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    Clinical Trial Results:
    A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once-weekly dosing of NNC0195-0092 with once-weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period

    Summary
    EudraCT number
    2013-002892-16
    Trial protocol
    SE   GB   DE   LT   LV  
    Global end of trial date
    07 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    22 May 2019
    First version publication date
    22 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN8640-4054
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02229851
    WHO universal trial number (UTN)
    U1111-1145-0211
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of once-weekly dosing of somapacitan (NNC0195-0092) compared to placebo after 34 weeks of treatment in AGHD patients
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013) and ICH Good Clinical Practice, including archiving of essential documents (May 1996) and EN ISO 14155 Part 1 and 2 and FDA 21 CFR 312.120.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    31 Oct 2014
    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
    Germany: 8
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    India: 28
    Country: Number of subjects enrolled
    Japan: 46
    Country: Number of subjects enrolled
    Lithuania: 8
    Country: Number of subjects enrolled
    Latvia: 3
    Country: Number of subjects enrolled
    Malaysia: 7
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Romania: 28
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    Australia: 30
    Country: Number of subjects enrolled
    United States: 79
    Country: Number of subjects enrolled
    South Africa: 9
    Worldwide total number of subjects
    300
    EEA total number of subjects
    67
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    259
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 92 sites in 16 countries namely Australia, Germany, India, Japan, Latvia, Lithuania, Malaysia, Poland, Romania, Russian federation, South Africa, Sweden, Turkey, Ukraine, United Kingdom and United States.

    Pre-assignment
    Screening details
    In the main phase of the study, 8 weeks of titration was followed by 26 weeks of fixed dose administration followed by a 1 week washout period. In the open-label extension phase, 8 weeks of titration was followed by 44 weeks of fixed dose administration followed by a 1-week washout period.

    Period 1
    Period 1 title
    Main phase (Double-blind phase)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    For the main part of the trial, somapacitan PDS290 10 mg/1.5 ml and somapacitan PDS290 placebo pens were visually identical and labelled blinded, whereas Norditropin® FlexPro® was open-labelled.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received placebo (somapacitan) for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
    Arm type
    Placebo

    Investigational medicinal product name
    Somapacitan PDS290 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects injected themselves once-weekly subcutaneously (s.c.; under the skin) in the morning (before 10 AM). On site visit days this was extended until 12:00 PM (noon). Injections were taken in the thigh and/or abdomen alternating within these body areas for every injection. Subjects were trained to use the pen injector under the supervision of site staff. Dose adjustments were allowed during the first 8 weeks titration period (at week 2, 4, 6 and 8). Dose adjustments were based on insulin like growth factor - I (IGF-I) standard deviation score (SDS). The minimum and maximum weekly dose was set to 0.1 mg and 8 mg, respectively.

    Arm title
    Norditropin
    Arm description
    Subjects recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
    Arm type
    Active comparator

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Norditropin® FlexPro® 10 mg/1.5 mL
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects injected themselves daily subcutaneously (s.c.; under the skin) in the evening, which was usual practice except when administered under observation. On site visit days the product was administered in the morning (up to 12 PM) and at least 12 hours after injection, the evening before. Injections were taken in the thigh and/or abdomen alternating within these body areas for every injection. Subjects were trained to use the pen injector under the supervision of site staff. Dose adjustments were allowed during the first 8 weeks titration period (at week 2, 4, 6 and 8). Dose adjustments were based on insulin like growth factor - I (IGF-I) standard deviation score (SDS). The minimum and maximum weekly dose was set to 0.05 mg and 1.1 mg, respectively. In Japanese subjects, the maximum daily dose was set to 1.0 mg.

    Arm title
    Somapacitan
    Arm description
    Subjects received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Somapacitan PDS290 10mg/1.5mL
    Investigational medicinal product code
    Other name
    NNC0195-0092
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects injected themselves once-weekly subcutaneously (s.c.; under the skin) in the morning (before 10 AM). On site visit days this was extended until 12:00 PM (noon). Injections were taken in the thigh and/or abdomen alternating within these body areas for every injection. Subjects were trained to use the pen injector under the supervision of site staff. Dose adjustments were allowed during the first 8 weeks titration period (at week 2, 4, 6 and 8). Dose adjustments were based on insulin like growth factor - I (IGF-I) standard deviation score (SDS). The minimum and maximum weekly dose was set to 0.1 mg and 8 mg, respectively.

    Number of subjects in period 1
    Placebo Norditropin Somapacitan
    Started
    61
    119
    120
    Completed
    55
    105
    114
    Not completed
    6
    14
    6
         Protocol deviation
    -
    -
    2
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    4
    12
    4
         Lost to follow-up
    -
    1
    -
         Unclassified
    1
    1
    -
    Period 2
    Period 2 title
    Extension phase (Open-label phase)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Somapacitan
    Arm description
    Subjects who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Somapacitan PDS290 10mg/1.5mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were trained for use of the pen injector under the supervision of site staff. Patients receiving Somapacitan injected themselves once a week, subcutaneously, in the morning before 10 AM. On site visit days, the time window was extended to 12:00 noon.

    Arm title
    Somapacitan/Somapacitan
    Arm description
    Subjects who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Somapacitan PDS290 10mg/1.5mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were trained for use of the pen injector under the supervision of site staff. Patients receiving Somapacitan injected themselves once a week, subcutaneously, in the morning before 10 AM. On site visit days, the time window was extended to 12:00 noon.

    Arm title
    Norditropin/Norditropin
    Arm description
    Subjects who received norditropin in the main period, continued to receive norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
    Arm type
    Active comparator

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Norditropin® FlexPro® 10 mg/1.5 mL
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were trained for use of the pen injector under the supervision of site staff. Patients receiving Norditropin injected themselves daily, subcutaneously, in the evening, while during observed trial drug administration, they injected themselves in the morning (before 12:00 PM and at least 12 hours after the previous injection).

    Arm title
    Norditropin/Somapacitan
    Arm description
    Subjects who received norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Somapacitan PDS290 10mg/1.5mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were trained for use of the pen injector under the supervision of site staff. Patients receiving Somapacitan injected themselves once a week, subcutaneously, in the morning before 10 AM. On site visit days, the time window was extended to 12:00 noon.

    Number of subjects in period 2 [1]
    Placebo/Somapacitan Somapacitan/Somapacitan Norditropin/Norditropin Norditropin/Somapacitan
    Started
    55
    114
    52
    51
    Completed
    53
    109
    47
    48
    Not completed
    2
    5
    5
    3
         Adverse event, serious fatal
    1
    -
    1
    1
         Consent withdrawn by subject
    1
    4
    3
    1
         Lost to follow-up
    -
    1
    1
    1
    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: Two subjects on Norditropin, who completed the main phase didn’t initiate treatment in the extension phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo (somapacitan) for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.

    Reporting group title
    Norditropin
    Reporting group description
    Subjects recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.

    Reporting group title
    Somapacitan
    Reporting group description
    Subjects received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.

    Reporting group values
    Placebo Norditropin Somapacitan Total
    Number of subjects
    61 119 120 300
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    51 101 107 259
        From 65-84 years
    10 18 13 41
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    45.0 ± 15.7 45.7 ± 15.3 44.6 ± 14.3 -
    Gender Categorical
    Units: Subjects
        Female
    32 61 62 155
        Male
    29 58 58 145

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo (somapacitan) for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.

    Reporting group title
    Norditropin
    Reporting group description
    Subjects recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.

    Reporting group title
    Somapacitan
    Reporting group description
    Subjects received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
    Reporting group title
    Placebo/Somapacitan
    Reporting group description
    Subjects who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Somapacitan/Somapacitan
    Reporting group description
    Subjects who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Norditropin/Norditropin
    Reporting group description
    Subjects who received norditropin in the main period, continued to receive norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Norditropin/Somapacitan
    Reporting group description
    Subjects who received norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Subject analysis set title
    Placebo/Somapacitan
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This analysis set represents all the subjects that received placebo in the main study and switched to receive somapacitan in the extesion period

    Subject analysis set title
    Somapacitan/Somapacitan
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This analysis set represents all the subjects that received somapacitan in the main phase and continued to receive somapacitan in the extension study

    Subject analysis set title
    Norditropin/Norditropin
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This analysis set represents all the subjects that received Norditropin in the main phase and were re-randomised to receive Norditropin in the extension phase

    Subject analysis set title
    Norditropin/Somapacitan
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This analysis set represents all the subjects that received Norditropin in the main phase of the study and were re-randomised to receive somapacitan in the extension study

    Subject analysis set title
    Norditropin/-
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This subject analysis set represents all the subjects that received Norditropin in the main phase of the study but discontinued the study after the main phase and did not continue into the extension phase

    Primary: Change in truncal fat percentage

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    End point title
    Change in truncal fat percentage
    End point description
    Change in truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34). Results are based on the full analysis set (FAS), which included subjects who received at least one dose of randomised treatment. Number of subjects analysed (n) = Number of subjects with available data for respective arm.
    End point type
    Primary
    End point timeframe
    From baseline to end of main treatment period (Week 34)
    End point values
    Placebo Norditropin Somapacitan
    Number of subjects analysed
    61
    119
    120
    Units: Percentage of truncal fat
    arithmetic mean (standard deviation)
        Baseline (n=60, 119 and 119)
    36.90 ± 8.98
    38.10 ± 9.65
    39.11 ± 8.81
        Change from baseline (week 34) (n=56, 111 and 116)
    0.49 ± 3.31
    -2.39 ± 4.48
    -1.17 ± 2.89
    Statistical analysis title
    Treatment difference (Somapacitan - Placebo)
    Statistical analysis description
    Changes in truncal fat percentage from baseline to the 34 week’s measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.
    Comparison groups
    Placebo v Somapacitan
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.009
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -1.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.68
         upper limit
    -0.38

    Secondary: Change in truncal fat mass (kg)

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    End point title
    Change in truncal fat mass (kg)
    End point description
    The change in truncal fat mass (TFM) was measured from baseline (week -3) until end of main treatment period (week 34). Results are based on the FAS, which included all subjects who received at least one dose of randomised treatment. Number of subjects analysed (n) = Number of subjects with available data for respective arm. Results are presented in grams.
    End point type
    Secondary
    End point timeframe
    From baseline to end of main treatment period (Week 34)
    End point values
    Placebo Norditropin Somapacitan
    Number of subjects analysed
    61
    119
    120
    Units: Grams
    arithmetic mean (standard deviation)
        Baseline (week -3) (n = 60, 119, 119)
    12669.57 ± 6010.05
    14121.73 ± 6318.79
    14777.05 ± 6269.71
        Change from baseline(week 34) (n =56,111,116)
    417.86 ± 1536.36
    -619.67 ± 1887.50
    -180.98 ± 1762.31
    No statistical analyses for this end point

    Secondary: Change in truncal lean body mass (kg)

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    End point title
    Change in truncal lean body mass (kg)
    End point description
    Change in truncal lean body mass was evaluated from baseline (week -3) until end of main treatment period (week 34). Results are based on the FAS, which included all subjects who received at least one dose of randomised treatment. Number of subjects analysed (n) = Number of subjects with available data for respective arm. Results are presented in grams.
    End point type
    Secondary
    End point timeframe
    From baseline to end of main treatment period (Week 34)
    End point values
    Placebo Norditropin Somapacitan
    Number of subjects analysed
    61
    119
    120
    Units: Grams
    arithmetic mean (standard deviation)
        Baseline (week -3) (n = 60, 119, 119)
    20698.51 ± 5569.03
    22464.16 ± 7338.22
    22297.20 ± 22297.20
        Change from baseline (week 34) (n = 56, 111, 116)
    402.69 ± 1247.67
    832.77 ± 1409.74
    800.27 ± 1377.75
    No statistical analyses for this end point

    Secondary: Incidence of adverse events, including injection site reactions (week 35)

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    End point title
    Incidence of adverse events, including injection site reactions (week 35)
    End point description
    All presented adverse events (AEs) are treatment emergent, which was defined as an AE with onset date after first trial product administration and no later than 7 days of last trial product administration. The results were based on the safety analysis set (SAS) which included all randomised subjects who received at least one dose of randomised treatment.
    End point type
    Secondary
    End point timeframe
    In the main trial period (up to week 35) (including follow-up visits/washout periods)
    End point values
    Placebo Norditropin Somapacitan
    Number of subjects analysed
    61
    119
    120
    Units: Number of adverse events
        Main study
    184
    426
    385
    No statistical analyses for this end point

    Secondary: Incidence of adverse events, including injection site reactions (week 88)

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    End point title
    Incidence of adverse events, including injection site reactions (week 88)
    End point description
    All presented adverse events (AEs) are treatment emergent, which was defined as an AE with onset date after first trial product administration and no later than 7 days of last trial product administration. The results were based on the SAS which included all randomised subjects who received at least one dose of randomised treatment.
    End point type
    Secondary
    End point timeframe
    In both the main trial period (up to week 35) and extension trial period (up to week 88) (including follow-up visits/washout periods)
    End point values
    Placebo/Somapacitan Somapacitan/Somapacitan Norditropin/Norditropin Norditropin/Somapacitan Norditropin/-
    Number of subjects analysed
    49
    101
    46
    46
    12
    Units: Number of adverse events
    395
    699
    384
    385
    49
    No statistical analyses for this end point

    Secondary: Occurrence of anti-NNC0195-0092 antibodies (week 35)

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    End point title
    Occurrence of anti-NNC0195-0092 antibodies (week 35)
    End point description
    Presented results are the occurrence of anti-NNC0195-0092 antibodies at week 35. The results were based on the SAS which included all randomised subjects who received at least one dose of randomised treatment.
    End point type
    Secondary
    End point timeframe
    In the main trial period (up to week 35) (including follow-up visits/washout periods)
    End point values
    Placebo Norditropin Somapacitan
    Number of subjects analysed
    56
    101
    117
    Units: Subjects
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Occurrence of anti-NNC0195-0092 antibodies (week 88)

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    End point title
    Occurrence of anti-NNC0195-0092 antibodies (week 88)
    End point description
    Presented results are the occurrence of anti-NNC0195-0092 antibodies at week 88. The results were based on the SAS which included all randomised subjects who received at least one dose of randomised treatment.
    End point type
    Secondary
    End point timeframe
    In both the main trial period (up to week 35) and extension trial period (up to week 88) (including follow-up visits/washout periods)
    End point values
    Placebo/Somapacitan Somapacitan/Somapacitan Norditropin/Norditropin Norditropin/Somapacitan
    Number of subjects analysed
    54
    109
    48
    48
    Units: Subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In both the main trial period (up to week 35) and extension trial period (up to week 88) (including follow-up visits/washout periods)
    Adverse event reporting additional description
    All presented AEs are treatment emergent. The results are based on the safety analysis set (SAS).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Placebo/Somapacitan
    Reporting group description
    Subjects who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Somapacitan/Somapacitan
    Reporting group description
    Subjects who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Norditropin/Norditropin
    Reporting group description
    Subjects who received norditropin in the main period, continued to receive norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Norditropin/Somapacitan
    Reporting group description
    Subjects who received norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.

    Reporting group title
    Norditropin/No treatment
    Reporting group description
    Subjects in this group received norditropin in the main phase of the study but were not re-randomised in the extension phase of the study and hence did not receive any product.

    Serious adverse events
    Placebo/Somapacitan Somapacitan/Somapacitan Norditropin/Norditropin Norditropin/Somapacitan Norditropin/No treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 61 (13.11%)
    13 / 120 (10.83%)
    5 / 52 (9.62%)
    7 / 51 (13.73%)
    4 / 16 (25.00%)
         number of deaths (all causes)
    2
    0
    1
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arterial stent insertion
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia repair
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Drug dispensing error
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth fracture
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood testosterone increased
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiogram
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiogenic shock
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemoconcentration
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dental cyst
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Secondary adrenocortical insufficiency
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes insipidus
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypopituitarism
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenocortical insufficiency acute
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 120 (1.67%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo/Somapacitan Somapacitan/Somapacitan Norditropin/Norditropin Norditropin/Somapacitan Norditropin/No treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 61 (73.77%)
    83 / 120 (69.17%)
    39 / 52 (75.00%)
    37 / 51 (72.55%)
    11 / 16 (68.75%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 61 (3.28%)
    6 / 120 (5.00%)
    3 / 52 (5.77%)
    4 / 51 (7.84%)
    0 / 16 (0.00%)
         occurrences all number
    2
    6
    3
    4
    0
    Immune system disorders
    Allergy to plants
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 61 (4.92%)
    7 / 120 (5.83%)
    4 / 52 (7.69%)
    6 / 51 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    3
    9
    4
    7
    0
    Injection site bruising
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 120 (0.83%)
    3 / 52 (5.77%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    3
    1
    3
    3
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 61 (4.92%)
    8 / 120 (6.67%)
    4 / 52 (7.69%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    4
    19
    7
    3
    0
    Chills
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    2
    Pain
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    3 / 16 (18.75%)
         occurrences all number
    2
    1
    0
    1
    3
    Pyrexia
         subjects affected / exposed
    1 / 61 (1.64%)
    4 / 120 (3.33%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    1 / 16 (6.25%)
         occurrences all number
    1
    6
    0
    2
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    2
    1
    Contusion
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 120 (1.67%)
    3 / 52 (5.77%)
    2 / 51 (3.92%)
    0 / 16 (0.00%)
         occurrences all number
    1
    3
    5
    2
    0
    Foot fracture
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    0
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 61 (3.28%)
    7 / 120 (5.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    9
    0
    0
    0
    Blood testosterone decreased
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 120 (0.00%)
    2 / 52 (3.85%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    2
    3
    0
    Thyroxine free decreased
         subjects affected / exposed
    3 / 61 (4.92%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    3
    2
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 61 (6.56%)
    6 / 120 (5.00%)
    2 / 52 (3.85%)
    4 / 51 (7.84%)
    0 / 16 (0.00%)
         occurrences all number
    4
    8
    2
    5
    0
    Dyspnoea
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    4 / 61 (6.56%)
    6 / 120 (5.00%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    0 / 16 (0.00%)
         occurrences all number
    4
    6
    0
    3
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 61 (22.95%)
    17 / 120 (14.17%)
    11 / 52 (21.15%)
    7 / 51 (13.73%)
    1 / 16 (6.25%)
         occurrences all number
    43
    56
    65
    16
    1
    Dizziness
         subjects affected / exposed
    3 / 61 (4.92%)
    9 / 120 (7.50%)
    2 / 52 (3.85%)
    3 / 51 (5.88%)
    2 / 16 (12.50%)
         occurrences all number
    3
    12
    2
    7
    3
    Hypoaesthesia
         subjects affected / exposed
    3 / 61 (4.92%)
    1 / 120 (0.83%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    3
    1
    2
    3
    0
    Eye disorders
    Eyelid disorder
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Glaucoma
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 120 (0.83%)
    3 / 52 (5.77%)
    2 / 51 (3.92%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    3
    4
    0
    Vertigo
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    4 / 51 (7.84%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    4
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 61 (14.75%)
    7 / 120 (5.83%)
    6 / 52 (11.54%)
    5 / 51 (9.80%)
    2 / 16 (12.50%)
         occurrences all number
    14
    9
    6
    10
    2
    Nausea
         subjects affected / exposed
    2 / 61 (3.28%)
    5 / 120 (4.17%)
    1 / 52 (1.92%)
    4 / 51 (7.84%)
    1 / 16 (6.25%)
         occurrences all number
    2
    6
    1
    15
    1
    Abdominal pain
         subjects affected / exposed
    2 / 61 (3.28%)
    3 / 120 (2.50%)
    1 / 52 (1.92%)
    2 / 51 (3.92%)
    1 / 16 (6.25%)
         occurrences all number
    3
    4
    1
    3
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Dental caries
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 120 (1.67%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    4
    1
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 120 (2.50%)
    2 / 52 (3.85%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    2
    3
    2
    4
    0
    Oesophagitis
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 120 (2.50%)
    2 / 52 (3.85%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    5
    2
    3
    0
    Vomiting
         subjects affected / exposed
    3 / 61 (4.92%)
    7 / 120 (5.83%)
    2 / 52 (3.85%)
    4 / 51 (7.84%)
    1 / 16 (6.25%)
         occurrences all number
    3
    8
    3
    6
    2
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Nocturia
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 120 (0.83%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 61 (4.92%)
    4 / 120 (3.33%)
    5 / 52 (9.62%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences all number
    3
    4
    7
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 61 (8.20%)
    9 / 120 (7.50%)
    8 / 52 (15.38%)
    7 / 51 (13.73%)
    0 / 16 (0.00%)
         occurrences all number
    5
    9
    9
    9
    0
    Back pain
         subjects affected / exposed
    5 / 61 (8.20%)
    13 / 120 (10.83%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    2 / 16 (12.50%)
         occurrences all number
    7
    13
    1
    1
    2
    Myalgia
         subjects affected / exposed
    4 / 61 (6.56%)
    5 / 120 (4.17%)
    4 / 52 (7.69%)
    2 / 51 (3.92%)
    0 / 16 (0.00%)
         occurrences all number
    4
    7
    4
    2
    0
    Pain in extremity
         subjects affected / exposed
    1 / 61 (1.64%)
    5 / 120 (4.17%)
    5 / 52 (9.62%)
    2 / 51 (3.92%)
    0 / 16 (0.00%)
         occurrences all number
    1
    5
    7
    2
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 61 (16.39%)
    11 / 120 (9.17%)
    8 / 52 (15.38%)
    6 / 51 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    14
    13
    13
    8
    0
    Bronchitis
         subjects affected / exposed
    4 / 61 (6.56%)
    4 / 120 (3.33%)
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    1 / 16 (6.25%)
         occurrences all number
    5
    4
    2
    1
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 61 (4.92%)
    9 / 120 (7.50%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    1 / 16 (6.25%)
         occurrences all number
    3
    13
    1
    1
    2
    Influenza
         subjects affected / exposed
    4 / 61 (6.56%)
    5 / 120 (4.17%)
    1 / 52 (1.92%)
    5 / 51 (9.80%)
    0 / 16 (0.00%)
         occurrences all number
    8
    5
    2
    6
    0
    Nasopharyngitis
         subjects affected / exposed
    14 / 61 (22.95%)
    32 / 120 (26.67%)
    15 / 52 (28.85%)
    12 / 51 (23.53%)
    1 / 16 (6.25%)
         occurrences all number
    25
    48
    21
    20
    1
    Pharyngitis
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 120 (1.67%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    5
    0
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 120 (0.00%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    2
    1
    Sinusitis
         subjects affected / exposed
    4 / 61 (6.56%)
    2 / 120 (1.67%)
    4 / 52 (7.69%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    8
    3
    4
    4
    0
    Tonsillitis
         subjects affected / exposed
    3 / 61 (4.92%)
    5 / 120 (4.17%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences all number
    3
    5
    4
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 120 (1.67%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    3
    1
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 61 (4.92%)
    6 / 120 (5.00%)
    2 / 52 (3.85%)
    3 / 51 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    3
    9
    2
    6
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jan 2015
    Updates based on comments received on the protocol during End of Phase 2 meetings with US Food and drug administration (FDA) and Pharmaceuticals and Medical Devices Agency, Japan (PMDA): FDA: Primary analysis to be based on intention-to-treat principle; Additional antibody and PK sampling to align with the time points for immunogenicity assessments as recommended in the FDA Immunogenicity guideline of February 2013; Inclusion of subjects with diabetes. PMDA: Patients with diabetes mellitus will be excluded at sites in Japan. Application of Japanese guidelines for the diagnosis of adult growth hormone deficiency (AGHD) for patients included at sites in Japan. Changes to subect information-informed consent (SI-IC): specification of discontinuation of trial drug, and withdrawal and termination of the trial; Urine sample was deleted and eye examination was added. Full title was added.
    29 Jan 2015
    Based on feedback from Ethics Committee, clarifications and feedback from investigators: Alternative test for adrenocorticotropic hormone (ACTH) stimulation test (limited availability in some countries). Impact on inclusion criterion regarding serum levels of free thyroxine (T4) and the patient informed consent form. Process for local tolerability assessments includes external review of photos by a dermatologist. Clarification of follow-up process after last patient last visit (LPLV) if 2 consecutive positive antibody results. Ethics Committee, Germany: 2 additional exclusion criteria added, applicable to Germany only. These criteria cover exclusion of patients committed to an institution and persons employed with the sponsor/CRO/trial centre. Novo Nordisk: Clarifications when and how deviation from the titration schedule should be handled; adrenal insufficient patients on stable replacement therapy for 3 months the option of re-screening.
    24 Sep 2015
    This amendment was implemented due to recruitment difficulties and more flexibility was needed in the inclusion/exclusion criteria, and titration visit schedule. Allowed visits 1a and 1b to be combined into one visit. Request from FDA to ensure that electrocardiograms (ECGs) were performed at time of mean Cmax. Changes to SI-IC: Information added that replacement therapy could be initiated if low thyroid or adrenal function or testosterone levels. Text on evidence of intracranial tumour growth was rephrased (‘no evidence of intracranial tumour growth since removal of the tumour’).

    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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