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    Clinical Trial Results:
    A phase IV open-label study of predictive markers in growth hormone deficient pre-pubertal children treated with Saizen®

    Summary
    EudraCT number
    		 2015-001569-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Apr 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    27709
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01187550
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Centre Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.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?
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Apr 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the response between GHD children born appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4 weeks of Saizen® therapy
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2007
    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
    China: 214
    Worldwide total number of subjects
    214
    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)
    214
    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
    		 Out of 214 subjects enrolled in the study, 1 subject could not be categorized as appropriate for gestational age (AGA) or small for gestational age (SGA) since weight and height at birth was not available.

    Period 1
    Period 1 title
    Overall Study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Appropriate for gestational age (AGA)
    Arm description
    		 Subjects in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen (r-hGH) was administered subcutaneously at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Arm title
    		 Small for gestational age (SGA)
    Arm description
    		 Subjects in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen (r-hGH) was administered subcutaneously at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Number of subjects in period 1
    		Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Started
    183
    30
    Treated
    175
    30
    Completed
    169
    29
    Not completed
    14
    1
         Randomized but not treated
    8
    -
         Unspecified
    3
    -
         Protocol deviation
    3
    1
    Period 2
    Period 2 title
    Baseline period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Appropriate for gestational age (AGA)
    Arm description
    		 Subjects in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen (r-hGH) was administered subcutaneously at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen (r-hGH) was administered subcutaneously at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Arm title
    		 Small for gestational age (SGA)
    Arm description
    		 Subjects in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen (r-hGH) was administered subcutaneously at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Out of a total of 213 subjects, data for baseline measure (age) was available for only 205 subjects who were treated. Hence, a separate period is created to add baseline data only.
    Number of subjects in period 2 [2]
    		Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Started
    175
    30
    Completed
    169
    29
    Not completed
    6
    1
         Adverse event
    2
    -
         Unspecified
    4
    -
         Lost to follow-up
    -
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 214 subjects enrolled in the study, 1 subject could not be categorized as appropriate for gestational age (AGA) or small for gestational age (SGA) since weight and height at birth was not available.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Appropriate for gestational age (AGA)
    Reporting group description
    		 Subjects in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.

    Reporting group title
    Small for gestational age (SGA)
    Reporting group description
    		 Subjects in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Reporting group values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA) Total
    Number of subjects
    		 175 30 205
    Age categorical
    Units: Subjects
    Age Continuous
    Out of a total of 213 subjects data for baseline measure (age) was available for only 205 subjects who were treated.
    Units: years
        arithmetic mean (standard deviation)
    		 10.52 ( 3.844 ) 9.39 ( 4.349 ) -
    Gender, Male/Female
    Out of a total of 213 subjects, data for baseline measure (gender) was available for only 205 subjects who were treated.
    Units: participants
        Female
    		 46 6 52
        Male
    		 129 24 153

    End points

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    End points reporting groups
    Reporting group title
    Appropriate for gestational age (AGA)
    Reporting group description
    		 Subjects in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.

    Reporting group title
    Small for gestational age (SGA)
    Reporting group description
    		 Subjects in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
    Reporting group title
    Appropriate for gestational age (AGA)
    Reporting group description
    		 Subjects in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.

    Reporting group title
    Small for gestational age (SGA)
    Reporting group description
    		 Subjects in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Primary: Change from baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4

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    End point title
    		 Change from baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4
    End point description
    Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1. The intent-to-treat (ITT) population set included all the subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Number of subjects analysed
    175
    30
    Units: nanogram/millilter (ng/mL)
    arithmetic mean (standard deviation)
        Baseline
    -2.04 ( 2.341 )
    -2.22 ( 2.39 )
        Change at Week 4
    1.38 ( 1.358 )
    0.85 ( 1.257 )
    Statistical analysis title
    		 Statistical analysis: IGF-1SDS
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.194
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change from Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) levels at Week 4

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    End point title
    		 Change from Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) levels at Week 4
    End point description
    ITT population set included all the subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Number of subjects analysed
    175
    30
    Units: microgram/mL (mcg/mL)
    arithmetic mean (standard deviation)
        Baseline
    3.16 ( 1.386 )
    2.57 ( 1.525 )
        Change at Week 4
    0.58 ( 0.869 )
    0.51 ( 0.805 )
    Statistical analysis title
    		 Statistical Analysis :IGFBP-3
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.752
    Method
    		 Wilcoxon rank sum test
    Confidence interval
         level
    		 95%

    Secondary: Change from baseline in fasting glucose at Week 4

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    End point title
    		 Change from baseline in fasting glucose at Week 4
    End point description
    ITT population set included all the subjects who received at least 1 dose of study medication. Here ‘N’ (Number of subjects analyzed) signified those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Number of subjects analysed
    173
    30
    Units: millimole/liter (mmol/L)
    arithmetic mean (standard deviation)
        Baseline
    4.83 ( 0.471 )
    4.46 ( 1.106 )
        Change at Week 4
    0.17 ( 0.578 )
    0.22 ( 0.886 )
    Statistical analysis title
    		 Statistical Analysis :Fasting Glucose
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.71
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change from baseline in fasting insulin at Week 4

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    End point title
    		 Change from baseline in fasting insulin at Week 4
    End point description
    ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Number of subjects analysed
    172
    26
    Units: picomole/L (pmol/L)
    arithmetic mean (standard deviation)
        Baseline
    36.17 ( 74.575 )
    23.58 ( 14.892 )
        Change at Week 4
    10.08 ( 81.674 )
    12.04 ( 32.389 )
    Statistical analysis title
    		 Statistical Analysis: Fasting Insulin
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.265
    Method
    		 Wilcoxon rank sum test
    Confidence interval
         level
    		 95%

    Secondary: Change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) test at Week 4

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    End point title
    		 Change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) test at Week 4
    End point description
    HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5. ITT population set included all the subjects who received at least 1 dose of study medication. Here ‘N’ (Number of subjects analyzed) signified those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Number of subjects analysed
    171
    26
    Units: pmol/L*mmol/L
    arithmetic mean (standard deviation)
        Baseline
    7.91 ( 15.662 )
    5.06 ( 3.29 )
        Change at Week 4
    2.96 ( 18.458 )
    2.48 ( 6.527 )
    Statistical analysis title
    		 Statistical Analysis: HOMA -IR
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.308
    Method
    		 Wilcoxon rank sum test
    Confidence interval
         level
    		 95%

    Secondary: Change from baseline in lipid profile at Week 4

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    End point title
    		 Change from baseline in lipid profile at Week 4
    End point description
    Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated. ITT population set included all the subjects who received at least 1 dose of study medication. Here ‘N’ (Number of subjects analyzed) signified those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 Appropriate for gestational age (AGA) Small for gestational age (SGA)
    Number of subjects analysed
    174
    30
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline (Total Cholesterol)
    4.16 ( 0.752 )
    4.22 ( 0.833 )
        Baseline (HDL-Cholesterol)
    1.56 ( 0.452 )
    1.59 ( 0.443 )
        Baseline (LDL-Cholesterol)
    2.18 ( 0.672 )
    2.19 ( 0.709 )
        Baseline (Triglycerides)
    0.99 ( 0.527 )
    1.02 ( 0.638 )
        Change at Week 4 (Total Cholesterol)
    -0.28 ( 0.601 )
    -0.03 ( 0.612 )
        Change at Week 4 (HDL-Cholesterol)
    -0.1 ( 0.317 )
    0.02 ( 0.329 )
        Change at Week 4 (LDL-Cholesterol)
    -0.24 ( 0.546 )
    0.02 ( 0.502 )
        Change at Week 4 (Triglycerides)
    0.12 ( 0.551 )
    -0.09 ( 0.831 )
    Statistical analysis title
    		 Statistical Analysis :total cholesterol
    Statistical analysis description
    For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.078
    Method
    		 Wilcoxon rank sum test
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis :HDL-cholesterol
    Statistical analysis description
    For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 Wilcoxon rank sum test
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis:LDL-cholesterol
    Statistical analysis description
    For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.041
    Method
    		 Wilcoxon rank sum test
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis:triglycerides
    Statistical analysis description
    For triglycerides: Wilcoxon rank sum test was used to calculate p-value.
    Comparison groups
    Appropriate for gestational age (AGA) v Small for gestational age (SGA)
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.091
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
    Adverse event reporting additional description
    Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for subjects who completed the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Small for gestational age (SGA)
    Reporting group description
    		 Subjects in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.

    Reporting group title
    Appropriate for gestational age (AGA)
    Reporting group description
    		 Subjects in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.

    Serious adverse events
    		 Small for gestational age (SGA) Appropriate for gestational age (AGA)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Small for gestational age (SGA) Appropriate for gestational age (AGA)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
    27 / 175 (15.43%)
    Investigations
    Liver Function Test Abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 175 (1.71%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Hyperhidrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 175 (0.00%)
         occurrences all number
    1
    0
    Injection Site Dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Injection Site Reaction
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 30 (3.33%)
    5 / 175 (2.86%)
         occurrences all number
    1
    5
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Eye Oedema
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Ocular Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 175 (1.14%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal Pain Upper
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 175 (1.14%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 175 (1.14%)
         occurrences all number
    0
    2
    Rhinorrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 175 (1.14%)
         occurrences all number
    0
    2
    Tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 175 (2.29%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Skin Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain In Extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 175 (0.57%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 175 (0.00%)
         occurrences all number
    1
    0

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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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    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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