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    Clinical Trial Results:
    A Three Month Prospective Open Label Study of Therapy With Fragmin (Dalteparin Sodium Injection) in Children With Venous Thromboembolism With or Without Malignancies

    Summary
    EudraCT number
    		 2016-000394-21
    Trial protocol
    		 ES   SI   PL   GB   DE   HR  
    Global end of trial date
    20 Mar 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Jun 2019
    First version publication date
    03 Oct 2018
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    A6301094
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00952380
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with venous thromboembolism (VTE), and with or without cancer, using anti-factor Xa levels and a population PD analysis methodology; 2. To determine the median dose (IU/kg) required to achieve therapeutic anti-Xa levels (0.5 to 1.0 International Units [IU]/mL) based on subject age and weight.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2009
    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
    Russian Federation: 8
    Country: Number of subjects enrolled
    Slovenia: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    38
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    1
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    2
    Children (2-11 years)
    15
    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
    		 The study was conducted in the 5 countries from 20 August 2009 to 20 March 2018. A total of 38 subjects were enrolled. This study had dose adjustment (DA) phase (Day 1-7), pharmacodynamic (PD) phase (Day 8-14) and follow up (FU) phase (Day 15-104).

    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
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week)
    Arm description
    		 Subjects aged greater than or equal to (>=) 0 to less than (<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalteparin sodium
    Investigational medicinal product code
    Other name
    Fragmin
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 125 IU/kg of dalteparin sodium injection subcutaneously twice daily.

    Arm title
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year)
    Arm description
    		 Subjects aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalteparin sodium
    Investigational medicinal product code
    Other name
    Fragmin
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 150 IU/kg of dalteparin sodium injection subcutaneously twice daily.

    Arm title
    		 Dalteparin Sodium: Group 3 (>=2 year to <8 year)
    Arm description
    		 Subjects aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalteparin sodium
    Investigational medicinal product code
    Other name
    Fragmin
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 125 IU/kg of dalteparin sodium injection subcutaneously twice daily.

    Arm title
    		 Dalteparin Sodium: Group 4 (>=8 year to <12 year)
    Arm description
    		 Subjects aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalteparin sodium
    Investigational medicinal product code
    Other name
    Fragmin
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 125 IU/kg of dalteparin sodium injection subcutaneously twice daily.

    Arm title
    		 Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Arm description
    		 Subjects aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalteparin sodium
    Investigational medicinal product code
    Other name
    Fragmin
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 100 IU/kg of dalteparin sodium injection subcutaneously twice daily.

    Number of subjects in period 1
    		Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Started
    1
    2
    8
    7
    20
    Completed
    1
    1
    6
    4
    14
    Not completed
    0
    1
    2
    3
    6
         Physician decision
    -
    -
    1
    2
    -
         Adverse Event
    -
    1
    -
    -
    3
         Non-compliant to protocol
    -
    -
    -
    1
    -
         Unspecified
    -
    -
    -
    -
    1
         Withdrawal by subject
    -
    -
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dalteparin Sodium: Group 1 (>=0 to <8 week)
    Reporting group description
    		 Subjects aged greater than or equal to (>=) 0 to less than (<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 2 (>=8 week to <2 year)
    Reporting group description
    		 Subjects aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 3 (>=2 year to <8 year)
    Reporting group description
    		 Subjects aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 4 (>=8 year to <12 year)
    Reporting group description
    		 Subjects aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Reporting group description
    		 Subjects aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year) Total
    Number of subjects
    		 1 2 8 7 20 38
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 1 0 0 0 0 1
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 2 0 0 0 2
        Children (2-11 years)
    		 0 0 8 7 0 15
        Adolescents (12-17 years)
    		 0 0 0 0 20 20
        Adults (18-64 years)
    		 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 0.0684 (0.0684 to 0.0684) 1.0569 (0.1999 to 1.9138) 5.3676 (2.3409 to 7.3949) 10.0287 (8.3833 to 11.8741) 15.7208 (12.4682 to 18.7187) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 0 1 2 5 6 14
        Male
    		 1 1 6 2 14 24
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 0 0 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 3 4 7
        White
    		 1 2 7 4 15 29
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 1 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 2 2 4 8
        Not Hispanic or Latino
    		 1 2 6 5 16 30
        Unknown or Not Reported
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Dalteparin Sodium: Group 1 (>=0 to <8 week)
    Reporting group description
    		 Subjects aged greater than or equal to (>=) 0 to less than (<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 2 (>=8 week to <2 year)
    Reporting group description
    		 Subjects aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 3 (>=2 year to <8 year)
    Reporting group description
    		 Subjects aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 4 (>=8 year to <12 year)
    Reporting group description
    		 Subjects aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Reporting group description
    		 Subjects aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Subject analysis set title
    Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 132 days).

    Primary: Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level

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    End point title
    		 Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level [1]
    End point description
    Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported. The PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
    End point type
    Primary
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Number of subjects analysed
    34
    Units: IU/mL
        median (full range (min-max))
    125 (99.1 to 213.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels

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    End point title
    		 Percentage of Subjects Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
    End point description
    Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of subjects who achieved the prespecified level during the dose adjustment phase were reported in this endpoint. Analysis population included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 to 7 in dose adjustment phase
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0.00 to 97.50)
    100.0 (15.81 to 100.0)
    100.0 (63.06 to 100.0)
    100.0 (59.04 to 100.0)
    85.0 (62.11 to 96.79)
    No statistical analyses for this end point

    Secondary: Number of Subjects With New or Progressive Symptomatic Venous Thromboembolism (VTE)

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    End point title
    		 Number of Subjects With New or Progressive Symptomatic Venous Thromboembolism (VTE) [2]
    End point description
    Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. The PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this endpoint was not planned to be collected and analysed for age group of >=0 to <8 weeks.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    Notes
    [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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: subjects
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)

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    End point title
    		 Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
    End point description
    It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis. The PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    End point values
    		 Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Number of subjects analysed
    0 [3]
    Units: days
        median (confidence interval 95%)
    ( to )
    Notes
    [3] - Median and 95% CI was not estimable due to the low number of subjects who had VTE.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)

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    End point title
    		 Percentage of Subjects With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE) [4]
    End point description
    VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit. The PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this endpoint was not planned to be collected and analysed for age group of >=0 to <8 weeks.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    Notes
    [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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: percentage of subjects
    number (confidence interval 95%)
        Progression
    0 (0.00 to 84.19)
    0 (0.00 to 36.94)
    0 (0.00 to 40.96)
    0 (0.00 to 19.51)
        Regression
    0 (0.00 to 84.19)
    12.5 (0.32 to 52.65)
    14.3 (0.36 to 57.87)
    29.4 (10.31 to 55.96)
        Resolution
    100.0 (15.81 to 100.0)
    62.5 (24.49 to 91.48)
    57.1 (18.41 to 90.10)
    58.8 (32.92 to 81.56)
        No Change
    0 (0.00 to 84.19)
    0 (0.00 to 36.94)
    14.3 (0.36 to 57.87)
    5.9 (0.15 to 28.69)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Major and Minor Bleeding Event

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    End point title
    		 Percentage of Subjects With Major and Minor Bleeding Event
    End point description
    A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the subject's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding). The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: percentage of subjects
    number (confidence interval 95%)
        Major Bleeding
    0 (0.00 to 97.50)
    50.0 (1.26 to 98.74)
    0 (0.00 to 36.94)
    0 (0.00 to 40.96)
    0 (0.00 to 16.84)
        Minor Bleeding
    0 (0.00 to 97.50)
    0 (0.00 to 84.19)
    50.0 (15.70 to 84.30)
    57.1 (18.41 to 90.10)
    40.0 (19.12 to 63.95)
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. The safety analysis set included all the subjects who received at least 1 dose of study drug. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: subjects
        AEs
    1
    2
    7
    7
    19
        SAEs
    0
    2
    3
    3
    13
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities

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    End point title
    		 Number of Subjects With Laboratory Abnormalities
    End point description
    Hematology:hemoglobin,hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes lymphocytes/Leukocytes%, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN,basophils, basophils/leukocytes%,eosinophils,eosinophils/leukocytes, monocytes monocytes/leukocytes% >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio >1.1* ULN.Chemistry: bilirubin >1.5*ULN, AST, ALT, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated creatinine clearance, estimated Glomerular filtration rate modified and bedside schwartz, >1.0*ULN. Urinalysis: creatinine >1.0*ULN.N=number of subjects evaluable for this end point.Safety set.
    End point type
    Secondary
    End point timeframe
    Baseline up to 104 days
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    19
    Units: subjects
    1
    2
    8
    5
    19
    No statistical analyses for this end point

    Secondary: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Subjects

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    End point title
    		 Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Subjects
    End point description
    Here "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: millimeters of mercury (mmHg)
    median (full range (min-max))
        SBP: Baseline (n= 1,1,6,3,12)
    101.00 (101.00 to 101.00)
    50.00 (50.00 to 50.00)
    110.50 (95.00 to 119.00)
    96.00 (94.00 to 119.00)
    117.50 (97.00 to 140.00)
        SBP: Day 1 (n= 1,2,4,6,15)
    97.00 (97.00 to 97.00)
    105.50 (63.00 to 148.00)
    112.00 (100.00 to 137.00)
    111.00 (100.00 to 126.00)
    113.00 (92.00 to 130.00)
        SBP: Day 2 (n= 1,1,8,7,18)
    94.00 (94.00 to 94.00)
    75.00 (75.00 to 75.00)
    107.00 (90.00 to 128.00)
    112.00 (101.00 to 126.00)
    119.50 (98.00 to 158.00)
        SBP: Day 30 (n=1,1,7,5,17)
    77.00 (77.00 to 77.00)
    77.00 (77.00 to 77.00)
    112.00 (100.00 to 123.00)
    109.00 (100.00 to 113.00)
    118.00 (95.00 to 133.00)
        SBP: Day 60 (n=1,1,7,5,14)
    74.00 (74.00 to 74.00)
    102.00 (102.00 to 102.00)
    101.00 (91.00 to 124.00)
    118.00 (102.00 to 130.00)
    117.50 (102.00 to 134.00)
        SBP: Day 90(n=1,2,8,7,19)
    76.00 (76.00 to 76.00)
    105.00 (93.00 to 117.00)
    97.50 (90.00 to 105.00)
    116.00 (99.00 to 123.00)
    116.00 (89.00 to 151.00)
        DSBP:Baseline (n=1,1,6,3,12)
    60.00 (60.00 to 60.00)
    41.00 (41.00 to 41.00)
    66.00 (50.00 to 77.00)
    67.00 (60.00 to 75.00)
    65.00 (46.00 to 80.00)
        DSBP: Day 1(n=1,2,4,6,15)
    61.00 (61.00 to 61.00)
    57.00 (41.00 to 73.00)
    65.50 (50.00 to 87.00)
    66.50 (54.00 to 81.00)
    64.00 (48.00 to 80.00)
        DSBP:Day 2 (n= 1,1,8,7,18)
    48.00 (48.00 to 48.00)
    53.00 (53.00 to 53.00)
    60.50 (53.00 to 70.00)
    70.00 (65.00 to 79.00)
    65.00 (53.00 to 95.00)
        DSBP:Day 30 (n= 1,1,7,5,17)
    53.00 (53.00 to 53.00)
    61.00 (61.00 to 61.00)
    64.00 (54.00 to 68.00)
    68.00 (53.00 to 71.00)
    69.00 (55.00 to 87.00)
        DSBP: Day 60 (n= 1,1,7,5,14)
    51.00 (51.00 to 51.00)
    57.00 (57.00 to 57.00)
    60.00 (46.00 to 73.00)
    67.00 (59.00 to 70.00)
    67.00 (57.00 to 80.00)
        DSBP: Day 90 (n=1,2,8,7,19)
    53.00 (53.00 to 53.00)
    55.50 (51.00 to 60.00)
    60.50 (52.00 to 70.00)
    67.00 (56.00 to 80.00)
    69.00 (59.00 to 95.00)
    No statistical analyses for this end point

    Secondary: Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Subjects

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    End point title
    		 Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Subjects
    End point description
    Heart rate and pulse rate of subjects were measured in terms of beats per minute. Here 99999 signifies that median and full range could not be calculated as no subjects were evaluable and "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: beats per minute (bpm)
    median (full range (min-max))
        HR: Baseline (n=1,1,4,0,5)
    148.00 (148.00 to 148.00)
    146.00 (146.00 to 146.00)
    115.00 (66.00 to 126.00)
    99999 (-99999 to 99999)
    70.00 (52.00 to 84.00)
        HR: Day 1 (n=1,1,1,0,7)
    146.00 (146.00 to 146.00)
    142.00 (142.00 to 142.00)
    112.00 (112.00 to 112.00)
    99999 (-99999 to 99999)
    85.00 (46.00 to 139.00)
        HR: Day 2 (n=1,1,5,0,8)
    136.00 (136.00 to 136.00)
    130.00 (130.00 to 130.00)
    114.00 (100.00 to 136.00)
    99999 (-99999 to 99999)
    75.00 (56.00 to 124.00)
        HR: Day 30 (n=1,1,4,0,8)
    138.00 (138.00 to 138.00)
    130.00 (130.00 to 130.00)
    120.50 (100.00 to 124.00)
    99999 (-99999 to 99999)
    87.50 (56.00 to 126.00)
        HR: Day 60 (n=1,1,4,0,8)
    132.00 (132.00 to 132.00)
    184.00 (184.00 to 184.00)
    120.00 (114.00 to 139.00)
    99999 (-99999 to 99999)
    94.50 (56.00 to 134.00)
        HR: Day 90 (n=1,1,4,0,8)
    122.00 (122.00 to 122.00)
    134.00 (134.00 to 134.00)
    107.00 (96.00 to 116.00)
    99999 (-99999 to 99999)
    80.00 (66.00 to 118.00)
        PR: Baseline (n=0,0,2,3,7)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    96.50 (68.00 to 125.00)
    114.00 (80.00 to 119.00)
    73.00 (67.00 to 150.00)
        PR: Day 1 (n=0,1,3,6,8)
    99999 (-99999 to 99999)
    108.00 (108.00 to 108.00)
    121.00 (86.00 to 122.00)
    87.00 (76.00 to 120.00)
    94.50 (72.00 to 123.00)
        PR: Day 2 (n=0,0,3,7,10)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    117.00 (113.00 to 138.00)
    98.00 (84.00 to 127.00)
    93.00 (57.00 to 161.00)
        PR:Day 30 (n=0,0,3,5,9)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    88.00 (88.00 to 147.00)
    101.00 (90.00 to 150.00)
    102.00 (72.00 to 123.00)
        PR: Day 60 (n=0,0,3,5,6)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    88.00 (88.00 to 99.00)
    93.00 (75.00 to 108.00)
    95.00 (62.00 to 117.00)
        PR: Day 90 (n=0,1,3,7,11)
    99999 (-99999 to 99999)
    140.00 (140.00 to 140.00)
    114.00 (113.00 to 120.00)
    96.00 (67.00 to 109.00)
    92.00 (74.00 to 124.00)
    No statistical analyses for this end point

    Secondary: Absolute Values of Height of Subjects

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    End point title
    		 Absolute Values of Height of Subjects
    End point description
    Here 99999 signifies that median and full range could not be calculated as no subjects were evaluable and "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: centimeters (cm)
    median (full range (min-max))
        Baseline (n=1,1,4,2,9)
    54.00 (54.00 to 54.00)
    55.00 (55.00 to 55.00)
    110.00 (98.00 to 125.50)
    133.00 (126.00 to 140.00)
    166.00 (142.00 to 178.00)
        Day 1 (n=1,0,3,2,11)
    54.00 (54.00 to 54.00)
    99999 (-99999 to 99999)
    115.80 (98.00 to 118.00)
    134.00 (126.00 to 142.00)
    166.00 (113.50 to 184.00)
        Day 2 (n=0,0,6,5,15)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    107.90 (89.50 to 120.00)
    142.00 (126.00 to 159.90)
    166.90 (113.60 to 189.00)
        Day 30 (n=1,1,5,6,14)
    60.00 (60.00 to 60.00)
    56.60 (56.60 to 56.60)
    115.10 (89.50 to 124.50)
    140.30 (128.00 to 159.90)
    167.75 (113.90 to 184.00)
        Day 60 (n=1,1,5,5,13)
    63.00 (63.00 to 63.00)
    60.00 (60.00 to 60.00)
    115.00 (90.00 to 124.50)
    139.70 (128.00 to 161.60)
    168.50 (114.20 to 183.60)
        Day 90 (n=1,1,6,5,18)
    64.00 (64.00 to 64.00)
    61.00 (61.00 to 61.00)
    109.50 (91.50 to 127.00)
    140.70 (129.00 to 161.60)
    166.65 (115.00 to 184.00)
    No statistical analyses for this end point

    Secondary: Absolute Values of Weight of Subjects

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    End point title
    		 Absolute Values of Weight of Subjects
    End point description
    Here "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: kilograms (kg)
    median (full range (min-max))
        Baseline (n=1,1,6,3,9)
    4.05 (4.05 to 4.05)
    3.93 (3.93 to 3.93)
    18.78 (12.80 to 34.70)
    36.60 (25.40 to 45.80)
    60.00 (48.00 to 86.90)
        Day 1 (n=1,1,4,3,13)
    4.17 (4.17 to 4.17)
    4.04 (4.04 to 4.04)
    17.23 (13.40 to 21.20)
    37.00 (25.40 to 40.60)
    63.40 (19.60 to 95.20)
        Day 2 (n=1,1,7,6,16)
    4.50 (4.50 to 4.50)
    4.15 (4.15 to 4.15)
    14.95 (11.90 to 34.70)
    39.35 (25.40 to 64.50)
    58.00 (19.70 to 89.80)
        Day 30 (n=1,1,7,6,17)
    6.30 (6.30 to 6.30)
    4.56 (4.56 to 4.56)
    15.50 (13.00 to 37.20)
    39.20 (23.00 to 64.50)
    63.80 (21.80 to 91.70)
        Day 60 (n=1,1,7,5,14)
    7.15 (7.15 to 7.15)
    4.60 (4.60 to 4.60)
    16.60 (12.70 to 37.20)
    38.30 (24.10 to 68.60)
    65.80 (22.70 to 90.80)
        Day 90 (n=1,1,7,6,19)
    7.70 (7.70 to 7.70)
    4.70 (4.70 to 4.70)
    21.50 (14.00 to 38.50)
    39.30 (24.40 to 68.60)
    59.60 (22.60 to 89.80)
    No statistical analyses for this end point

    Secondary: Absolute Values of Respiratory Rate of Subjects

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    End point title
    		 Absolute Values of Respiratory Rate of Subjects
    End point description
    Respiratory rate was defined as the number of breaths per minute. Here "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: breaths per minute
    median (full range (min-max))
        Baseline (n=1,1,6,3,12)
    35.00 (35.00 to 35.00)
    25.00 (25.00 to 25.00)
    24.00 (18.00 to 24.00)
    20.00 (18.00 to 30.00)
    20.00 (17.00 to 36.00)
        Day 1 (n=1,2,4,6,15)
    34.00 (34.00 to 34.00)
    36.00 (36.00 to 36.00)
    21.00 (20.00 to 24.00)
    18.00 (16.00 to 20.00)
    18.00 (16.00 to 30.00)
        Day 2 (n=1,1,7,7,17)
    34.00 (34.00 to 34.00)
    34.00 (34.00 to 34.00)
    20.00 (18.00 to 24.00)
    20.00 (18.00 to 24.00)
    18.00 (16.00 to 24.00)
        Day 30 (n=1,1,7,4,16)
    34.00 (34.00 to 34.00)
    36.00 (36.00 to 36.00)
    22.00 (16.00 to 28.00)
    22.00 (20.00 to 24.00)
    18.00 (16.00 to 32.00)
        Day 60 (n=1,1,7,4,14)
    30.00 (30.00 to 30.00)
    36.00 (36.00 to 36.00)
    20.00 (16.00 to 24.00)
    20.00 (18.00 to 20.00)
    20.00 (16.00 to 30.00)
        Day 90 (n=1,2,7,6,19)
    24.00 (24.00 to 24.00)
    34.00 (32.00 to 36.00)
    22.00 (20.00 to 24.00)
    20.00 (18.00 to 22.00)
    18.00 (12.00 to 28.00)
    No statistical analyses for this end point

    Secondary: Absolute Values of Body Temperature of Subjects

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    End point title
    		 Absolute Values of Body Temperature of Subjects
    End point description
    Here "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: celsius
    median (full range (min-max))
        Baseline (n=1,1,6,3,12)
    36.60 (36.60 to 36.60)
    36.70 (36.70 to 36.70)
    36.50 (36.10 to 37.30)
    37.00 (36.20 to 37.20)
    36.80 (35.60 to 39.30)
        Day 1 (n=1,2,4,6,15)
    36.70 (36.70 to 36.70)
    36.85 (36.70 to 37.00)
    36.80 (36.70 to 36.90)
    36.70 (36.00 to 37.00)
    36.80 (36.10 to 37.10)
        Day 2 (n=1,1,8,7,18)
    36.90 (36.90 to 36.90)
    36.40 (36.40 to 36.40)
    36.70 (35.30 to 37.30)
    36.70 (36.60 to 36.80)
    36.70 (36.40 to 37.70)
        Day 30 (n=1,1,7,5,17)
    36.50 (36.50 to 36.50)
    36.50 (36.50 to 36.50)
    36.60 (35.50 to 37.30)
    36.50 (36.40 to 38.60)
    36.70 (35.10 to 37.10)
        Day 60 (n=1,1,7,5,13)
    36.60 (36.60 to 36.60)
    36.70 (36.70 to 36.70)
    36.80 (36.40 to 38.60)
    36.60 (35.60 to 36.90)
    36.60 (35.70 to 37.00)
        Day 90 (n=1,2,8,7,19)
    36.70 (36.70 to 36.70)
    37.15 (36.70 to 37.60)
    36.75 (35.90 to 37.50)
    36.90 (36.70 to 38.40)
    36.80 (36.10 to 38.40)
    No statistical analyses for this end point

    Secondary: Absolute Values of Body Length of Subjects

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    End point title
    		 Absolute Values of Body Length of Subjects
    End point description
    Here 99999 signifies that median and full range could not be calculated as no subjects were evaluable and "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: cm
    median (full range (min-max))
        Baseline (n= 1,1,1,0,1)
    54.00 (54.00 to 54.00)
    55.00 (55.00 to 55.00)
    100.00 (100.00 to 100.00)
    99999 (-99999 to 99999)
    172.00 (172.00 to 172.00)
        Day 1 (n=1,1,0,0,1)
    54.00 (54.00 to 54.00)
    55.00 (55.00 to 55.00)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    135.00 (135.00 to 135.00)
        Day 2 (n= 1,1,2,0,1)
    56.00 (56.00 to 56.00)
    55.30 (55.30 to 55.30)
    104.75 (89.50 to 120.00)
    99999 (-99999 to 99999)
    135.00 (135.00 to 135.00)
        Day 30 (n=1,1,3,0,1)
    60.00 (60.00 to 60.00)
    56.60 (56.60 to 56.60)
    100.00 (89.50 to 124.5)
    99999 (-99999 to 99999)
    135.00 (135.00 to 135.00)
        Day 60 (n=1,1,3,0,1)
    63.00 (63.00 to 63.00)
    60.00 (60.00 to 60.00)
    103.00 (90.00 to 124.50)
    99999 (-99999 to 99999)
    135.00 (135.00 to 135.00)
        Day 90 (n=1,1,2,0,2)
    64.00 (64.00 to 64.00)
    61.00 (61.00 to 61.00)
    97.75 (91.50 to 104.00)
    99999 (-99999 to 99999)
    151.75 (135.00 to 168.50)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Physical Examination Abnormalities of Subjects

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    End point title
    		 Number of Subjects With Physical Examination Abnormalities of Subjects
    End point description
    Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Here, 9999 signifies as no subjects evaluable. Only those categories in which at least 1 subject had abnormality were reported and "n" signifies the number of subjects evaluable at specific time points. The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)
    End point values
    		 Dalteparin Sodium: Group 1 (>=0 to <8 week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    1
    2
    8
    7
    20
    Units: subjects
        Abdomen: Screening (n=1,2,7,7,19)
    0
    1
    2
    0
    2
        Abdomen: Visit 2 (n=1,1,4,0,7)
    0
    0
    2
    9999
    0
        Abdomen: Visit 3 (n=1,2,4,6,12)
    0
    1
    1
    0
    2
        Abdomen: Visit 4 (n=1,2,7,7,18)
    0
    0
    1
    1
    3
        Abdomen: Visit 5 (n=1,1,7,6,17)
    0
    0
    0
    1
    4
        Abdomen: Visit 6 (n=1,1,7,4,14)
    0
    0
    0
    1
    1
        Abdomen: Visit 7 (n=1,2,7,7,18)
    0
    1
    0
    1
    3
        Chest: Screening (n=1,2,7,7,19)
    0
    0
    1
    2
    2
        Chest: Visit 2 (n=1,1,4,0,7)
    0
    0
    2
    9999
    0
        Chest: Visit 3 (n=1,2,4,5,12)
    0
    0
    0
    2
    0
        Chest: Visit 4 (n=1,2,7,6,18)
    0
    0
    0
    3
    1
        Chest: Visit 5 (n=1,1,7,5,17)
    0
    0
    0
    1
    0
        Chest: Visit 6 (n=1,1,7,3,14)
    0
    0
    0
    1
    0
        Chest: Visit 7 (n=1,2,7,6,18)
    0
    0
    0
    2
    3
        Extremities: Screening (n=1,2,7,7,19)
    0
    0
    0
    4
    10
        Extremities: Visit 2 (n=1,1,4,0,7)
    0
    0
    1
    9999
    1
        Extremities: Visit 3 (n=1,2,4,6,12)
    0
    0
    1
    3
    3
        Extremities: Visit 4 (n=1,2,7,7,17)
    0
    0
    0
    4
    8
        Extremities: Visit 5 (n=1,1,7,6,16)
    0
    0
    0
    1
    3
        Extremities: Visit 6 (n=1,1,7,4,14)
    0
    0
    0
    1
    2
        Extremities: Visit 7 (n=1,2,7,7,18)
    0
    0
    0
    2
    2
        Eyes: Screening (n=1,1,5,0,8)
    0
    0
    1
    9999
    1
        Eyes: Visit 2 (n=1,1,3,0,5)
    0
    0
    0
    9999
    1
        Eyes: Visit 3 (n=1,1,1,0,7)
    0
    0
    0
    9999
    1
        Eyes: Visit 4 (n=1,1,4,0,8)
    0
    0
    0
    9999
    2
        Eyes: Visit 5 (n=1,1,4,0,8)
    0
    0
    0
    9999
    1
        Eyes: Visit 6 (n=1,1,4,0,8)
    0
    0
    0
    9999
    1
        Eyes: Visit 7 (n=1,1,4,0,8)
    0
    0
    0
    9999
    1
        Eyes, ears, nose, throat:Screening (n= 0,1,2,7,11)
    9999
    1
    1
    0
    2
        Eyes, ears, nose, throat: Visit 3 (n= 0,1,3,6,5)
    9999
    0
    1
    0
    1
        Eyes, ears, nose, throat: Visit 4 (n= 0,1,3,7,10)
    9999
    0
    0
    0
    2
        Eyes, ears, nose, throat: Visit 5 (n=0,0,3,6,9)
    9999
    9999
    0
    0
    3
        Eyes, ears, nose, throat: Visit 6 (n=0,0,3,4,6)
    9999
    9999
    2
    0
    1
        Eyes, ears, nose, throat: Visit 7 (n= 0,1,3,7,10)
    9999
    0
    1
    0
    2
        General appearance: Screening (n= 1,2,7,7,19)
    0
    0
    2
    1
    3
        General appearance: Visit 2 (n=1,1,4,0,7)
    0
    0
    1
    9999
    0
        General appearance: Visit 3 (n=1,2,4,6,12)
    0
    0
    1
    0
    1
        General appearance: Visit 4 (n=1,2,7,7,18)
    0
    0
    0
    1
    2
        General appearance: Visit 5 (n=1,1,7,6,17)
    0
    0
    0
    0
    2
        General appearance: Visit 6 (n=1,1,7,4,14)
    0
    1
    0
    0
    1
        General appearance: Visit 7 (n=1,2,7,7,18)
    0
    0
    1
    2
    2
        Head: Screening (n=1,2,7,7,19)
    0
    0
    1
    1
    4
        Head: Visit 3 (n=1,2,4,6,12)
    0
    0
    1
    0
    2
        Head: Visit 4 (n=1,2,7,7,18)
    0
    0
    1
    0
    5
        Head: Visit 5 (n=1,1,7,6,17)
    0
    0
    1
    1
    4
        Head: Visit 6 (n=1,1,7,4,14)
    0
    0
    1
    1
    3
        Head: Visit 7 (n=1,2,7,7,18)
    0
    0
    1
    1
    5
        Heart: Screening (n=1,2,7,7,19)
    0
    0
    1
    1
    0
        Heart: Visit 3 (n=1,2,4,6,12)
    0
    1
    0
    0
    0
        Heart: Visit 4 (n=1,2,7,7,18)
    0
    1
    1
    0
    1
        Heart: Visit 7 (n=1,2,7,7,18)
    0
    1
    0
    0
    2
        Lungs: Screening (n=1,2,7,7,19)
    0
    0
    0
    1
    0
        Lungs: Visit 4 (n=1,2,7,7,18)
    0
    0
    0
    0
    1
        Lungs: Visit 6 (n=1,1,7,4,14)
    0
    0
    0
    0
    1
        Lungs: Visit 7 (n=1,2,7,7,18)
    0
    0
    0
    0
    1
        Neck: Screening (n=1,2,7,7,19)
    0
    1
    1
    1
    2
        Neck: Visit 4 (n=1,2,7,5,18)
    0
    0
    0
    0
    1
        Neurological: Screening (n=1,2,7,7,19)
    0
    0
    2
    0
    0
        Neurological: Visit 2 (n=1,1,4,0,7)
    0
    0
    1
    9999
    0
        Neurological: Visit 3 (n=1,2,4,6,12)
    0
    0
    1
    0
    0
        Neurological: Visit 4 (n=1,2,7,6,18)
    0
    0
    0
    0
    1
        Neurological: Visit 5 (n=1,1,7,6,17)
    0
    0
    0
    0
    1
        Neurological: Visit 7 (n=1,2,7,7,18)
    0
    1
    0
    0
    0
        Nose: Screening (n=1,1,5,0,8)
    0
    0
    1
    9999
    0
        Nose: Visit 2 (n=1,1,3,0,5)
    0
    0
    1
    9999
    0
        Skin: Screening (n=1,2,7,7,19)
    1
    1
    1
    3
    5
        Skin: Visit 2 (n=1,1,4,0,7)
    1
    0
    0
    9999
    1
        Skin: Visit 3 (n=1,2,4,6,12)
    1
    1
    1
    1
    3
        Skin: Visit 4 (n=1,2,7,7,18)
    0
    1
    2
    2
    6
        Skin: Visit 5 (n=1,1,7,6,17)
    0
    0
    2
    2
    7
        Skin: Visit 6 (n=1,1,7,4,14)
    0
    0
    0
    2
    5
        Skin: Visit 7 (n=1,2,7,7,18)
    0
    1
    1
    3
    4
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of Major Bleeding Event 

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    End point title
    		 Time to First Occurrence of Major Bleeding Event 
    End point description
    Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the subject’s underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal). The safety analysis set included all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    End point values
    		 Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Number of subjects analysed
    0 [5]
    Units: days
        median (confidence interval 95%)
    ( to )
    Notes
    [5] - Median and 95% CI was not estimable due to the low number of subjects who had bleeding episodes.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase

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    End point title
    		 Percentage of Subjects Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase [6]
    End point description
    Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of subjects who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this endpoint. PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, “n” signifies number of subjects analysed at specific time points. Data for this endpoint was not planned to be collected and analysed for age group of >=0 to <8 weeks.
    End point type
    Secondary
    End point timeframe
    Day 30, Day 60, Day 90 in follow up phase
    Notes
    [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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 30 (n=1,5,6,15)
    100.0 (2.50 to 100.0)
    100.0 (47.82 to 100.0)
    33.3 (4.33 to 77.72)
    93.3 (68.05 to 99.83)
        Day 60 (n= 1,5,4,11)
    100.0 (2.50 to 100.0)
    100.0 (47.82 to 100.0)
    75.0 (19.41 to 99.37)
    81.8 (48.22 to 97.72)
        Day 90 (n= 1,4,2,11)
    100.0 (2.50 to 100.0)
    100.0 (39.76 to 100.0)
    50.0 (1.26 to 98.74)
    72.7 (39.03 to 93.98)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase

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    End point title
    		 Percentage of Subjects With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase [7]
    End point description
    Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of subjects who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this endpoint. Here, “n” signifies the number of subjects analysed at specific time points. The PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
    End point type
    Secondary
    End point timeframe
    Day 30, Day 60, Day 90 in follow-up phase
    Notes
    [7] - 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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 30 (n= 1,5,6,15)
    0 (0.00 to 97.50)
    0 (0.00 to 52.18)
    66.7 (22.28 to 95.67)
    6.7 (0.17 to 31.95)
        Day 60 (n= 1,5,4,11)
    0 (0.00 to 97.50)
    0 (0.00 to 52.18)
    25.0 (0.63 to 80.59)
    18.2 (2.28 to 51.78)
        Day 90 (n= 1,4,2,11)
    0 (0.00 to 97.50)
    0 (0.00 to 60.24)
    50.0 (1.26 to 98.74)
    27.3 (6.02 to 60.97)
    No statistical analyses for this end point

    Secondary: Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels

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    End point title
    		 Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels [8]
    End point description
    Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported. The PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, “n” signifies number of subjects analysed at specific time points. Data for this endpoint was not planned to be collected and analysed for age group of >=0 to <8 weeks.
    End point type
    Secondary
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    Notes
    [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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: IU/kg
        arithmetic mean (standard deviation)
    207.50 ± 8.485
    141.85 ± 23.550
    132.40 ± 12.934
    115.06 ± 17.164
    No statistical analyses for this end point

    Secondary: Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels

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    End point title
    		 Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels [9]
    End point description
    Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported. PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this endpoint was not planned to be collected and analysed for age group of >=0 to <8 weeks.
    End point type
    Secondary
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    Notes
    [9] - 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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: days
        median (full range (min-max))
    4.5 (4 to 5)
    3.0 (1 to 7)
    2.0 (1 to 3)
    2.0 (1 to 4)
    No statistical analyses for this end point

    Secondary: Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels

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    End point title
    		 Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels [10]
    End point description
    During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported. PD analysis set included all subjects who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this endpoint was not planned to be collected and analysed for age group of >=0 to <8 weeks.
    End point type
    Secondary
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    Notes
    [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: Justification: Descriptive analysis was planned to be reported for arms Dalteparin Sodium: Group 2 (>=8 week to <2 year), Group 3 (>=2 year to <8 year), Group 4 (>=8 year to <12 year) and Group 5 (>=12 year to <19 year
    End point values
    		 Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Number of subjects analysed
    2
    8
    7
    17
    Units: dose adjustment
        median (full range (min-max))
    3.5 (3 to 4)
    0.5 (0 to 2)
    0.0 (0 to 1)
    0.0 (0 to 2)
    No statistical analyses for this end point

    Other pre-specified: Total Body Clearance of Dalteparin

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    End point title
    		 Total Body Clearance of Dalteparin
    End point description
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. Data not reported for the endpoint, since the PK data was collected and analysed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
    End point type
    Other pre-specified
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    End point values
    		 Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Number of subjects analysed
    0 [11]
    Units: milliliter per hour
    Notes
    [11] - Data was not reported for the endpoint.
    No statistical analyses for this end point

    Other pre-specified: Volume of Distribution of Dalteparin

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    End point title
    		 Volume of Distribution of Dalteparin
    End point description
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Data not reported for the endpoint, since the PK data was collected and analysed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
    End point type
    Other pre-specified
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    End point values
    		 Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Number of subjects analysed
    0 [12]
    Units: milliliter
    Notes
    [12] - Data was not reported for the endpoint.
    No statistical analyses for this end point

    Other pre-specified: Absorption Rate Constant (Ka) of Dalteparin

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    End point title
    		 Absorption Rate Constant (Ka) of Dalteparin
    End point description
    Data not reported for the endpoint, since the PK data was collected and analysed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
    End point type
    Other pre-specified
    End point timeframe
    4 hours post-dose at each Day 1 to 7 in dose adjustment phase
    End point values
    		 Dalteparin Sodium: All Subjects (>= 0 to < 19 years)
    Number of subjects analysed
    0 [13]
    Units: 1/hour (hr)
    Notes
    [13] - Data was not reported for the endpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after the last dose of study drug (up to Day 132)
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v21.0
    Reporting groups
    Reporting group title
    Dalteparin Sodium: Group 1 (>=0 to <8 Week)
    Reporting group description
    		 Subjects aged >=0 to <8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 2 (>=8 week to <2 year)
    Reporting group description
    		 Subjects aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 3 (>=2 year to <8 year)
    Reporting group description
    		 Subjects aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 4 (>=8 year to <12 year)
    Reporting group description
    		 Subjects aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Reporting group title
    Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Reporting group description
    		 Subjects aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Subjects were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Subjects were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).

    Serious adverse events
    		 Dalteparin Sodium: Group 1 (>=0 to <8 Week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 2 (100.00%)
    3 / 8 (37.50%)
    3 / 7 (42.86%)
    13 / 20 (65.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure like phenomena
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal haematoma
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    5 / 20 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dalteparin Sodium: Group 1 (>=0 to <8 Week) Dalteparin Sodium: Group 2 (>=8 week to <2 year) Dalteparin Sodium: Group 3 (>=2 year to <8 year) Dalteparin Sodium: Group 4 (>=8 year to <12 year) Dalteparin Sodium: Group 5 (>=12 year to <19 year)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 2 (100.00%)
    7 / 8 (87.50%)
    7 / 7 (100.00%)
    16 / 20 (80.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Haematoma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    1
    0
    2
    Vein disorder
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Catheter site bruise
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Catheter site haematoma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Catheter site pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Gait disturbance
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infusion site bruising
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Infusion site haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site bruising
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    2 / 8 (25.00%)
    4 / 7 (57.14%)
    8 / 20 (40.00%)
         occurrences all number
    0
    1
    3
    23
    14
    Injection site haematoma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Injection site haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    2
    1
    Injection site mass
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site nodule
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Injection site pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    4 / 20 (20.00%)
         occurrences all number
    0
    0
    0
    0
    5
    Localised oedema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Mucosal haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    1
    2
    2
    Nodule
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    2
    1
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    2 / 8 (25.00%)
    2 / 7 (28.57%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    3
    5
    2
    Swelling
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Catheter site inflammation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    3
    Hypocomplementaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Vulvovaginal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    3
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    1
    0
    9
    Haemoptysis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    4 / 20 (20.00%)
         occurrences all number
    0
    0
    1
    1
    5
    Pharyngeal erythema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pulmonary oedema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Sinus disorder
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tachypnoea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Mental disorder
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    1
    2
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    1
    0
    0
    2
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    4
    2
    Aspergillus test positive
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood calcium increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood urea increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Haematocrit decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    16
    2
    Hepatitis A virus test positive
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    International normalised ratio increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    3
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    9
    1
    Platelet count increased
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Transaminases increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    Weight decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    0
    2
    White blood cell count decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    8
    1
    Injury, poisoning and procedural complications
    Bone contusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    2 / 7 (28.57%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    1
    3
    6
    Fall
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Laceration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Refractoriness to platelet transfusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    2 / 8 (25.00%)
    2 / 7 (28.57%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    3
    2
    0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    2 / 7 (28.57%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    3
    2
    Hypoaesthesia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neuralgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    3 / 8 (37.50%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    1
    4
    1
    3
    Coagulopathy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    1
    0
    0
    4
    Pancytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    2
    0
    3
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Eye swelling
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Photophobia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Ascites
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Chapped lips
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Colitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 8 (37.50%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    3
    1
    2
    Dry mouth
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Erosive oesophagitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Haematemesis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Haematochezia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Intestinal dilatation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lip dry
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lip haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    2 / 8 (25.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    Oesophageal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Perianal erythema
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    1
    1
    2
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 2 (100.00%)
    1 / 8 (12.50%)
    2 / 7 (28.57%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    1
    2
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Acanthosis nigricans
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    1
    1
    2
    Dermatitis contact
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Eczema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Petechiae
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash macular
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Red man syndrome
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin discolouration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin disorder
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin induration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Urticaria contact
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Leukocyturia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    1
    2
    Back pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemarthrosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    1
    2
    Pain in jaw
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bacterial infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Bacteriuria
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Genitourinary tract infection
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infusion site cellulitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Pharyngitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sinusitis bacteria
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Stoma site cellulitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Vaginal infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Viral diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fluid overload
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    6
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    1
    3
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    5
    2
    Hypomagnesaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    8
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Magnesium deficiency
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2008
    1. Clarified the timing of dose adjustments was to be within 12 to 30 hours if the target therapeutic range was not achieved. 2. Clarified the definition of a major bleeding event. 3. Updated the exclusion criteria to remove overt bleeding deemed by the investigator to necessitate discontinuation of study medication. 4. Clarified guidelines for subject withdrawal from the study due to an elevated platelet count to be consistent with the standard of care. 5. Removed glucose tolerance test from list of clinical chemistry assessments.
    20 Feb 2009
    1. Refined the age groups to the following: 0 to <8 weeks (newborns); >=8 weeks to <1 year (infants); >=1 year to <6 years (preschool); >=6 years to <13 years (school); >=13 years to <19 years. 2. Removed the first-dose-only requirement for daily anti-Xa level measurements at 4 hours postdose during the Dose Adjustment Phase. 3. Removed the requirement to receive at least 5 doses after achieving the target therapeutic range before entering the PD Phase. 4. Updated the exclusion criteria to allow newborns with a creatinine clearance less than 60 mL/min. 5. Updated the exclusion criteria to exclude subjects with uncontrolled hypertension characterized by sustained systolic or diastolic blood pressure greater than the 99th percentile of age- and height-related norms. 6. Updated the exclusion criteria to allow subjects with common fungal infections that would not interfere with the study. 7. Updated the exclusion criteria to allow subjects presently or previously, within 30 days, enrolled in a study evaluating erwinia asparaginase. 8. Updated to allow for redrawing of PD samples for active subjects any time prior to the last study visit. 9. Added direction regarding the management of subjects with platelet counts below 50,000/mm3. 10. Added direction regarding procedures that required interruption of study treatment.
    15 Sep 2010
    1. The determination of PD profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and VTE was updated to a primary objective rather than a secondary objective. 2. Updated the target enrollment to a total of 50 subjects who completed the PD Phase. 3. Revised the inclusion criteria to simplify the definition for cancer/malignancy, specify the appropriate age range, and include informed consent. 4. Updated the exclusion criteria for clarification, primarily investigator determination of bleeding risk and clarity regarding clotting disorders. 5. Updated dosing windows to every 12 hours for clarification. 6. Added details to the definition for treatment discontinuation and treatment according to the standard of care. Also added guidance regarding subjects that experienced renal impairment. 7. Added a description of dalteparin dose adjustments for subjects with renal dysfunction.
    01 Sep 2011
    1. Updated exclusion criteria to allow subjects participating in other studies to be eligible for this study. 2. Removed the Day 90 imaging requirement for subjects with clot resolution prior to Day 90. 3. Allowed for the first anti-Xa blood draw to be after the first, second, or third study drug dose. 4. Changed the 15-hour washout period to greater than 12 hours for subjects switching from LMWH to Fragmin.
    21 Apr 2015
    Safety sections were updated per Pfizer safety reporting processes and procedures, and other relevant sections per Pfizer, Inc. processes and procedures.
    18 Nov 2015
    The primary purpose of this Pfizer amendment was to include protocol modifications endorsed by the FDA in a Type C Meeting conducted on 05 November 2015, including updates to the age cohort groups, inclusion of all subjects with VTE
    18 Oct 2016
    The Schwartz Method and Revised Schwartz Method for creatinine clearance calculations were added, as well as other minor changes.
    27 Sep 2017
    The primary purpose of this letter was to clarify the starting dose and the window for the baseline anti-Xa and anti-IIa sample.

    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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