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    Clinical Trial Results:
    A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) with Overactive Bladder

    Summary
    EudraCT number
    		 2009-017197-21
    Trial protocol
    		 BE   GB   DK   SE   NO   PL  
    Global end of trial date
    14 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    11 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    905-CL-075
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01262391
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands, 2333 BE
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000573-PIP01-09
    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
    14 Aug 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetics (PK) of solifenacin succinate suspension after single-dose administration at different dose levels in children and adolescents with overactive bladder (OAB).
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    22
    Adolescents (12-17 years)
    20
    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
    		 -

    Pre-assignment
    Screening details
    		 Children and adolescents with OAB, who consented to enter this study and fulfilled all the eligibility criteria, were enrolled in the study. A wash out period of 14 days was performed prior to study drug treatment.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AD-PED 2.5 mg
    Arm description
    		 Male and female adolescents aged 12 to less than 18 years old who received pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Adolescents were given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 2.5 mg dose of solifenacin once daily in adults (referred to as PED of 2.5 mg).

    Arm title
    		 AD-PED 5 mg
    Arm description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 5 mg of solifenacin succinate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Adolescents were given a single dose of solifenacin liquid suspension succinate orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

    Arm title
    		 AD-PED 10 mg
    Arm description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 10 mg of solifenacin succinate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Adolescents were given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 10 mg dose of solifenacin once daily in adults (referred to as PED of 10 mg).

    Arm title
    		 CH-PED 2.5 mg
    Arm description
    		 Male and female children aged 5 to less than 12 years old who received PED of 2.5 mg of solifenacin succinate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children were given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 2.5 mg dose of solifenacin once daily in adults (referred to as PED of 2.5 mg).

    Arm title
    		 CH-PED 5 mg
    Arm description
    		 Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children were given a single dose of solifenacin liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

    Arm title
    		 CH-PED 10 mg
    Arm description
    		 Male and female children aged 5 to less than 12 years old who received PED of 10 mg of solifenacin succinate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children were given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 10 mg dose of solifenacin once daily in adults (referred to as PED of 10 mg).

    Number of subjects in period 1
    		AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Started
    6
    6
    8
    8
    8
    6
    Treated
    6
    6
    8
    8
    8
    6
    Completed
    6
    6
    8
    8
    8
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AD-PED 2.5 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate.

    Reporting group title
    AD-PED 5 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 5 mg of solifenacin succinate.

    Reporting group title
    AD-PED 10 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 10 mg of solifenacin succinate.

    Reporting group title
    CH-PED 2.5 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 2.5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 5 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 10 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 10 mg of solifenacin succinate.

    Reporting group values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg Total
    Number of subjects
    		 6 6 8 8 8 6 42
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.2 ± 1.17 14.2 ± 1.47 13.3 ± 1.91 8.4 ± 1.77 7.4 ± 2 7.3 ± 0.82 -
    Gender categorical
    Units: Subjects
        Female
    		 6 4 5 4 2 2 23
        Male
    		 0 2 3 4 6 4 19

    End points

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    End points reporting groups
    Reporting group title
    AD-PED 2.5 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate.

    Reporting group title
    AD-PED 5 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 5 mg of solifenacin succinate.

    Reporting group title
    AD-PED 10 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 10 mg of solifenacin succinate.

    Reporting group title
    CH-PED 2.5 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 2.5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 5 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 10 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 10 mg of solifenacin succinate.

    Primary: Maximum concentration (Cmax)

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    End point title
    		 Maximum concentration (Cmax) [1]
    End point description
    The analysis population was the pharmacokinetic analysis set (PKAS), defined as all participants who received the dose of study drug and who had values of concentration for a sufficient number of time points to calculate reliably at least 1 pharmacokinetic parameter. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    5
    6
    8
    5
    8
    5
    Units: ng/mL
        arithmetic mean (standard deviation)
    7.97 ± 4.23
    17.1 ± 3.9
    29.7 ± 8.7
    8.34 ± 2.11
    18.5 ± 6.4
    42.3 ± 29.8
    No statistical analyses for this end point

    Primary: Area under the curve extrapolated to infinity (AUCinf)

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    End point title
    		 Area under the curve extrapolated to infinity (AUCinf) [2]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    5
    6
    8
    5
    8
    5
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    446 ± 296
    752 ± 228
    1458 ± 969
    365 ± 146
    657 ± 236
    2331 ± 2882
    No statistical analyses for this end point

    Primary: Apparent terminal elimination half-life (t1/2)

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    End point title
    		 Apparent terminal elimination half-life (t1/2) [3]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    5
    6
    8
    5
    8
    5
    Units: hours
        arithmetic mean (standard deviation)
    37.1 ± 5.4
    32.2 ± 4.8
    33.3 ± 11.4
    27.5 ± 7.5
    23.4 ± 2.6
    39.2 ± 35
    No statistical analyses for this end point

    Primary: Time to attain Cmax (tmax)

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    End point title
    		 Time to attain Cmax (tmax) [4]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples.
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    5
    6
    8
    5
    8
    5
    Units: hours
        arithmetic mean (standard deviation)
    4.31 ± 0.93
    3.51 ± 0.33
    3.77 ± 0.58
    4.08 ± 0.38
    3.37 ± 1.17
    3.56 ± 1.8
    No statistical analyses for this end point

    Primary: Apparent total body clearance (CL/F)

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    End point title
    		 Apparent total body clearance (CL/F) [5]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples.
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    5
    6
    8
    5
    8
    5
    Units: L/h
        arithmetic mean (standard deviation)
    15.9 ± 11.8
    13.1 ± 4.1
    15.2 ± 6.3
    9.95 ± 7.68
    8.62 ± 5.33
    7.56 ± 3.66
    No statistical analyses for this end point

    Primary: Apparent volume of distribution during the terminal phase (Vz/F)

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    End point title
    		 Apparent volume of distribution during the terminal phase (Vz/F) [6]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    5
    6
    8
    5
    8
    5
    Units: liters
        arithmetic mean (standard deviation)
    804 ± 572
    609 ± 201
    652 ± 151
    381 ± 277
    288 ± 177
    311 ± 155
    No statistical analyses for this end point

    Primary: Area under the concentration-time curve from the time of dosing until the last measurable concentration (AUClast)

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    End point title
    		 Area under the concentration-time curve from the time of dosing until the last measurable concentration (AUClast) [7]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-8 years old: 4 samples; aged 9-11 years old: 6 samples; aged 12-17 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    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: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Notes
    [8] - AUClast was not calculated since non-compartmental modeling was not used for PK analysis.
    [9] - AUClast was not calculated since non-compartmental modeling was not used for PK analysis.
    [10] - AUClast was not calculated since non-compartmental modeling was not used for PK analysis.
    [11] - AUClast was not calculated since non-compartmental modeling was not used for PK analysis.
    [12] - AUClast was not calculated since non-compartmental modeling was not used for PK analysis.
    [13] - AUClast was not calculated since non-compartmental modeling was not used for PK analysis.
    No statistical analyses for this end point

    Secondary: Safety as assessed by adverse events (AEs), vital signs, clinical laboratory tests, physical examination and electrocardiograms (ECGs)

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    End point title
    		 Safety as assessed by adverse events (AEs), vital signs, clinical laboratory tests, physical examination and electrocardiograms (ECGs)
    End point description
    Safety was monitored by collecting AEs, which included abnormal laboratory tests, vital signs or ECG data that were defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred or worsened after study drug administration. A serious AE (SAE) was any untoward medical occurrence that, at any dose: Resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly, or birth defect, required inpatient hospitalization or led to prolongation of hospitalization or other medically important events. The analysis population was the safety analysis set (SAF), which consisted of all enrolled participants who received the dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 7 days postdose
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    6
    6
    8
    8
    8
    6
    Units: participants
        Incidence of AEs
    0
    2
    2
    3
    1
    1
        Number of AEs
    0
    2
    2
    3
    2
    1
        Incidence of drug-related AEs
    0
    1
    2
    0
    1
    1
        Number of drug-related AEs
    0
    1
    2
    0
    1
    1
        Incidence of deaths
    0
    0
    0
    0
    0
    0
        Incidence of SAEs
    0
    0
    0
    0
    0
    0
        Number of SAEs
    0
    0
    0
    0
    0
    0
        Incidence of drug-related SAEs
    0
    0
    0
    0
    0
    0
        Number of drug-related SAEs
    0
    0
    0
    0
    0
    0
        Incidence of AEs leading to discontinuation
    0
    0
    0
    0
    0
    0
        Incidence of drug-related AEs leading to discont.
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in postvoid residual (PVR) volume

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    End point title
    		 Change from baseline in postvoid residual (PVR) volume
    End point description
    PVR volume was assessed by ultrasonography or bladder scan. The analysis population was the SAF.
    End point type
    Secondary
    End point timeframe
    Baseline (screening) and 4 hours postdose
    End point values
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Number of subjects analysed
    6
    6
    8
    8
    8
    6
    Units: mL
        arithmetic mean (standard deviation)
    -4.5 ± 8.09
    3 ± 6.96
    -2.9 ± 8.13
    5.1 ± 14.99
    -0.1 ± 7.38
    2 ± 6.93
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 7 days postdose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    AD-PED 2.5 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 2.5 mg of solifenacin.

    Reporting group title
    AD-PED 5 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 5 mg of solifenacin.

    Reporting group title
    AD-PED 10 mg
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years old who received PED of 10 mg of solifenacin.

    Reporting group title
    CH-PED 2.5 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 2.5 mg of solifenacin.

    Reporting group title
    CH-PED 5 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin.

    Reporting group title
    CH-PED 10 mg
    Reporting group description
    		 Male and female children aged 5 to less than 12 years old who received PED of 10 mg of solifenacin.

    Serious adverse events
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 AD-PED 2.5 mg AD-PED 5 mg AD-PED 10 mg CH-PED 2.5 mg CH-PED 5 mg CH-PED 10 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    2 / 8 (25.00%)
    3 / 8 (37.50%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    Investigations
    Eosinophil count increased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Residual urine
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0

    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.
    None reported
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