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    Clinical Trial Results:
    A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age

    Summary
    EudraCT number
    		 2015-004445-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2016
    First version publication date
    18 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVAL489K1101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01447485
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    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
    08 Oct 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to determine the single-dose Pharmacokinetics (PK) of valsartan 20 mg or 40 mg in Japanese pediatric subjects from 6 to 14 years of age.
    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 Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 2011
    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
    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)
    9
    Adolescents (12-17 years)
    3
    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
    		 The study was conducted at three centers in Japan.

    Pre-assignment
    Screening details
    		 A total of 12 subjects were enrolled and completed the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label study, hence no blinding was performed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Valsartan 20 mg
    Arm description
    		 Subjects with body weight <35 kilograms (kg) were administered with a single dose of valsartan 20 milligram (mg) orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Diovan
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight <35 kg were administered with a single dose of valsartan 20 mg orally.

    Arm title
    		 Valsartan 40 mg
    Arm description
    		 Subjects with body weight >=35 kg were administered with a single dose of valsartan 40 mg orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valsartan
    Investigational medicinal product code
    VAL489
    Other name
    Diovan
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight >=35 kg were administered with a single dose of valsartan 40 mg orally.

    Number of subjects in period 1
    		Valsartan 20 mg Valsartan 40 mg
    Started
    6
    6
    Completed
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Valsartan 20 mg
    Reporting group description
    		 Subjects with body weight <35 kilograms (kg) were administered with a single dose of valsartan 20 milligram (mg) orally.

    Reporting group title
    Valsartan 40 mg
    Reporting group description
    		 Subjects with body weight >=35 kg were administered with a single dose of valsartan 40 mg orally.

    Reporting group values
    		 Valsartan 20 mg Valsartan 40 mg Total
    Number of subjects
    		 6 6 12
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 6 3 9
        Adolescents (12-17 years)
    		 0 3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.5 ± 1.05 11.5 ± 1.64 -
    Gender categorical
    Units: Subjects
        Female
    		 0 4 4
        Male
    		 6 2 8

    End points

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    End points reporting groups
    Reporting group title
    Valsartan 20 mg
    Reporting group description
    		 Subjects with body weight <35 kilograms (kg) were administered with a single dose of valsartan 20 milligram (mg) orally.

    Reporting group title
    Valsartan 40 mg
    Reporting group description
    		 Subjects with body weight >=35 kg were administered with a single dose of valsartan 40 mg orally.

    Primary: Maximum plasma concentration (Cmax) of Valsartan

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    End point title
    		 Maximum plasma concentration (Cmax) of Valsartan [1]
    End point description
    Cmax was defined as the observed maximum plasma concentration following drug administration [mass / volume]. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The lower limit of quantification (LLOQ) of valsartan was 5 nanograms (ng)/millilitre (mL). The analysis was performed in pharmacokinetic analysis set (PAS) population, defined as all dosed subjects with evaluable PK data.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hours (hr) post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: Nanograms (ng) / milliLitre (mL)
        arithmetic mean (standard deviation)
    2450 ± 856
    2110 ± 837
    No statistical analyses for this end point

    Primary: Maximum plasma concentration per dose (Cmax/dose) of Valsartan

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    End point title
    		 Maximum plasma concentration per dose (Cmax/dose) of Valsartan [2]
    End point description
    Cmax/dose was defined as the observed maximum plasma concentration following drug administration [mass / volume] per dose. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: ng/mL/mg
        arithmetic mean (standard deviation)
    122 ± 42.8
    52.7 ± 20.9
    No statistical analyses for this end point

    Primary: Maximum plasma concentration (Cmax) for body-weight adjusted dose of Valsartan

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    End point title
    		 Maximum plasma concentration (Cmax) for body-weight adjusted dose of Valsartan [3]
    End point description
    Cmax was defined as the observed maximum plasma concentration following drug administration [mass / volume]. Cmax was adjusted for body-weight using formula = (Cmax/dose)*weight (pre-dose). It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose.
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: ng*kg/mL/mg
        arithmetic mean (standard deviation)
    3120 ± 1080
    2460 ± 850
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of Valsartan

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    End point title
    		 Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of Valsartan [4]
    End point description
    AUClast was defined as the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [mass * time / volume]. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    12000 ± 3850
    2460 ± 850
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration per dose (AUClast/dose) of Valsartan

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    End point title
    		 Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration per dose (AUClast/dose) of Valsartan [5]
    End point description
    AUClast/dose was defined as the area under the plasma (or serum or blood) concentration-time curve from time zero to the time of the last quantifiable concentration [mass * time / volume] per dose. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng/mL/mg
        arithmetic mean (standard deviation)
    600 ± 192
    283 ± 153
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for body weight-adjusted dose of Valsartan

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    End point title
    		 Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for body weight-adjusted dose of Valsartan [6]
    End point description
    AUClast was defined as the area under the plasma (or serum or blood) concentration-time curve from time zero to the time of the last quantifiable concentration [mass * time / volume]. AUClast was adjusted for body-weight using following formula = (AUClast/dose) * weight(pre-dose). It was determined using non-compartmental method(s) using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng*kg/mL/mg
        arithmetic mean (standard deviation)
    15400 ± 5350
    13200 ± 6900
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Valsartan

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    End point title
    		 Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Valsartan [7]
    End point description
    AUCinf was defined as the area under the plasma concentration-time curve from time zero to infinity [mass * time / volume]. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    12300 ± 3930
    11800 ± 6610
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to infinity per dose (AUCinf/dose) of Valsartan

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    End point title
    		 Area under the plasma concentration-time curve from time zero to infinity per dose (AUCinf/dose) of Valsartan [8]
    End point description
    AUCinf/dose was defined as the area under the plasma concentration-time curve from time zero to infinity [mass * time / volume] per dose. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng/mL/mg
        arithmetic mean (standard deviation)
    615 ± 197
    295 ± 165
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for body-weight adjusted dose of Valsartan

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    End point title
    		 Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for body-weight adjusted dose of Valsartan [9]
    End point description
    AUCinf was defined as the area under the plasma concentration-time curve from time zero to infinity [mass * time / volume]. AUCinf was adjusted for body-weight using following formula = (AUCinf/dose)*weight (pre-dose). It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng*kg/mL/mg
        arithmetic mean (standard deviation)
    15800 ± 5620
    13800 ± 7490
    No statistical analyses for this end point

    Primary: Terminal elimination half-life (T1/2) of Valsartan

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    End point title
    		 Terminal elimination half-life (T1/2) of Valsartan [10]
    End point description
    T1/2 was defined as the terminal elimination half-life [time]. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose.
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr
        arithmetic mean (standard deviation)
    4.9 ± 0.763
    5.2 ± 0.864
    No statistical analyses for this end point

    Primary: Apparent systemic clearance from plasma following extravascular administration (CL/F) of Valsartan

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    End point title
    		 Apparent systemic clearance from plasma following extravascular administration (CL/F) of Valsartan [11]
    End point description
    CL/F was defined as the apparent systemic (or total body) clearance from plasma following extravascular administration [volume / time]. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: Litre (L)/hr
        arithmetic mean (standard deviation)
    1.82 ± 0.72
    4.44 ± 2.46
    No statistical analyses for this end point

    Primary: Apparent systemic clearance from plasma following extravascular administration (CL/F) for body-weight adjusted dose of Valsartan

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    End point title
    		 Apparent systemic clearance from plasma following extravascular administration (CL/F) for body-weight adjusted dose of Valsartan [12]
    End point description
    CL/F was defined as the apparent systemic (or total body) clearance from plasma following extravascular administration [volume / time]. CL/F was adjusted for body-weight using following formula = (CL/F/dose)*weight (pre-dose). It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: L/hr/kg
        arithmetic mean (standard deviation)
    0.071 ± 0.027
    0.093 ± 0.047
    No statistical analyses for this end point

    Primary: Time to reach the maximum concentration after drug administration (Tmax) of Valsartan

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    End point title
    		 Time to reach the maximum concentration after drug administration (Tmax) of Valsartan [13]
    End point description
    Tmax was defined as the time to reach the maximum concentration after drug administration [time]. It was determined using non-compartmental method using WinNonlin Pro (Version 5.2). Plasma concentrations of valsartan were determined using a validated LC-MS/MS method. The LLOQ of valsartan was 5 ng/mL. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 6, 8 and 24 hr post-dose
    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: Only descriptive statistics was planned for this primary end point.
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: hr
        median (full range (min-max))
    2.03 (1.92 to 2.08)
    2.02 (1.93 to 2.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, Drug-Related AEs and who died

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    End point title
    		 Number of subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, Drug-Related AEs and who died
    End point description
    AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events were any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigator represent significant hazards. AEs suspected to be related to study drug were determined by the investigator. The analysis was performed on safety population, defined as all subjects who received the study drug.
    End point type
    Secondary
    End point timeframe
    From informed consent until 30 days after administration of single dose of study treatment
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: Subjects
        AEs
    0
    3
        SAEs
    0
    0
        Deaths
    0
    0
        AEs leading to discontinuation
    0
    0
        Drug-Related AEs
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant hematology laboratory abnormalities

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    End point title
    		 Number of subjects with clinically significant hematology laboratory abnormalities
    End point description
    Subjects with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. The normal range for white blood cell (WBC) count was 3.8-10.1*10*E^9/L. The analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    From informed consent until 30 days after administration of single dose of study treatment
    End point values
    		 Valsartan 20 mg Valsartan 40 mg
    Number of subjects analysed
    6
    6
    Units: Subjects
        WBC Count (High) - Leukocytosis
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All AEs reported in this record were from date of First Subject First Treatment until LSLV.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Valsartan 40 mg
    Reporting group description
    		 Subjects with body weight >=35 kg were administered with a single dose of valsartan 40 mg orally.

    Reporting group title
    Valsartan 20 mg
    Reporting group description
    		 Subjects with body weight <35 kg were administered with a single dose of valsartan 20 mg orally.

    Serious adverse events
    		 Valsartan 40 mg Valsartan 20 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Valsartan 40 mg Valsartan 20 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 6 (0.00%)
    Investigations
    Blood pressure diastolic decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Feeling abnormal
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    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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