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Clinical Trial Results:
A 24-Week Randomised, Open-Label, Study to Evaluate the Safety and Efficacy of Fesoterodine in Subjects Aged 6 To 17 Years With Symptoms of Detrusor Overactivity Associated With a Neurological Condition (Neurogenic Detrusor Overactivity)

Summary
EudraCT number	2010-022475-55
Trial protocol	SE EE FI SK GB ES GR FR NL BE RO DK DE LT
Global end of trial date	13 Feb 2020

Results information
Results version number	v1
This version publication date	08 Aug 2020
First version publication date	08 Aug 2020
Other versions	v2

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

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Trial information

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Sponsor protocol code

A0221047

ISRCTN number

US NCT number

NCT02501928

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

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

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

01 Jul 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Feb 2020

Was the trial ended prematurely?

Main objective of the trial

1) To determine the safety and efficacy of fesoterodine 4 milligram (mg) and 8 mg following once daily treatment for 12 weeks in pediatric neurogenic detrusor overactivity (NDO) subjects with weight greater than (>) 25 kilogram (kg). 2) To determine the safety and efficacy of fesoterodine 2 mg and 4 mg following once daily treatment for 12 weeks in pediatric NDO subjects with weight less than or equal to (<=) 25 kg.

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

02 Jul 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 5

Country: Number of subjects enrolled

Canada: 1

Country: Number of subjects enrolled

Estonia: 4

Country: Number of subjects enrolled

Finland: 3

Country: Number of subjects enrolled

France: 3

Country: Number of subjects enrolled

Greece: 3

Country: Number of subjects enrolled

Italy: 12

Country: Number of subjects enrolled

Japan: 36

Country: Number of subjects enrolled

Korea, Republic of: 27

Country: Number of subjects enrolled

Malaysia: 9

Country: Number of subjects enrolled

Poland: 3

Country: Number of subjects enrolled

Russian Federation: 7

Country: Number of subjects enrolled

Slovakia: 12

Country: Number of subjects enrolled

South Africa: 3

Country: Number of subjects enrolled

Spain: 9

Country: Number of subjects enrolled

Sweden: 2

Country: Number of subjects enrolled

Switzerland: 1

Country: Number of subjects enrolled

Taiwan: 3

Country: Number of subjects enrolled

Turkey: 8

Country: Number of subjects enrolled

United Kingdom: 1

Country: Number of subjects enrolled

United States: 14

Country: Number of subjects enrolled

Germany: 2

Country: Number of subjects enrolled

Lithuania: 4

Country: Number of subjects enrolled

Philippines: 9

Worldwide total number of subjects

181

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

132

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Study had 2 cohorts: cohort 1 had subjects with body weight >25 kg and cohort 2 had subjects with body weight <=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.

Period 1 title

Active Comparator/Efficacy Phase:12Weeks

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1: Fesoterodine 4 mg

Arm description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 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 subjects continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Prolonged-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the active comparator phase.

Cohort 1: Fesoterodine 8 mg

Arm description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, subjects received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where subjects continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Prolonged-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 4 mg PR tablet orally once for 1 week and if this dose was tolerated well, then subjects received fesoterodine 8 mg PR tablet orally once daily for 11 weeks in the active comparator phase.

Cohort 1: Oxybutynin

Arm description

Subjects with body weight >25 kg were randomised 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, subjects remained on the optimised daily dose for next 8 weeks, in active comparator phase.

Arm type

Active comparator

Investigational medicinal product name

Oxybutynin

Investigational medicinal product code

Other name

Pharmaceutical forms

Modified-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received 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, subjects remained on the optimised daily dose for next 8 weeks, in active comparator phase.

Cohort 2: Fesoterodine 2 mg

Arm description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Active comparator phase was followed by safety extension phase, where subjects continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in the efficacy phase.

Cohort 2: Fesoterodine 4 mg

Arm description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, subjects received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase. Active comparator phase was followed by safety extension phase, where subjects continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, subjects received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in the efficacy phase.

Number of subjects in period 1	Cohort 1: Fesoterodine 4 mg	Cohort 1: Fesoterodine 8 mg	Cohort 1: Oxybutynin	Cohort 2: Fesoterodine 2 mg	Cohort 2: Fesoterodine 4 mg
Started	42	42	40	28	29
Treated	42	42	40	28	29
Completed	33	40	36	21	28
Not completed	9	2	4	7	1
Medication Error Without Associated AEs	-	1	-	-	-
Withdrawal By Parent/Guardian	2	-	-	3	-
Failure to Meet Randomisation Criteria	-	1	1	1	-
Unspecified	2	-	2	-	-
Adverse Events	2	-	-	2	-
Lost to follow-up	1	-	-	-	-
Protocol deviation	2	-	1	-	-
Lack of efficacy	-	-	-	1	1

Period 2 title

Safety Extension Phase (SEP): 12 Weeks

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1: Fesoterodine 4 mg

Arm description

Subjects with body weight >25 kg were randomised 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 subjects continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Prolonged-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.

Cohort 1: Fesoterodine 8 mg

Arm description

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Prolonged-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in the safety extension phase.

Cohort 1: Oxybutynin Then Fesoterodine 4 mg

Arm description

Edit Arm Properties |Delete Subjects with body weight >25 kg who were randomised 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.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Prolonged-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.

Cohort 1: Oxybutynin Then Fesoterodine 8 mg

Arm description

Subjects with body weight >25 kg who were randomised 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.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Prolonged-release tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 4 mg PR tablet orally once daily for first 1 week and if dose was tolerated well, subjects received fesoterodine 8 mg PR tablet orally once daily for another 11 weeks in the safety extension phase.

Cohort 2: Fesoterodine 2 mg

Arm description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. Active comparator phase was followed by safety extension phase, where subjects continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in the safety extension phase.

Cohort 2: Fesoterodine 4 mg

Arm description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsules orally once daily for first 1 week and if this dose was tolerated well, subjects received fesoterodine 4 mg BIC capsules orally once daily for next 11 weeks in efficacy phase. Active comparator phase was followed by safety extension phase, where subjects continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 12 weeks.

Arm type

Experimental

Investigational medicinal product name

Fesoterodine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in the safety extension phase.

Number of subjects in period 2	Cohort 1: Fesoterodine 4 mg	Cohort 1: Fesoterodine 8 mg	Cohort 1: Oxybutynin Then Fesoterodine 4 mg	Cohort 1: Oxybutynin Then Fesoterodine 8 mg	Cohort 2: Fesoterodine 2 mg	Cohort 2: Fesoterodine 4 mg
Started	33	40	16	20	21	28
Treated	30	37	16	20	20	28
Completed	30	36	15	20	20	28
Not completed	3	4	1	0	1	0
SEP: Withdrawal By Parent/Guardian	1	1	-	-	-	-
SEP: Adverse Event	1	1	-	-	1	-
SEP: Medication Error No Associated AEs	-	-	1	-	-	-
Lack of efficacy	1	2	-	-	-	-

Baseline characteristics

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Reporting group title

Cohort 1: Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 1: Fesoterodine 8 mg

Reporting group description

Reporting group title

Cohort 1: Oxybutynin

Reporting group description

Reporting group title

Cohort 2: Fesoterodine 2 mg

Reporting group description

Reporting group title

Cohort 2: Fesoterodine 4 mg

Reporting group description

Reporting group values	Cohort 1: Fesoterodine 4 mg	Cohort 1: Fesoterodine 8 mg	Cohort 1: Oxybutynin	Cohort 2: Fesoterodine 2 mg	Cohort 2: Fesoterodine 4 mg	Total
Number of subjects	42	42	40	28	29	181
Age Categorical
Units: Subject
<=18 years	42	42	40	28	29	181
Between 18 and 65 years	0	0	0	0	0	0
>=65 years	0	0	0	0	0	0
Sex: Female, Male
Units: Subject
Female	16	22	17	12	19	86
Male	26	20	23	16	10	95
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0
Asian	14	18	22	16	16	86
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	2	0	1	0	0	3
White	24	24	17	12	11	88
More than one race	0	0	0	0	0	0
Unknown or Not Reported	2	0	0	0	2	4
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	3	2	1	0	2	8
Not Hispanic or Latino	39	40	39	28	27	173
Unknown or Not Reported	0	0	0	0	0	0

End points

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Reporting group title

Cohort 1: Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 1: Fesoterodine 8 mg

Reporting group description

Reporting group title

Cohort 1: Oxybutynin

Reporting group description

Reporting group title

Cohort 2: Fesoterodine 2 mg

Reporting group description

Reporting group title

Cohort 2: Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 1: Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 1: Fesoterodine 8 mg

Reporting group description

Reporting group title

Cohort 1: Oxybutynin Then Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 1: Oxybutynin Then Fesoterodine 8 mg

Reporting group description

Reporting group title

Cohort 2: Fesoterodine 2 mg

Reporting group description

Reporting group title

Cohort 2: Fesoterodine 4 mg

Reporting group description

Subject analysis set title

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Full analysis set included all subjects who have been randomised, received at least one dose of study medication and have provided baseline primary endpoint data.

Subject analysis set title

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, then subjects received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase. Full analysis set included all subjects who have been randomised, received at least one dose of study medication and have provided baseline primary endpoint data.

Subject analysis set title

Cohort 1, Active Comparator Phase: Oxybutynin

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with body weight >25 kg were randomised 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, subjects remained on the optimised daily dose for next 8 weeks, in active comparator phase. Full analysis set included all subjects who have been randomised, received at least one dose of study medication and have provided baseline primary endpoint data.

Subject analysis set title

Cohort 2, Efficacy Phase: Fesoterodine 2 mg

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. Full analysis set included all subjects who have been randomised, received at least one dose of study medication and have provided baseline primary endpoint data.

Subject analysis set title

Cohort 2, Efficacy Phase: Fesoterodine 4 mg

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, then subjects received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase. Full analysis set included all subjects who have been randomised, received at least one dose of study medication and have provided baseline primary endpoint data.

Subject analysis set title

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, then subjects received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, Active Comparator Phase: Oxybutynin

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight >25 kg were randomised 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, subjects remained on the optimised daily dose for next 8 weeks, in active comparator phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 2, Efficacy Phase: Fesoterodine 2 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 2, Efficacy Phase: Fesoterodine 4 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, then subjects received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, Safety Extension Phase: Fesoterodine 4 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight >25 kg who were randomised 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. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, SEP: Oxybutynin Then Fesoterodine 8 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Cohort 2, Safety Extension Phase: Fesoterodine 2 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 2, Safety Extension Phase: Fesoterodine 4 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase. Safety analysis set included all subjects who received at least one dose of study medication during the relevant phase.

Subject analysis set title

Cohort 1, Safety Extension Phase: Fesoterodine 8 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Fesoterodine Pooled

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects received any dose of fesoterodine in the study from Week 1 to Week 24 and provided at least 1 PK observation.

Primary: Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

Maximum cystometric bladder capacity was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O). Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	41	41	38	25	28
Units: milliliter
least squares mean (confidence interval 95%)	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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in Least square (LS) Mean

Point estimate

-29.06

Confidence interval

level

95%

sides

2-sided

lower limit

-71.42

upper limit

13.31

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-3.82

Confidence interval

level

95%

sides

2-sided

lower limit

-45.87

upper limit

38.23

Secondary: Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

Detrusor pressure at maximum urinary bladder capacity was measured using urodynamic testing. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	40	41	38	25	28
Units: cm H2O
least squares mean (confidence interval 95%)	-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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-7.28

upper limit

6.33

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.82

Confidence interval

level

95%

sides

2-sided

lower limit

-5.96

upper limit

7.6

Secondary: Number of Subjects With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Number of Subjects With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

In this end point, shift data have been reported using 4 categories: (1) number of subjects who did not have IDC at Baseline and at Week 12, (2) number of subjects who did not have IDC at Baseline but had IDC at Week 12, (3) number of subjects who had IDC at Baseline but no IDC at Week 12, and (4) number of subjects who had IDC at Baseline and at Week 12. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	41	41	38	25	28
Units: subjects
Baseline IDC = No; Week 12 IDC = No	12	4	6	0	1
Baseline IDC = No; Week 12 IDC = Yes	2	1	0	0	0
Baseline IDC = Yes; Week 12 IDC = No	9	18	14	6	11
Baseline IDC = Yes; Week 12 IDC = Yes	18	18	18	19	16

No statistical analyses for this end point

Secondary: Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

Bladder volume at first IDC was measured using urodynamic testing. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	26	36	32	25	27
Units: milliliter
least squares mean (confidence interval 95%)	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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-10.78

Confidence interval

level

95%

sides

2-sided

lower limit

-48.75

upper limit

27.19

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-15.25

Confidence interval

level

95%

sides

2-sided

lower limit

-50.15

upper limit

19.64

Secondary: Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	40	40	38	25	28
Units: mL per cm H2O
least squares mean (confidence interval 95%)	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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-4.96

Confidence interval

level

95%

sides

2-sided

lower limit

-14.81

upper limit

4.89

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-5.95

Confidence interval

level

95%

sides

2-sided

lower limit

-15.85

upper limit

3.95

Secondary: Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 micturitions at Baseline. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	18	21	26	14	17
Units: micturitions per 24 hours
least squares mean (confidence interval 95%)	-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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.16

upper limit

0.97

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-0.74

upper limit

1.31

Secondary: Change From Baseline in Mean Number of Catheterisations per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Number of Catheterisations per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean number of catheterisations per 24 hours were calculated as the total number of catheterisations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 catheterisations at Baseline. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	37	33	31	22	24
Units: catheterisations per 24 hours
least squares mean (confidence interval 95%)	-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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-0.45

upper limit

0.54

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-0.49

upper limit

0.52

Secondary: Change From Baseline in Mean Number of Micturitions and Catheterisations Combined per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Number of Micturitions and Catheterisations Combined per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean number of micturitions and catheterisations combined per 24 hours were calculated as the total number of micturitions and catheterisations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hr) period. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	41	37	38	23	26
Units: micturitions and catheterisations/24 hr
least squares mean (confidence interval 95%)	-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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-0.53

upper limit

0.82

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-0.54

upper limit

0.84

Secondary: Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 incontinence episodes at Baseline. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	33	33	35	22	20
Units: incontinence episodes per 24 hours
least squares mean (confidence interval 95%)	-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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.55

Confidence interval

level

95%

sides

2-sided

lower limit

-0.09

upper limit

1.19

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-0.52

upper limit

0.77

Secondary: Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour period. Urgency episodes were defined as urgency marked as ‘yes’ in the diary. This endpoint was only calculated for subjects with >0 urgency episodes at Baseline and who were sensate. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	26	18	26	13	9
Units: urgency episodes per 24 hours
least squares mean (confidence interval 95%)	-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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-0.48

Confidence interval

level

95%

sides

2-sided

lower limit

-1.28

upper limit

0.32

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-0.36

Confidence interval

level

95%

sides

2-sided

lower limit

-1.24

upper limit

0.52

Secondary: Change From Baseline in Mean Volume Voided per Micturition at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Volume Voided per Micturition at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	15	15	20	8	10
Units: milliliter per micturition
least squares mean (confidence interval 95%)	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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-42.11

upper limit

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

15.07

Confidence interval

level

95%

sides

2-sided

lower limit

-26.5

upper limit

56.63

Secondary: Change From Baseline in Mean Volume Voided per Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

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End point title

Change From Baseline in Mean Volume Voided per Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean volume per catheterisation was calculated as sum of voided volume divided by the total number of catheterisation, with a recorded voided volume greater than 0. Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	36	32	28	23	25
Units: milliliter per catheterisation
least squares mean (confidence interval 95%)	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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-16.43

Confidence interval

level

95%

sides

2-sided

lower limit

-63.14

upper limit

30.29

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

1.28

Confidence interval

level

95%

sides

2-sided

lower limit

-46

upper limit

48.57

Secondary: Change From Baseline in Mean Volume Voided per Micturition or Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Top of page

End point title

Change From Baseline in Mean Volume Voided per Micturition or Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

End point description

The mean voided volume per micturition or catheterisation was calculated as sum of voided volume divided by the total number of micturitions or catheterisations with a recorded volume voided greater than 0 Full analysis set included all subjects who were randomised in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here ‘Number of Subjects Analysed’ (N) signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	39	38	38	24	28
Units: mL per micturition or catheterisation
least squares mean (confidence interval 95%)	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)

Attachments

Statistical Analysis for Change From Baseline

Cohort 1, ACP: Fesoterodine 4 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

-18.24

Confidence interval

level

95%

sides

2-sided

lower limit

-61

upper limit

24.53

Cohort 1, ACP: Fesoterodine 8 mg vs Oxybutynin

Comparison groups

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg v Cohort 1, Active Comparator Phase: Oxybutynin

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in LS Mean

Point estimate

18.86

Confidence interval

level

95%

sides

2-sided

lower limit

-22.93

upper limit

60.65

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase

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End point title

Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase

End point description

An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; 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 serious and non-serious adverse events. Safety analysis set population for active comparator phase and efficacy phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase.

End point type

Secondary

End point timeframe

Baseline up to Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	42	42	40	28	29
Units: subjects
Treatment Emergent AEs	26	20	30	19	18
Treatment Emergent SAEs	3	2	1	2	2

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase

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End point title

Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase

End point description

An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; 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 serious and non-serious adverse events. Safety analysis set population for safety extension phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

End point type

Secondary

End point timeframe

Week 12 up to Week 26 (including 2 weeks of follow up after last dose)

End point values	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, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Number of subjects analysed	30	37	16	20	20	28
Units: subjects
Treatment emergent AEs	14	13	9	11	11	16
Treatment emergent SAEs	0	2	0	0	0	2

No statistical analyses for this end point

Secondary: Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase

End point 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. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and subjects divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint data have been reported for right and left eye separately. Safety analysis set population for active comparator phase and efficacy phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	42	42	40	28	29
Units: logMAR unit
arithmetic mean (standard deviation)
Right Eye: Baseline (n=42, 41, 40, 28, 29)	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 (n=37, 40, 40,24,29)	0.01 ( 0.11 )	-0.01 ( 0.10 )	0.02 ( 0.18 )	0.03 ( 0.12 )	-0.00 ( 0.09 )
Left Eye: Baseline (n=42, 42, 40, 28, 29)	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 (n=37, 41, 40, 24, 29)	0.00 ( 0.13 )	-0.01 ( 0.10 )	0.00 ( 0.13 )	-0.02 ( 0.08 )	0.00 ( 0.08 )

No statistical analyses for this end point

Secondary: Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase

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End point title

Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase

End point description

VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and subject divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint data have been reported for right and left eye separately. Safety analysis set population for safety extension phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	20	20	28	37
Units: logMAR unit
arithmetic mean (standard deviation)
Right Eye: Change at Week 24 (n=30,36,16,20,19,28)	0.04 ( 0.17 )	-0.01 ( 0.05 )	0.02 ( 0.13 )	0.00 ( 0.07 )	0.01 ( 0.11 )	-0.02 ( 0.11 )
Left Eye: Change at Week 24 (n=30, 37,16,20,19,28)	0.01 ( 0.19 )	0.00 ( 0.08 )	-0.04 ( 0.09 )	-0.02 ( 0.07 )	0.03 ( 0.13 )	-0.01 ( 0.11 )

No statistical analyses for this end point

Secondary: Change From baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase

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End point title

Change From baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase

End point description

The visual accommodation was the distance for each eye at which vision became blurred – the mean of triplicate measurements. The subjects focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Safety analysis set population for active comparator phase and efficacy phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	42	42	40	28	29
Units: centimeter
arithmetic mean (standard deviation)
Right Eye: Baseline (n=38,39,39,26,28)	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 (n=33,38,39,22,28)	1.74 ( 7.45 )	7.77 ( 45.53 )	0.50 ( 4.64 )	-1.04 ( 6.79 )	1.02 ( 3.89 )
Left Eye: Baseline (n=39,40,39,26,27)	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 (n=34,39,39,22,27)	0.27 ( 4.29 )	5.79 ( 36.75 )	0.81 ( 4.78 )	-1.45 ( 9.60 )	0.90 ( 3.38 )

No statistical analyses for this end point

Secondary: Change From baseline in Visual Accommodation at Week 24: Safety Extension Phase

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End point title

Change From baseline in Visual Accommodation at Week 24: Safety Extension Phase

End point description

The visual accommodation was the distance for each eye at which vision became blurred – the mean of triplicate measurements. The subjects focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Safety analysis set population for safety extension phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	20	20	28	37
Units: centimeter
arithmetic mean (standard deviation)
Right Eye: Change at Week 24 (n=27,34,16,20,18,27)	0.73 ( 5.47 )	1.50 ( 4.80 )	0.50 ( 4.30 )	-1.35 ( 13.03 )	0.96 ( 4.38 )	4.33 ( 28.89 )
Left Eye: Change at Week 24 (n=28,35,16,20,18,26)	0.90 ( 5.85 )	1.66 ( 6.25 )	0.58 ( 4.53 )	0.43 ( 11.53 )	1.12 ( 4.20 )	3.79 ( 29.81 )

No statistical analyses for this end point

Secondary: Change From Baseline in Child Behaviour Checklist (CBCL) for Each Domain, T Score at Week 12: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Child Behaviour Checklist (CBCL) for Each Domain, T Score at Week 12: Active Comparator Phase/Efficacy Phase

End point description

CBCL:questionnaire of 113 items to assess a child's problem behaviours and competencies, answered by parent/caregiver of child. Scale for each item: 0=not true/absent, 1=somewhat or sometimes true/occurs sometime, 2=very true or often true/occurs often. 8 domains/syndrome scales derived: aggressive behaviour (AgB), anxious/depressed (An/De), attention problems (AttP), rule-breaking behaviour (RuB), social problems (SocP), somatic complaints (SomC), thought problems (ThP), withdrawn (Wd). T-score range for each domain= 50 to 10; lower scores= better outcomes. An/De, Wd and SomC summarised to internalising behaviour (IntB), with a T-score range of 34 to 100, lower scores= better outcomes. Externalising behaviour (ExtB) combined RuB and AgB, with a T-score range of 33 to 100, lower scores= better outcomes. All items combined to form total problem (TotP), with a T-score range of 24 to 100, lower scores= better outcomes. Safety analysis population. n=subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	42	42	40	28	29
Units: units on a scale
arithmetic mean (standard deviation)
AgB: Baseline (n =42, 41, 40, 28, 29)	53.86 ( 5.67 )	54.32 ( 5.88 )	54.58 ( 5.75 )	54.9 ( 5.25 )	52.8 ( 4.48 )
AgB: Change at Week 12 (n= 37, 40, 39, 24, 29)	-1.03 ( 3.17 )	-0.95 ( 3.71 )	-1.28 ( 2.77 )	-1.29 ( 3.58 )	-0.03 ( 2.96 )
An/De: Baseline (n= 42, 41, 40, 28, 29)	56.07 ( 6.99 )	57.00 ( 8.26 )	56.75 ( 7.32 )	55.5 ( 6.58 )	56.3 ( 6.55 )
An/De: Change at Week 12 (n= 37, 40, 39, 24, 29)	-1.73 ( 3.05 )	-1.38 ( 5.25 )	-1.92 ( 4.66 )	-0.79 ( 4.55 )	-3.21 ( 5.27 )
AttP: Baseline (n= 42, 41, 40, 28, 29)	56.29 ( 5.32 )	56.66 ( 7.47 )	56.30 ( 5.68 )	55.4 ( 5.06 )	55.3 ( 5.74 )
AttP: Change at Week 12 (n= 37, 40, 39, 24, 29)	-1.97 ( 3.79 )	-1.40 ( 4.30 )	-1.28 ( 3.69 )	-1.29 ( 3.61 )	-1.45 ( 3.41 )
RuB: Baseline (n= 42, 41, 40, 28, 29)	53.26 ( 3.52 )	53.80 ( 5.53 )	53.43 ( 4.96 )	54.5 ( 4.96 )	52.3 ( 3.74 )
RuB: Change at Week 12 (n= 37, 40, 39, 24, 29)	-0.92 ( 2.99 )	-0.88 ( 3.91 )	-0.72 ( 2.76 )	-1.71 ( 4.84 )	-0.10 ( 2.19 )
SocP: Baseline (n= 42, 41, 40, 28, 29)	57.52 ( 5.42 )	58.54 ( 9.43 )	57.95 ( 7.90 )	57.9 ( 6.66 )	55.8 ( 5.90 )
SocP: Change at Week 12 (n= 37, 40, 39, 24, 29)	-1.35 ( 3.90 )	-2.55 ( 4.74 )	-0.67 ( 3.73 )	-2.21 ( 4.38 )	-1.10 ( 3.41 )
SomC: Baseline (n= 42, 41, 40, 28, 29)	61.14 ( 6.24 )	60.46 ( 8.73 )	60.58 ( 8.44 )	57.1 ( 6.47 )	58.4 ( 6.55 )
SomC: Change at Week 12 (n= 37, 40, 39, 24, 29)	-0.46 ( 5.99 )	-1.28 ( 6.35 )	-0.87 ( 7.16 )	-0.38 ( 3.97 )	-1.69 ( 5.90 )
ThP: Baseline (n= 42, 41, 40, 28, 29)	55.00 ( 6.19 )	53.54 ( 5.93 )	56.73 ( 7.64 )	51.9 ( 2.81 )	54.9 ( 5.60 )
ThP: Change at Week 12 (n= 37, 40, 39, 24, 29)	-0.92 ( 4.69 )	-0.48 ( 4.25 )	-1.59 ( 3.65 )	-0.42 ( 1.67 )	-1.38 ( 5.42 )
Wd: Baseline (n= 42, 41, 40, 28, 29)	54.60 ( 5.17 )	57.54 ( 8.34 )	58.25 ( 7.93 )	55.7 ( 5.96 )	55.0 ( 7.11 )
Wd: Change at Week 12 (n= 37, 40, 39, 24, 29)	0.35 ( 4.70 )	-1.25 ( 5.13 )	-1.92 ( 5.08 )	-1.75 ( 3.97 )	-0.59 ( 4.48 )
ExtB: Baseline (n= 42, 41, 40, 28, 29)	49.48 ( 8.68 )	49.46 ( 10.00 )	50.10 ( 9.73 )	51.1 ( 9.83 )	48.0 ( 7.84 )
ExtB: Change at Week 12 (n= 37, 40, 39, 24, 29)	-2.08 ( 5.26 )	-2.33 ( 5.28 )	-1.95 ( 4.62 )	-2.63 ( 4.72 )	-1.45 ( 4.56 )
IntB: Baseline (n= 42, 41, 40, 28, 29)	56.45 ( 8.06 )	55.93 ( 12.84 )	57.25 ( 11.00 )	53.9 ( 10.34 )	54.6 ( 10.14 )
IntB: Change at Week 12 (n= 37, 40, 39, 24, 29)	-2.14 ( 6.46 )	-2.35 ( 6.98 )	-3.05 ( 7.12 )	-1.96 ( 6.53 )	-3.52 ( 6.38 )
TotP: Baseline (n=42, 41, 40, 28, 29)	55.05 ( 8.20 )	53.61 ( 11.98 )	55.45 ( 10.28 )	53.4 ( 10.70 )	52.7 ( 9.37 )
TotP: Change at Week 12 (n=37, 40, 39, 24, 29)	-2.51 ( 4.63 )	-3.23 ( 5.45 )	-2.36 ( 4.68 )	-2.17 ( 5.05 )	-3.38 ( 4.55 )

No statistical analyses for this end point

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, T Score at Week 24: Safety Extension Phase

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End point title

Change From Baseline in Child Behaviour Checklist for Each Domain, T Score at Week 24: Safety Extension Phase

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	20	20	28	37
Units: units on a scale
arithmetic mean (standard deviation)
AgB: Change at Week 24 (n=29, 36, 16, 20, 20, 28)	-1.59 ( 3.85 )	-1.25 ( 3.40 )	-2.40 ( 4.89 )	-1.70 ( 3.40 )	-1.86 ( 3.63 )	-1.31 ( 4.57 )
An/De: Change at Week 24 (n=29,36, 16, 20, 20,28)	-3.45 ( 4.86 )	-1.50 ( 3.76 )	-3.25 ( 5.66 )	-2.60 ( 5.24 )	-3.89 ( 4.95 )	-2.31 ( 5.64 )
AttP: Change at Week 24 (n=29, 36, 16, 20, 20,28)	-2.21 ( 3.99 )	-3.38 ( 4.65 )	-1.70 ( 3.01 )	-1.50 ( 3.15 )	-1.71 ( 3.29 )	-2.64 ( 5.72 )
RuB: Change at Week 24 (n=29, 36, 16, 20, 20, 28)	-1.59 ( 3.62 )	-1.31 ( 4.01 )	-0.90 ( 2.36 )	-2.15 ( 3.17 )	-0.36 ( 2.63 )	-1.47 ( 5.12 )
SocP: Change at Week 24 (n=29, 36, 16, 20, 20, 28)	-2.83 ( 4.12 )	-3.19 ( 5.79 )	-2.65 ( 3.28 )	-3.90 ( 4.35 )	-2.36 ( 4.17 )	-2.56 ( 4.15 )
SomC: Change at Week 24 (n=29, 36,16, 20, 20, 28)	-4.38 ( 6.59 )	-1.69 ( 9.20 )	-1.50 ( 5.82 )	-0.60 ( 3.12 )	-1.96 ( 6.77 )	-2.64 ( 6.58 )
ThP: Change at Week 24 (n=29, 36, 16, 20, 20, 28)	-3.10 ( 5.45 )	-3.25 ( 6.62 )	-2.30 ( 3.50 )	-1.40 ( 3.00 )	-1.75 ( 3.99 )	-1.03 ( 4.52 )
Wd: Change at Week 24 (n=29, 36, 16, 20, 20, 28)	-0.69 ( 4.33 )	-2.19 ( 3.90 )	-4.35 ( 5.24 )	-1.80 ( 5.43 )	-0.43 ( 3.75 )	-1.50 ( 5.98 )
ExtB: Change at Week 24 (n=29, 36,16, 20, 20, 28)	-5.21 ( 8.20 )	-1.81 ( 5.42 )	-4.15 ( 7.44 )	-4.20 ( 5.15 )	-4.21 ( 6.86 )	-2.89 ( 7.06 )
IntB: Change at Week 24 (n=29,36, 16, 20, 20, 28)	-7.69 ( 7.46 )	-3.25 ( 8.10 )	-5.35 ( 7.21 )	-4.40 ( 6.21 )	-4.32 ( 6.70 )	-4.14 ( 7.62 )
TotP: Change at Week 24 (n=29,36,16,20,20,28)	-7.03 ( 7.77 )	-3.69 ( 6.74 )	-4.90 ( 4.78 )	-5.20 ( 4.32 )	-5.25 ( 6.22 )	-4.44 ( 6.57 )

No statistical analyses for this end point

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 12: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 12: Active Comparator Phase/Efficacy Phase

End point description

CBCL: questionnaire of 113 items to assess a child's problem behaviours and competencies, answered by parent/caregiver of child. Scale for each item: 0=not true/absent, 1=somewhat or sometimes true/occurs sometime, 2=very true or often true/occurs often. 8 domains/syndrome scales derived; AgB: total score range (TSR) = 0 to 36, An/De: TSR = 0 to 26, AttP: TSR = 0 to 20, RuB: TSR = 0 to 34, SocP: TSR = 0 to 22, SomC: TSR = 0 to 22, ThP: TSR = 0 to 30, Wd. RuB and AgB summarised to ExtB, with a TSR = 0 to 70. IntB combined An/De, Wd and SomC summarised, with a TSR = 0 to 64. All items combined to TotP, TSR = 0 to 240. Lower scores for each domain, summary and total problem = better outcomes. Safety analysis population. n=subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	42	42	40	28	29
Units: units on a scale
arithmetic mean (standard deviation)
AgB: Baseline (n=42, 41, 40, 28, 29)	4.19 ( 4.39 )	4.66 ( 4.46 )	4.88 ( 4.35 )	5.1 ( 3.95 )	3.5 ( 3.37 )
AgB: Change at Week 12 (n=37, 40, 39, 24, 29)	-0.62 ( 2.35 )	-0.90 ( 2.56 )	-0.97 ( 2.08 )	-0.92 ( 2.39 )	-0.17 ( 1.85 )
An/De: Baseline (n=42, 41, 40, 28, 29)	3.83 ( 3.33 )	4.20 ( 4.06 )	4.10 ( 3.53 )	3.8 ( 3.15 )	4.0 ( 3.35 )
An/De: Change at Week 12 (n=37, 40, 39, 24, 29)	-0.97 ( 1.46 )	-0.73 ( 2.43 )	-1.05 ( 2.26 )	-0.58 ( 2.28 )	-1.48 ( 2.43 )
AttP: Baseline (n=42, 41, 40, 28, 29)	4.79 ( 3.18 )	4.49 ( 4.11 )	4.85 ( 3.33 )	4.2 ( 2.78 )	3.9 ( 3.11 )
AttP: Change at Week 12 (n=37, 40, 39, 24, 29)	-1.05 ( 2.25 )	-0.73 ( 2.16 )	-0.77 ( 2.03 )	-0.71 ( 1.90 )	-0.83 ( 1.63 )
RuB: Baseline (n=42, 41, 40, 28, 29)	1.64 ( 1.48 )	1.66 ( 1.98 )	1.70 ( 1.87 )	1.9 ( 1.63 )	1.0 ( 1.30 )
RuB: Change at Week 12 (37, 40, 39, 24, 29)	-0.43 ( 1.09 )	-0.30 ( 1.36 )	-0.38 ( 0.99 )	-0.63 ( 1.56 )	0.52 ( 3.45 )
SocP: Baseline (n=42, 41,40, 28, 29)	3.60 ( 2.30 )	4.07 ( 4.12 )	3.80 ( 3.36 )	3.9 ( 2.99 )	3.2 ( 2.64 )
SocP: Change at Week 12(n=37, 40, 39, 24, 29)	-0.54 ( 1.54 )	-1.13 ( 2.09 )	-0.26 ( 1.57 )	-0.83 ( 1.86 )	-0.62 ( 1.52 )
SomC: Baseline (n=42, 41, 40, 28, 29)	3.40 ( 2.18 )	3.46 ( 3.26 )	3.40 ( 3.23 )	2.1 ( 1.93 )	2.6 ( 2.16 )
SomC: Change at Week 12 (n=37, 40, 39 ,24, 29)	-0.05 ( 2.26 )	-0.53 ( 2.44 )	-0.51 ( 2.64 )	-0.04 ( 1.55 )	-0.55 ( 2.03 )
ThP: Baseline (n=42, 41,40, 28, 29)	2.05 ( 2.23 )	1.46 ( 2.34 )	2.58 ( 2.92 )	1.0 ( 1.04 )	2.0 ( 1.79 )
ThP: Change at Week 12 (n=37, 40, 39, 24, 29)	-0.46 ( 1.69 )	-0.10 ( 1.37 )	-0.51 ( 1.30 )	-0.21 ( 0.72 )	-0.45 ( 1.64 )
Wd: Baseline (n=42, 41, 40, 28, 29)	1.52 ( 1.77 )	2.49 ( 2.78 )	2.75 ( 2.66 )	1.7 ( 1.81 )	1.6 ( 2.26 )
Wd: Change at Week 12 (n=37, 40, 39, 24, 29)	0.14 ( 1.44 )	-0.35 ( 1.59 )	-0.64 ( 1.77 )	-0.50 ( 1.10 )	-0.17 ( 1.39 )
ExtB Baseline (n=42, 41, 40,28, 29)	5.83 ( 5.23 )	6.32 ( 6.14 )	6.53 ( 5.87 )	6.9 ( 5.16 )	4.5 ( 4.32 )
ExtB: Change at Week 12 (n=37, 40, 39, 24, 29)	-1.05 ( 2.85 )	-1.20 ( 3.42 )	-1.31 ( 2.30 )	-1.54 ( 3.50 )	-0.31 ( 2.33 )
IntB: Baseline (n= 42, 41, 40, 28, 29)	8.76 ( 5.56 )	10.15 ( 8.64 )	10.25 ( 7.02 )	7.5 ( 5.61 )	8.2 ( 6.13 )
IntB: Change at Week 12 (n= 37, 40, 39, 24, 29)	-0.89 ( 3.62 )	-1.70 ( 5.16 )	-2.21 ( 4.35 )	-1.13 ( 3.85 )	-2.21 ( 3.91 )
TotP: Baseline (n=42, 41, 40, 28, 29)	31.52 ( 16.84 )	31.88 ( 23.78 )	34.18 ( 22.16 )	29.5 ( 17.41 )	27.0 ( 16.59 )
TotP: Change at Week 12 (n=37, 40, 39, 24, 29)	-4.92 ( 8.73 )	-5.83 ( 12.16 )	-5.85 ( 9.77 )	-5.33 ( 8.29 )	-5.10 ( 7.41 )

No statistical analyses for this end point

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 24: Safety Extension Phase

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End point title

Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 24: Safety Extension Phase

End point description

CBCL: questionnaire of 113 items to assess a child's problem behaviours and competencies, answered by parent/caregiver of child. Scale for each item: 0=not true/absent, 1=somewhat or sometimes true/occurs sometime, 2=very true or often true/occurs often. 8 domains/syndrome scales derived; AgB: total score range (TSR) = 0 to 36, An/De: TSR = 0 to 26, AttP: TSR = 0 to 20, RuB: TSR = 0 to 34, SocP: TSR = 0 to 22, SomC: TSR = 0 to 22, ThP: TSR = 0 to 30, Wd. RuB and AgB summarised to ExtB, with a TSR = 0 to 70. IntB combined An/De, Wd and SomC summarised, with a TSR = 0 to 64. All items combined to TotP, TSR = 0 to 240. Lower scores for each domain, summary and total problem = better outcomes. Safety analysis population. n=subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	29	16	20	20	28	36
Units: units on a scale
arithmetic mean (standard deviation)
Aggressive behaviour: Change at Week 24	-1.34 ( 2.92 )	-0.81 ( 2.43 )	-1.75 ( 3.58 )	-1.40 ( 2.41 )	-1.57 ( 2.70 )	-1.17 ( 3.10 )
Anxious/depressed: Change at Week 24	-1.93 ( 2.22 )	-1.06 ( 1.88 )	-1.60 ( 2.48 )	-1.70 ( 2.36 )	-1.75 ( 2.34 )	-1.28 ( 2.42 )
Attention problems: Change at Week 24	-1.41 ( 2.31 )	-1.94 ( 2.35 )	-1.25 ( 1.77 )	-1.15 ( 1.76 )	-0.89 ( 1.69 )	-1.36 ( 2.77 )
Rule-breaking behaviour: Change at Week 24	-0.62 ( 1.29 )	-0.50 ( 1.21 )	-0.55 ( 0.94 )	-0.80 ( 1.01 )	-0.18 ( 0.94 )	-0.50 ( 1.65 )
Social problems: Change at Week 24	-1.28 ( 1.53 )	-1.13 ( 2.33 )	-1.20 ( 1.36 )	-1.65 ( 1.81 )	-1.14 ( 1.74 )	-1.19 ( 1.97 )
Somatic complaints: Change at Week 24	-1.34 ( 2.22 )	-0.88 ( 3.32 )	-0.45 ( 1.73 )	-0.15 ( 0.88 )	-0.68 ( 2.04 )	-0.89 ( 2.38 )
Thought problems: Change at Week 24	-1.31 ( 1.95 )	-1.06 ( 2.14 )	-0.90 ( 1.21 )	-0.65 ( 1.04 )	-0.64 ( 1.28 )	-0.36 ( 1.40 )
Withdrawn: Change at Week 24	-0.24 ( 1.43 )	-0.69 ( 1.35 )	-1.35 ( 1.66 )	-0.45 ( 1.50 )	-0.14 ( 1.04 )	-0.44 ( 2.01 )
Externalising: Change at Week 24	-1.97 ( 3.50 )	-1.19 ( 3.23 )	-2.30 ( 4.03 )	-2.20 ( 2.84 )	-1.79 ( 3.28 )	-1.67 ( 4.27 )
Internalising: Change at Week 24	-3.52 ( 4.00 )	-2.63 ( 4.65 )	-3.40 ( 4.68 )	-2.30 ( 3.64 )	-2.57 ( 3.63 )	-2.61 ( 4.95 )
Total Problems: Change at Week 24	-10.90 ( 11.98 )	-9.00 ( 13.45 )	-10.10 ( 10.47 )	-9.45 ( 7.93 )	-8.39 ( 10.22 )	-8.58 ( 12.86 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

End point 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. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. Safety analysis set population for active comparator phase and efficacy phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	9	9	7	18	21
Units: seconds
arithmetic mean (standard deviation)
Dominant hand: Baseline (n=9,8,7,18,20)	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 (n=7,7,6,15,19)	-7.71 ( 11.06 )	10.14 ( 37.18 )	-5.33 ( 6.15 )	-11.20 ( 41.11 )	-10.26 ( 27.21 )
Non-dominant hand: Baseline (n=9,9, 7,17,21)	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(n=7,6,6,14,20)	-21.71 ( 25.44 )	15.33 ( 49.28 )	-2.00 ( 12.25 )	-19.36 ( 81.03 )	-3.25 ( 22.53 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Time to Completion: Safety Extension Phase

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Time to Completion: Safety Extension Phase

End point 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. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. Safety analysis set population for safety extension phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	3	2	3	15	19	7
Units: seconds
arithmetic mean (standard deviation)
Dominant hand:Change at Week 24(n=3,7,2,3,15,18)	-11.33 ( 9.07 )	-2.00 ( 8.49 )	-6.33 ( 3.06 )	-7.07 ( 6.80 )	-15.00 ( 28.54 )	-3.71 ( 22.94 )
Nondominant hand:Change at Week24(n=3,6,2,3,14,19)	-2.00 ( 13.75 )	1.50 ( 10.61 )	-11.00 ( 5.00 )	-9.14 ( 14.33 )	-18.47 ( 38.13 )	-4.00 ( 29.09 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

End point 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. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. Safety analysis set population for active comparator phase and efficacy phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	33	34	33	10	9
Units: seconds
arithmetic mean (standard deviation)
Dominant hand: Baseline (n=33,34,33,10,9)	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 (n=30,33,33,8,9)	-5.40 ( 10.43 )	-8.88 ( 20.76 )	1.21 ( 11.87 )	-14.38 ( 25.90 )	-18.44 ( 32.23 )
Non-dominant hand: Baseline (33, 32,33,10,8)	110.61 ( 59.63 )	109.00 ( 49.75 )	92.94 ( 25.05 )	130.30 ( 83.58 )	126.1 ( 48.93 )
Nondominant hand:Change at Week 12(n=30,31,33,8,8)	-9.10 ( 19.94 )	-4.10 ( 10.79 )	-1.97 ( 14.00 )	-13.50 ( 18.81 )	-12.50 ( 20.30 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 24, Time to Completion: Safety Extension Phase

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 24, Time to Completion: Safety Extension Phase

End point 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. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. Safety analysis set population for safety extension phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	25	14	16	5	9	30
Units: seconds
arithmetic mean (standard deviation)
Dominant hand: Change at Week 24;n=25,30,14,16,5,9	-8.20 ( 11.67 )	-5.71 ( 9.55 )	-7.00 ( 13.25 )	-38.20 ( 31.67 )	-17.00 ( 33.16 )	-12.27 ( 18.28 )
Nondominant hand:Change Week24;n=25,28,14,15,5,8	-9.24 ( 15.79 )	-3.79 ( 11.89 )	-11.87 ( 14.15 )	-38.00 ( 29.35 )	-15.50 ( 29.11 )	-8.46 ( 10.42 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

End point 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. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. Safety analysis set population for active comparator phase and efficacy phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	9	9	7	18	21
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline (n=9,8,7, 18,20)	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 (n=7,7,6,15,19)	0.29 ( 0.76 )	0.57 ( 1.13 )	-0.17 ( 0.75 )	0.00 ( 1.77 )	0.05 ( 0.52 )
Non-dominant hand: Baseline (n=9, 9,7,17,21)	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(n=7,6,6,14,20)	0.43 ( 1.27 )	1.00 ( 2.00 )	0.17 ( 0.41 )	0.00 ( 0.68 )	0.60 ( 3.45 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

End point 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. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. Safety analysis set population for safety extension phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	3	2	3	15	19	7
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Change at week 24 (n=3,7,2,3,15,18)	0.33 ( 0.58 )	0.00 ( 0.00 )	-0.33 ( 0.58 )	-0.27 ( 1.39 )	-0.06 ( 0.54 )	0.43 ( 0.79 )
Nondominant hand: Change Week 24;n=3,6,2,3,14,19	1.33 ( 2.31 )	0.50 ( 0.71 )	0.00 ( 0.00 )	-0.36 ( 0.74 )	0.11 ( 3.45 )	0.00 ( 1.10 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

End point 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. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. Safety analysis set population for active comparator phase and efficacy phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	33	34	33	10	9
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline (n=33,34,33,10,9)	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 (n=30,33,33,8,9)	0.00 ( 1.05 )	-0.18 ( 0.58 )	0.09 ( 0.77 )	0.00 ( 0.53 )	0.44 ( 1.33 )
Non-dominant hand: Baseline (n=33,32,33,10,8)	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;n=30,31,33,8,8	-0.33 ( 1.60 )	0.06 ( 1.03 )	0.21 ( 1.78 )	0.13 ( 0.35 )	0.00 ( 0.00 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

End point 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. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. Safety analysis set population for safety extension phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	25	14	16	5	9	30
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Change at Week 24;n=25,30,14,16,5,9	0.00 ( 0.87 )	0.14 ( 0.36 )	0.25 ( 1.24 )	0.00 ( 0.00 )	0.44 ( 1.33 )	0.63 ( 4.63 )
Nondominant hand:Change Week24;n=25,28,14,15,5,8	-0.28 ( 2.17 )	0.00 ( 0.39 )	0.27 ( 1.67 )	0.60 ( 0.89 )	-0.13 ( 0.35 )	0.68 ( 4.79 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

End point 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. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. Safety analysis set population for active comparator phase and efficacy phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	9	9	7	18	21
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline (n=9,8,7,18,20)	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 (n=7,7,6,15,19)	-0.29 ( 0.76 )	0.00 ( 0.00 )	0.00 ( 0.00 )	0.00 ( 0.38 )	-0.11 ( 0.46 )
Non-dominant hand: Baseline (n=9, 9,7,17,21)	9.56 ( 1.01 )	9.00 ( 2.35 )	10.00 ( 0.00 )	9.82 ( 0.73 )	9.62 ( 1.20 )
Nondominant hand:Change at Week 12 (n=7,6,6,14,20)	-0.57 ( 1.13 )	0.00 ( 0.00 )	0.00 ( 0.00 )	-0.07 ( 0.62 )	0.00 ( 0.32 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

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End point title

Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

End point 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. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. Safety analysis set population for safety extension phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	3	2	3	15	19	7
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Change at Week 24 (n=3,7,2,3,15,18)	-0.33 ( 0.58 )	0.00 ( 0.00 )	0.00 ( 0.00 )	0.07 ( 0.26 )	0.00 ( 0.00 )	0.00 ( 0.00 )
Nondominant hand:Change at Week 24;n=3,6,2,3,14,19	-1.33 ( 2.31 )	0.00 ( 0.00 )	0.00 ( 0.00 )	0.14 ( 0.53 )	0.21 ( 0.92 )	0.00 ( 0.00 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

End point 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. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. Safety analysis set population for active comparator phase and efficacy phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	33	34	33	10	9
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Baseline (n=33,34,33,10,9)	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 (n=30,33,33,8,9)	-0.07 ( 0.25 )	0.42 ( 1.77 )	-0.12 ( 0.70 )	-0.13 ( 0.35 )	0.11 ( 2.76 )
Non-dominant hand: Baseline (n=33, 32,33,10,8)	24.45 ( 2.09 )	24.75 ( 0.92 )	24.88 ( 0.42 )	24.50 ( 1.58 )	24.25 ( 1.75 )
Nondominant hand: Change at Week 12;n=30,31,33,8,8	0.53 ( 2.19 )	0.26 ( 0.93 )	0.03 ( 0.30 )	0.63 ( 1.77 )	-0.63 ( 1.77 )

No statistical analyses for this end point

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

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End point title

Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

End point 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. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. Safety analysis set population for safety extension phase analysed. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	25	14	16	5	9	30
Units: pegs
arithmetic mean (standard deviation)
Dominant hand: Change at Week 24;n=25,30,14,16,5,9	0.00 ( 0.00 )	0.00 ( 0.00 )	0.00 ( 0.00 )	0.00 ( 0.00 )	0.11 ( 2.76 )	0.50 ( 2.01 )
Nondominant hand:Change Week24;n=25,28,14,15,5,8	0.60 ( 2.40 )	0.14 ( 0.66 )	0.00 ( 0.00 )	0.60 ( 2.61 )	-0.50 ( 1.85 )	0.21 ( 0.96 )

No statistical analyses for this end point

Secondary: Number of subjects Meeting Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase

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End point title

Number of subjects Meeting Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase

End point description

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. Safety analysis set population for active comparator phase and efficacy phase: all subjects of respective cohorts who received at least 1 dose of study medication in relevant phase. Here “N”: subjects evaluable for this end point

End point type

Secondary

End point timeframe

Baseline up to Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	40	41	40	24	29
Units: subjects
SBP: <90 mmHg	2	2	0	7	4
SBP: Change >= 30 mmHg increase	1	2	1	0	1
SBP: Change >= 30 mmHg decrease	1	0	0	0	0
DBP: <50 mmHg	2	1	2	3	1
DBP: Change >= 20 mmHg increase	1	2	1	3	4
DBP: Change >= 20 mmHg decrease	1	1	1	2	0
Pulse rate: <40 bpm	0	0	0	0	0
Pulse rate: >120 bpm	2	4	0	2	3

No statistical analyses for this end point

Secondary: Number of Subjects Meeting Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase

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End point title

Number of Subjects Meeting Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase

End point description

Criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 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 bpm, b) pulse rate value >120 bpm. Safety analysis set population for safety extension phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

End point type

Secondary

End point timeframe

Baseline up to Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	20	20	28	37
Units: subjects
SBP: <90 mmHg	0	2	1	4	2	3
SBP: Change >= 30 mmHg increase	1	0	0	0	0	0
SBP: Change >= 30 mmHg decrease	0	0	0	0	0	1
DBP: <50 mmHg	0	0	0	2	0	2
DBP: Change >= 20 mmHg increase	1	0	0	1	2	0
DBP: Change >= 20 mmHg decrease	1	0	0	0	0	0
Pulse rate: <40 bpm	0	0	0	0	0	0
Pulse rate: >120 bpm	0	0	0	0	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase

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End point title

Number of Subjects With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase

End point 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 subject with a documented history of vesicoureteral reflux (VUR). Safety analysis set population for active comparator phase and efficacy phase: all subject of respective cohorts who received at least 1 dose of study medication in relevant phase of the study.

End point type

Secondary

End point timeframe

Week 1 up to Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	42	42	40	28	29
Units: subjects	4	1	4	3	4

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase

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End point title

Number of Subjects With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase

End point 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 subject with a documented history of VUR. Safety analysis set population for safety extension phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

End point type

Secondary

End point timeframe

Week 12 up to Week 26

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	20	20	28	37
Units: subjects	0	2	0	1	5	1

No statistical analyses for this end point

Secondary: Number of Subjects With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase

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End point title

Number of Subjects With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase

End point description

Hemoglobin gram per deciliter (g/L) 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; bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, pohosphate <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, 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. Safety analysis set analysed. Here “N”: subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 1 up to Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	39	41	39	24	29
Units: subjects	30	29	27	19	19

No statistical analyses for this end point

Secondary: Number of Subjects With Clinical Laboratory Abnormalities: Safety Extension Phase

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End point title

Number of Subjects With Clinical Laboratory Abnormalities: Safety Extension Phase

End point description

End point type

Secondary

End point timeframe

Week 12 up to Week 26

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	19	20	28	36
Units: subjects	19	7	12	15	21	22

No statistical analyses for this end point

Secondary: Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase

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End point title

Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase

End point description

PVR volume measurement was measured by an ultrasound. PVR volume was only assessed for subjects who did not perform clean intermittent catheterisation or in any subjects who had >1 UTI during the study. Safety analysis set population for active comparator phase and efficacy phase included all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here “N”: subjects evaluable for this endpoint and “n”: subjects evaluable for this endpoint for time points.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	6	7	9	6	6
Units: mL
arithmetic mean (standard deviation)
Baseline (n=6, 7, 9, 6, 6)	7.00 ( 8.20 )	9.57 ( 12.54 )	5.78 ( 7.98 )	14.7 ( 14.31 )	10.7 ( 7.94 )
Change at Week 4 (n=5, 6, 9, 3, 4)	5.40 ( 7.60 )	-7.33 ( 10.88 )	19.11 ( 24.52 )	-2.00 ( 6.24 )	10.25 ( 34.40 )
Change at Week 12 (n=5, 6 7, 4, 4)	25.60 ( 53.42 )	-4.00 ( 8.41 )	12.86 ( 43.48 )	2.50 ( 16.05 )	0.75 ( 17.46 )

No statistical analyses for this end point

Secondary: Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase

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End point title

Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase

End point description

PVR volume measurement was measured by an ultrasound. PVR volume was only assessed for subjects who did not perform clean intermittent catheterisation or in any subjects who had >1 UTI during the study. Safety analysis set population for safety extension phase: all subjects of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here “N”: subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	4	5	3	3	4	5
Units: mL
arithmetic mean (standard deviation)	11.50 ( 23.67 )	18.00 ( 31.36 )	36.67 ( 59.23 )	21.67 ( 20.21 )	2.75 ( 14.50 )	11.60 ( 29.43 )

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase

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End point title

Number of Subjects With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase

End point 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. Safety analysis set population for active comparator phase and efficacy phase: all subjects of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. Here “N”: subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline up to Week 12

End point values	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Efficacy Phase: Fesoterodine 4 mg
Number of subjects analysed	38	42	40	28	29
Units: subjects	2	1	1	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase

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End point title

Number of Subjects With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase

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

End point type

Secondary

End point timeframe

Baseline up to Week 24

End point values	Cohort 1, Safety Extension Phase: Fesoterodine 4 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	Cohort 1, Safety Extension Phase: Fesoterodine 8 mg
Number of subjects analysed	30	16	20	20	28	37
Units: subjects	3	0	0	0	2	2

No statistical analyses for this end point

Secondary: Absorption Rate Constant (Ka) of Fesoterodine

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End point title

Absorption Rate Constant (Ka) of Fesoterodine

End point 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. The PK analysis population included all subjects randomised and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

End point type

Secondary

End point timeframe

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 subjects remained at clinic)

End point values	Fesoterodine Pooled
Number of subjects analysed	121
Units: liter per hour
arithmetic mean (standard error)	0.0897 ( 5.99 )

No statistical analyses for this end point

Secondary: Apparent Oral Clearance (CL/F) of Fesoterodine

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End point title

Apparent Oral Clearance (CL/F) of Fesoterodine

End point 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. The PK analysis population included all subjects randomised and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

End point type

Secondary

End point timeframe

End point values	Fesoterodine Pooled
Number of subjects analysed	121
Units: liter per hour
arithmetic mean (standard error)	71.6 ( 6.7 )

No statistical analyses for this end point

Secondary: Volume of Distribution (Vd) of Fesoterodine

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End point title

Volume of Distribution (Vd) of Fesoterodine

End point 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. The PK analysis population included all subjects randomised and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

End point type

Secondary

End point timeframe

End point values	Fesoterodine Pooled
Number of subjects analysed	121
Units: liter
arithmetic mean (standard error)	68.1 ( 29.7 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to Week 26

Adverse event reporting additional description

Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as non-serious in another subject or 1 subject may have experienced both serious and non-serious event during study. Safety analysis population.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg

Reporting group description

Subjects with body weight >25 kg were randomised to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.

Reporting group title

Cohort 1, Active Comparator Phase: Fesoterodine 8 mg

Reporting group description

Reporting group title

Cohort 1, Safety Extension Phase: Fesoterodine 4 mg

Reporting group description

Subjects with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.

Reporting group title

Cohort 1, Active Comparator Phase: Oxybutynin

Reporting group description

Reporting group title

Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg

Reporting group description

Subjects with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.

Reporting group title

Cohort 1, SEP: Oxybutynin Then Fesoterodine 8 mg

Reporting group description

Reporting group title

Cohort 2, Efficacy Phase: Fesoterodine 2 mg

Reporting group description

Subjects with body weight <=25 kg were randomised to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.

Reporting group title

Cohort 2, Safety Extension Phase: Fesoterodine 2 mg

Reporting group description

Subjects with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.

Reporting group title

Cohort 2 Efficacy Phase: Fesoterodine 4 mg

Reporting group description

Reporting group title

Cohort 2, Safety Extension Phase: Fesoterodine 4 mg

Reporting group description

Subjects with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.

Serious adverse events	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2 Efficacy Phase: Fesoterodine 4 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 42 (7.14%)	2 / 42 (4.76%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	2 / 37 (5.41%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	2 / 29 (6.90%)	2 / 28 (7.14%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Animal bite
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Decubitus ulcer
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Epiphysiolysis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 29 (3.45%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Fesoterodine 8 mg	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg	Cohort 1, Active Comparator Phase: Oxybutynin	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg	Cohort 1, SEP: Oxybutynin Then Fesoterodine 8 mg	Cohort 2, Efficacy Phase: Fesoterodine 2 mg	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg	Cohort 2 Efficacy Phase: Fesoterodine 4 mg	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	26 / 42 (61.90%)	19 / 42 (45.24%)	14 / 30 (46.67%)	30 / 40 (75.00%)	9 / 16 (56.25%)	13 / 37 (35.14%)	11 / 20 (55.00%)	19 / 28 (67.86%)	11 / 20 (55.00%)	17 / 29 (58.62%)	14 / 28 (50.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Vascular disorders
Flushing
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Catheter site pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Fatigue
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	1 / 30 (3.33%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	1	1	0	0	0	0	0	0	0
Malaise
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Mass
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Pyrexia
subjects affected / exposed	2 / 42 (4.76%)	1 / 42 (2.38%)	1 / 30 (3.33%)	1 / 40 (2.50%)	2 / 16 (12.50%)	1 / 37 (2.70%)	0 / 20 (0.00%)	1 / 28 (3.57%)	2 / 20 (10.00%)	2 / 29 (6.90%)	1 / 28 (3.57%)
occurrences all number	3	1	2	1	2	1	0	1	3	3	1
Adverse drug reaction
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Feeling cold
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Thirst
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Temperature intolerance
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Social circumstances
Wheelchair user
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Reproductive system and breast disorders
Genital pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Menstruation irregular
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Cough
subjects affected / exposed	0 / 42 (0.00%)	2 / 42 (4.76%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	2	0	0	0	1	0	1	0	0	0
Dyspnoea
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	3	0	0	0
Epistaxis
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	2 / 29 (6.90%)	1 / 28 (3.57%)
occurrences all number	0	1	0	1	0	0	1	0	0	2	1
Nasal obstruction
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	2	1	0	0	1	0	0	0	0	0
Upper respiratory tract inflammation
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	1	0	0	1	0	0	0	1	0	0	1
Respiratory disorder
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Dry throat
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Rhinitis allergic
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Psychiatric disorders
Aggression
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Anxiety
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Behaviour disorder
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Encopresis
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Restlessness
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Investigations
Bacterial test positive
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Blood glucose decreased
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Eosinophil count increased
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Heart rate increased
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	1
Investigation abnormal
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Residual urine volume increased
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Urine analysis abnormal
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Weight increased
subjects affected / exposed	2 / 42 (4.76%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	2	0	0	1	0	0	0	0	0	0	0
Urine output increased
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
White blood cells urine positive
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Cystogram
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Skin laceration
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Contusion
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
Supraventricular extrasystoles
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Tachycardia
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	4	0	0	0
Headache
subjects affected / exposed	2 / 42 (4.76%)	3 / 42 (7.14%)	1 / 30 (3.33%)	5 / 40 (12.50%)	1 / 16 (6.25%)	3 / 37 (8.11%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	2 / 29 (6.90%)	1 / 28 (3.57%)
occurrences all number	2	3	1	5	1	4	1	0	0	2	1
Peripheral sensory neuropathy
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Cognitive disorder
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Syncope
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
Vertigo positional
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Ear pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Eye disorders
Astigmatism
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Myopia
subjects affected / exposed	1 / 42 (2.38%)	1 / 42 (2.38%)	1 / 30 (3.33%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	1 / 28 (3.57%)
occurrences all number	1	1	1	2	0	0	1	0	0	1	1
Strabismus
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Vision blurred
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Accommodation disorder
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Eye pruritus
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Visual impairment
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 42 (2.38%)	1 / 42 (2.38%)	0 / 30 (0.00%)	2 / 40 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	1	1	0	2	0	0	0	1	0	1	0
Abdominal pain upper
subjects affected / exposed	2 / 42 (4.76%)	1 / 42 (2.38%)	0 / 30 (0.00%)	2 / 40 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	2	1	0	2	0	0	0	0	0	0	0
Constipation
subjects affected / exposed	3 / 42 (7.14%)	3 / 42 (7.14%)	0 / 30 (0.00%)	5 / 40 (12.50%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	2 / 29 (6.90%)	0 / 28 (0.00%)
occurrences all number	3	3	0	5	1	0	0	0	0	2	0
Diarrhoea
subjects affected / exposed	5 / 42 (11.90%)	3 / 42 (7.14%)	1 / 30 (3.33%)	1 / 40 (2.50%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	7	4	1	1	0	1	0	1	1	1	0
Dry mouth
subjects affected / exposed	3 / 42 (7.14%)	4 / 42 (9.52%)	1 / 30 (3.33%)	11 / 40 (27.50%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	3	4	1	12	1	0	0	0	0	1	0
Faeces soft
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Lip dry
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Nausea
subjects affected / exposed	2 / 42 (4.76%)	1 / 42 (2.38%)	0 / 30 (0.00%)	2 / 40 (5.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	2	2	0	2	0	1	0	1	0	1	0
Vomiting
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	2 / 40 (5.00%)	1 / 16 (6.25%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	2	1	1	0	0	1	1	0
Toothache
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0
Abdominal discomfort
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Abdominal pain lower
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Dental caries
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Dysphagia
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Enteritis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Flatulence
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Lip erythema
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Stomatitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Decubitus ulcer
subjects affected / exposed	2 / 42 (4.76%)	1 / 42 (2.38%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	3	1	1	0	0	0	0	1	0	0	0
Dermal cyst
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Dermatitis acneiform
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Dermatitis atopic
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Eczema
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Pruritus
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	1	0	1	0	0	0	0	0
Seborrhoeic dermatitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Skin odour abnormal
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Urticaria
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Dermatitis allergic
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Rash macular
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Renal and urinary disorders
Haematuria
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Hypertonic bladder
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0
Incontinence
subjects affected / exposed	0 / 42 (0.00%)	2 / 42 (4.76%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	2	0	0	0	2	1	0	0	0	0
Pollakiuria
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	0
Renal failure
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Urinary incontinence
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	4 / 40 (10.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	2 / 29 (6.90%)	0 / 28 (0.00%)
occurrences all number	1	0	0	4	1	0	0	0	0	3	0
Urine odour abnormal
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	2 / 20 (10.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	1	0
Urethral pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Urinary tract disorder
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Urine flow decreased
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Pain in extremity
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	1	0	0	0	1	0	0	0	0
Spinal deformity
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Synovitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Arthritis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	2	0	0	1	0	0	0	0	0	0	0
Joint contracture
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Muscular weakness
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Neck pain
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Infections and infestations
Asymptomatic bacteriuria
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 20 (0.00%)	4 / 28 (14.29%)	3 / 20 (15.00%)	2 / 29 (6.90%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	1	0	0	4	3	2	0
Bacteriuria
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	1
Conjunctivitis bacterial
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0
Escherichia urinary tract infection
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Gastroenteritis
subjects affected / exposed	1 / 42 (2.38%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	2	0	0	0	2	0	1	1	0	0
Gastroenteritis viral
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Impetigo
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Infection parasitic
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Influenza
subjects affected / exposed	4 / 42 (9.52%)	1 / 42 (2.38%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	5	1	0	1	0	0	1	0	0	0	0
Mastitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Nasopharyngitis
subjects affected / exposed	5 / 42 (11.90%)	1 / 42 (2.38%)	1 / 30 (3.33%)	2 / 40 (5.00%)	1 / 16 (6.25%)	2 / 37 (5.41%)	2 / 20 (10.00%)	3 / 28 (10.71%)	2 / 20 (10.00%)	3 / 29 (10.34%)	1 / 28 (3.57%)
occurrences all number	6	1	1	2	2	2	2	3	3	3	1
Oral herpes
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 29 (3.45%)	1 / 28 (3.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1
Pharyngitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 29 (3.45%)	1 / 28 (3.57%)
occurrences all number	0	0	1	1	0	0	0	0	1	1	1
Pyelonephritis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	2 / 40 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	2	0	0	2	0	0	0	0
Rhinitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	1
Sinusitis
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	1	0	0
Tonsillitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Upper respiratory tract infection
subjects affected / exposed	1 / 42 (2.38%)	1 / 42 (2.38%)	0 / 30 (0.00%)	1 / 40 (2.50%)	1 / 16 (6.25%)	1 / 37 (2.70%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 29 (3.45%)	2 / 28 (7.14%)
occurrences all number	1	2	0	1	2	1	0	0	1	1	2
Urinary tract infection
subjects affected / exposed	3 / 42 (7.14%)	1 / 42 (2.38%)	0 / 30 (0.00%)	3 / 40 (7.50%)	2 / 16 (12.50%)	1 / 37 (2.70%)	0 / 20 (0.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	3 / 29 (10.34%)	4 / 28 (14.29%)
occurrences all number	4	1	0	5	3	2	0	7	1	4	4
Varicella
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Viral upper respiratory tract infection
subjects affected / exposed	4 / 42 (9.52%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	4	0	0	0	0	0	0	0	0	0	0
Dermatitis infected
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Ear lobe infection
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	1 / 30 (3.33%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Cystitis
subjects affected / exposed	1 / 42 (2.38%)	1 / 42 (2.38%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	1	0	1	0	0	0	0	0	0	0
Cystitis bacterial
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Device related infection
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Folliculitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Fungal skin infection
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Hordeolum
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Paronychia
subjects affected / exposed	1 / 42 (2.38%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Pharyngotonsillitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Scrotal infection
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Eye infection
subjects affected / exposed	0 / 42 (0.00%)	1 / 42 (2.38%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 29 (0.00%)	1 / 28 (3.57%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	1
Dehydration
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	0 / 40 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Polydipsia
subjects affected / exposed	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 30 (0.00%)	1 / 40 (2.50%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 29 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

03 Mar 2014

To enroll subjects <=25 kg as a separate cohort within the study who will be administered a beads-in capsule (BIC) formulation.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A 24-Week Randomised, Open-Label, Study to Evaluate the Safety and Efficacy of Fesoterodine in Subjects Aged 6 To 17 Years With Symptoms of Detrusor Overactivity Associated With a Neurological Condition (Neurogenic Detrusor Overactivity)

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Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Primary: Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Number of Subjects With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Number of Subjects With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Catheterisations per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Catheterisations per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Micturitions and Catheterisations Combined per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Micturitions and Catheterisations Combined per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Volume Voided per Micturition at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Volume Voided per Micturition at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Volume Voided per Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Volume Voided per Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Volume Voided per Micturition or Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Change From Baseline in Mean Volume Voided per Micturition or Catheterisation at Week 12: Active Comparator Phase (ACP)/Efficacy Phase (EP)

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase

Secondary: Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase

Secondary: Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase

Secondary: Change From baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From baseline in Visual Accommodation at Week 24: Safety Extension Phase

Secondary: Change From baseline in Visual Accommodation at Week 24: Safety Extension Phase

Secondary: Change From Baseline in Child Behaviour Checklist (CBCL) for Each Domain, T Score at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Child Behaviour Checklist (CBCL) for Each Domain, T Score at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, T Score at Week 24: Safety Extension Phase

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, T Score at Week 24: Safety Extension Phase

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 12: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 24: Safety Extension Phase

Secondary: Change From Baseline in Child Behaviour Checklist for Each Domain, Total Score at Week 24: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Time to Completion: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Time to Completion: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Time to Completion: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 24, Time to Completion: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 24, Time to Completion: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12, Number of Pegs Dropped: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Dropped: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Weeks 12, Number of Pegs Placed Correctly: Active Comparator Phase/Efficacy Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

Secondary: Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 24, Number of Pegs Placed Correctly: Safety Extension Phase

Clinical Trial Results:
A 24-Week Randomised, Open-Label, Study to Evaluate the Safety and Efficacy of Fesoterodine in Subjects Aged 6 To 17 Years With Symptoms of Detrusor Overactivity Associated With a Neurological Condition (Neurogenic Detrusor Overactivity)