A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

• ClinicalTrials.gov Identifier: NCT01557244
• Recruitment Status: Completed
• First Posted: March 19, 2012
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urinary Bladder, Neurogenic
• Interventions: Drug: Fesoterodine PR 4 mg; Drug: Fesoterodine PR 8 mg; Drug: Oxybutynin; Drug: Fesoterodine PR; Drug: Fesoterodine BIC 2 mg; Drug: Fesoterodine BIC 4 mg
• Enrollment: 181

Participant Flow

Recruitment Details	Study had 2 cohorts: cohort 1 had participants with body weight greater than (>) 25 kilogram (kg) and cohort 2 had participants with body weight less than or equal to (<=) 25 kg. There were 2 phases in each cohort: cohort 1- active comparator phase followed by safety extension phase; cohort 2- efficacy phase followed by safety extension phase.
Pre-assignment Details

Arm/Group Title	Cohort 1: Fesoterodine 4 mg	Cohort 1: Fesoterodine 4 mg Then 8 mg	Cohort 1: Oxybutynin	Cohort 1: Oxybutynin Then Fesoterodine 4 mg	Cohort 1: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2: Fesoterodine 2 mg	Cohort 2: Fesoterodine 2 mg Then 4 mg
Arm/Group Description	Participants with body weight >25 kg were randomized to receive fesoterodine 4 milligram (mg) prolonged release (PR) tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.	Participants with body weight >25 kg were randomized to receive oxybutynin extended release (ER) tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.
Period Title: Active Comparator/Efficacy Phase:12Weeks
Started	42	42	40	0	0	28	29
Treated	42	42	40	0	0	28	29
Completed	33	40	36	0	0	21	28
Not Completed	9	2	4	0	0	7	1
Reason Not Completed
Adverse Event	2	0	0	0	0	2	0
Protocol Violation	2	0	1	0	0	0	0
Lost to Follow-up	1	0	0	0	0	0	0
Withdrawal By Parent/Guardian	2	0	0	0	0	3	0
Medication Error Without Associated AEs	0	1	0	0	0	0	0
Insufficient Clinical Response	0	0	0	0	0	1	1
Failure to Meet Randomization Criteria	0	1	1	0	0	1	0
Other	2	0	2	0	0	0	0
Period Title: Safety Extension Phase: 12 Weeks
Started	33	40	0 [1]	16 [2]	20 [2]	21	28
Treated	30	37	0	16	20	20	28
Completed	30	36	0	15	20	20	28
Not Completed	3	4	0	1	0	1	0
Reason Not Completed
Adverse Event	1	1	0	0	0	1	0
Withdrawal By Parent/Guardian	1	1	0	0	0	0	0
Medication Error Without Associated AEs	0	0	0	1	0	0	0
Insufficient Clinical Response	1	2	0	0	0	0	0
[1] Did not receive oxybutynin in safety extension phase.; [2] Allocated from oxybutynin arm to this arm by investigator in safety extension phase.

Baseline Characteristics

Arm/Group Title		Cohort 1: Fesoterodine 4 mg	Cohort 1: Fesoterodine 4 mg Then 8 mg	Cohort 1: Oxybutynin	Cohort 2: Fesoterodine 2 mg	Cohort 2: Fesoterodine 2 mg Then 4 mg	Total
Arm/Group Description		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		42	42	40	28	29	181
Baseline Analysis Population Description		Analysis population included all randomized participants.
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	40 participants	28 participants	29 participants	181 participants
	>=6-9 Years	15 35.7%	15 35.7%	15 37.5%	24 85.7%	23 79.3%	92 50.8%
	>=10-12 Years	15 35.7%	14 33.3%	13 32.5%	3 10.7%	5 17.2%	50 27.6%
	>=13-17 Years	12 28.6%	13 31.0%	12 30.0%	1 3.6%	1 3.4%	39 21.5%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	40 participants	28 participants	29 participants	181 participants
	Female	16 38.1%	22 52.4%	17 42.5%	12 42.9%	19 65.5%	86 47.5%
	Male	26 61.9%	20 47.6%	23 57.5%	16 57.1%	10 34.5%	95 52.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	40 participants	28 participants	29 participants	181 participants
	Hispanic or Latino	3 7.1%	2 4.8%	1 2.5%	0 0.0%	2 6.9%	8 4.4%
	Not Hispanic or Latino	39 92.9%	40 95.2%	39 97.5%	28 100.0%	27 93.1%	173 95.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants	42 participants	40 participants	28 participants	29 participants	181 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	14 33.3%	18 42.9%	22 55.0%	16 57.1%	16 55.2%	86 47.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 4.8%	0 0.0%	1 2.5%	0 0.0%	0 0.0%	3 1.7%
	White	24 57.1%	24 57.1%	17 42.5%	12 42.9%	11 37.9%	88 48.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 4.8%	0 0.0%	0 0.0%	0 0.0%	2 6.9%	4 2.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
Description	Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	41	41	38	25	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: milliliter
	58.12; (28.84 to 87.39)	83.36; (54.22 to 112.49)	87.17; (56.82 to 117.53)	23.49; (3.03 to 43.95)	40.17; (20.84 to 59.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Least square (LS) Mean
	Estimated Value	-29.06
	Confidence Interval	(2-Sided) 95%; -71.42 to 13.31
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-3.82
	Confidence Interval	(2-Sided) 95%; -45.87 to 38.23
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
Description	Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	40	41	38	25	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: cm H2O
	-2.86; (-7.60 to 1.87)	-1.57; (-6.25 to 3.12)	-2.39; (-7.27 to 2.48)	-2.74; (-10.62 to 5.15)	-9.73; (-17.18 to -2.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2334
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5087
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3333
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -7.28 to 6.33
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; -5.96 to 7.60
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase
Description	In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	41	41	38	25	28
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline IDC = No; Week 12 IDC = No	12 29.3%	4 9.8%	6 15.8%	0 0.0%	1 3.6%
Baseline IDC = No; Week 12 IDC = Yes	2 4.9%	1 2.4%	0 0.0%	0 0.0%	0 0.0%
Baseline IDC = Yes; Week 12 IDC = No	9 22.0%	18 43.9%	14 36.8%	6 24.0%	11 39.3%
Baseline IDC = Yes; Week 12 IDC = Yes	18 43.9%	18 43.9%	18 47.4%	19 76.0%	16 57.1%

4. Secondary Outcome

Title	Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase
Description	Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	26	36	32	25	27
Least Squares Mean (95% Confidence Interval); Unit of Measure: milliliter
	30.53; (2.42 to 58.64)	26.06; (2.19 to 49.92)	41.31; (15.92 to 66.70)	23.80; (-1.60 to 49.19)	31.26; (6.85 to 55.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0336
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0327
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0017
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-10.78
	Confidence Interval	(2-Sided) 95%; -48.75 to 27.19
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-15.25
	Confidence Interval	(2-Sided) 95%; -50.15 to 19.64
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase
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).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	40	40	38	25	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: mL per cm H2O
	6.40; (-0.48 to 13.28)	5.41; (-1.49 to 12.32)	11.36; (4.30 to 18.42)	12.44; (-0.64 to 25.53)	16.44; (4.08 to 28.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0679
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1233
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0019
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-4.96
	Confidence Interval	(2-Sided) 95%; -14.81 to 4.89
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-5.95
	Confidence Interval	(2-Sided) 95%; -15.85 to 3.95
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
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 outcome measure was only calculated for participants with >0 micturitions at Baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	18	21	26	14	17
Least Squares Mean (95% Confidence Interval); Unit of Measure: micturitions per 24 hours
	-1.07; (-1.88 to -0.25)	-0.68; (-1.44 to 0.08)	-0.97; (-1.65 to -0.29)	-0.37; (-1.10 to 0.36)	-0.70; (-1.36 to -0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0116
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0765
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0061
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -1.16 to 0.97
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 95%; -0.74 to 1.31
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
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 hours period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	37	33	31	22	24
Least Squares Mean (95% Confidence Interval); Unit of Measure: catheterizations per 24 hours
	-0.30; (-0.63 to 0.04)	-0.32; (-0.68 to 0.03)	-0.34; (-0.71 to 0.02)	-0.10; (-0.50 to 0.29)	-0.22; (-0.60 to 0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0787
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0727
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0666
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.45 to 0.54
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.49 to 0.52
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
Description	The mean number of micturitions or 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 (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	41	37	38	23	26
Least Squares Mean (95% Confidence Interval); Unit of Measure: micturitions and catheterizations/24 hrs
	-0.61; (-1.08 to -0.14)	-0.60; (-1.09 to -0.11)	-0.75; (-1.24 to -0.26)	-0.24; (-0.67 to 0.19)	-0.28; (-0.68 to 0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0111
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0171
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0028
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.53 to 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; -0.54 to 0.84
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
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 hours period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	33	33	35	22	20
Least Squares Mean (95% Confidence Interval); Unit of Measure: incontinence episodes per 24 hours
	-0.46; (-0.92 to -0.00)	-0.89; (-1.35 to -0.43)	-1.01; (-1.46 to -0.56)	-0.38; (-0.95 to 0.20)	-0.69; (-1.29 to -0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0496
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; -0.09 to 1.19
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.52 to 0.77
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
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 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with >0 urgency episodes at Baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	26	18	26	13	9
Least Squares Mean (95% Confidence Interval); Unit of Measure: urgency episodes per 24 hours
	-0.62; (-1.18 to -0.06)	-0.50; (-1.17 to 0.17)	-0.14; (-0.70 to 0.42)	-0.23; (-0.84 to 0.38)	-0.62; (-1.35 to 0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0298
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1417
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6219
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -1.28 to 0.32
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -1.24 to 0.52
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase
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 greater than 0.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	15	15	20	8	10
Least Squares Mean (95% Confidence Interval); Unit of Measure: milliliter per micturition
	4.10; (-28.05 to 36.24)	19.21; (-12.67 to 51.10)	4.15; (-22.69 to 30.98)	-12.72; (-34.96 to 9.52)	-8.41; (-28.27 to 11.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7986
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2313
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7571
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95%; -42.11 to 42.00
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	15.07
	Confidence Interval	(2-Sided) 95%; -26.50 to 56.63
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase
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 greater than 0.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	36	32	28	23	25
Least Squares Mean (95% Confidence Interval); Unit of Measure: milliliter per catheterization
	29.47; (-1.38 to 60.32)	47.18; (14.74 to 79.62)	45.90; (11.24 to 80.55)	11.50; (-9.87 to 32.88)	1.74; (-18.76 to 22.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0610
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0048
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0100
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-16.43
	Confidence Interval	(2-Sided) 95%; -63.14 to 30.29
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	1.28
	Confidence Interval	(2-Sided) 95%; -46.00 to 48.57
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase
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 greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	39	38	38	24	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: mL per micturition or catheterization
	18.45; (-11.49 to 48.40)	55.55; (25.80 to 85.31)	36.69; (6.95 to 66.43)	7.12; (-11.87 to 26.11)	-2.65; (-20.22 to 14.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2246
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0161
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-18.24
	Confidence Interval	(2-Sided) 95%; -61.00 to 24.53
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg, Cohort 1, Active Comparator Phase: Oxybutynin
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	18.86
	Confidence Interval	(2-Sided) 95%; -22.93 to 60.65
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase
Description	An AE was any untoward medical occurrence in a participant 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 the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	42	42	40	28	29
Measure Type: Count of Participants; Unit of Measure: Participants
Treatment Emergent AEs	26 61.9%	20 47.6%	30 75.0%	19 67.9%	18 62.1%
Treatment Emergent SAEs	3 7.1%	2 4.8%	1 2.5%	2 7.1%	2 6.9%

15. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase
Description	An AE was any untoward medical occurrence in a participant 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 the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
Time Frame	Week 12 up to Week 26 (including 2 weeks of follow up after last dose)

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	30	37	16	20	20	28
Measure Type: Count of Participants; Unit of Measure: Participants
Treatment emergent AEs	14 46.7%	13 35.1%	9 56.3%	11 55.0%	11 55.0%	16 57.1%
Treatment emergent SAEs	0 0.0%	2 5.4%	0 0.0%	0 0.0%	0 0.0%	2 7.1%

16. Secondary Outcome

Title	Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase
Description	Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants 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 participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		42	42	40	28	29
Mean (Standard Deviation); Unit of Measure: logMAR unit
Right Eye: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		0.09 (0.16)	0.11 (0.19)	0.03 (0.11)	0.15 (0.21)	0.10 (0.18)
Right Eye: Change at Week 12	Number Analyzed	37 participants	40 participants	40 participants	24 participants	29 participants
		0.01 (0.11)	-0.01 (0.10)	0.02 (0.18)	0.03 (0.12)	-0.00 (0.09)
Left Eye: Baseline	Number Analyzed	42 participants	42 participants	40 participants	28 participants	29 participants
		0.08 (0.16)	0.10 (0.17)	0.02 (0.13)	0.16 (0.21)	0.14 (0.30)
Left Eye: Change at Week 12	Number Analyzed	37 participants	41 participants	40 participants	24 participants	29 participants
		0.00 (0.13)	-0.01 (0.10)	0.00 (0.13)	-0.02 (0.08)	0.00 (0.08)

17. Secondary Outcome

Title	Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase
Description	VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants 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 participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		30	37	16	20	20	28
Mean (Standard Deviation); Unit of Measure: logMAR unit
Right Eye: Change at Week 24	Number Analyzed	30 participants	36 participants	16 participants	20 participants	19 participants	28 participants
		0.04 (0.17)	-0.02 (0.11)	-0.01 (0.05)	0.02 (0.13)	0.00 (0.07)	0.01 (0.11)
Left Eye: Change at Week 24	Number Analyzed	30 participants	37 participants	16 participants	20 participants	19 participants	28 participants
		0.01 (0.19)	-0.01 (0.11)	0.00 (0.08)	-0.04 (0.09)	-0.02 (0.07)	0.03 (0.13)

18. Secondary Outcome

Title	Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase
Description	The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		42	42	40	28	29
Mean (Standard Deviation); Unit of Measure: centimeter
Right Eye: Baseline	Number Analyzed	38 participants	39 participants	39 participants	26 participants	28 participants
		11.88 (7.39)	15.94 (18.64)	9.59 (5.05)	9.67 (16.71)	8.17 (6.89)
Right Eye: Change at Week 12	Number Analyzed	33 participants	38 participants	39 participants	22 participants	28 participants
		1.74 (7.45)	7.77 (45.53)	0.50 (4.64)	-1.04 (6.79)	1.02 (3.89)
Left Eye: Baseline	Number Analyzed	39 participants	40 participants	39 participants	26 participants	27 participants
		12.31 (8.67)	15.83 (17.85)	9.69 (5.13)	8.81 (14.89)	8.04 (7.17)
Left Eye: Change at Week 12	Number Analyzed	34 participants	39 participants	39 participants	22 participants	27 participants
		0.27 (4.29)	5.79 (36.75)	0.81 (4.78)	-1.45 (9.60)	0.90 (3.38)

19. Secondary Outcome

Title	Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase
Description	The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		30	37	16	20	20	28
Mean (Standard Deviation); Unit of Measure: centimeter
Right Eye: Change at Week 24	Number Analyzed	27 participants	34 participants	16 participants	20 participants	18 participants	27 participants
		0.73 (5.47)	4.33 (28.89)	1.50 (4.80)	0.50 (4.30)	-1.35 (13.03)	0.96 (4.38)
Left Eye: Change at Week 24	Number Analyzed	28 participants	35 participants	16 participants	20 participants	18 participants	26 participants
		0.90 (5.85)	3.79 (29.81)	1.66 (6.25)	0.58 (4.53)	0.43 (11.53)	1.12 (4.20)

20. Secondary Outcome

Title	Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase
Description	CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		42	42	40	28	29
Mean (Standard Deviation); Unit of Measure: T score
Aggressive behavior: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		53.86 (5.67)	54.32 (5.88)	54.58 (5.75)	54.9 (5.25)	52.8 (4.48)
Aggressive behavior: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-1.03 (3.17)	-0.95 (3.71)	-1.28 (2.77)	-1.29 (3.58)	-0.03 (2.96)
Anxious/depressed: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		56.07 (6.99)	57.00 (8.26)	56.75 (7.32)	55.5 (6.58)	56.3 (6.55)
Anxious/depressed: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-1.73 (3.05)	-1.38 (5.25)	-1.92 (4.66)	-0.79 (4.55)	-3.21 (5.27)
Attention problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		56.29 (5.32)	56.66 (7.47)	56.30 (5.68)	55.4 (5.06)	55.3 (5.74)
Attention problems: Change at week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-1.97 (3.79)	-1.40 (4.30)	-1.28 (3.69)	-1.29 (3.61)	-1.45 (3.41)
Rule-breaking behavior: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		53.26 (3.52)	53.80 (5.53)	53.43 (4.96)	54.5 (4.96)	52.3 (3.74)
Rule-breaking behavior: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.92 (2.99)	-0.88 (3.91)	-0.72 (2.76)	-1.71 (4.84)	-0.10 (2.19)
Social problems : Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		57.52 (5.42)	58.54 (9.43)	57.95 (7.90)	57.9 (6.66)	55.8 (5.90)
Social problems : Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-1.35 (3.90)	-2.55 (4.74)	-0.67 (3.73)	-2.21 (4.38)	-1.10 (3.41)
Somatic complaints: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		61.14 (6.24)	60.46 (8.73)	60.58 (8.44)	57.1 (6.47)	58.4 (6.55)
Somatic complaints: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.46 (5.99)	-1.28 (6.35)	-0.87 (7.16)	-0.38 (3.97)	-1.69 (5.90)
Thought problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		55.00 (6.19)	53.54 (5.93)	56.73 (7.64)	51.9 (2.81)	54.9 (5.60)
Thought problems: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.92 (4.69)	-0.48 (4.25)	-1.59 (3.65)	-0.42 (1.67)	-1.38 (5.42)
Withdrawn: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		54.60 (5.17)	57.54 (8.34)	58.25 (7.93)	55.7 (5.96)	55.0 (7.11)
Withdrawn: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		0.35 (4.70)	-1.25 (5.13)	-1.92 (5.08)	-1.75 (3.97)	-0.59 (4.48)
Externalizing: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		49.48 (8.68)	49.46 (10.00)	50.10 (9.73)	51.1 (9.83)	48.0 (7.84)
Externalizing: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-2.08 (5.26)	-2.33 (5.28)	-1.95 (4.62)	-2.63 (4.72)	-1.45 (4.56)
Internalizing: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		56.45 (8.06)	55.93 (12.84)	57.25 (11.00)	53.9 (10.34)	54.6 (10.14)
Internalizing: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-2.14 (6.46)	-2.35 (6.98)	-3.05 (7.12)	-1.96 (6.53)	-3.52 (6.38)
Total Problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		55.05 (8.20)	53.61 (11.98)	55.45 (10.28)	53.4 (10.70)	52.7 (9.37)
Total Problems: Change at Week 12	Number Analyzed	42 participants	42 participants	40 participants	28 participants	29 participants
		-2.51 (4.63)	-3.23 (5.45)	-2.36 (4.68)	-2.17 (5.05)	-3.38 (4.55)

21. Secondary Outcome

Title	Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase
Description	CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		30	37	16	20	20	28
Mean (Standard Deviation); Unit of Measure: T score
Aggressive behavior: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-1.59 (3.85)	-1.31 (4.57)	-1.25 (3.40)	-2.40 (4.89)	-1.70 (3.40)	-1.86 (3.63)
Anxious/depressed: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-3.45 (4.86)	-2.31 (5.64)	-1.50 (3.76)	-3.25 (5.66)	-2.60 (5.24)	-3.89 (4.95)
Attention problems: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-2.21 (3.99)	-2.64 (5.72)	-3.38 (4.65)	-1.70 (3.01)	-1.50 (3.15)	-1.71 (3.29)
Rule-breaking behavior: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-1.59 (3.62)	-1.47 (5.12)	-1.31 (4.01)	-0.90 (2.36)	-2.15 (3.17)	-0.36 (2.63)
Social problems : Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-2.83 (4.12)	-2.56 (4.15)	-3.19 (5.79)	-2.65 (3.28)	-3.90 (4.35)	-2.36 (4.17)
Somatic complaints: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-4.38 (6.59)	-2.64 (6.58)	-1.69 (9.20)	-1.50 (5.82)	-0.60 (3.12)	-1.96 (6.77)
Thought problems: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-3.10 (5.45)	-1.03 (4.52)	-3.25 (6.62)	-2.30 (3.50)	-1.40 (3.00)	-1.75 (3.99)
Withdrawn: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-0.69 (4.33)	-1.50 (5.98)	-2.19 (3.90)	-4.35 (5.24)	-1.80 (5.43)	-0.43 (3.75)
Externalizing: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-5.21 (8.20)	-2.89 (7.06)	-1.81 (5.42)	-4.15 (7.44)	-4.20 (5.15)	-4.21 (6.86)
Internalizing: Change at Week 24	Number Analyzed	29 participants	36 participants	16 participants	20 participants	20 participants	28 participants
		-7.69 (7.46)	-4.14 (7.62)	-3.25 (8.10)	-5.35 (7.21)	-4.40 (6.21)	-4.32 (6.70)
Total Problems: Change at Week 24	Number Analyzed	30 participants	37 participants	16 participants	20 participants	20 participants	28 participants
		-7.03 (7.77)	-4.44 (6.57)	-3.69 (6.74)	-4.90 (4.78)	-5.20 (4.32)	-5.25 (6.22)

22. Secondary Outcome

Title	Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase
Description	CBCL: It consisted of 120 items on behavior and emotional problems. 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 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		42	42	40	28	29
Mean (Standard Deviation); Unit of Measure: units on a scale
Aggressive behavior: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		4.19 (4.39)	4.66 (4.46)	4.88 (4.35)	5.1 (3.95)	3.5 (3.37)
Aggressive behavior: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.62 (2.35)	-0.90 (2.56)	-0.97 (2.08)	-0.92 (2.39)	-0.17 (1.85)
Anxious/depressed: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		3.83 (3.33)	4.20 (4.06)	4.10 (3.53)	3.8 (3.15)	4.0 (3.35)
Anxious/depressed: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.97 (1.46)	-0.73 (2.43)	-1.05 (2.26)	-0.58 (2.28)	-1.48 (2.43)
Attention problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		4.79 (3.18)	4.49 (4.11)	4.85 (3.33)	4.2 (2.78)	3.9 (3.11)
Attention problems: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-1.05 (2.25)	-0.73 (2.16)	-0.77 (2.03)	-0.71 (1.90)	-0.83 (1.63)
Rule-breaking behavior: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		1.64 (1.48)	1.66 (1.98)	1.70 (1.87)	1.9 (1.63)	1.0 (1.30)
Rule-breaking behavior: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.43 (1.09)	-0.30 (1.36)	-0.38 (0.99)	-0.63 (1.56)	0.52 (3.45)
Social problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		3.60 (2.30)	4.07 (4.12)	3.80 (3.36)	3.9 (2.99)	3.2 (2.64)
Social problems: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.54 (1.54)	-1.13 (2.09)	-0.26 (1.57)	-0.83 (1.86)	-0.62 (1.52)
Somatic complaints: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		3.40 (2.18)	3.46 (3.26)	3.40 (3.23)	2.1 (1.93)	2.6 (2.16)
Somatic complaints: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.05 (2.26)	-0.53 (2.44)	-0.51 (2.64)	-0.04 (1.55)	-0.55 (2.03)
Thought problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		2.05 (2.23)	1.46 (2.34)	2.58 (2.92)	1.0 (1.04)	2.0 (1.79)
Thought problems: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.46 (1.69)	-0.10 (1.37)	-0.51 (1.30)	-0.21 (0.72)	-0.45 (1.64)
Withdrawn: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		1.52 (1.77)	2.49 (2.78)	2.75 (2.66)	1.7 (1.81)	1.6 (2.26)
Withdrawn: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		0.14 (1.44)	-0.35 (1.59)	-0.64 (1.77)	-0.50 (1.10)	-0.17 (1.39)
Externalizing: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		5.83 (5.23)	6.32 (6.14)	6.53 (5.87)	6.9 (5.16)	4.5 (4.32)
Externalizing: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-1.05 (2.85)	-1.20 (3.42)	-1.31 (2.30)	-1.54 (3.50)	-0.31 (2.33)
Internalizing: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		8.76 (5.56)	10.15 (8.64)	10.25 (7.02)	7.5 (5.61)	8.2 (6.13)
Internalizing: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-0.89 (3.62)	-1.70 (5.16)	-2.21 (4.35)	-1.13 (3.85)	-2.21 (3.91)
Total Problems: Baseline	Number Analyzed	42 participants	41 participants	40 participants	28 participants	29 participants
		31.52 (16.84)	31.88 (23.78)	34.18 (22.16)	29.5 (17.41)	27.0 (16.59)
Total Problems: Change at Week 12	Number Analyzed	37 participants	40 participants	39 participants	24 participants	29 participants
		-4.92 (8.73)	-5.83 (12.16)	-5.85 (9.77)	-5.33 (8.29)	-5.10 (7.41)

23. Secondary Outcome

Title	Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase
Description	CBCL: It consisted of 120 items on behavior and emotional problems. 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 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	29	36	16	20	20	28
Mean (Standard Deviation); Unit of Measure: units on a scale
Aggressive behavior: Change at Week 24	-1.34 (2.92)	-1.17 (3.10)	-0.81 (2.43)	-1.75 (3.58)	-1.40 (2.41)	-1.57 (2.70)
Anxious/depressed: Change at Week 24	-1.93 (2.22)	-1.28 (2.42)	-1.06 (1.88)	-1.60 (2.48)	-1.70 (2.36)	-1.75 (2.34)
Attention problems: Change at Week 24	-1.41 (2.31)	-1.36 (2.77)	-1.94 (2.35)	-1.25 (1.77)	-1.15 (1.76)	-0.89 (1.69)
Rule-breaking behavior: Change at Week 24	-0.62 (1.29)	-0.50 (1.65)	-0.50 (1.21)	-0.55 (0.94)	-0.80 (1.01)	-0.18 (0.94)
Social problems: Change at Week 24	-1.28 (1.53)	-1.19 (1.97)	-1.13 (2.33)	-1.20 (1.36)	-1.65 (1.81)	-1.14 (1.74)
Somatic complaints: Change at Week 24	-1.34 (2.22)	-0.89 (2.38)	-0.88 (3.32)	-0.45 (1.73)	-0.15 (0.88)	-0.68 (2.04)
Thought problems: Change at Week 24	-1.31 (1.95)	-0.36 (1.40)	-1.06 (2.14)	-0.90 (1.21)	-0.65 (1.04)	-0.64 (1.28)
Withdrawn: Change at Week 24	-0.24 (1.43)	-0.44 (2.01)	-0.69 (1.35)	-1.35 (1.66)	-0.45 (1.50)	-0.14 (1.04)
Externalizing: Change at Week 24	-1.97 (3.50)	-1.67 (4.27)	-1.19 (3.23)	-2.30 (4.03)	-2.20 (2.84)	-1.79 (3.28)
Internalizing: Change at Week 24	-3.52 (4.00)	-2.61 (4.95)	-2.63 (4.65)	-3.40 (4.68)	-2.30 (3.64)	-2.57 (3.63)
Total Problems: Change at Week 24	-10.90 (11.98)	-8.58 (12.86)	-9.00 (13.45)	-10.10 (10.47)	-9.45 (7.93)	-8.39 (10.22)

24. Secondary Outcome

Title	Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants 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. Time taken to complete the test was inversely correlated to the cognitive ability.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		9	9	7	18	21
Mean (Standard Deviation); Unit of Measure: seconds
Dominant hand: Baseline	Number Analyzed	9 participants	8 participants	7 participants	18 participants	20 participants
		61.11 (31.66)	56.50 (32.09)	46.43 (16.28)	69.56 (58.52)	52.20 (31.06)
Dominant hand: Change at Week 12	Number Analyzed	7 participants	7 participants	6 participants	15 participants	19 participants
		-7.71 (11.06)	10.14 (37.18)	-5.33 (6.15)	-11.20 (41.11)	-10.26 (27.21)
Non-dominant hand: Baseline	Number Analyzed	9 participants	9 participants	7 participants	17 participants	21 participants
		80.44 (41.45)	114.00 (89.43)	48.00 (15.14)	91.29 (110.76)	76.29 (76.71)
Non-dominant hand: Change at Week 12	Number Analyzed	7 participants	6 participants	6 participants	14 participants	20 participants
		-21.71 (25.44)	15.33 (49.28)	-2.00 (12.25)	-19.36 (81.03)	-3.25 (22.53)

25. Secondary Outcome

Title	Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants 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. Time taken to complete the test was inversely correlated to the cognitive ability.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		3	7	2	3	15	19
Mean (Standard Deviation); Unit of Measure: seconds
Dominant hand: Change at Week 24	Number Analyzed	3 participants	7 participants	2 participants	3 participants	15 participants	18 participants
		-11.33 (9.07)	-3.71 (22.94)	-2.00 (8.49)	-6.33 (3.06)	-7.07 (6.80)	-15.00 (28.54)
Non-dominant hand: Change at Week 24	Number Analyzed	3 participants	6 participants	2 participants	3 participants	14 participants	19 participants
		-2.00 (13.75)	-4.00 (29.09)	1.50 (10.61)	-11.00 (5.00)	-9.14 (14.33)	-18.47 (38.13)

26. Secondary Outcome

Title	Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants 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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		33	34	33	10	9
Mean (Standard Deviation); Unit of Measure: seconds
Dominant hand: Baseline	Number Analyzed	33 participants	34 participants	33 participants	10 participants	9 participants
		88.85 (24.22)	92.15 (40.51)	82.64 (24.32)	106.7 (64.07)	124.7 (71.99)
Dominant hand: Change at Week 12	Number Analyzed	30 participants	33 participants	33 participants	8 participants	9 participants
		-5.40 (10.43)	-8.88 (20.76)	1.21 (11.87)	-14.38 (25.90)	-18.44 (32.23)
Non-dominant hand: Baseline	Number Analyzed	33 participants	32 participants	33 participants	10 participants	8 participants
		110.61 (59.63)	109.00 (49.75)	92.94 (25.05)	130.30 (83.58)	126.1 (48.93)
Non-dominant hand: Change at Week 12	Number Analyzed	30 participants	31 participants	33 participants	8 participants	8 participants
		-9.10 (19.94)	-4.10 (10.79)	-1.97 (14.00)	-13.50 (18.81)	-12.50 (20.30)

27. Secondary Outcome

Title	Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants 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.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		25	30	14	16	5	9
Mean (Standard Deviation); Unit of Measure: seconds
Dominant hand: Change at Week 24	Number Analyzed	25 participants	30 participants	14 participants	16 participants	5 participants	9 participants
		-8.20 (11.67)	-12.27 (18.28)	-5.71 (9.55)	-7.00 (13.25)	-38.20 (31.67)	-17.00 (33.16)
Non-dominant hand: Change at Week 24	Number Analyzed	25 participants	28 participants	14 participants	15 participants	5 participants	8 participants
		-9.24 (15.79)	-8.46 (10.42)	-3.79 (11.89)	-11.87 (14.15)	-38.00 (29.35)	-15.50 (29.11)

28. Secondary Outcome

Title	Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		9	9	7	18	21
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Baseline	Number Analyzed	9 participants	8 participants	7 participants	18 participants	20 participants
		0.11 (0.33)	0.75 (1.75)	0.29 (0.49)	0.39 (1.24)	0.10 (0.45)
Dominant hand: Change at Week 12	Number Analyzed	7 participants	7 participants	6 participants	15 participants	19 participants
		0.29 (0.76)	0.57 (1.13)	-0.17 (0.75)	0.00 (1.77)	0.05 (0.52)
Non-dominant hand: Baseline	Number Analyzed	9 participants	9 participants	7 participants	17 participants	21 participants
		0.44 (0.53)	1.22 (2.28)	0.00 (0.00)	0.35 (0.86)	0.76 (2.26)
Non-dominant hand: Change at Week 12	Number Analyzed	7 participants	6 participants	6 participants	14 participants	20 participants
		0.43 (1.27)	1.00 (2.00)	0.17 (0.41)	0.00 (0.68)	0.60 (3.45)

29. Secondary Outcome

Title	Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin 5 mg ER tablets orally once daily in active comparator phase, were allocated by investigator to receive fesoterodine 8 mg for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		3	7	2	3	15	19
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Change at week 24	Number Analyzed	3 participants	7 participants	2 participants	3 participants	15 participants	18 participants
		0.33 (0.58)	0.43 (0.79)	0.00 (0.00)	-0.33 (0.58)	-0.27 (1.39)	-0.06 (0.54)
Non-dominant hand: Change at week 24	Number Analyzed	3 participants	6 participants	2 participants	3 participants	14 participants	19 participants
		1.33 (2.31)	0.00 (1.10)	0.50 (0.71)	0.00 (0.00)	-0.36 (0.74)	0.11 (3.45)

30. Secondary Outcome

Title	Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		33	34	33	10	9
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Baseline	Number Analyzed	33 participants	34 participants	33 participants	10 participants	9 participants
		0.45 (1.20)	0.24 (0.50)	0.24 (0.66)	0.10 (0.32)	0.11 (0.33)
Dominant hand: Change at Week 12	Number Analyzed	30 participants	33 participants	33 participants	8 participants	9 participants
		0.00 (1.05)	-0.18 (0.58)	0.09 (0.77)	0.00 (0.53)	0.44 (1.33)
Non-dominant hand: Baseline	Number Analyzed	33 participants	32 participants	33 participants	10 participants	8 participants
		0.91 (2.36)	0.28 (0.46)	0.36 (0.78)	0.40 (0.97)	0.13 (0.35)
Non-dominant hand: Change at Week 12	Number Analyzed	30 participants	31 participants	33 participants	8 participants	8 participants
		-0.33 (1.60)	0.06 (1.03)	0.21 (1.78)	0.13 (0.35)	0.00 (0.00)

31. Secondary Outcome

Title	Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		25	30	14	16	5	9
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Change at Week 24	Number Analyzed	25 participants	30 participants	14 participants	16 participants	5 participants	9 participants
		0.00 (0.87)	0.63 (4.63)	0.14 (0.36)	0.25 (1.24)	0.00 (0.00)	0.44 (1.33)
Non-dominant hand: Change at Week 24	Number Analyzed	25 participants	28 participants	14 participants	15 participants	5 participants	8 participants
		-0.28 (2.17)	0.68 (4.79)	0.00 (0.39)	0.27 (1.67)	0.60 (0.89)	-0.13 (0.35)

32. Secondary Outcome

Title	Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		9	9	7	18	21
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Baseline	Number Analyzed	9 participants	8 participants	7 participants	18 participants	20 participants
		9.56 (1.01)	9.38 (1.77)	10.00 (0.00)	9.89 (0.47)	10.0 (0.00)
Dominant hand: Change at Week 12	Number Analyzed	7 participants	7 participants	6 participants	15 participants	19 participants
		-0.29 (0.76)	0.00 (0.00)	0.00 (0.00)	0.00 (0.38)	-0.11 (0.46)
Non-dominant hand: Baseline	Number Analyzed	9 participants	9 participants	7 participants	17 participants	21 participants
		9.56 (1.01)	9.00 (2.35)	10.00 (0.00)	9.82 (0.73)	9.62 (1.20)
Non-dominant hand: Change at Week 12	Number Analyzed	7 participants	6 participants	6 participants	14 participants	20 participants
		-0.57 (1.13)	0.00 (0.00)	0.00 (0.00)	-0.07 (0.62)	0.00 (0.32)

33. Secondary Outcome

Title	Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		3	7	2	3	15	19
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Change at Week 24	Number Analyzed	3 participants	7 participants	2 participants	3 participants	15 participants	18 participants
		-0.33 (0.58)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.07 (0.26)	0.00 (0.00)
Non-dominant hand: Change at Week 24	Number Analyzed	3 participants	6 participants	2 participants	3 participants	14 participants	19 participants
		-1.33 (2.31)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.14 (0.53)	0.21 (0.92)

34. Secondary Outcome

Title	Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		33	34	33	10	9
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Baseline	Number Analyzed	33 participants	34 participants	33 participants	10 participants	9 participants
		25.00 (0.00)	24.56 (1.89)	25.00 (0.00)	25.00 (0.00)	23.22 (3.83)
Dominant hand: Change at Week 12	Number Analyzed	30 participants	33 participants	33 participants	8 participants	9 participants
		-0.07 (0.25)	0.42 (1.77)	-0.12 (0.70)	-0.13 (0.35)	0.11 (2.76)
Non-dominant hand: Baseline	Number Analyzed	33 participants	32 participants	33 participants	10 participants	8 participants
		24.45 (2.09)	24.75 (0.92)	24.88 (0.42)	24.50 (1.58)	24.25 (1.75)
Non-dominant hand: Change at Week 12	Number Analyzed	30 participants	31 participants	33 participants	8 participants	8 participants
		0.53 (2.19)	0.26 (0.93)	0.03 (0.30)	0.63 (1.77)	-0.63 (1.77)

35. Secondary Outcome

Title	Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
Description	The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Arm/Group Title		Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:		Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed		25	30	14	16	5	9
Mean (Standard Deviation); Unit of Measure: pegs
Dominant hand: Change at Week 24	Number Analyzed	25 participants	30 participants	14 participants	16 participants	5 participants	9 participants
		0.00 (0.00)	0.50 (2.01)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.11 (2.76)
Non-dominant hand: Change at Week 24	Number Analyzed	25 participants	28 participants	14 participants	15 participants	5 participants	8 participants
		0.60 (2.40)	0.21 (0.96)	0.14 (0.66)	0.00 (0.00)	0.60 (2.61)	-0.50 (1.85)

36. Secondary Outcome

Title	Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase
Description	Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

Analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	40	41	40	24	29
Measure Type: Count of Participants; Unit of Measure: Participants
SBP: <90 mmHg	2 5.0%	2 4.9%	0 0.0%	7 29.2%	4 13.8%
SBP: Change >=30 mmHg increase	1 2.5%	2 4.9%	1 2.5%	0 0.0%	1 3.4%
SBP: Change >=30 mmHg decrease	1 2.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
DBP: <50 mmHg	2 5.0%	1 2.4%	2 5.0%	3 12.5%	1 3.4%
DBP: Change >=20 mmHg increase	1 2.5%	2 4.9%	1 2.5%	3 12.5%	4 13.8%
DBP: Change >=20 mmHg decrease	1 2.5%	1 2.4%	1 2.5%	2 8.3%	0 0.0%
Pulse rate: <40 bpm	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Pulse rate: >120 bpm	2 5.0%	4 9.8%	0 0.0%	2 8.3%	3 10.3%

37. Secondary Outcome

Title	Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase
Description	Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	30	37	16	20	20	28
Measure Type: Count of Participants; Unit of Measure: Participants
SBP: <90 mmHg	0 0.0%	3 8.1%	2 12.5%	1 5.0%	4 20.0%	2 7.1%
SBP: Change >=30 mmHg increase	1 3.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
SBP: Change >=30 mmHg decrease	0 0.0%	1 2.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
DBP: <50 mmHg	0 0.0%	2 5.4%	0 0.0%	0 0.0%	2 10.0%	0 0.0%
DBP: Change >=20 mmHg increase	1 3.3%	0 0.0%	0 0.0%	0 0.0%	1 5.0%	2 7.1%
DBP: Change >=20 mmHg decrease	1 3.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Pulse rate: <40 bpm	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Pulse rate: >120 bpm	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.6%

38. Secondary Outcome

Title	Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase
Description	Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 colony forming unit per milliliter [CFU/mL]) and the presence of symptoms, or pyuria (defined as >50 white blood cells [WBC] per high-pass filter [hpf]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).
Time Frame	Week 1 up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	42	42	40	28	29
Measure Type: Count of Participants; Unit of Measure: Participants
	4 9.5%	1 2.4%	4 10.0%	3 10.7%	4 13.8%

39. Secondary Outcome

Title	Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase
Description	Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) and the presence of symptoms, or pyuria (defined as >50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.
Time Frame	Week 12 up to Week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	30	37	16	20	20	28
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 2.7%	2 12.5%	0 0.0%	1 5.0%	5 17.9%

40. Secondary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase
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*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >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, phosphate <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, calcium 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, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.
Time Frame	Week 1 up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	39	41	39	24	29
Measure Type: Count of Participants; Unit of Measure: Participants
	30 76.9%	29 70.7%	27 69.2%	19 79.2%	19 65.5%

41. Secondary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase
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*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >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, phosphate <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, calcium 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, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.
Time Frame	Week 12 up to Week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	30	36	16	19	20	28
Measure Type: Count of Participants; Unit of Measure: Participants
	19 63.3%	22 61.1%	7 43.8%	12 63.2%	15 75.0%	21 75.0%

42. Secondary Outcome

Title	Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase
Description	Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure; "Number Analyzed": participants evaluable at specified time points.

Arm/Group Title		Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:		Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed		6	7	9	6	6
Mean (Standard Deviation); Unit of Measure: milliliter
Baseline	Number Analyzed	6 participants	7 participants	9 participants	6 participants	6 participants
		7.00 (8.20)	9.57 (12.54)	5.78 (7.98)	14.7 (14.31)	10.7 (7.94)
Change at Week 4	Number Analyzed	5 participants	6 participants	9 participants	3 participants	4 participants
		5.40 (7.60)	-7.33 (10.88)	19.11 (24.52)	-2.00 (6.24)	10.25 (34.40)
Change at Week 12	Number Analyzed	5 participants	6 participants	7 participants	4 participants	4 participants
		25.60 (53.42)	-4.00 (8.41)	12.86 (43.48)	2.50 (16.05)	0.75 (17.46)

43. Secondary Outcome

Title	Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase
Description	Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	4	5	5	3	3	4
Mean (Standard Deviation); Unit of Measure: milliliter
	11.50 (23.67)	11.60 (29.43)	18.00 (31.36)	36.67 (59.23)	21.67 (20.21)	2.75 (14.50)

44. Secondary Outcome

Title	Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase
Description	Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg
Arm/Group Description:	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
Overall Number of Participants Analyzed	38	42	40	28	29
Measure Type: Count of Participants; Unit of Measure: Participants
	2 5.3%	1 2.4%	1 2.5%	1 3.6%	0 0.0%

45. Secondary Outcome

Title	Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase
Description	Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Arm/Group Title	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description:	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Overall Number of Participants Analyzed	30	37	16	20	20	28
Measure Type: Count of Participants; Unit of Measure: Participants
	3 10.0%	2 5.4%	0 0.0%	0 0.0%	0 0.0%	2 7.1%

46. Secondary Outcome

Title	Absorption Rate Constant (Ka) of Fesoterodine
Description	Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Time Frame	Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)

Outcome Measure Data

Analysis Population Description

The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Arm/Group Title	Fesoterodine Pooled
Arm/Group Description:	Participants received any dose of fesoterodine in the study from Week 1 to Week 24.
Overall Number of Participants Analyzed	121
Mean (Standard Error); Unit of Measure: per hour
	0.0897 (5.99)

47. Secondary Outcome

Title	Apparent Oral Clearance (CL/F) of Fesoterodine
Description	Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Time Frame	Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)

Outcome Measure Data

Analysis Population Description

The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Arm/Group Title	Fesoterodine Pooled
Arm/Group Description:	Participants received any dose of fesoterodine in the study from Week 1 to Week 24.
Overall Number of Participants Analyzed	121
Mean (Standard Error); Unit of Measure: liter per hour
	71.6 (6.7)

48. Secondary Outcome

Title	Volume of Distribution (Vd) of Fesoterodine
Description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Time Frame	Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)

Outcome Measure Data

Analysis Population Description

The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Arm/Group Title	Fesoterodine Pooled
Arm/Group Description:	Participants received any dose of fesoterodine in the study from Week 1 to Week 24.
Overall Number of Participants Analyzed	121
Mean (Standard Error); Unit of Measure: liter
	68.1 (29.7)

Adverse Events

Time Frame	Baseline up to Week 26 (includes 2 week of follow up)
Adverse Event Reporting Description	Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Arm/Group Title	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2 Efficacy Phase: Fesoterodine 4 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Arm/Group Description	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.	Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
All-Cause Mortality
	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2 Efficacy Phase: Fesoterodine 4 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Serious Adverse Events
	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2 Efficacy Phase: Fesoterodine 4 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/42 (7.14%)	2/42 (4.76%)	1/40 (2.50%)	0/30 (0.00%)	2/37 (5.41%)	0/16 (0.00%)	0/20 (0.00%)	2/28 (7.14%)	2/29 (6.90%)	0/20 (0.00%)	2/28 (7.14%)
Infections and infestations
Cellulitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Complicated appendicitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Epididymitis * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Peritonitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Pyelonephritis acute * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Urinary tract infection * 1	1/42 (2.38%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	1/29 (3.45%)	0/20 (0.00%)	1/28 (3.57%)
Viral infection * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Appendicitis * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Dengue fever * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Injury, poisoning and procedural complications
Animal bite * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Musculoskeletal and connective tissue disorders
Epiphysiolysis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Renal and urinary disorders
Acute kidney injury * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Hydronephrosis * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Reproductive system and breast disorders
Ovarian cyst * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Skin and subcutaneous tissue disorders
Decubitus ulcer * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
1 Term from vocabulary, MedDRA v22.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2 Efficacy Phase: Fesoterodine 4 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	26/42 (61.90%)	19/42 (45.24%)	30/40 (75.00%)	14/30 (46.67%)	13/37 (35.14%)	9/16 (56.25%)	11/20 (55.00%)	19/28 (67.86%)	17/29 (58.62%)	11/20 (55.00%)	14/28 (50.00%)
Blood and lymphatic system disorders
Thrombocytopenia * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cardiac disorders
Supraventricular extrasystoles * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Tachycardia * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Ear and labyrinth disorders
Vertigo positional * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Ear pain * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Eye disorders
Astigmatism * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Myopia * 1	1/42 (2.38%)	1/42 (2.38%)	1/40 (2.50%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	1/28 (3.57%)
Strabismus * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Vision blurred * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Accommodation disorder * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Eye pruritus * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Visual impairment * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Gastrointestinal disorders
Abdominal pain * 1	1/42 (2.38%)	1/42 (2.38%)	2/40 (5.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Abdominal pain upper * 1	2/42 (4.76%)	1/42 (2.38%)	2/40 (5.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Constipation * 1	3/42 (7.14%)	3/42 (7.14%)	5/40 (12.50%)	0/30 (0.00%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	2/29 (6.90%)	0/20 (0.00%)	0/28 (0.00%)
Diarrhoea * 1	5/42 (11.90%)	3/42 (7.14%)	1/40 (2.50%)	1/30 (3.33%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	1/29 (3.45%)	1/20 (5.00%)	0/28 (0.00%)
Dry mouth * 1	3/42 (7.14%)	4/42 (9.52%)	11/40 (27.50%)	1/30 (3.33%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Faeces soft * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Lip dry * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Nausea * 1	2/42 (4.76%)	1/42 (2.38%)	2/40 (5.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Vomiting * 1	0/42 (0.00%)	0/42 (0.00%)	2/40 (5.00%)	0/30 (0.00%)	1/37 (2.70%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	1/20 (5.00%)	0/28 (0.00%)
Toothache * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Abdominal discomfort * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Abdominal pain lower * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dental caries * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dysphagia * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Enteritis * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Flatulence * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Lip erythema * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Stomatitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
General disorders
Catheter site pain * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Fatigue * 1	1/42 (2.38%)	0/42 (0.00%)	1/40 (2.50%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Malaise * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Mass * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Non-cardiac chest pain * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Pyrexia * 1	2/42 (4.76%)	1/42 (2.38%)	1/40 (2.50%)	1/30 (3.33%)	1/37 (2.70%)	2/16 (12.50%)	0/20 (0.00%)	1/28 (3.57%)	2/29 (6.90%)	2/20 (10.00%)	1/28 (3.57%)
Adverse drug reaction * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Feeling cold * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Oedema peripheral * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Thirst * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Temperature intolerance * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Immune system disorders
Hypersensitivity * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Infections and infestations
Asymptomatic bacteriuria * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	4/28 (14.29%)	2/29 (6.90%)	3/20 (15.00%)	0/28 (0.00%)
Bacteriuria * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Conjunctivitis bacterial * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Escherichia urinary tract infection * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Gastroenteritis * 1	1/42 (2.38%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	2/37 (5.41%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Gastroenteritis viral * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Hand-foot-and-mouth disease * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Impetigo * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Infection parasitic * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Influenza * 1	4/42 (9.52%)	1/42 (2.38%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Mastitis * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Nasopharyngitis * 1	5/42 (11.90%)	1/42 (2.38%)	2/40 (5.00%)	1/30 (3.33%)	2/37 (5.41%)	1/16 (6.25%)	2/20 (10.00%)	3/28 (10.71%)	3/29 (10.34%)	2/20 (10.00%)	1/28 (3.57%)
Oral herpes * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	1/28 (3.57%)
Pharyngitis * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	1/20 (5.00%)	1/28 (3.57%)
Pyelonephritis * 1	0/42 (0.00%)	0/42 (0.00%)	2/40 (5.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Rhinitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Sinusitis * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Tonsillitis * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Upper respiratory tract infection * 1	1/42 (2.38%)	1/42 (2.38%)	1/40 (2.50%)	0/30 (0.00%)	1/37 (2.70%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	1/20 (5.00%)	2/28 (7.14%)
Urinary tract infection * 1	3/42 (7.14%)	1/42 (2.38%)	3/40 (7.50%)	0/30 (0.00%)	1/37 (2.70%)	2/16 (12.50%)	0/20 (0.00%)	2/28 (7.14%)	3/29 (10.34%)	1/20 (5.00%)	4/28 (14.29%)
Varicella * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Viral upper respiratory tract infection * 1	4/42 (9.52%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dermatitis infected * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Ear lobe infection * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Bronchitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cellulitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Conjunctivitis * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cystitis * 1	1/42 (2.38%)	1/42 (2.38%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cystitis bacterial * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Device related infection * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Ear infection * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Folliculitis * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Fungal skin infection * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Hordeolum * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Paronychia * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Pharyngotonsillitis * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Scrotal infection * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Eye infection * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Injury, poisoning and procedural complications
Skin laceration * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Contusion * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Investigations
Bacterial test positive * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Blood glucose decreased * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Eosinophil count increased * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Heart rate increased * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Investigation abnormal * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Residual urine volume increased * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Urine analysis abnormal * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Weight increased * 1	2/42 (4.76%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Urine output increased * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
White blood cells urine positive * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cystogram * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Metabolism and nutrition disorders
Decreased appetite * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	1/20 (5.00%)	1/28 (3.57%)
Dehydration * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Polydipsia * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Pain in extremity * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Spinal deformity * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Synovitis * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Arthritis * 1	1/42 (2.38%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Joint contracture * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Muscular weakness * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Neck pain * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Nervous system disorders
Dizziness * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	2/28 (7.14%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Headache * 1	2/42 (4.76%)	3/42 (7.14%)	5/40 (12.50%)	1/30 (3.33%)	3/37 (8.11%)	1/16 (6.25%)	1/20 (5.00%)	0/28 (0.00%)	2/29 (6.90%)	0/20 (0.00%)	1/28 (3.57%)
Peripheral sensory neuropathy * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cognitive disorder * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Syncope * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Psychiatric disorders
Aggression * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Anxiety * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Behaviour disorder * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Encopresis * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Restlessness * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Renal and urinary disorders
Haematuria * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Hypertonic bladder * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Incontinence * 1	0/42 (0.00%)	2/42 (4.76%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Pollakiuria * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Renal failure * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Urinary incontinence * 1	1/42 (2.38%)	0/42 (0.00%)	4/40 (10.00%)	0/30 (0.00%)	0/37 (0.00%)	1/16 (6.25%)	0/20 (0.00%)	0/28 (0.00%)	2/29 (6.90%)	0/20 (0.00%)	0/28 (0.00%)
Urine odour abnormal * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	2/20 (10.00%)	0/28 (0.00%)
Urethral pain * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Urinary tract disorder * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Urine flow decreased * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Reproductive system and breast disorders
Genital pain * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Menstruation irregular * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Cough * 1	0/42 (0.00%)	2/42 (4.76%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dyspnoea * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Epistaxis * 1	0/42 (0.00%)	1/42 (2.38%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	1/20 (5.00%)	0/28 (0.00%)	2/29 (6.90%)	0/20 (0.00%)	1/28 (3.57%)
Nasal obstruction * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Oropharyngeal pain * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	1/30 (3.33%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Upper respiratory tract inflammation * 1	1/42 (2.38%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	1/28 (3.57%)
Respiratory disorder * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dry throat * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Rhinitis allergic * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Rhinorrhoea * 1	0/42 (0.00%)	1/42 (2.38%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Nasal congestion * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Skin and subcutaneous tissue disorders
Acne * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Decubitus ulcer * 1	2/42 (4.76%)	1/42 (2.38%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dermal cyst * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Dermatitis acneiform * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dermatitis atopic * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Eczema * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	1/28 (3.57%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Pruritus * 1	1/42 (2.38%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Seborrhoeic dermatitis * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	1/20 (5.00%)	0/28 (0.00%)
Skin odour abnormal * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	1/29 (3.45%)	0/20 (0.00%)	0/28 (0.00%)
Urticaria * 1	0/42 (0.00%)	0/42 (0.00%)	1/40 (2.50%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Dermatitis allergic * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Rash macular * 1	1/42 (2.38%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Rash * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/30 (0.00%)	1/37 (2.70%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Social circumstances
Wheelchair user * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
Vascular disorders
Flushing * 1	0/42 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	1/30 (3.33%)	0/37 (0.00%)	0/16 (0.00%)	0/20 (0.00%)	0/28 (0.00%)	0/29 (0.00%)	0/20 (0.00%)	0/28 (0.00%)
1 Term from vocabulary, MedDRA v22.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01557244
• Other Study ID Numbers: A0221047; 2010-022475-55 ( EudraCT Number )
• First Submitted: March 15, 2012
• First Posted: March 19, 2012
• Results First Submitted: October 23, 2020
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021