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    Clinical Trial Results:
    Long-Term Study of PNU-180307 For Short Children Born Small for Gestational Age (SGA) Without Epiphyseal Closure (Extension of The Study 307-MET-0021-002)

    Summary
    EudraCT number
    		 2015-004552-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2016
    First version publication date
    12 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GENASG-0021-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    ClinicalTrials.gov_Inquiries@pfizer.com, Pfizer Inc., 1 8007181021, ClinicalTrials.govCallCenter@pfizer.com
    Scientific contact
    ClinicalTrials.gov_Inquiries@pfizer.com, Pfizer Inc., 1 8007181021, ClinicalTrials.govCallCenter@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate safety of long-term administration of PNU-180307 (Genotropin) until a final height is reached in short children born small for gestational age (SGA) without epiphyseal closure
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2002
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    61
    Adolescents (12-17 years)
    0
    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
    		 Before enrolled this study, participants with short stature due to SGA had completed the 1-year(12-month) treatment in previous study.

    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
    		 Dose-Increasing Group
    Arm description
    		 Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Genotropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.067 mg/kg/day

    Arm title
    		 Dose-Remaining Group
    Arm description
    		 Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Genotropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.067 mg/kg/day

    Number of subjects in period 1
    		Dose-Increasing Group Dose-Remaining Group
    Started
    29
    32
    Completed
    15
    15
    Not completed
    14
    17
         Physician decision
    2
    4
         Consent withdrawn by subject
    11
    10
         Adverse event, non-fatal
    -
    1
         Family Matters
    -
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dose-Increasing Group
    Reporting group description
    		 Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day

    Reporting group title
    Dose-Remaining Group
    Reporting group description
    		 Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose

    Reporting group values
    		 Dose-Increasing Group Dose-Remaining Group Total
    Number of subjects
    		 29 32 61
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 29 32 61
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 5.2 ± 1.64 5.4 ± 1.27 -
    Gender, Male/Female
    Units: Participants
        Female
    		 14 14 28
        Male
    		 15 18 33

    End points

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    End points reporting groups
    Reporting group title
    Dose-Increasing Group
    Reporting group description
    		 Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day

    Reporting group title
    Dose-Remaining Group
    Reporting group description
    		 Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose

    Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    End point type
    Primary
    End point timeframe
    Month 12 (at the end of previous study) to 156
    End point values
    		 Dose-Increasing Group Dose-Remaining Group
    Number of subjects analysed
    29
    32
    Units: participant
        AE
    27
    31
        SAE
    10
    5
    Statistical analysis title
    		 The number of participants with adverse event
    Statistical analysis description
    The number of participants with adverse event by treatment group was tabulated by system organ class and by preferred term.
    Comparison groups
    Dose-Increasing Group v Dose-Remaining Group
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Number of participants with AE
    Point estimate
    0
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0

    Secondary: Height Velocity Standard Deviation Score (SDS) for Chronological Age

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    End point title
    		 Height Velocity Standard Deviation Score (SDS) for Chronological Age
    End point description
    Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values of the participants age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
    End point type
    Secondary
    End point timeframe
    Month 12 (at the end of previous study) to 156
    End point values
    		 Dose-Increasing Group Dose-Remaining Group
    Number of subjects analysed
    29
    32
    Units: SDS
    arithmetic mean (standard deviation)
        Month 12-24 (Increasing:n=28, Remaining:n=32)
    2.782 ± 1.978
    2.595 ± 1.731
        Month 24-36 (Increasing:n=26, Remaining:n=28)
    1.812 ± 1.526
    1.696 ± 2.111
        Month 36-48 (Increasing:n=24, Remaining:n=23)
    1.48 ± 1.543
    0.824 ± 1.527
        Month 48-60 (Increasing:n=21, Remaining:n=20)
    -0.041 ± 2.081
    0.48 ± 1.651
        Month 60-72 (Increasing:n=20, Remaining:n=16)
    -0.293 ± 1.585
    -0.046 ± 2.434
        Month 72-84 (Increasing:n=15, Remaining:n=16)
    -0.488 ± 3.117
    -1.511 ± 2.692
        Month 84-96 (Increasing: n=11, Remaining: n=14)
    0.263 ± 1.802
    -0.114 ± 1.964
        Month 96-108 (Increasing:n=9, Remaining:n=8)
    0.521 ± 2.058
    -0.466 ± 2.055
        Month 108-120 (Increasing:n=6, Remaining:n=6)
    -0.668 ± 2.126
    -0.59 ± 2.693
        Month 120-132 (Increasing:n=5, Remaining:n=4)
    -1.08 ± 1.953
    1.173 ± 3.042
        Month 132-144 (Increasing:n=4, Remaining:n=2)
    2.655 ± 4.329
    0.73 ± 2.022
        Month 144-156 (Increasing:n=3, Remaining:n=0)
    3.373 ± 1.995
    0 ± 0
    No statistical analyses for this end point

    Secondary: Height Velocity

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    End point title
    		 Height Velocity
    End point description
    Height velocity is the yearly height gain
    End point type
    Secondary
    End point timeframe
    Month 12 (at the end of previous study) to 156
    End point values
    		 Dose-Increasing Group Dose-Remaining Group
    Number of subjects analysed
    29
    32
    Units: cm/year
    arithmetic mean (standard deviation)
        Month 12-24(Increasing:n=28, Remaining:n=32)
    7.83 ± 1.33
    7.7 ± 1.19
        Month 24-36 (Increasing:n=26, Remaining:n=28)
    6.88 ± 0.94
    6.75 ± 1.52
        Month 36-48 (Increasing:n=24, Remaining:n=23)
    6.68 ± 0.98
    6.08 ± 1.14
        Month 48-60 (Increasing:n=21, Remaining:n=20)
    6.06 ± 1.49
    6.3 ± 1.24
        Month 60-72 (Increasing:n=20, Remaining: n=16)
    6.08 ± 1.45
    6.49 ± 1.37
        Month 72-84 (Increasing:n=15, Remaining:n=16)
    4.89 ± 2.18
    4.88 ± 1.86
        Month 84-96 (Increasing:n=11, Remaining:n=14)
    5.16 ± 1.2
    4.82 ± 2.12
        Month 96-108 (Increasing:n=9, Remaining:n=8)
    5.18 ± 2.16
    5.55 ± 2.42
        Month 108-120 (Increasing:n=6, Remaining:n=6)
    5.72 ± 2.24
    5.03 ± 1.86
        Month 120-132 (Increasing:n=5, Remaining:n=4)
    4.84 ± 1.3
    4.3 ± 1.84
        Month 132-144 (Increasing:n=4, Remaining:n=2)
    4.38 ± 1.1
    2.6 ± 0.14
        Month144-156(Increasing:n=3, Remaining:n=0)
    3.1 ± 1.92
    0 ± 0
    No statistical analyses for this end point

    Secondary: Height SDS for Chronological Age

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    End point title
    		 Height SDS for Chronological Age
    End point description
    Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values on the participant age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
    End point type
    Secondary
    End point timeframe
    Month 12 (at the end of previous study) to 156
    End point values
    		 Dose-Increasing Group Dose-Remaining Group
    Number of subjects analysed
    29
    32
    Units: SDS
    arithmetic mean (standard deviation)
        Month 12 (Increasing:n=29, Remaining:n=32)
    -2.53 ± 0.92
    -2.17 ± 0.96
        Month 24 (Increasing:n=28, Remaining:n=32)
    -2.02 ± 0.97
    -1.7 ± 1.03
        Month 36 (Increasing:n=26, Remaining:n=28)
    -1.8 ± 0.99
    -1.53 ± 1.1
        Month 48 (Increasing:n=24, Remaining:n=23)
    -1.48 ± 1.05
    -1.49 ± 1.15
        Month 60 (Increasing:n=21, Remaining:n=20)
    -1.53 ± 1.06
    -1.44 ± 1.1
        Month 72 (Increasing:n=20, Remaining:n=16)
    -1.56 ± 1.11
    -1.43 ± 1.06
        Month 84 (Increasing:n=15, Remaining:n=16)
    -1.73 ± 1.13
    -1.58 ± 1.17
        Month 96 (Increasing:n=11, Remaining:n=14)
    -1.52 ± 0.89
    -1.87 ± 1.36
        Month 108 (Increasing:n=9, Remaining:n=8)
    -1.52 ± 1.01
    -1.63 ± 1.48
        Month 120 (Increasing:n=6, Remaining:n=6)
    -1.52 ± 1.2
    -1.25 ± 0.59
        Month 132 (Increasing:n=5, Remaining:n=4)
    -1.96 ± 1.11
    -0.98 ± 0.51
        Month 144 (Increasing:n=4, Remaining:n=2)
    -1.73 ± 0.87
    -0.7 ± 0.42
        Month 156 (Increasing:n=3, Remaining:n=0)
    -1.77 ± 0.76
    0 ± 0
    No statistical analyses for this end point

    Secondary: Height Velocity SDS for Bone Age

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    End point title
    		 Height Velocity SDS for Bone Age
    End point description
    To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
    End point type
    Secondary
    End point timeframe
    Month 12 (at the end of previous study) to 156
    End point values
    		 Dose-Increasing Group Dose-Remaining Group
    Number of subjects analysed
    29
    32
    Units: SDS
    arithmetic mean (standard deviation)
        Month 12-24 (Increasing: n=26, Remaining: n=31)
    2.586 ± 2.268
    2.461 ± 1.99
        Month 24-36 (Increasing: n=24, Remaining: n=27)
    1.503 ± 1.83
    1.091 ± 1.852
        Month 36-48 (Increasing: n=22, Remaining: n=22)
    1.196 ± 1.409
    0.51 ± 1.809
        Month 48-60 (Increasing: n=20, Remaining: n=19)
    -0.062 ± 1.775
    0.913 ± 2.146
        Month 60-72 (Increasing: n=16, Remaining: n=14)
    0.281 ± 2.814
    0.949 ± 2.729
        Month 72-84 (Increasing: n=13, Remaining: n=13)
    -1.249 ± 2.558
    0.932 ± 2.545
        Month 84-96 (Increasing: n=10, Remaining: n=13)
    0.804 ± 3.44
    0.286 ± 2.351
        Month 96-108 (Increasing: n=8, Remaining: n=7)
    -0.634 ± 2.419
    -0.223 ± 1.352
        Month 108-120 (Increasing: n=5, Remaining: n=5)
    0.07 ± 4.12
    0.532 ± 1.809
        Month 120-132 (Increasing: n=4, Remaining: n=4)
    1.553 ± 3.019
    2.718 ± 0.864
        Month 132-144 (Increasing: n=3, Remaining: n=2)
    2.31 ± 1.711
    2.185 ± 0.304
        Month 144-156 (Increasing: n=2, Remaining: n=0)
    2.71 ± 2.942
    0 ± 0
    No statistical analyses for this end point

    Secondary: Height SDS for Bone Age

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    End point title
    		 Height SDS for Bone Age
    End point description
    To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
    End point type
    Secondary
    End point timeframe
    Month 12 (at the end of previous study) to 156
    End point values
    		 Dose-Increasing Group Dose-Remaining Group
    Number of subjects analysed
    29
    32
    Units: SDS
    arithmetic mean (standard deviation)
        Month 12 (Increasing: n=27, Remaining: n=31)
    -1.19 ± 1.2
    -0.68 ± 1.54
        Month 24 (Increasing:n=26, Remaining:n=31)
    -1.15 ± 1.15
    -0.88 ± 1.79
        Month 36 (Increasing:n=24, Remaining:n=27)
    -1.2 ± 1.35
    -1.17 ± 1.62
        Month 48 (Increasing:n=22, Remaining:n=22)
    -0.74 ± 1.32
    -1.46 ± 1.01
        Month 60 (Increasing:n=20, Remaining:n=19)
    -1.16 ± 1.21
    -1.8 ± 0.97
        Month 72 (Increasing:n=16, Remaining:n=14)
    -1.78 ± 1.02
    -1.7 ± 0.77
        Month 84 (Increasing:n=13, Remaining:n=13)
    -1.85 ± 1.17
    -2.15 ± 0.92
        Month 96 (Increasing:n=10, Remaining:n=13)
    -1.77 ± 1.12
    -2.27 ± 1.06
        Month 108 (Increasing:n=8, Remaining:n=7)
    -1.41 ± 0.97
    -1.94 ± 1.37
        Month 120 (Increasing:n=5, Remaining:n=5)
    -1.58 ± 1.5
    -1.38 ± 0.98
        Month 132 (Increasing:n=4, Remaining:n=4)
    -2.1 ± 1.21
    -0.98 ± 0.74
        Month 144 (Increasing:n=3, Remaining:n=2)
    -1.4 ± 0.17
    -0.65 ± 0.64
        Month 156 (Increasing:n=2, Remaining:n=0)
    -1.55 ± 0.92
    0 ± 0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Month 12 (at the end of previous study) to 156
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 WHO-ART, 2001(014)
    Dictionary version
    2001 (014)
    Reporting groups
    Reporting group title
    Dose-Remainig Group
    Reporting group description
    		 Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study

    Reporting group title
    Dose-Increasing Group
    Reporting group description
    		 Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day

    Serious adverse events
    		 Dose-Remainig Group Dose-Increasing Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 32 (15.63%)
    10 / 29 (34.48%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    HYPOSPADIAS
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CRYPTORCHISM
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    INFLICTED INJURY
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    DEAFNESS
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    RETINAL DETACHMENT
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROENTERITIS
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    HERNIA INGUINAL
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OVARIAN DISORDER
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HEPATIC FUNCTION ABNORMAL
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PHARYNGITIS
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESP TRACT INFECTION
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASTHMA
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    ADENOID HYPERTROPHY
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    INFECTION VIRAL
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEALING IMPAIRED
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dose-Remainig Group Dose-Increasing Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 32 (96.88%)
    27 / 29 (93.10%)
    General disorders and administration site conditions
    PURPURA
         subjects affected / exposed
    5 / 32 (15.63%)
    6 / 29 (20.69%)
         occurrences all number
    8
    6
    HAEMATOMA
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    ALLERGIC REACTION
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 29 (0.00%)
         occurrences all number
    9
    0
    FEVER
         subjects affected / exposed
    1 / 32 (3.13%)
    11 / 29 (37.93%)
         occurrences all number
    3
    18
    PAIN
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    INFLUENZA-LIKE SYMPTOMS
         subjects affected / exposed
    15 / 32 (46.88%)
    16 / 29 (55.17%)
         occurrences all number
    28
    24
    VARICELLA
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    INFLICTED INJURY
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 29 (6.90%)
         occurrences all number
    5
    2
    MOLLUSCUM CONTAGIOSUM
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    4
    0
    SCOLIOSIS
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    LACERATION
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    Reproductive system and breast disorders
    OVARIAN DISORDER
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    COUGHING
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    PHARYNGITIS
         subjects affected / exposed
    9 / 32 (28.13%)
    7 / 29 (24.14%)
         occurrences all number
    16
    9
    PNEUMONIA
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    RHINITIS
         subjects affected / exposed
    12 / 32 (37.50%)
    8 / 29 (27.59%)
         occurrences all number
    29
    14
    SINUSITIS
         subjects affected / exposed
    4 / 32 (12.50%)
    5 / 29 (17.24%)
         occurrences all number
    6
    6
    UPPER RESP TRACT INFECTION
         subjects affected / exposed
    28 / 32 (87.50%)
    25 / 29 (86.21%)
         occurrences all number
    157
    214
    BRONCHITIS
         subjects affected / exposed
    10 / 32 (31.25%)
    9 / 29 (31.03%)
         occurrences all number
    25
    31
    ASTHMA
         subjects affected / exposed
    6 / 32 (18.75%)
    6 / 29 (20.69%)
         occurrences all number
    34
    20
    Injury, poisoning and procedural complications
    INJECTION SITE BLEEDING
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    STING
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    Congenital, familial and genetic disorders
    SKELETAL MALFORMATION
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    TOOTH MALFORMATION
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Cardiac disorders
    HYPOTENSION POSTURAL
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    3 / 32 (9.38%)
    4 / 29 (13.79%)
         occurrences all number
    4
    5
    Blood and lymphatic system disorders
    EOSINOPHILIA
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 29 (6.90%)
         occurrences all number
    4
    7
    LEUKOCYTOSIS
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 29 (6.90%)
         occurrences all number
    5
    3
    LYMPHADENOPATHY
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    LYMPHOCYTES ATYPICA
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Eye disorders
    CONJUNCTIVITIS
         subjects affected / exposed
    12 / 32 (37.50%)
    8 / 29 (27.59%)
         occurrences all number
    16
    17
    EYE ABNORMALITY
         subjects affected / exposed
    5 / 32 (15.63%)
    4 / 29 (13.79%)
         occurrences all number
    8
    5
    MYOPIA
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    4 / 32 (12.50%)
    3 / 29 (10.34%)
         occurrences all number
    6
    5
    DIARRHOEA
         subjects affected / exposed
    2 / 32 (6.25%)
    5 / 29 (17.24%)
         occurrences all number
    2
    5
    VOMITING
         subjects affected / exposed
    3 / 32 (9.38%)
    5 / 29 (17.24%)
         occurrences all number
    3
    7
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    GASTROENTERITIS
         subjects affected / exposed
    10 / 32 (31.25%)
    17 / 29 (58.62%)
         occurrences all number
    22
    34
    NAUSEA
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    STOMATITIS
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 29 (6.90%)
         occurrences all number
    3
    6
    TOOTH CARIES
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 29 (13.79%)
         occurrences all number
    2
    6
    TOOTH DISORDER
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    ENTEROCOLITIS
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Hepatobiliary disorders
    SGOT INCREASED
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    SGPT INCREASED
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    DERMATITIS
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 29 (10.34%)
         occurrences all number
    3
    12
    ECZEMA
         subjects affected / exposed
    5 / 32 (15.63%)
    6 / 29 (20.69%)
         occurrences all number
    10
    20
    PRURITUS
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    RASH
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 29 (10.34%)
         occurrences all number
    1
    4
    RASH ERYTHEMATOUS
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    RASH PUSTULAR
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 29 (13.79%)
         occurrences all number
    2
    4
    SKIN DISORDER
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    URTICARIA
         subjects affected / exposed
    2 / 32 (6.25%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    DERMATITIS CONTACT
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    OTITIS EXTERNA
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    BULLOUS ERUPTION
         subjects affected / exposed
    2 / 32 (6.25%)
    2 / 29 (6.90%)
         occurrences all number
    2
    3
    VERRUCA
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 29 (3.45%)
         occurrences all number
    5
    1
    Renal and urinary disorders
    URINARY INCONTINENCE
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    HAEMATURIA
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 29 (0.00%)
         occurrences all number
    6
    0
    Endocrine disorders
    SIALOADENITIS
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    5 / 32 (15.63%)
    4 / 29 (13.79%)
         occurrences all number
    7
    4
    Infections and infestations
    INFECTION BACTERIAL
         subjects affected / exposed
    6 / 32 (18.75%)
    4 / 29 (13.79%)
         occurrences all number
    9
    8
    INFECTION VIRAL
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    OTITIS MEDIA
         subjects affected / exposed
    14 / 32 (43.75%)
    13 / 29 (44.83%)
         occurrences all number
    31
    32
    HERPES ZOSTER
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    ABSCESS
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    GLUCOSE TOLERANCE ABNORMAL
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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