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    Clinical Trial Results:
    A long-term, multi-centre, randomised, controlled, double-blind, parallel-group trial, investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational age.

    Summary
    EudraCT number
    		 2017-000914-47
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2018
    First version publication date
    08 Feb 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GHLIQUID-1517
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00184717
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Japanese trial Number: JapicCTI-050132
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allè, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    31 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the long-term efficacy as assessed by change in height standard deviation score (SDS) for chronological age (CA) (delta height SDS for CA) after treatment in subjects with short stature born small for gestational age (SGA), comparing two doses of NN-220 (0.033 mg/kg/day and 0.067 mg/kg/day).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, MHW Ordinance on GCP(MHW Ordinance No. 28; 27 March 1997) and the applicable relevant regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    17 Aug 2004
    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: 98
    Worldwide total number of subjects
    98
    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)
    98
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial was conducted at 44 sites in Japan.

    Pre-assignment
    Screening details
    		 Subjects completed the main period (GHLiquid 1516) offered to continue in the extension period.(GHLIQUID 1517).

    Period 1
    Period 1 title
    Main Period (GHLIQUID-1516)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Prior to randomisation and blinding , the trial products (NN220 5 mg/1.5mL and 10 mg/1.5mL) were confirmed to be visibly indistinguishable. The products (put in small and large boxes) were then assigned a randomisation number and blinded by the responsible person for randomisation. The trial products were injected using Nordipen 5 to maintain blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 0.033 mg/NN-220
    Arm description
    		 In the 104-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c (under the skin) injected at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The NN-220 was injected subcutaneously using Growth Hormone injection device (NordiPen®5) and PenNeedle®, or in combination with an injection supportive device (NordiPenMate®) in a daily regimen at bedtime. The stated dose/day of the trial products for each subject was determined based on the subject’s body weight at each visit.

    Arm title
    		 0.067 mg/NN-220
    Arm description
    		 In the 104-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The NN-220 was injected subcutaneously using Growth Hormone injection device (NordiPen®5) and PenNeedle®, or in combination with an injection supportive device (NordiPenMate®) in a daily regimen at bedtime. The stated dose/day of the trial products for each subject was determined based on the subject’s body weight at each visit.

    Arm title
    		 No treatment
    Arm description
    		 No somatropin (NN-220) treatment was given in the 52-week main period. Subjects were re-randomized to receive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		0.033 mg/NN-220 0.067 mg/NN-220 No treatment
    Started
    39
    38
    21
    Exposed to trial drug
    38
    38
    21
    Completed
    36
    36
    20
    Not completed
    3
    2
    1
         Non completed
    3
    2
    1
    Period 2
    Period 2 title
    Extension Period (GHLIQUID -1517)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The subjects in the no treatment arm were randomized to receive 0.033mg or 0.067mg in the extension period. Prior to randomisation and blinding, the trial products (NN- 220 5mg/1.5mL and 10 mg/ 1.5 mL) were confirmed to be visibly indistinguishable. The products (put in small and large boxes) were then assigned a randomisation number and blinded by the responsible person for randomisation. The trial products were injected using Nordipen 5 to maintain blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 0.033 mg/NN-220
    Arm description
    		 In the 104-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c (under the skin) injected at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The NN-220 was injected subcutaneously using Growth Hormone injection device (NordiPen®5) and PenNeedle®, or in combination with an injection supportive device (NordiPenMate®) in a daily regimen at bedtime. The stated dose/day of the trial products for each subject was determined based on the subject’s body weight at each visit.

    Arm title
    		 0.067 mg/NN-220
    Arm description
    		 In the 104-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The NN-220 was injected subcutaneously using Growth Hormone injection device (NordiPen®5) and PenNeedle®, or in combination with an injection supportive device (NordiPenMate®) in a daily regimen at bedtime. The stated dose/day of the trial products for each subject was determined based on the subject’s body weight at each visit.

    Arm title
    		 No treatment ->0.033 mg
    Arm description
    		 In the 208- week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The NN-220 was injected subcutaneously using GH injection device (NordiPen®5) and PenNeedle®, or in combination with an injection supportive device (NordiPenMate®) in a daily regimen at bedtime. The stated dose/day of the trial products for each subject was determined based on the subject’s body weight at each visit.

    Arm title
    		 No treatment ->0.067 mg
    Arm description
    		 In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The NN-220 was injected subcutaneously using Growth Hormone injection device (NordiPen®5) and PenNeedle®, or in combination with an injection supportive device (NordiPenMate®) in a daily regimen at bedtime. The stated dose/day of the trial products for each subject was determined based on the subject’s body weight at each visit.

    Number of subjects in period 2 [1]
    		0.033 mg/NN-220 0.067 mg/NN-220 No treatment ->0.033 mg No treatment ->0.067 mg
    Started
    33
    33
    10
    10
    Completed
    23
    27
    7
    5
    Not completed
    10
    6
    3
    5
         Non completers
    10
    6
    3
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 92 subjects completed GHLiquid 1516. Of these subjects, all in the NN-220 treatment group of GHLiquid 1516, 6 subjects did not participate in GHLiquid 1517.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    0.033 mg/NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c (under the skin) injected at bedtime.

    Reporting group title
    0.067 mg/NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime.

    Reporting group title
    No treatment
    Reporting group description
    		 No somatropin (NN-220) treatment was given in the 52-week main period. Subjects were re-randomized to receive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period.

    Reporting group values
    		 0.033 mg/NN-220 0.067 mg/NN-220 No treatment Total
    Number of subjects
    		 39 38 21 98
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 33 34 15 82
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
        Unknown
    		 6 4 6 16
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.38 ± 1.36 5.15 ± 1.2 5.09 ± 1.37 -
    Gender Categorical
    Units: Subjects
        Female
    		 11 14 8 33
        Male
    		 22 20 7 49
        Unknown
    		 6 4 6 16
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 33 34 15 82
        Unknown
    		 6 4 6 16
    Race
    Units: Subjects
        Asian
    		 33 34 15 82
        Unknown
    		 6 4 6 16
    Region of enrolment
    Units: Subjects
        Japan
    		 33 34 15 82
        Unknown
    		 6 4 6 16
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 95.68 ± 8.46 94.57 ± 7.28 94.42 ± 8.48 -
    Body weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 13.24 ± 2.61 12.62 ± 1.81 12.47 ± 2.93 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    0.033 mg/NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c (under the skin) injected at bedtime.

    Reporting group title
    0.067 mg/NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime.

    Reporting group title
    No treatment
    Reporting group description
    		 No somatropin (NN-220) treatment was given in the 52-week main period. Subjects were re-randomized to receive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period.
    Reporting group title
    0.033 mg/NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c (under the skin) injected at bedtime.

    Reporting group title
    0.067 mg/NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime.

    Reporting group title
    No treatment ->0.033 mg
    Reporting group description
    		 In the 208- week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period.

    Reporting group title
    No treatment ->0.067 mg
    Reporting group description
    		 In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period.

    Primary: Change in height standard deviation scores (SDS) for chronological age (CA) at week 260-subjects received NN220 treatment for 5 years

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    End point title
    		 Change in height standard deviation scores (SDS) for chronological age (CA) at week 260-subjects received NN220 treatment for 5 years [1]
    End point description
    Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit. The FAS consisted of all subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity.
    End point type
    Primary
    End point timeframe
    week 0, week 260
    Notes
    [1] - 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: The data is presented only for the treatment arms with NN-220 in GHLiquid-1516. The baseline period had an arm with no treatment for 52 weeks; hence no data is presented for this arm.
    End point values
    		 0.033 mg/NN-220 0.067 mg/NN-220
    Number of subjects analysed
    28
    29
    Units: Standard deviations score
    arithmetic mean (standard deviation)
        week 0
    -2.9988 ± 0.6336
    -2.8304 ± 0.6244
        Change from baseline to week 260
    1.2233 ± 0.5183
    2.0113 ± 0.6432
    Statistical analysis title
    		 Change in Height SDS for CA at 260 weeks
    Statistical analysis description
    The analysis was based on an analysis of variance (ANOVA) model including dose group as a fixed effect and baseline height SDS for CA and age at start of treatment as covariates. Point estimate was derived as 0.067 mg/NN-220 minus 0.033 mg/NN-220.
    Comparison groups
    0.033 mg/NN-220 v 0.067 mg/NN-220
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8208
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5093
         upper limit
    		 1.1322

    Primary: Change in height Standard Deviation Score (SDS) for chronological age (CA) at week 208-subjects received NN220 treatment for 4 years

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    End point title
    		 Change in height Standard Deviation Score (SDS) for chronological age (CA) at week 208-subjects received NN220 treatment for 4 years
    End point description
    Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit. The FAS consisted of all subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity.
    End point type
    Primary
    End point timeframe
    week 0, week 208
    End point values
    		 No treatment ->0.033 mg No treatment ->0.067 mg
    Number of subjects analysed
    7
    8
    Units: Standard Deviation Score
    arithmetic mean (standard deviation)
        Week 0
    -2.9603 ± 0.6689
    -2.7481 ± 0.3524
        Change from baseline to Week 208
    1.0117 ± 0.4678
    1.9921 ± 0.6670
    Statistical analysis title
    		 Change in Height SDS for CA at 208 weeks
    Statistical analysis description
    The analysis was based on an ANOVA model including dose group as a fixed effect and baseline height SDS for CA and age at start of treatment as covariates. Point estimate was derived as 0.067 mg/NN-220 minus 0.033 mg/NN-220.
    Comparison groups
    No treatment ->0.033 mg v No treatment ->0.067 mg
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8154
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0341
         upper limit
    		 1.5966

    Secondary: Yearly Height velocity SDS for chronological age-subjects received NN220 treatment for 5 years

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    End point title
    		 Yearly Height velocity SDS for chronological age-subjects received NN220 treatment for 5 years [2]
    End point description
    Yearly Height velocity SDS for chronological age were summarised and graphically presented. The FAS consisted of all subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity.
    End point type
    Secondary
    End point timeframe
    weeks 0-260
    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: The data is presented only for the treatment arms with NN-220 in GHLiquid-1516. The baseline period had an arm with no treatment for 52 weeks; hence no data is presented for this arm.
    End point values
    		 0.033 mg/NN-220 0.067 mg/NN-220
    Number of subjects analysed
    31
    34
    Units: Standard Deviation Score
    arithmetic mean (standard deviation)
        Baseline, N= 31, 34
    -1.6299 ± 0.9738
    -2.0303 ± 1.4527
        Week 52, N=29, 34
    2.4717 ± 1.9848
    4.7875 ± 1.9365
        Week 104, N=29, 32
    1.1344 ± 1.2782
    2.8877 ± 1.1272
        Week 156, N=25, 29
    0.8015 ± 1.0583
    2.1641 ± 1.5929
        Week 208, N=25, 28
    0.3991 ± 1.3006
    1.4724 ± 1.8696
        Week 260, N=23, 27
    0.4612 ± 2.1558
    0.7973 ± 2.1822
    No statistical analyses for this end point

    Secondary: Yearly Height velocity SDS for chronological age-subjects received NN220 treatment for 4 years

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    End point title
    		 Yearly Height velocity SDS for chronological age-subjects received NN220 treatment for 4 years
    End point description
    Yearly Height velocity SDS for chronological age were summarised and graphically presented. The FAS consisted of all subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity.
    End point type
    Secondary
    End point timeframe
    Week 0-280
    End point values
    		 No treatment ->0.033 mg No treatment ->0.067 mg
    Number of subjects analysed
    7
    8
    Units: Standard Deviation Score
    arithmetic mean (standard deviation)
        Baseline, N=7, 8
    0.073 ± 1.5681
    -1.356 ± 0.708
        Week 52, N=7, 8
    2.1677 ± 0.61
    5.9303 ± 1.2096
        Week 104, N=6, 7
    1.5268 ± 1.1715
    3.3979 ± 1.0542
        Week 156, N=6, 7
    1.7617 ± 2.0956
    2.3539 ± 1.3149
        Week 208, N=6, 6
    0.5475 ± 1.6055
    2.199 ± 1.5973
    No statistical analyses for this end point

    Secondary: Change in bone age (left hand X-Ray) at Week 260 - subjects received NN220 treatment for 5 years

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    End point title
    		 Change in bone age (left hand X-Ray) at Week 260 - subjects received NN220 treatment for 5 years [3]
    End point description
    Bone age is measured as years and months (displayed as xx.x years). The FAS consisted of all subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity.
    End point type
    Secondary
    End point timeframe
    Week 0, week 260
    Notes
    [3] - 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: The data is presented only for the treatment arms with NN-220 in GHLiquid-1516. The baseline period had an arm with no treatment for 52 weeks; hence no data is presented for this arm.
    End point values
    		 0.033 mg/NN-220 0.067 mg/NN-220
    Number of subjects analysed
    21
    26
    Units: Years
        arithmetic mean (standard deviation)
    5.79 ± 1.05
    7.15 ± 1.05
    No statistical analyses for this end point

    Secondary: Change in bone age (left hand X-Ray) at Week 208 - subjects received NN220 treatment for 4 years

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    End point title
    		 Change in bone age (left hand X-Ray) at Week 208 - subjects received NN220 treatment for 4 years
    End point description
    Bone age is measured as years and months (displayed as xx.x years). The FAS consisted of all subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity.
    End point type
    Secondary
    End point timeframe
    Week 0, week 208
    End point values
    		 No treatment ->0.033 mg No treatment ->0.067 mg
    Number of subjects analysed
    5
    6
    Units: Years
        arithmetic mean (standard deviation)
    6.54 ± 1.26
    5.6 ± 1.68
    No statistical analyses for this end point

    Secondary: Adverse events - subjects received NN220 treatment for 5 years

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    End point title
    		 Adverse events - subjects received NN220 treatment for 5 years [4]
    End point description
    Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly. The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity
    End point type
    Secondary
    End point timeframe
    Week 0-260
    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: The data is presented only for the treatment arms with NN-220 in GHLiquid-1516. The baseline period had an arm with no treatment for 52 weeks; hence no data is presented for this arm.
    End point values
    		 0.033 mg/NN-220 0.067 mg/NN-220
    Number of subjects analysed
    31
    34
    Units: Subjects
        AEs
    31
    34
        AEs possibly/probably related
    9
    16
        SAEs
    12
    11
    No statistical analyses for this end point

    Secondary: Adverse events - subjects received N220 treatment for 4 years

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    End point title
    		 Adverse events - subjects received N220 treatment for 4 years
    End point description
    Occurrence of Adverse Events during treatment period, occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or occurrence of congenital anomaly. The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLiquid-1516 or GHLiquid-1517, except subjects with GCP nonconformity
    End point type
    Secondary
    End point timeframe
    Weeks 0-208
    End point values
    		 No treatment ->0.033 mg No treatment ->0.067 mg
    Number of subjects analysed
    7
    8
    Units: Subjects
        AEs
    7
    8
        AEs possibly /probably related
    1
    3
        SAEs
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events were collected from Aug 2004 to Dec 2009.
    Adverse event reporting additional description
    The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    0.033 mg / NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c (under the skin) injected at bedtime.

    Reporting group title
    0.067 mg / NN-220
    Reporting group description
    		 In the 104-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 156-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime.

    Reporting group title
    0.033 mg / No treatment
    Reporting group description
    		 In the 208- week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

    Reporting group title
    0.067 mg / No treatment
    Reporting group description
    		 In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period.

    Serious adverse events
    		 0.033 mg / NN-220 0.067 mg / NN-220 0.033 mg / No treatment 0.067 mg / No treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 31 (38.71%)
    11 / 34 (32.35%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sebaceous naevus
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Strabismus
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular retraction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillar disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitiligo
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    IgA nephropathy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Torticollis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mumps
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis mycoplasmal
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 0.033 mg / NN-220 0.067 mg / NN-220 0.033 mg / No treatment 0.067 mg / No treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 31 (100.00%)
    34 / 34 (100.00%)
    7 / 7 (100.00%)
    8 / 8 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibromatosis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Skin papilloma
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    4
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    5
    Pyrexia
         subjects affected / exposed
    10 / 31 (32.26%)
    10 / 34 (29.41%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    17
    23
    0
    1
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 34 (2.94%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    7 / 31 (22.58%)
    5 / 34 (14.71%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
         occurrences all number
    11
    26
    1
    2
    Cough
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 34 (11.76%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    2
    7
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    0
    4
    Oropharyngeal pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    8 / 31 (25.81%)
    8 / 34 (23.53%)
    1 / 7 (14.29%)
    5 / 8 (62.50%)
         occurrences all number
    10
    21
    1
    6
    Rhinitis seasonal
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    0
    6
    Rhinorrhoea
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    5
    4
    0
    4
    Tonsillar disorder
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    22 / 31 (70.97%)
    22 / 34 (64.71%)
    5 / 7 (71.43%)
    6 / 8 (75.00%)
         occurrences all number
    147
    94
    14
    32
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 34 (2.94%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    2
    1
    Antibody test positive
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    2
    1
    Blood urine present
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Chillblains
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Contusion
         subjects affected / exposed
    1 / 31 (3.23%)
    6 / 34 (17.65%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    1
    7
    0
    2
    Excoriation
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Hand fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Joint sprain
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 34 (8.82%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    3
    1
    1
    Thermal burn
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Febrile convulsion
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Headache
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 34 (11.76%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    4
    10
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Lymphadenitis
         subjects affected / exposed
    1 / 31 (3.23%)
    5 / 34 (14.71%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    5
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Motion sickness
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    5
    2
    0
    0
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    4 / 31 (12.90%)
    7 / 34 (20.59%)
    0 / 7 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    4
    13
    0
    4
    Conjunctivitis allergic
         subjects affected / exposed
    3 / 31 (9.68%)
    5 / 34 (14.71%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    5
    7
    0
    3
    Eye pain
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Eyelid oedema
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Myopia
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Strabismus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    3
    0
    0
    Constipation
         subjects affected / exposed
    6 / 31 (19.35%)
    5 / 34 (14.71%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    8
    7
    0
    3
    Dental caries
         subjects affected / exposed
    2 / 31 (6.45%)
    6 / 34 (17.65%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    7
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    5
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Enterocolitis
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    8
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 31 (3.23%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    4
    0
    1
    Toothache
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    2
    Vomiting
         subjects affected / exposed
    7 / 31 (22.58%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    7
    6
    0
    2
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    2
    0
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    4
    0
    2
    Dermatitis atopic
         subjects affected / exposed
    3 / 31 (9.68%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    4
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    1
    1
    Dry skin
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Eczema
         subjects affected / exposed
    9 / 31 (29.03%)
    10 / 34 (29.41%)
    2 / 7 (28.57%)
    2 / 8 (25.00%)
         occurrences all number
    14
    24
    2
    2
    Eczema asteatotic
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Rash
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    1
    Urticaria
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 34 (8.82%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    5
    3
    1
    0
    Xeroderma
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 31 (3.23%)
    6 / 34 (17.65%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    3
    10
    1
    0
    Dactylitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    3 / 31 (9.68%)
    3 / 34 (8.82%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    3
    7
    1
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    8
    0
    2
    Acute tonsillitis
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    11
    0
    0
    Adenoviral conjunctivitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    1
    Adenovirus infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    1
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    5
    5
    0
    2
    Bronchitis
         subjects affected / exposed
    14 / 31 (45.16%)
    15 / 34 (44.12%)
    0 / 7 (0.00%)
    6 / 8 (75.00%)
         occurrences all number
    66
    66
    0
    19
    Chronic sinusitis
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Enteritis infectious
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    0
    1
    Enterobiasis
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Enterocolitis viral
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 34 (8.82%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    3
    0
    2
    Folliculitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    1
    Furuncle
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    10 / 31 (32.26%)
    14 / 34 (41.18%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    18
    25
    0
    2
    Gastroenteritis viral
         subjects affected / exposed
    11 / 31 (35.48%)
    9 / 34 (26.47%)
    0 / 7 (0.00%)
    4 / 8 (50.00%)
         occurrences all number
    20
    14
    0
    8
    Herpes simplex
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Hordeolum
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Impetigo
         subjects affected / exposed
    6 / 31 (19.35%)
    9 / 34 (26.47%)
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    9
    9
    5
    2
    Infection
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    16 / 31 (51.61%)
    25 / 34 (73.53%)
    6 / 7 (85.71%)
    4 / 8 (50.00%)
         occurrences all number
    30
    39
    7
    7
    Lymphadenitis bacterial
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 34 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Molluscum contagiosum
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Mumps
         subjects affected / exposed
    5 / 31 (16.13%)
    6 / 34 (17.65%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    5
    6
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    19 / 31 (61.29%)
    27 / 34 (79.41%)
    6 / 7 (85.71%)
    5 / 8 (62.50%)
         occurrences all number
    66
    212
    38
    20
    Otitis externa
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
         occurrences all number
    2
    2
    1
    2
    Otitis media
         subjects affected / exposed
    7 / 31 (22.58%)
    12 / 34 (35.29%)
    1 / 7 (14.29%)
    3 / 8 (37.50%)
         occurrences all number
    11
    17
    11
    12
    Otitis media acute
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 34 (11.76%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    13
    6
    1
    2
    Parotitis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 34 (2.94%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Pharyngitis
         subjects affected / exposed
    8 / 31 (25.81%)
    14 / 34 (41.18%)
    2 / 7 (28.57%)
    3 / 8 (37.50%)
         occurrences all number
    46
    74
    8
    9
    Pneumonia mycoplasmal
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 34 (2.94%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    5 / 31 (16.13%)
    6 / 34 (17.65%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    9
    9
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 31 (3.23%)
    5 / 34 (14.71%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    9
    1
    9
    Tonsillitis
         subjects affected / exposed
    1 / 31 (3.23%)
    7 / 34 (20.59%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
         occurrences all number
    1
    19
    1
    4
    Varicella
         subjects affected / exposed
    6 / 31 (19.35%)
    4 / 34 (11.76%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    6
    4
    0
    1
    Metabolism and nutrition disorders
    Hyperinsulinaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 34 (5.88%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2004
    Some inadequate descriptions were corrected throughout the protocol.
    29 Jun 2004
    The main purposes of this amendment were: 1.To add one withdrawal criterion ‘Epiphyseal fusion’ based on a trial site’s IRB comment. 2. To add ‘GHLiquid-1517 will be changed to a post marketing clinical trial when the indication for short stature born small for gestational age (SGA) is approved before the completion of this trial.’ 3. To amend subject information/informed consent form according to above protocol changes.
    01 Jun 2005
    1.The description of GCP guidelines was corrected. 2. Obsolete GCP operational guidelines had been referenced in the protocol. As these types of GCP related notifications/amendments or corrections were expected to be released further, the description was amended to read ‘The trial must be conducted in accordance with the Helsinki Declaration, MHW Ordinance on GCP (MHW Ordinance No. 28; 27 March 1997) and the applicable relevant regulations.’
    22 Nov 2005
    1.PenNeedle® 31G, one of auxiliary supplies, was replaced by PenNeedle® due to the discontinuation of selling the product.
    17 Oct 2007
    The main purposes of this amendment were: 1.To include an interim analysis to be performed at a period 1 year shorter than the planned treatment period. 2.To extend the treatment period until NN-220 is approved for SGA indication. In line with the extension of the trial, the second part of the amendment No.2 (the possibility of switching this trial to a post marketing clinical trial) was deleted.
    29 Jun 2009
    The main purpose of this amendment was: 1.To explain that GHLiquid-1517 is switched to a post-marketing clinical trial after NN-220 is approved for SGA indication (from the date of approval and lasting until the final visit) and the post-marketing clinical trial is conducted in conformity to the protocol.

    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.
    All the serious and non-serious AEs were coded using the MedDRA terminology, version 12.1. The coding has been changed to a more current version (at least version 20) in order for the EudraCT system to accept the data for this trial.
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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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