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    Clinical Trial Results:
    Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder

    Summary
    EudraCT number
    		 2012-001581-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2021
    First version publication date
    31 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CV185-118
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001830-PIP10-80
    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
    06 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the PK of a single dose of apixaban in 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 Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Feb 2013
    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
    Canada: 4
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Mexico: 20
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    49
    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)
    1
    Infants and toddlers (28 days-23 months)
    20
    Children (2-11 years)
    18
    Adolescents (12-17 years)
    10
    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
    		 49 subjects were treated.

    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
    		 Group 1
    Arm description
    		 Neonates up to 27 days old. Single dose of Apixaban 0.44 mg/m^2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban Sprinkle Capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.1 mg

    Arm title
    		 Group 2B
    Arm description
    		 Infants 28 days to < 9 months. Single dose of Apixaban 1.08 mg/m^2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban Oral Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg/mL dosed to 1.08 mg/m^2

    Arm title
    		 Group 2A
    Arm description
    		 Young children 9 months to < 2 years. Single dose of Apixaban 1.08 mg/m^2 or 2.43 mg/m^2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban Oral Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg/mL dosed to 1.08 mg/m^2 or 2.43 mg/m^2

    Arm title
    		 Group 3
    Arm description
    		 Young children 2 years to < 6 years. Single dose of Apixaban 1.17 mg/m^2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban Oral Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg/mL dosed to 1.17 mg/m^2

    Arm title
    		 Group 4
    Arm description
    		 Children 6 years to < 12 years. Single dose of Apixaban 1.80 mg/m^2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban Oral Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg/mL dosed to 1.80 mg/m^2

    Arm title
    		 Group 5
    Arm description
    		 Adolescents 12 years to < 18 years. Single dose of Apixaban 2.19 mg/m^2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban Oral Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg/mL dosed to 2.19 mg/m^2

    Number of subjects in period 1
    		Group 1 Group 2B Group 2A Group 3 Group 4 Group 5
    Started
    1
    11
    9
    8
    10
    10
    Completed
    1
    11
    9
    8
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Neonates up to 27 days old. Single dose of Apixaban 0.44 mg/m^2.

    Reporting group title
    Group 2B
    Reporting group description
    		 Infants 28 days to < 9 months. Single dose of Apixaban 1.08 mg/m^2.

    Reporting group title
    Group 2A
    Reporting group description
    		 Young children 9 months to < 2 years. Single dose of Apixaban 1.08 mg/m^2 or 2.43 mg/m^2.

    Reporting group title
    Group 3
    Reporting group description
    		 Young children 2 years to < 6 years. Single dose of Apixaban 1.17 mg/m^2.

    Reporting group title
    Group 4
    Reporting group description
    		 Children 6 years to < 12 years. Single dose of Apixaban 1.80 mg/m^2.

    Reporting group title
    Group 5
    Reporting group description
    		 Adolescents 12 years to < 18 years. Single dose of Apixaban 2.19 mg/m^2.

    Reporting group values
    		 Group 1 Group 2B Group 2A Group 3 Group 4 Group 5 Total
    Number of subjects
    		 1 11 9 8 10 10 49
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 1 0 0 0 0 0 1
        Infants and toddlers (28 days-23 months)
    		 0 11 9 0 0 0 20
        Children (2-11 years)
    		 0 0 0 8 10 0 18
        Adolescents (12-17 years)
    		 0 0 0 0 0 10 10
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0.025 ± 99999 0.35 ± 0.18 1.11 ± 0.35 3.6 ± 1.2 7.4 ± 1.2 13.7 ± 1.4 -
    Gender Categorical
    Units: Subjects
        Female
    		 1 6 5 4 6 6 28
        Male
    		 0 5 4 4 4 4 21
    Race
    Units: Subjects
        White
    		 1 9 9 8 8 7 42
        Black or African American
    		 0 0 0 0 2 3 5
        Other
    		 0 2 0 0 0 0 2
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 1 5 0 1 3 0 10
        Not Hispanic/Latino
    		 0 3 4 2 5 6 20
        Not Reported
    		 0 3 5 5 2 4 19
    Subject analysis sets

    Subject analysis set title
    Group 2A - 2.43 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in the Group 2A ( 9 months to < 2 years) receiving study drug at a dose of 2.43 mg/m^2

    Subject analysis set title
    Group 2A - 1.08 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in the Group 2A ( 9 months to < 2 years) receiving study drug at a dose of 1.08 mg/m^2

    Subject analysis sets values
    		 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects
    3
    6
    Age Categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    3
    6
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    Gender Categorical
    Units: Subjects
        Female
        Male
    Race
    Units: Subjects
        White
        Black or African American
        Other
    Ethnicity
    Units: Subjects
        Hispanic/Latino
        Not Hispanic/Latino
        Not Reported

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Neonates up to 27 days old. Single dose of Apixaban 0.44 mg/m^2.

    Reporting group title
    Group 2B
    Reporting group description
    		 Infants 28 days to < 9 months. Single dose of Apixaban 1.08 mg/m^2.

    Reporting group title
    Group 2A
    Reporting group description
    		 Young children 9 months to < 2 years. Single dose of Apixaban 1.08 mg/m^2 or 2.43 mg/m^2.

    Reporting group title
    Group 3
    Reporting group description
    		 Young children 2 years to < 6 years. Single dose of Apixaban 1.17 mg/m^2.

    Reporting group title
    Group 4
    Reporting group description
    		 Children 6 years to < 12 years. Single dose of Apixaban 1.80 mg/m^2.

    Reporting group title
    Group 5
    Reporting group description
    		 Adolescents 12 years to < 18 years. Single dose of Apixaban 2.19 mg/m^2.

    Subject analysis set title
    Group 2A - 2.43 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in the Group 2A ( 9 months to < 2 years) receiving study drug at a dose of 2.43 mg/m^2

    Subject analysis set title
    Group 2A - 1.08 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in the Group 2A ( 9 months to < 2 years) receiving study drug at a dose of 1.08 mg/m^2

    Primary: Apparent Plasma Clearance (CL/F)

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    End point title
    		 Apparent Plasma Clearance (CL/F) [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1, from pre-dose up to 26 hours following drug administration
    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 performed for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: L/h
        geometric mean (geometric coefficient of variation)
    0.0979 ± 99999
    0.347 ± 41.3
    1.62 ± 60.6
    2.69 ± 38.4
    3.85 ± 66
    0.775 ± 98.8
    0.757 ± 55.4
    No statistical analyses for this end point

    Primary: Apparent Volume of Distribution of the Central Compartment (Vc/F)

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    End point title
    		 Apparent Volume of Distribution of the Central Compartment (Vc/F) [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1, from pre-dose up to 26 hours following drug administration
    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 performed for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: Liters (L)
        geometric mean (geometric coefficient of variation)
    1.82 ± 99999
    2.69 ± 27.9
    8.97 ± 36.5
    15.4 ± 39.5
    23.6 ± 46.5
    4.71 ± 57.3
    4.55 ± 36.8
    No statistical analyses for this end point

    Primary: Rate of absorption (Ka)

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    End point title
    		 Rate of absorption (Ka) [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1, from pre-dose up to 26 hours following drug administration
    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 performed for this endpoint.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: L/h
        geometric mean (geometric coefficient of variation)
    0.545 ± 99999
    0.717 ± 135
    1.03 ± 50
    1.15 ± 54.9
    1.14 ± 64.3
    1.31 ± 55
    1.36 ± 52.5
    No statistical analyses for this end point

    Primary: Estimated Area Under the Plasma Concentration-Time Curve_AUC(INF)

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    End point title
    		 Estimated Area Under the Plasma Concentration-Time Curve_AUC(INF) [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1, from pre-dose up to 26 hours following drug administration
    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 performed for this endpoint.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: ng*h/mL
        geometric mean (geometric coefficient of variation)
    1120 ± 99999
    806 ± 31.1
    423 ± 67.7
    662 ± 21.7
    815 ± 48.4
    1260 ± 68.7
    501 ± 43.8
    No statistical analyses for this end point

    Primary: Maximum Estimated Plasma Concentration (Cmax)

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    End point title
    		 Maximum Estimated Plasma Concentration (Cmax) [9] [10]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1, from pre-dose up to 26 hours following drug administration
    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 performed for this endpoint.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    45.9 ± 99999
    64 ± 59.5
    49.9 ± 54
    80 ± 28
    96.5 ± 29.6
    148 ± 35.1
    59.1 ± 37.8
    No statistical analyses for this end point

    Primary: Estimated Time at which Maximum Plasma Concentration Occurs (Tmax)

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    End point title
    		 Estimated Time at which Maximum Plasma Concentration Occurs (Tmax) [11] [12]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1, from pre-dose up to 26 hours following drug administration
    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 performed for this endpoint.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: Hours
        median (full range (min-max))
    4.54 (4.54 to 4.54)
    2.32 (1.46 to 9.42)
    1.91 (1.24 to 3.89)
    1.71 (1.3 to 3.46)
    1.95 (1.32 to 6.39)
    1.67 (1.15 to 2.61)
    1.6 (1.16 to 2.66)
    No statistical analyses for this end point

    Secondary: Number of Subjects Experiencing Adverse Events

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    End point title
    		 Number of Subjects Experiencing Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose to 5 days following first dose
    End point values
    		 Group 1 Group 2B Group 2A Group 3 Group 4 Group 5
    Number of subjects analysed
    1
    11
    9
    8
    10
    10
    Units: Subjects
        Adverse Events
    0
    4
    3
    2
    3
    3
        Serious Adverse Events (SAEs)
    0
    0
    0
    0
    2
    0
        Adverse Events leading to discontinuation
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Linear Slope of the Relationship Between Plasma Concentration and Anti-Xa Activity (SLP)

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    End point title
    		 Linear Slope of the Relationship Between Plasma Concentration and Anti-Xa Activity (SLP) [13]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1, from pre-dose up to 26 hours after drug administration
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    9
    8
    10 [14]
    10 [15]
    2
    6
    Units: IU/ng
        number (confidence interval 95%)
    0.0211 (0.015 to 0.0272)
    0.0158 (0.0143 to 0.0173)
    0.0163 (0.0138 to 0.0188)
    0.0153 (0.0146 to 0.016)
    0.0163 (0.0156 to 0.017)
    0.0131 (0.011 to 0.0152)
    0.0129 (0.0114 to 0.0145)
    Notes
    [14] - The actual number of subjects analyzed is 11, including 1 subject analyzed under a different study
    [15] - The actual number of subjects analyzed is 15, including 5 subjects analyzed under a different study
    No statistical analyses for this end point

    Secondary: Maximum Estimated Anti-Xa Activity (AXAmax)

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    End point title
    		 Maximum Estimated Anti-Xa Activity (AXAmax) [16]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1, from pre-dose up to 26 hours after drug administration
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results for Group 2A are being reported separately for subjects receiving 2.43 mg/m^2 or 1.08 mg/m^2 of study drug.
    End point values
    		 Group 1 Group 2B Group 3 Group 4 Group 5 Group 2A - 2.43 mg/m^2 Group 2A - 1.08 mg/m^2
    Number of subjects analysed
    1
    11
    8
    9
    10
    3
    6
    Units: IU/mL
        geometric mean (geometric coefficient of variation)
    0.0837 ± 99999
    0.456 ± 226
    0.464 ± 157
    0.303 ± 243
    0.307 ± 293
    0.309 ± 427
    0.204 ± 216
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from start of treatment up to 30 days of discontinuation of dosing
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    GROUP 1
    Reporting group description
    		 Neonates up to 27 days old. Single dose of Apixaban 0.44 mg/m^2.

    Reporting group title
    GROUP 2A
    Reporting group description
    		 Young children 9 months to < 2 years. Single dose of Apixaban 1.08 mg/m^2 or 2.43 mg/m^2.

    Reporting group title
    GROUP 2B
    Reporting group description
    		 Infants 28 days to < 9 months. Single dose of Apixaban 1.08 mg/m^2.

    Reporting group title
    GROUP 3
    Reporting group description
    		 Young children 2 years to < 6 years. Single dose of Apixaban 1.17 mg/m^2.

    Reporting group title
    GROUP 4
    Reporting group description
    		 Children 6 years to < 12 years. Single dose of Apixaban 1.80 mg/m^2.

    Reporting group title
    GROUP 5
    Reporting group description
    		 Adolescents 12 years to < 18 years. Single dose of Apixaban 2.19 mg/m^2.

    Serious adverse events
    		 GROUP 1 GROUP 2A GROUP 2B GROUP 3 GROUP 4 GROUP 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (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
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GROUP 1 GROUP 2A GROUP 2B GROUP 3 GROUP 4 GROUP 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    3 / 9 (33.33%)
    4 / 11 (36.36%)
    2 / 8 (25.00%)
    3 / 10 (30.00%)
    3 / 10 (30.00%)
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    1
    2
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gingival bleeding
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    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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