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

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

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A0221109
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02501928
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the safety and tolerability of fesoterodine following once daily longterm treatment in Japanese pediatric subjects.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    10
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

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

    Investigational medicinal product name
    Fesoterodine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Fesoterodine 8 mg PR tablet orally once daily for 28 weeks in this study.

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

    Investigational medicinal product name
    Fesoterodine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks in precedent study A0221047 and received fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this study.

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

    Investigational medicinal product name
    Fesoterodine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks (in active comparator phase) and 12 weeks (in safety extension phase) in precedent study A0220147 and received fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.

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

    Baseline characteristics

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

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

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

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

    End points

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

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

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

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

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

    Subject analysis set title
    Total of Treatment Groups
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Total Subjects who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive same treatment respectively, in this LTE study.

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

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109 [1]
    End point description
    An AE was any untoward medical occurrence in subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. AEs included both serious and non-serious adverse events. TEAEs were summarized for each cohort (Cohort 1 and Cohort 2, irrespective of treatment received), each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Safety analysis set was analyzed.
    End point type
    Primary
    End point timeframe
    Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: subjects
        Subjects with AEs
    2
    6
    3
    2
    9
    11
        Subjects with SAEs
    0
    1
    0
    0
    1
    1
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Acuity at Week 12: Study A0221109 [2]
    End point description
    Visual acuity (VA) was assessed for each eye using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and subject, divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint, data have been reported for right and left eye separately. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: LogMAR
    arithmetic mean (standard deviation)
        Right Eye: Baseline
    0.27 ± 0.376
    0.04 ± 0.137
    0.28 ± 0.334
        Right Eye: Change at Week 12
    0.14 ± 0.204
    -0.03 ± 0.083
    0.04 ± 0.067
        Left Eye: Baseline
    0.45 ± 0.350
    0.04 ± 0.183
    0.63 ± 0.663
        Left Eye: Change at Week 12
    0.03 ± 0.126
    0.03 ± 0.116
    0.07 ± 0.122
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Acuity at Week 28: Study A0221109 [3]
    End point description
    VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and subject, divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint, data have been reported for right and left eye separately. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    6
    3
    Units: LogMAR
    arithmetic mean (standard deviation)
        Right Eye
    0.00 ± 0.000
    0.03 ± 0.118
    0.02 ± 0.142
        Left Eye
    0.31 ± 0.681
    0.05 ± 0.057
    0.16 ± 0.208
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Acuity at Final Visit: Study A0221109 [4]
    End point description
    VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Subjects had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and subject, divided by distance at which subject was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this endpoint, data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: LogMAR
    arithmetic mean (standard deviation)
        Right Eye
    0.00 ± 0.000
    0.02 ± 0.108
    0.02 ± 0.142
        Left Eye
    0.31 ± 0.681
    0.04 ± 0.055
    0.16 ± 0.208
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Accommodation at Week 12: Study A0221109 [5]
    End point description
    The visual accommodation was the minimum focusing distance for each eye at which vision became blurred – the mean of triplicate measurements. The subjects focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: centimeter
    arithmetic mean (standard deviation)
        Right Eye: Baseline (n =2, 7, 3)
    9.33 ± 8.014
    8.62 ± 10.938
    5.56 ± 4.857
        Right Eye: Change at Week 12 (n =2, 7, 3)
    2.50 ± 2.593
    5.86 ± 13.287
    6.67 ± 10.990
        Left Eye: Baseline (n =2, 7, 2)
    14.00 ± 13.199
    9.86 ± 13.685
    4.83 ± 6.835
        Left Eye: Change at Week 12 (n =2, 7, 2)
    -1.83 ± 2.593
    3.24 ± 13.662
    16.17 ± 23.806
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Accommodation at Week 28: Study A0221109 [6]
    End point description
    The visual accommodation was the minimum focusing distance for each eye at which vision became blurred – the mean of triplicate measurements. The subject focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    6
    3
    Units: centimeter
    arithmetic mean (standard deviation)
        Right Eye (n =2, 6, 3)
    5.17 ± 7.307
    0.78 ± 2.639
    -0.11 ± 1.836
        Left Eye (n =2, 6, 2)
    3.17 ± 5.421
    -0.39 ± 3.803
    0.50 ± 0.707
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Accommodation at Final Visit: Study A0221109 [7]
    End point description
    The visual accommodation was the minimum focusing distance for each eye at which vision became blurred – the mean of triplicate measurements. The subject focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the subject until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this endpoint data have been reported for right and left eye separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: centimeter
    arithmetic mean (standard deviation)
        Right Eye (n =2, 7, 3)
    5.17 ± 7.307
    4.38 ± 9.833
    -0.11 ± 1.836
        Left Eye (n =2, 7, 2)
    3.17 ± 5.421
    2.86 ± 9.263
    0.50 ± 0.707
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109 [8]
    End point description
    CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: units on a scale
    arithmetic mean (standard deviation)
        Aggressive behavior: Baseline
    50.0 ± 0.00
    52.6 ± 3.82
    50.7 ± 1.15
        Aggressive behavior: Change at Week 12
    0.0 ± 0.00
    -0.1 ± 3.53
    0.0 ± 0.00
        Anxious/depressed: Baseline
    50.0 ± 0.00
    52.1 ± 3.34
    50.7 ± 0.58
        Anxious/depressed: Change at Week 12
    0.0 ± 0.00
    0.7 ± 4.11
    -0.7 ± 0.58
        Attention problems: Baseline
    50.0 ± 0.00
    53.6 ± 3.55
    53.3 ± 4.93
        Attention problems: Change at week 12
    0.0 ± 0.00
    -1.1 ± 2.34
    0.0 ± 0.00
        Rule-breaking behavior: Baseline
    50.5 ± 0.71
    52.4 ± 3.60
    53.3 ± 5.77
        Rule-breaking behavior: Change at Week 12
    0.0 ± 0.00
    -0.3 ± 4.11
    0.0 ± 0.00
        Social problems: Baseline
    50.0 ± 0.00
    52.4 ± 2.70
    54.3 ± 6.66
        Social problems: Change at Week 12
    0.0 ± 0.00
    0.0 ± 3.65
    0.7 ± 1.15
        Somatic complaints: Baseline
    51.5 ± 2.12
    53.4 ± 5.35
    55.7 ± 4.62
        Somatic complaints: Change at Week 12
    1.5 ± 2.12
    0.9 ± 1.46
    -2.3 ± 2.08
        Thought problems: Baseline
    50.0 ± 0.00
    50.9 ± 1.46
    53.0 ± 4.36
        Thought problems: Change at Week 12
    0.0 ± 0.00
    0.3 ± 1.70
    0.0 ± 0.00
        Withdrawn: Baseline
    50.0 ± 0.00
    53.4 ± 4.86
    52.7 ± 4.62
        Withdrawn: Change at Week 12
    0.0 ± 0.00
    -1.7 ± 4.54
    0.0 ± 0.00
        Externalizing problems: Baseline
    37.0 ± 4.24
    47.6 ± 8.79
    44.0 ± 10.00
        Externalizing problems: Change at Week 12
    0.0 ± 0.00
    -0.3 ± 6.07
    0.0 ± 0.00
        Internalizing problems: Baseline
    36.0 ± 4.24
    49.0 ± 3.79
    47.7 ± 7.51
        Internalizing problems: Change at Week 12
    3.0 ± 4.24
    0.4 ± 5.00
    -4.0 ± 2.00
        Total problems: Baseline
    30.5 ± 2.12
    49.1 ± 3.67
    46.7 ± 11.59
        Total problems: Change at Week 12
    3.0 ± 4.24
    -1.1 ± 2.12
    0.3 ± 1.53
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109 [9]
    End point description
    CBCL:assessed child's behavioral and emotional problems(pbl). Parent/caregiver of child answered 120 items,each on scale:0=not true,1=somewhat/sometimes true,2=very/often true.103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70;internalizing pbl combined anxious/depressed,withdrawn and somatic complaints,TSR=0-64.Total pbl combined 8 domains and 17 remaining items,TSR=0-240.TSR for each domain,summary and total pbl was sum of scores of related items respectively.Lower scores for each domain, summary,total pbl=better outcomes.Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety set. Number of subjects analysed=subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    6
    3
    Units: units on a scale
    arithmetic mean (standard deviation)
        Aggressive behavior
    0.0 ± 0.00
    -2.2 ± 3.76
    -0.3 ± 0.58
        Anxious/depressed
    0.0 ± 0.00
    -0.7 ± 4.13
    0.3 ± 1.53
        Attention problems
    0.0 ± 0.00
    -1.0 ± 2.45
    0.0 ± 0.00
        Rule-breaking behavior
    -0.5 ± 0.71
    -1.0 ± 2.97
    1.3 ± 2.31
        Social problems
    0.0 ± 0.00
    0.3 ± 1.63
    1.0 ± 1.73
        Somatic complaints
    0.0 ± 0.00
    1.2 ± 1.83
    -2.3 ± 2.08
        Thought problems
    0.0 ± 0.00
    -0.2 ± 0.41
    -0.3 ± 0.58
        Withdrawn
    0.0 ± 0.00
    -2.0 ± 7.04
    0.0 ± 0.00
        Externalizing problems
    -3.0 ± 4.24
    -3.5 ± 5.92
    0.0 ± 0.00
        Internalizing problems
    0.0 ± 0.00
    -2.5 ± 6.83
    -2.7 ± 3.06
        Total problems
    -2.5 ± 3.54
    -1.7 ± 2.94
    1.0 ± 1.00
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109 [10]
    End point description
    CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: units on a scale
    arithmetic mean (standard deviation)
        Aggressive behavior
    0.0 ± 0.00
    -1.9 ± 3.53
    -0.3 ± 0.58
        Anxious/depressed
    0.0 ± 0.00
    -0.6 ± 3.78
    0.3 ± 1.53
        Attention problems
    0.0 ± 0.00
    -0.9 ± 2.27
    0.0 ± 0.00
        Rule-breaking behavior
    -0.5 ± 0.71
    -0.9 ± 2.73
    1.3 ± 2.31
        Social problems
    0.0 ± 0.00
    0.3 ± 1.50
    1.0 ± 1.73
        Somatic complaints
    0.0 ± 0.00
    1.0 ± 1.73
    -2.3 ± 2.08
        Thought problems
    0.0 ± 0.00
    -0.1 ± 0.38
    -0.3 ± 0.58
        Withdrawn
    0.0 ± 0.00
    -1.7 ± 6.47
    0.0 ± 0.00
        Externalizing problems
    -3.0 ± 4.24
    -3.0 ± 5.57
    0.0 ± 0.00
        Internalizing problems
    0.0 ± 0.00
    -2.1 ± 6.31
    -2.7 ± 3.06
        Total problems
    -2.5 ± 3.54
    -1.4 ± 2.76
    1.0 ± 1.00
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109 [11]
    End point description
    CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: units on a scale
    arithmetic mean (standard deviation)
        Aggressive behavior: Baseline
    0.0 ± 0.00
    3.4 ± 3.05
    2.0 ± 2.00
        Aggressive behavior: Change at Week 12
    0.0 ± 0.00
    -0.1 ± 2.97
    0.0 ± 0.00
        Anxious/depressed: Baseline
    0.0 ± 0.00
    1.9 ± 1.57
    1.3 ± 1.15
        Anxious/depressed: Change at Week 12
    0.0 ± 0.00
    0.3 ± 1.60
    -0.7 ± 0.58
        Attention problems: Baseline
    0.0 ± 0.00
    3.6 ± 2.64
    3.0 ± 3.46
        Attention problems: Change at week 12
    0.0 ± 0.00
    -0.6 ± 1.27
    0.0 ± 0.00
        Rule-breaking behavior: Baseline
    0.5 ± 0.71
    1.3 ± 1.50
    1.3 ± 2.31
        Rule-breaking behavior: Change at Week 12
    0.0 ± 0.00
    -0.1 ± 1.21
    0.0 ± 0.00
        Social problems: Baseline
    0.0 ± 0.00
    1.6 ± 1.27
    2.3 ± 3.21
        Social problems: Change at Week 12
    0.0 ± 0.00
    0.0 ± 1.63
    0.3 ± 0.58
        Somatic complaints: Baseline
    0.5 ± 0.71
    1.0 ± 1.53
    1.7 ± 1.15
        Somatic complaints: Change at Week 12
    0.5 ± 0.71
    0.3 ± 0.49
    -0.7 ± 0.58
        Thought problems: Baseline
    0.0 ± 0.00
    0.6 ± 0.79
    1.3 ± 1.53
        Thought problems: Change at Week 12
    0.0 ± 0.00
    -0.1 ± 0.69
    0.0 ± 0.00
        Withdrawn: Baseline
    0.0 ± 0.00
    0.9 ± 1.21
    0.7 ± 1.15
        Withdrawn: Change at Week 12
    0.0 ± 0.00
    -0.4 ± 1.13
    0.0 ± 0.00
        Externalizing: Baseline
    0.5 ± 0.71
    4.7 ± 4.27
    3.3 ± 4.16
        Externalizing: Change at Week 12
    0.0 ± 0.00
    -0.3 ± 3.59
    0.0 ± 0.00
        Internalizing: Baseline
    0.5 ± 0.71
    3.7 ± 1.38
    3.7 ± 2.31
        Internalizing: Change at Week 12
    0.5 ± 0.71
    0.1 ± 2.19
    -1.3 ± 0.58
        Total problems: Baseline
    1.5 ± 0.71
    19.1 ± 5.79
    18.0 ± 17.78
        Total problems: Change at Week 12
    1.0 ± 1.41
    -1.3 ± 4.07
    -0.3 ± 1.15
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109 [12]
    End point description
    CBCL: assessed child's behavioral and emotional (pbl).Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior,TSR =0-36;anxious/depressed,TSR=0-26;attention pbl,TSR=0-20;rule-breaking behavior,TSR=0-34;social pbl,TSR=0-22;somatic complaints,TSR=0-22;thought pbl,TSR=0-30;withdrawn,TSR=0-16.Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set. Number of subjects analysed=subjects evaluable for the endpoint
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    6
    3
    Units: units on a scale
    arithmetic mean (standard deviation)
        Aggressive behavior
    0.0 ± 0.00
    -1.8 ± 3.06
    -0.3 ± 0.58
        Anxious/depressed
    0.0 ± 0.00
    -0.3 ± 1.37
    0.0 ± 1.00
        Attention problems
    0.0 ± 0.00
    -0.5 ± 1.22
    0.0 ± 0.00
        Rule-breaking behavior
    -0.5 ± 0.71
    -0.2 ± 0.98
    0.3 ± 0.58
        Social problems
    0.0 ± 0.00
    0.2 ± 0.98
    0.3 ± 0.58
        Somatic complaints
    0.0 ± 0.00
    0.3 ± 0.52
    -0.7 ± 0.58
        Thought problems
    0.0 ± 0.00
    -0.2 ± 0.41
    -0.3 ± 0.58
        Withdrawn
    0.0 ± 0.00
    -0.5 ± 1.76
    0.0 ± 0.00
        Externalizing
    -0.5 ± 0.71
    -2.0 ± 3.58
    0.0 ± 0.00
        Internalizing
    0.0 ± 0.00
    -0.5 ± 2.88
    -0.7 ± 0.58
        Total problems
    -0.5 ± 0.71
    -2.7 ± 4.63
    0.7 ± 0.58
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109 [13]
    End point description
    CBCL: assessed child's behavioral and emotional problems (pbl). Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, TSR =0-36; anxious/depressed, TSR=0-26; attention pbl, TSR=0-20; rule-breaking behavior, TSR=0-34; social pbl, TSR=0-22; somatic complaints, TSR=0-22; thought pbl, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing pbl combined rule-breaking and aggressive behavior, TSR=0-70; internalizing pbl combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total pbl combined 8 domains and 17 remaining items, TSR=0-240. TSR for each domain, summary and total pbl was sum of scores of related items respectively. Lower scores for each domain, summary, total pbl = better outcomes. Data for this endpoint was planned to be analyzed for each treatment group of study A0221109. Safety analysis set.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: units on a scale
    arithmetic mean (standard deviation)
        Aggressive behavior
    0.0 ± 0.00
    -1.6 ± 2.88
    -0.3 ± 0.58
        Anxious/depressed
    0.0 ± 0.00
    -0.3 ± 1.25
    0.0 ± 1.00
        Attention problems
    0.0 ± 0.00
    -0.4 ± 1.13
    0.0 ± 0.00
        Rule-breaking behavior
    -0.5 ± 0.71
    -0.1 ± 0.90
    0.3 ± 0.58
        Social problems
    0.0 ± 0.00
    0.1 ± 0.90
    0.3 ± 0.58
        Somatic complaints
    0.0 ± 0.00
    0.3 ± 0.49
    -0.7 ± 0.58
        Thought problems
    0.0 ± 0.00
    -0.1 ± 0.38
    -0.3 ± 0.58
        Withdrawn
    0.0 ± 0.00
    -0.4 ± 1.62
    0.0 ± 0.00
        Externalizing
    -0.5 ± 0.71
    -1.7 ± 3.35
    0.0 ± 0.00
        Internalizing
    0.0 ± 0.00
    -0.4 ± 2.64
    -0.7 ± 0.58
        Total problems
    -0.5 ± 0.71
    -2.3 ± 4.35
    0.7 ± 0.58
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109 [14]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [15]
    5
    3
    Units: seconds
    arithmetic mean (standard deviation)
        Dominant hand: Baseline
    ±
    43.0 ± 23.44
    39.3 ± 15.18
        Dominant hand: Change at Week 12
    ±
    0.8 ± 6.72
    -0.3 ± 15.28
        Non-dominant hand: Baseline
    ±
    33.4 ± 10.74
    52.0 ± 19.67
        Non-dominant hand: Change at Week 12
    ±
    8.2 ± 19.93
    -1.3 ± 9.45
    Notes
    [15] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109 [16]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [17]
    4
    3
    Units: seconds
    arithmetic mean (standard deviation)
        Dominant hand
    ±
    4.5 ± 2.38
    3.7 ± 4.04
        Non-dominant hand
    ±
    6.3 ± 7.37
    -7.7 ± 10.26
    Notes
    [17] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109 [18]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [19]
    5
    3
    Units: seconds
    arithmetic mean (standard deviation)
        Dominant hand
    ±
    0.8 ± 8.53
    3.7 ± 4.04
        Non-dominant hand
    ±
    4.4 ± 7.60
    -7.7 ± 10.26
    Notes
    [19] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109 [20]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [21]
    Units: seconds
    arithmetic mean (standard deviation)
        Dominant hand: Baseline
    59.5 ± 6.36
    107.5 ± 75.66
    ±
        Dominant hand: Change at Week 12
    0.0 ± 2.83
    -11.5 ± 13.44
    ±
        Non-dominant hand: Baseline
    60.5 ± 6.36
    145.5 ± 132.23
    ±
        Non-dominant hand: Change at Week 12
    -0.5 ± 4.95
    -2.0 ± 9.90
    ±
    Notes
    [21] - No subjects were of age >=9 years.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109 [22]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [23]
    Units: seconds
    arithmetic mean (standard deviation)
        Dominant hand
    2.0 ± 7.07
    -14.0 ± 24.04
    ±
        Non-dominant hand
    -1.0 ± 2.83
    -35.0 ± 48.08
    ±
    Notes
    [23] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109 [24]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [25]
    Units: seconds
    arithmetic mean (standard deviation)
        Dominant hand
    2.08 ± 7.07
    -14.0 ± 24.04
    ±
        Non-dominant hand
    -1.0 ± 2.83
    -35.0 ± 48.08
    ±
    Notes
    [25] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109 [26]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [27]
    5
    3
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand: Baseline
    ±
    0.2 ± 0.45
    0.0 ± 0.00
        Dominant hand: Change at Week 12
    ±
    0.2 ± 0.45
    0.0 ± 0.00
        Non-dominant hand: Baseline
    ±
    0.0 ± 0.00
    0.0 ± 0.00
        Non-dominant hand: Change at Week 12
    ±
    0.6 ± 1.34
    0.0 ± 0.00
    Notes
    [27] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109 [28]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [29]
    4
    3
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    ±
    0.3 ± 0.96
    0.0 ± 0.00
        Non-dominant hand
    ±
    0.0 ± 0.00
    0.0 ± 0.00
    Notes
    [29] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109 [30]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [31]
    5
    3
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    ±
    0.2 ± 0.84
    0.0 ± 0.00
        Non-dominant hand
    ±
    0.0 ± 0.00
    0.0 ± 0.00
    Notes
    [31] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109 [32]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [33]
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand: Baseline
    0.0 ± 0.00
    0.5 ± 0.71
    ±
        Dominant hand: Change at Week 12
    0.0 ± 0.00
    -0.5 ± 0.71
    ±
        Non-dominant hand: Baseline
    0.0 ± 0.00
    0.5 ± 0.71
    ±
        Non-dominant hand: Change at Week 12
    0.0 ± 0.00
    -0.5 ± 0.71
    ±
    Notes
    [33] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109 [34]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [35]
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    0.0 ± 0.00
    0.0 ± 1.41
    ±
        Non-dominant hand
    0.0 ± 0.00
    -0.5 ± 0.71
    ±
    Notes
    [35] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109 [36]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [37]
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    0.0 ± 0.00
    0.0 ± 1.41
    ±
        Non-dominant hand
    0.0 ± 0.00
    -0.5 ± 0.71
    ±
    Notes
    [37] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109 [38]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [39]
    5
    3
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand: Baseline
    ±
    10.0 ± 0.00
    10.0 ± 0.00
        Dominant hand: Change at Week 12
    ±
    0.0 ± 0.00
    0.0 ± 0.00
        Non-dominant hand: Baseline
    ±
    10.0 ± 0.00
    10.0 ± 0.00
        Non-dominant hand: Change at Week 12
    ±
    0.0 ± 0.00
    0.0 ± 0.00
    Notes
    [39] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109 [40]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [41]
    4
    3
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    ±
    0.0 ± 0.00
    0.0 ± 0.00
        Non-dominant hand
    ±
    0.0 ± 0.00
    0.0 ± 0.00
    Notes
    [41] - No subject was of age below 9 years.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109 [42]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on subjects below age of 9 years. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [43]
    5
    3
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    ±
    0.0 ± 0.00
    0.0 ± 0.00
        Non-dominant hand
    ±
    0.0 ± 0.00
    0.0 ± 0.00
    Notes
    [43] - No subjects were of age <9 years.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109 [44]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [45]
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand: Baseline
    25.0 ± 0.00
    25.0 ± 0.00
    ±
        Dominant hand: Change at Week 12
    0.0 ± 0.00
    0.0 ± 0.00
    ±
        Non-dominant hand: Baseline
    25.0 ± 0.00
    25.0 ± 0.00
    ±
        Non-dominant hand: Change at Week 12
    0.0 ± 0.00
    0.0 ± 0.00
    ±
    Notes
    [45] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109 [46]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [47]
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    0.0 ± 0.00
    0.0 ± 0.00
    ±
        Non-dominant hand
    0.0 ± 0.00
    0.0 ± 0.00
    ±
    Notes
    [47] - No subject was of age 9 years and above.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109 [48]
    End point description
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Subjects were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Subjects were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on subjects of age 9 years and above. In this endpoint data for dominant and non-dominant hand have been reported separately. Data for this endpoint was planned to be analysed for each treatment group of Study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    2
    0 [49]
    Units: pegs
    arithmetic mean (standard deviation)
        Dominant hand
    0.0 ± 0.00
    0.0 ± 0.00
    ±
        Non-dominant hand
    0.0 ± 0.00
    0.0 ± 0.00
    ±
    Notes
    [49] - No subjects were of age >=9 years.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109 [50]
    End point description
    Systolic blood and diastolic blood pressure were evaluated for examination of vital signs. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: millimeter of mercury
    arithmetic mean (standard deviation)
        Systolic blood pressure
    6.0 ± 4.24
    2.1 ± 9.65
    5.0 ± 14.11
        Diastolic blood pressure
    10.5 ± 4.95
    -0.9 ± 8.90
    6.3 ± 15.31
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109 [51]
    End point description
    Systolic blood and diastolic blood pressure were evaluated for examination of vital signs. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    6
    3
    Units: millimeter of mercury
    arithmetic mean (standard deviation)
        Systolic blood pressure
    8.5 ± 16.26
    5.7 ± 11.18
    9.7 ± 2.52
        Diastolic blood pressure
    12.0 ± 4.24
    5.3 ± 9.03
    10.7 ± 2.52
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109 [52]
    End point description
    Systolic blood and diastolic blood pressure were evaluated for examination of vital sign. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: millimeter of mercury
    arithmetic mean (standard deviation)
        Systolic blood pressure
    8.5 ± 16.26
    5.1 ± 10.30
    9.7 ± 2.52
        Diastolic blood pressure
    12.0 ± 4.24
    4.6 ± 8.48
    10.7 ± 2.52
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109 [53]
    End point description
    Pulse rate was evaluated for examination of vital sign. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: beats per minute
        arithmetic mean (standard deviation)
    0.0 ± 18.38
    2.4 ± 12.53
    -8.0 ± 2.00
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109 [54]
    End point description
    Pulse rate was evaluated for examination of vital sign. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    6
    3
    Units: beats per minute
        arithmetic mean (standard deviation)
    -3.5 ± 6.36
    -2.7 ± 8.82
    -3.7 ± 9.61
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109 [55]
    End point description
    Pulse rate was evaluated for examination of vital sign. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: beats per minute
        arithmetic mean (standard deviation)
    -3.5 ± 6.36
    -1.4 ± 8.70
    -3.7 ± 9.61
    No statistical analyses for this end point

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

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    End point title
    Number of Subjects With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109 [56]
    End point description
    UTI data were summarized for each cohort, each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in Study A0221109.
    End point type
    Primary
    End point timeframe
    Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
    Notes
    [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: subjects
    0
    1
    0
    0
    1
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinical Laboratory Abnormalities

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    End point title
    Number of Subjects With Clinical Laboratory Abnormalities [57]
    End point description
    Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN); platelets<0.5*LLN>1.75*upper limit of normal (ULN); leukocytes <0.6*LLN>1.5*ULN; lymphocytes, neutrophils <0.8*LLN >1.2*UL; basophils, eosinophils, monocytes >1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin >1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein, albumin <0.8*LLN >1.2*ULN; blood urea nitrogen, creatinine >1.3*ULN; urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN; potassium, chloride, bicarbonate <0.9*LLN>1.1*ULN; glucose <0.6*LLN>1.5*ULN; creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, glucose, ketones, protein, hemoglobin, nitrite, leukocyte esterase >=1; erythrocytes, leukocytes >=20; epithelial cells >=6, bacteria >20, hyaline casts >1. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set analyzed.
    End point type
    Primary
    End point timeframe
    Baseline to 28 weeks of treatment in A0221109
    Notes
    [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    2
    7
    3
    Units: subjects
    2
    6
    2
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Post-Void Residual (PVR) Volume at Week 12: Study A0221109 [58]
    End point description
    Post-void residual volume was assessed by an ultrasound. PVR volume was assessed only in subjects who did not perform clean intermittent catheterization or in any subjects who had >1 UTI during the study. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. All subjects performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 12
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [59]
    0 [60]
    0 [61]
    Units: milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [59] - No subject was eligible for post-void residual volume assessment.
    [60] - No subject was eligible for post-void residual volume assessment.
    [61] - No subject was eligible for post-void residual volume assessment.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Post-Void Residual (PVR) Volume at Week 28: Study A0221109 [62]
    End point description
    Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for subjects who did not perform clean intermittent catheterization or in any subjects who had >1 UTI during the study. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. All subjects performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Week 28
    Notes
    [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [63]
    0 [64]
    0 [65]
    Units: milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [63] - No subject was eligible for post-void residual volume assessment.
    [64] - No subject was eligible for post-void residual volume assessment.
    [65] - No subject was eligible for post-void residual volume assessment.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Post-Void Residual (PVR) Volume at Final Visit: Study A0221109 [66]
    End point description
    Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for subjects who did not perform clean intermittent catheterization or in any subjects who had >1 UTI during the study. Data for this endpoint was planned to be analysed for each treatment group of study A0221109 only. Safety analysis set included all subjects who were enrolled and received at least one dose of study medication in study A0221109. All subjects performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
    End point type
    Primary
    End point timeframe
    A0221109: Baseline, Final visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    Notes
    [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule
    Number of subjects analysed
    0 [67]
    0 [68]
    0 [69]
    Units: milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [67] - No subject was eligible for post-void residual volume assessment.
    [68] - No subject was eligible for post-void residual volume assessment.
    [69] - No subject was eligible for post-void residual volume assessment.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    Maximum cystometric bladder capacity was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O). Maximum cystometric bladder capacity was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Full analysis set (FAS) included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: milliliter
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    181.0 ± 28.28
    149.7 ± 38.49
    102.3 ± 48.95
    181.0 ± 28.28
    135.5 ± 45.21
    143.1 ± 45.37
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    153.0 ± 56.57
    37.6 ± 28.83
    55.3 ± 38.76
    153.0 ± 56.57
    42.9 ± 31.01
    61.3 ± 53.98
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    121.5 ± 30.41
    32.8 ± 52.42
    48.0 ± 67.55
    121.5 ± 30.41
    37.9 ± 53.99
    53.1 ± 59.74
        Change at Final Visit (n =2, 6, 3, 2, 9, 11)
    121.5 ± 30.41
    32.8 ± 52.42
    48.0 ± 67.55
    121.5 ± 30.41
    37.9 ± 53.99
    53.1 ± 59.74
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    Detrusor pressure (cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing. Detrusor pressure was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: cm H2O
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    29.0 ± 8.49
    32.4 ± 11.57
    58.3 ± 57.55
    29.0 ± 8.49
    40.2 ± 31.34
    38.3 ± 28.79
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    -5.5 ± 0.71
    -6.0 ± 7.85
    -31.7 ± 43.73
    -5.5 ± 0.71
    -13.7 ± 24.90
    -12.3 ± 22.74
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    -7.0 ± 0.00
    -2.8 ± 2.86
    -7.3 ± 47.44
    -7.0 ± 0.00
    -4.3 ± 23.93
    -4.8 ± 21.43
        Change at Final Visit (n =2, 6, 3, 2, 9, 11)
    -7.0 ± 0.00
    -2.8 ± 2.86
    -7.3 ± 47.44
    -7.0 ± 0.00
    -4.3 ± 23.93
    -4.8 ± 21.43
    No statistical analyses for this end point

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

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    End point title
    Number of Subjects With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    Subjects with presence of IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: subjects
        Baseline
    1
    7
    3
    1
    10
    11
        Week 12
    0
    4
    3
    0
    7
    7
        Week 28
    0
    5
    3
    0
    8
    8
        Final Visit
    0
    5
    3
    0
    8
    8
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    Bladder volume at first IDC was measured using urodynamic testing. Bladder volume at first IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. 9999 =standard deviation was not estimable since only 1 subjects was analysed. 99999 =Arithmetic mean and SD were not estimable since no subjects were analysed. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    1
    7
    3
    1
    10
    11
    Units: milliliter
    arithmetic mean (standard deviation)
        Baseline (n =1, 7, 3, 1, 10, 11)
    175.0 ± 9999
    48.1 ± 36.57
    50.3 ± 22.14
    175.0 ± 9999
    48.8 ± 31.65
    60.3 ± 48.47
        Change at Week 12 (n =0, 4, 3, 0, 7, 7)
    99999 ± 99999
    113.8 ± 68.55
    70.0 ± 4.58
    99999 ± 99999
    95.0 ± 53.88
    95.0 ± 53.88
        Change at Week 28 (n =0, 5, 3, 0, 8, 8)
    99999 ± 99999
    38.6 ± 24.46
    70.0 ± 50.11
    99999 ± 99999
    50.4 ± 36.38
    50.4 ± 36.38
        Change at Final Visit (n =0, 5, 3, 8, 0, 8, )
    99999 ± 99999
    38.6 ± 24.46
    70.0 ± 50.11
    99999 ± 99999
    50.4 ± 36.38
    50.4 ± 36.38
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Bladder Compliance at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). Bladder Compliance was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: milliliter per cm H2O
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    7.00 ± 2.828
    8.16 ± 5.668
    4.20 ± 2.307
    7.00 ± 2.828
    6.97 ± 5.124
    6.98 ± 4.712
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    9.00 ± 7.071
    23.34 ± 55.493
    12.40 ± 14.855
    9.00 ± 7.071
    20.06 ± 46.151
    18.22 ± 42.021
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    8.65 ± 6.152
    13.18 ± 18.628
    13.30 ± 15.836
    8.65 ± 6.152
    13.22 ± 16.721
    12.39 ± 15.194
        Change at Final Visit (n =2, 6, 3, 2, 9, 11)
    8.65 ± 6.152
    13.18 ± 18.628
    13.30 ± 15.836
    8.65 ± 6.152
    13.22 ± 16.721
    12.39 ± 15.194
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Number of Micturitions per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 micturitions at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. No subject in reporting arms “Cohort 1”, “Fesoterodine 8 mg Tablet” and “Fesoterodine 4 mg Capsule” had >0 micturitions at baseline.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    0 [70]
    4
    0 [71]
    0 [72]
    4
    4
    Units: micturitions per 24 hours
    arithmetic mean (standard deviation)
        Baseline
    ±
    4.58 ± 4.541
    ±
    ±
    4.58 ± 4.541
    4.58 ± 4.541
        Change at Week 12
    ±
    -1.50 ± 1.036
    ±
    ±
    -1.50 ± 1.036
    -1.50 ± 1.036
        Change at Week 28
    ±
    -1.08 ± 0.631
    ±
    ±
    -1.08 ± 0.631
    -1.08 ± 0.631
        Change at Final Visit
    ±
    -1.08 ± 0.631
    ±
    ±
    -1.08 ± 0.631
    -1.08 ± 0.631
    Notes
    [70] - No subjects had >0 micturitions at baseline.
    [71] - No subjects had >0 micturitions at baseline.
    [72] - No subjects had >0 micturitions at baseline.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Number of Catheterizations per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: catheterizations per 24 hours
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    5.33 ± 0.943
    4.24 ± 1.641
    5.00 ± 0.000
    5.33 ± 0.943
    4.47 ± 1.390
    4.61 ± 1.332
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    0.00 ± 0.471
    0.03 ± 0.420
    0.11 ± 0.192
    0.00 ± 0.471
    0.05 ± 0.357
    0.04 ± 0.353
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    0.33 ± 0.000
    -0.19 ± 0.267
    0.11 ± 0.192
    0.33 ± 0.000
    -0.09 ± 0.278
    -0.02 ± 0.302
        Change at Final Visit (n =2, 7, 3, 2, 10, 12)
    0.33 ± 0.000
    -0.21 ± 0.249
    0.11 ± 0.192
    0.33 ± 0.000
    -0.12 ± 0.273
    -0.04 ± 0.303
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Number of Micturitions or Catheterizations Combined per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean number of micturitions and catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hr) period. This endpoint was only calculated for subjects with >0 micturitions or catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: micturitions or catheterizations/24 hr
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    5.33 ± 0.943
    6.86 ± 3.259
    5.00 ± 0.000
    5.33 ± 0.943
    6.30 ± 2.808
    6.14 ± 2.584
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    0.00 ± 0.471
    -0.83 ± 1.264
    0.11 ± 0.192
    0.00 ± 0.471
    -0.55 ± 1.131
    -0.46 ± 1.055
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    0.33 ± 0.000
    -0.92 ± 0.665
    0.11 ± 0.192
    0.33 ± 0.000
    -0.57 ± 0.741
    -0.41 ± 0.758
        Change at Final Visit (n =2, 7, 3, 2, 10, 12)
    0.33 ± 0.000
    -0.83 ± 0.645
    0.11 ± 0.192
    0.33 ± 0.000
    -0.55 ± 0.703
    -0.40 ± 0.723
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Number of Incontinence Episodes per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour period. This endpoint was only calculated for subjects with >0 incontinence episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: incontinence episodes per 24 hours
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    1.17 ± 0.236
    3.48 ± 2.768
    3.89 ± 0.770
    1.17 ± 0.236
    3.60 ± 2.298
    3.19 ± 2.285
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    0.50 ± 0.236
    -0.26 ± 2.074
    0.00 ± 0.667
    0.50 ± 0.236
    -0.18 ± 1.726
    -0.07 ± 1.586
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    1.83 ± 0.707
    -0.42 ± 1.577
    -0.11 ± 1.644
    1.83 ± 0.707
    -0.31 ± 1.501
    0.08 ± 1.615
        Change at Final Visit (n =2, 7, 3, 2, 10, 12)
    1.83 ± 0.707
    0.17 ± 2.110
    -0.11 ± 1.644
    1.83 ± 0.707
    0.08 ± 1.894
    0.38 ± 1.856
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Number of Urgency Episodes per 24 Hours at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour period. Urgency episodes were defined as urgency marked as ‘yes’ in the diary. This endpoint was only calculated for sensate subjects with >0 urgency episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. 9999 =standard deviation was not estimable since only one subjects was analysed. FAS was analyzed. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. No sensate subjects for reporting arms “Cohort 1” and “Fesoterodine 8 mg Tablet” had >0 urgency episodes at baseline.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    0 [73]
    2
    1
    0 [74]
    3
    3
    Units: urgency episodes per 24 hours
    arithmetic mean (standard deviation)
        Baseline
    ±
    0.75 ± 0.354
    0.33 ± 9999
    ±
    0.61 ± 0.347
    0.61 ± 0.347
        Change at Week 12
    ±
    -0.75 ± 0.354
    -0.33 ± 9999
    ±
    -0.61 ± 0.347
    -0.61 ± 0.347
        Change at Week 28
    ±
    -0.75 ± 0.354
    -0.33 ± 9999
    ±
    -0.61 ± 0.347
    -0.61 ± 0.347
        Change at Final Visit
    ±
    -0.75 ± 0.354
    -0.33 ± 9999
    ±
    -0.61 ± 0.347
    -0.61 ± 0.347
    Notes
    [73] - No subject had >0 urgency episodes.
    [74] - No subject had >0 urgency episodes.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Volume Voided per Micturition at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume > 0. This endpoint included only subjects who actually had the records of volume voided per micturition. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. Only subjects who actually had the records of volume voided per micturition were reported. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in Study A0221109. Here, ‘Number of subjects analysed’ = subjects evaluable for this endpoint. No subject in reporting arms “Cohort 1”, “Fesoterodine 8 mg Tablet” and “Fesoterodine 4 mg Capsule” had the records of volume voided per micturition.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    0 [75]
    2
    0 [76]
    0 [77]
    2
    2
    Units: milliliter per micturition
    arithmetic mean (standard deviation)
        Baseline
    ±
    73.42 ± 42.309
    ±
    ±
    73.42 ± 42.309
    73.42 ± 42.309
        Change at Week 12
    ±
    15.77 ± 6.924
    ±
    ±
    15.77 ± 6.924
    15.77 ± 6.924
        Change at Week 28
    ±
    4.75 ± 14.496
    ±
    ±
    4.75 ± 14.496
    4.75 ± 14.496
        Change at Final Visit
    ±
    4.75 ± 14.496
    ±
    ±
    4.75 ± 14.496
    4.75 ± 14.496
    Notes
    [75] - No subjects had records of volume voided per micturition.
    [76] - No subjects had records of volume voided per micturition.
    [77] - No subjects had records of volume voided per micturition.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Volume Voided per Catheterization at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume >0. This endpoint included only subjects who actually had the records of volume voided per catherization. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in Study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: milliliter per catheterization
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    198.75 ± 44.194
    48.76 ± 39.230
    80.58 ± 39.841
    198.75 ± 44.194
    58.31 ± 40.187
    81.72 ± 66.988
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    -0.92 ± 21.095
    17.90 ± 17.038
    27.08 ± 32.086
    -0.92 ± 21.095
    20.66 ± 21.024
    17.06 ± 21.739
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    -29.42 ± 12.139
    8.72 ± 33.245
    17.28 ± 9.659
    -29.42 ± 12.139
    11.58 ± 27.064
    4.12 ± 29.591
        Change at Final Visit (n =2, 6, 3, 2, 9, 11)
    -29.42 ± 12.139
    8.72 ± 33.245
    17.28 ± 9.659
    -29.42 ± 12.139
    11.58 ± 27.064
    4.12 ± 29.591
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Mean Volume Voided per Micturition or Catheterization at Week 12 of study A0221047 and at Week 28 and Final Visit of Study A0221109
    End point description
    The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume >0. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned. FAS included all subjects who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in Study A0221109. Here, ‘n’ = subjects evaluable for this endpoint for specified rows.
    End point type
    Secondary
    End point timeframe
    or Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for subjects who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)
    End point values
    Fesoterodine 8 mg Tablet Fesoterodine 2 mg Capsule Fesoterodine 4 mg Capsule Cohort 1 Cohort 2 Total of Treatment Groups
    Number of subjects analysed
    2
    7
    3
    2
    10
    12
    Units: mL per micturition or catheterization
    arithmetic mean (standard deviation)
        Baseline (n =2, 7, 3, 2, 10, 12)
    198.75 ± 44.194
    59.29 ± 33.550
    80.58 ± 39.841
    198.75 ± 44.194
    65.68 ± 34.769
    87.86 ± 62.045
        Change at Week 12 (n =2, 7, 3, 2, 10, 12)
    -0.92 ± 21.095
    13.94 ± 7.801
    27.08 ± 32.086
    -0.92 ± 21.095
    17.88 ± 17.597
    14.75 ± 18.638
        Change at Week 28 (n =2, 6, 3, 2, 9, 11)
    -29.42 ± 12.139
    9.86 ± 33.029
    17.28 ± 9.659
    -29.42 ± 12.139
    12.34 ± 26.812
    4.75 ± 29.583
        Change at Final Visit (n =2, 6, 3, 2, 9, 11)
    -29.42 ± 12.139
    9.86 ± 33.029
    17.28 ± 9.659
    -29.42 ± 12.139
    12.34 ± 26.812
    4.75 ± 29.583
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
    Adverse event reporting additional description
    Safety analysis population was evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort 2
    Reporting group description
    Subjects of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily in efficacy and safety phase in precedent study A0221047 and then continued same dose and dosage form of fesoterodine for 28 weeks in this LTE study.

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

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

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

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

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

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

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Prioritization of endpoints was based on study team's discretion.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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