00 ± 0.471	-0.55 ± 1.131	-0.46 ± 1.055
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	0.33 ± 0.000	-0.92 ± 0.665	0.11 ± 0.192	0.33 ± 0.000	-0.57 ± 0.741	-0.41 ± 0.758
Change at Final Visit (n =2, 7, 3, 2, 10, 12)	0.33 ± 0.000	-0.83 ± 0.645	0.11 ± 0.192	0.33 ± 0.000	-0.55 ± 0.703	-0.40 ± 0.723

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 incontinence episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: incontinence episodes per 24 hours
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	1.17 ± 0.236	3.48 ± 2.768	3.89 ± 0.770	1.17 ± 0.236	3.60 ± 2.298	3.19 ± 2.285
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	0.50 ± 0.236	-0.26 ± 2.074	0.00 ± 0.667	0.50 ± 0.236	-0.18 ± 1.726	-0.07 ± 1.586
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	1.83 ± 0.707	-0.42 ± 1.577	-0.11 ± 1.644	1.83 ± 0.707	-0.31 ± 1.501	0.08 ± 1.615
Change at Final Visit (n =2, 7, 3, 2, 10, 12)	1.83 ± 0.707	0.17 ± 2.110	-0.11 ± 1.644	1.83 ± 0.707	0.08 ± 1.894	0.38 ± 1.856

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour period. Urgency episodes were defined as urgency marked as ‘yes’ in the diary. This endpoint was only calculated for sensate subjects with >0 urgency episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. 9999 =standard deviation was not estimable since only one subjects was analysed. FAS was analyzed. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. No sensate subjects for reporting arms “Cohort 1” and “Fesoterodine 8 mg Tablet” had >0 urgency episodes at baseline.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	0 ^[73]	2	1	0 ^[74]	3	3
Units: urgency episodes per 24 hours
arithmetic mean (standard deviation)
Baseline	±	0.75 ± 0.354	0.33 ± 9999	±	0.61 ± 0.347	0.61 ± 0.347
Change at Week 12	±	-0.75 ± 0.354	-0.33 ± 9999	±	-0.61 ± 0.347	-0.61 ± 0.347
Change at Week 28	±	-0.75 ± 0.354	-0.33 ± 9999	±	-0.61 ± 0.347	-0.61 ± 0.347
Change at Final Visit	±	-0.75 ± 0.354	-0.33 ± 9999	±	-0.61 ± 0.347	-0.61 ± 0.347

Notes
[73] - No subject had >0 urgency episodes.
[74] - No subject had >0 urgency episodes.

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Volume Voided per Micturition at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Volume Voided per Micturition at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume > 0. This endpoint included only subjects who actually had the records of volume voided per micturition. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Only subjects who actually had the records of volume voided per micturition were reported. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. No subject in reporting arms “Cohort 1”, “Fesoterodine 8 mg Tablet” and “Fesoterodine 4 mg Capsule” had the records of volume voided per micturition.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	0 ^[75]	2	0 ^[76]	0 ^[77]	2	2
Units: milliliter per micturition
arithmetic mean (standard deviation)
Baseline	±	73.42 ± 42.309	±	±	73.42 ± 42.309	73.42 ± 42.309
Change at Week 12	±	15.77 ± 6.924	±	±	15.77 ± 6.924	15.77 ± 6.924
Change at Week 28	±	4.75 ± 14.496	±	±	4.75 ± 14.496	4.75 ± 14.496
Change at Final Visit	±	4.75 ± 14.496	±	±	4.75 ± 14.496	4.75 ± 14.496

Notes
[75] - No subjects had records of volume voided per micturition.
[76] - No subjects had records of volume voided per micturition.
[77] - No subjects had records of volume voided per micturition.

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Volume Voided per Catheterization at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Volume Voided per Catheterization at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume >0. This endpoint included only subjects who actually had the records of volume voided per catherization. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in Study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: milliliter per catheterization
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	198.75 ± 44.194	48.76 ± 39.230	80.58 ± 39.841	198.75 ± 44.194	58.31 ± 40.187	81.72 ± 66.988
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	-0.92 ± 21.095	17.90 ± 17.038	27.08 ± 32.086	-0.92 ± 21.095	20.66 ± 21.024	17.06 ± 21.739
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	-29.42 ± 12.139	8.72 ± 33.245	17.28 ± 9.659	-29.42 ± 12.139	11.58 ± 27.064	4.12 ± 29.591
Change at Final Visit (n =2, 6, 3, 2, 9, 11)	-29.42 ± 12.139	8.72 ± 33.245	17.28 ± 9.659	-29.42 ± 12.139	11.58 ± 27.064	4.12 ± 29.591

No statistical analyses for this end point

Secondary: Change From Baseline in Mean Volume Voided per Micturition or Catheterization at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

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End point title

Change From Baseline in Mean Volume Voided per Micturition or Catheterization at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109

End point description

The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume >0. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in Study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

or Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

End point values	Fesoterodine 8 mg Tablet	Fesoterodine 2 mg Capsule	Fesoterodine 4 mg Capsule	Cohort 1	Cohort 2	Total of Treatment Groups
Number of subjects analysed	2	7	3	2	10	12
Units: mL per micturition or catheterization
arithmetic mean (standard deviation)
Baseline (n =2, 7, 3, 2, 10, 12)	198.75 ± 44.194	59.29 ± 33.550	80.58 ± 39.841	198.75 ± 44.194	65.68 ± 34.769	87.86 ± 62.045
Change at Week 12 (n =2, 7, 3, 2, 10, 12)	-0.92 ± 21.095	13.94 ± 7.801	27.08 ± 32.086	-0.92 ± 21.095	17.88 ± 17.597	14.75 ± 18.638
Change at Week 28 (n =2, 6, 3, 2, 9, 11)	-29.42 ± 12.139	9.86 ± 33.029	17.28 ± 9.659	-29.42 ± 12.139	12.34 ± 26.812	4.75 ± 29.583
Change at Final Visit (n =2, 6, 3, 2, 9, 11)	-29.42 ± 12.139	9.86 ± 33.029	17.28 ± 9.659	-29.42 ± 12.139	12.34 ± 26.812	4.75 ± 29.583

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)

Adverse event reporting additional description

Safety analysis population was evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Cohort 2

Reporting group description

Reporting group title

Cohort 1

Reporting group description

Reporting group title

Fesoterodine 2 mg Capsule

Reporting group description

Subjects of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.

Reporting group title

Fesoterodine 8 mg Tablet

Reporting group description

Subjects of cohort 1, with body weight > 25 kg, who received fesoterodine 8 mg PR tablet once daily for 24 weeks (12 weeks in each active comparator and safety extension phase) in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.

Reporting group title

Total of Treatment Groups

Reporting group description

Total Subjects who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive same treatment respectively in this LTE study.

Reporting group title

Fesoterodine 4 mg Capsule

Reporting group description

Subjects of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks (in efficacy phase) and 12 weeks (in safety extension phase) in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.

Serious adverse events	Cohort 2	Cohort 1	Fesoterodine 2 mg Capsule	Fesoterodine 8 mg Tablet	Total of Treatment Groups	Fesoterodine 4 mg Capsule
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Infections and infestations
Urinary tract infection
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Cohort 2	Cohort 1	Fesoterodine 2 mg Capsule	Fesoterodine 8 mg Tablet	Total of Treatment Groups	Fesoterodine 4 mg Capsule
Total subjects affected by non serious adverse events
subjects affected / exposed	9 / 10 (90.00%)	2 / 2 (100.00%)	6 / 7 (85.71%)	2 / 2 (100.00%)	11 / 12 (91.67%)	3 / 3 (100.00%)
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Pyrexia
subjects affected / exposed	2 / 10 (20.00%)	1 / 2 (50.00%)	1 / 7 (14.29%)	1 / 2 (50.00%)	3 / 12 (25.00%)	1 / 3 (33.33%)
occurrences all number	3	1	2	1	4	1
Immune system disorders
Seasonal allergy
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	2	0	2	0	2	0
Upper respiratory tract inflammation
subjects affected / exposed	2 / 10 (20.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	2 / 12 (16.67%)	1 / 3 (33.33%)
occurrences all number	2	0	1	0	2	1
Product issues
Device malfunction
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Investigations
Urodynamics measurement abnormal
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 2 (0.00%)	1 / 12 (8.33%)	1 / 3 (33.33%)
occurrences all number	1	0	0	0	1	1
Injury, poisoning and procedural complications
Chillblains
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Nervous system disorders
Headache
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Eye disorders
Astigmatism
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Conjunctivitis allergic
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Myopia
subjects affected / exposed	2 / 10 (20.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 2 (0.00%)	2 / 12 (16.67%)	2 / 3 (66.67%)
occurrences all number	2	0	0	0	2	2
Strabismus
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Visual acuity reduced
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Gastrointestinal disorders
Anal fissure
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Aphthous ulcer
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Diarrhoea
subjects affected / exposed	1 / 10 (10.00%)	1 / 2 (50.00%)	1 / 7 (14.29%)	1 / 2 (50.00%)	2 / 12 (16.67%)	0 / 3 (0.00%)
occurrences all number	1	1	1	1	2	0
Faeces soft
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Skin and subcutaneous tissue disorders
Decubitus ulcer
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Dermal cyst
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 2 (0.00%)	1 / 12 (8.33%)	1 / 3 (33.33%)
occurrences all number	1	0	0	0	1	1
Eczema
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Seborrhoeic dermatitis
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Renal and urinary disorders
Renal failure
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Urinary incontinence
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 2 (0.00%)	1 / 12 (8.33%)	1 / 3 (33.33%)
occurrences all number	1	0	0	0	1	1
Musculoskeletal and connective tissue disorders
Spinal deformity
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Infections and infestations
Abscess limb
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	11	0
Asymptomatic bacteriuria
subjects affected / exposed	4 / 10 (40.00%)	0 / 2 (0.00%)	3 / 7 (42.86%)	0 / 2 (0.00%)	4 / 12 (33.33%)	1 / 3 (33.33%)
occurrences all number	5	0	4	0	5	1
Bronchitis
subjects affected / exposed	0 / 10 (0.00%)	1 / 2 (50.00%)	0 / 7 (0.00%)	1 / 2 (50.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	1	0
Conjunctivitis bacterial
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 2 (0.00%)	1 / 12 (8.33%)	1 / 3 (33.33%)
occurrences all number	2	0	0	0	2	2
Impetigo
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	1 / 12 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	0
Influenza
subjects affected / exposed	2 / 10 (20.00%)	0 / 2 (0.00%)	2 / 7 (28.57%)	0 / 2 (0.00%)	2 / 12 (16.67%)	0 / 3 (0.00%)
occurrences all number	2	0	2	0	2	0
Nasopharyngitis
subjects affected / exposed	6 / 10 (60.00%)	1 / 2 (50.00%)	4 / 7 (57.14%)	1 / 2 (50.00%)	7 / 12 (58.33%)	2 / 3 (66.67%)
occurrences all number	13	1	10	1	14	3
Oral herpes
subjects affected / exposed	1 / 10 (10.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 2 (0.00%)	1 / 12 (8.33%)	1 / 3 (33.33%)
occurrences all number	2	0	0	0	2	2
Pharyngitis
subjects affected / exposed	2 / 10 (20.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	2 / 12 (16.67%)	1 / 3 (33.33%)
occurrences all number	2	0	1	0	2	1
Sinusitis
subjects affected / exposed	2 / 10 (20.00%)	0 / 2 (0.00%)	1 / 7 (14.29%)	0 / 2 (0.00%)	2 / 12 (16.67%)	1 / 3 (33.33%)
occurrences all number	3	0	2	0	3	1

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Prioritization of endpoints was based on study team's discretion.

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Clinical trials

Clinical Trial Results: Long-term Extension Study to Evaluate the Safety of Fesoterodine in Japanese Pediatric Subjects With Symptoms of Detrusor Overactivity Associated With a Neurological Condition (Neurogenic Detrusor Overactivity) who Have Completed 24 Weeks Treatment in Study A0221047

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109

Primary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109

Primary: Change From Baseline in Visual Acuity at Week 12: Study A0221109

Primary: Change From Baseline in Visual Acuity at Week 12: Study A0221109

Primary: Change From Baseline in Visual Acuity at Week 28: Study A0221109

Primary: Change From Baseline in Visual Acuity at Week 28: Study A0221109

Primary: Change From Baseline in Visual Acuity at Final Visit: Study A0221109

Primary: Change From Baseline in Visual Acuity at Final Visit: Study A0221109

Primary: Change From Baseline in Visual Accommodation at Week 12: Study A0221109

Primary: Change From Baseline in Visual Accommodation at Week 12: Study A0221109

Primary: Change From Baseline in Visual Accommodation at Week 28: Study A0221109

Primary: Change From Baseline in Visual Accommodation at Week 28: Study A0221109

Primary: Change From Baseline in Visual Accommodation at Final Visit: Study A0221109

Primary: Change From Baseline in Visual Accommodation at Final Visit: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109

Primary: Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109

Primary: Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109

Primary: Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109

Primary: Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109

Clinical Trial Results:
Long-term Extension Study to Evaluate the Safety of Fesoterodine in Japanese Pediatric Subjects With Symptoms of Detrusor Overactivity Associated With a Neurological Condition (Neurogenic Detrusor Overactivity) who Have Completed 24 Weeks Treatment in Study A0221047