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    Clinical Trial Results:
    NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

    Summary
    EudraCT number
    2008-001674-32
    Trial protocol
    FI  
    Global end of trial date
    31 Dec 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GHLIQUID-3676
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00960128
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure, Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure, 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
    15 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To collect the post-marketing data on effectiveness and safety of real-life treatment with Norditropin.
    Protection of trial subjects
    The study was carried out in accordance with the Declaration of Helsinki. The study reference documents were submitted for notification/approval to IEC/IRB and, if locally required, for notification/approval to regulatory authorities and data privacy agencies.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Apr 2006
    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
    Belgium: 33
    Country: Number of subjects enrolled
    Czech Republic: 1341
    Country: Number of subjects enrolled
    Denmark: 1186
    Country: Number of subjects enrolled
    Finland: 211
    Country: Number of subjects enrolled
    France: 3803
    Country: Number of subjects enrolled
    Germany: 7927
    Country: Number of subjects enrolled
    Hungary: 111
    Country: Number of subjects enrolled
    Ireland: 41
    Country: Number of subjects enrolled
    Israel: 152
    Country: Number of subjects enrolled
    Italy: 158
    Country: Number of subjects enrolled
    Lithuania: 108
    Country: Number of subjects enrolled
    Luxembourg: 2
    Country: Number of subjects enrolled
    Montenegro: 85
    Country: Number of subjects enrolled
    Netherlands: 153
    Country: Number of subjects enrolled
    Norway: 312
    Country: Number of subjects enrolled
    Russian Federation: 159
    Country: Number of subjects enrolled
    Serbia: 1373
    Country: Number of subjects enrolled
    Slovenia: 282
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Sweden: 1381
    Country: Number of subjects enrolled
    Switzerland: 534
    Country: Number of subjects enrolled
    United Kingdom: 866
    Worldwide total number of subjects
    20224
    EEA total number of subjects
    17921
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    40
    Infants and toddlers (28 days-23 months)
    557
    Children (2-11 years)
    12691
    Adolescents (12-17 years)
    4443
    Adults (18-64 years)
    2204
    From 65 to 84 years
    288
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The study included 469 clinics from 23 countries: Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Lithuania, Luxembourg, Montenegro, Netherlands, Norway, Russian Federation, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

    Pre-assignment
    Screening details
    This was an international, multi-centre, observational study based on all clinical data registered in NordiNet® as part of normal clinical practice. Patients were included in the study if they were treated with Norditropin® according to routine clinical practice.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Norditropin®
    Arm description
    The study population comprised children and adults treated with Norditropin® in the course of normal clinical practice. The overall study period was from 01 Apr 2006 to 31 Dec 2016.
    Arm type
    Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Somatropin as per routine clinical practice.

    Number of subjects in period 1
    Norditropin®
    Started
    20224
    Completed
    12938
    Not completed
    7286
         Included in FAS but Excluded from EAS
    7286

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Norditropin®
    Reporting group description
    The study population comprised children and adults treated with Norditropin® in the course of normal clinical practice. The overall study period was from 01 Apr 2006 to 31 Dec 2016.

    Reporting group values
    Norditropin® Total
    Number of subjects
    20224 20224
    Age Categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    40 40
        Infants and toddlers (28 days-23 months)
    557 557
        Children (2-11 years)
    12691 12691
        Adolescents (12-17 years)
    4443 4443
        Adults (18-64 years)
    2204 2204
        From 65-84 years
    288 288
        85 years and over
    1 1
    Gender Categorical
    Units: Subjects
        Female
    8678 8678
        Male
    11546 11546
    Subject analysis sets

    Subject analysis set title
    Growth Hormone Deficiency (GHD) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Growth Hormone Deficiency who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Small for Gestational Age (SGA) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Small for Gestational Age (SGA) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Turner Syndrome (TS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Turner Syndrome (TS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Chronic Renal Disease (CRD) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with chronic renal disease (CRD) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Idiopathic Short Stature (ISS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with idiopathic short stature (ISS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Noonan Syndrome (NS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Noonan Syndrome (NS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Prader-Willi Syndrome (PWS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Prader-Willi Syndrome (PWS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Adult patients with adult growth hormone deficiency (AGHD) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis sets values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects
    7141
    3200
    936
    200
    317
    106
    67
    971
    Age Categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender Categorical
    Units: Subjects
        Female
    2460
    1463
    936
    75
    136
    30
    28
    434
        Male
    4681
    1737
    0
    125
    181
    76
    39
    537

    End points

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    End points reporting groups
    Reporting group title
    Norditropin®
    Reporting group description
    The study population comprised children and adults treated with Norditropin® in the course of normal clinical practice. The overall study period was from 01 Apr 2006 to 31 Dec 2016.

    Subject analysis set title
    Growth Hormone Deficiency (GHD) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Growth Hormone Deficiency who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Small for Gestational Age (SGA) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Small for Gestational Age (SGA) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Turner Syndrome (TS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Turner Syndrome (TS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Chronic Renal Disease (CRD) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with chronic renal disease (CRD) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Idiopathic Short Stature (ISS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with idiopathic short stature (ISS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Noonan Syndrome (NS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Noonan Syndrome (NS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Prader-Willi Syndrome (PWS) - Paediatric Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Paediatric patients with Prader-Willi Syndrome (PWS) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Subject analysis set title
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Adult patients with adult growth hormone deficiency (AGHD) who were being treated with Norditropin®. The population represents effectiveness analysis set.

    Primary: Change from baseline in Height Standard Deviation Scores (SDS) - Paediatric population

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    End point title
    Change from baseline in Height Standard Deviation Scores (SDS) - Paediatric population [1]
    End point description
    Height standard deviation scores were calculated as per national standard. Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Primary
    End point timeframe
    Up to 10 Years of follow up
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was an observational, non-interventional study. Only descriptive statistics was performed.
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: Standard Deviation Scores
    arithmetic mean (standard deviation)
        Baseline (n=7141,3200,936,200,317,106,67)
    -2.55 ± 1.10
    -2.97 ± 0.91
    -2.66 ± 0.93
    -2.74 ± 1.17
    -2.82 ± 0.99
    -2.83 ± 1.13
    -1.94 ± 1.48
        Year 1 Follow Up (n=5173,2231,725,136,245,70,43)
    0.69 ± 0.56
    0.65 ± 0.44
    0.54 ± 0.36
    0.61 ± 1.19
    0.52 ± 0.38
    0.51 ± 0.38
    0.85 ± 0.9
        Year 2 Follow Up (n=4403,1882,642,94,190,56,30)
    1.09 ± 0.75
    1.01 ± 0.57
    0.81 ± 0.52
    0.9 ± 0.76
    0.89 ± 0.59
    0.83 ± 0.64
    1.19 ± 1.13
        Year 3 Follow Up (n=3574,1538,540,69,139,40,28)
    1.36 ± 0.85
    1.29 ± 0.65
    0.99 ± 0.61
    1.14 ± 0.97
    1.09 ± 0.7
    1.01 ± 0.69
    1.23 ± 1.05
        Year 4 Follow Up (n=2683,1195,429,44,94,37,25)
    1.56 ± 0.95
    1.46 ± 0.69
    1.04 ± 0.66
    1.21 ± 1.14
    1.28 ± 0.74
    1.07 ± 0.7
    1.34 ± 1.22
        Year 5 Follow Up (n=1916,897,344,31,65,25,17)
    1.72 ± 1.05
    1.64 ± 0.71
    1.12 ± 0.67
    1.6 ± 1.07
    1.43 ± 0.81
    1.18 ± 0.82
    1.43 ± 1.26
        Year 6 Follow Up (n=1388,644,249,22,40,16,12)
    1.87 ± 1.11
    1.8 ± 0.77
    1.16 ± 0.65
    1.92 ± 1.13
    1.71 ± 0.85
    0.99 ± 0.75
    1.9 ± 1.01
        Year 7 Follow Up (n=941,447,184,14,28,10,11)
    2.03 ± 1.15
    1.94 ± 0.79
    1.07 ± 0.69
    1.95 ± 1.17
    1.86 ± 0.99
    0.93 ± 1.03
    1.26 ± 1.07
        Year 8 Follow Up (n=648,280,135,14,18,7,10)
    2.21 ± 1.21
    2.04 ± 0.77
    0.98 ± 0.68
    2.14 ± 1.07
    1.7 ± 0.68
    1.29 ± 1.02
    1.16 ± 1.06
        Year 9 Follow Up (n=456,186,85,9,9,7,7)
    2.26 ± 1.25
    2.01 ± 0.76
    0.88 ± 0.6
    2.54 ± 1.08
    1.74 ± 0.82
    1.05 ± 0.8
    1.63 ± 1.36
        Year 10 Follow Up (n=273,96,47,7,9,4,6)
    2.41 ± 1.35
    1.93 ± 0.89
    0.77 ± 0.78
    2.8 ± 0.74
    1.28 ± 0.96
    1.21 ± 0.51
    1.8 ± 1.25
    No statistical analyses for this end point

    Primary: Change from baseline in waist circumference - Adult population

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    End point title
    Change from baseline in waist circumference - Adult population [2]
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Primary
    End point timeframe
    Up to 10 years of follow up
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was an observational, non-interventional study. Only descriptive statistics was performed.
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: cm
    arithmetic mean (standard deviation)
        Female: Baseline (n=241)
    95.76 ± 15.77
        Female: Year 1 follow-up (n=130)
    -1.32 ± 5.29
        Female: Year 2 follow-up (n=93)
    -0.33 ± 6.88
        Female: Year 3 follow-up (n=64)
    0.68 ± 7.36
        Female: Year 4 follow-up (n=55)
    -0.2 ± 8.32
        Female: Year 5 follow-up (n=47)
    -0.51 ± 7.92
        Female: Year 6 follow-up (n=38)
    -0.33 ± 9
        Female: Year 7 follow-up (n=34)
    -1.94 ± 9.03
        Female: Year 8 follow-up (n=24)
    1.04 ± 10.93
        Female: Year 9 follow-up (n=20)
    1.1 ± 12.39
        Female: Year 10 follow-up (n=16)
    1.47 ± 10.66
        Male: Baseline (n=290)
    102.29 ± 13.21
        Male: Year 1 follow-up (n=124)
    -0.76 ± 6.56
        Male: Year 2 follow-up (n=104)
    -1.41 ± 5.94
        Male: Year 3 follow-up (n=71)
    -0.12 ± 6.43
        Male: Year 4 follow-up (n=63)
    0.1 ± 7.15
        Male: Year 5 follow-up (n=50)
    -0.24 ± 7.32
        Male: Year 6 follow-up (n=35)
    1.2 ± 5.95
        Male: Year 7 follow-up (n=31)
    -0.18 ± 6.88
        Male: Year 8 follow-up (n=31)
    2 ± 8.24
        Male: Year 9 follow-up (n=19)
    -2.74 ± 11.89
        Male: Year 10 follow-up (n=19)
    -0.37 ± 7.4
    No statistical analyses for this end point

    Secondary: Change from baseline in body weight - Adult population

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    End point title
    Change from baseline in body weight - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: kg
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=269)
    -0.19 ± 8.3
        Female: Year 2 follow-up (n=206)
    1.46 ± 13.3
        Female: Year 3 follow-up (n=166)
    1.51 ± 11.26
        Female: Year 4 follow-up (n=134)
    1.05 ± 7.85
        Female: Year 5 follow-up (n=112)
    0.32 ± 7.51
        Female: Year 6 follow-up (n=97)
    0.67 ± 13.47
        Female: Year 7 follow-up (n=82)
    0.5 ± 8.2
        Female: Year 8 follow-up (n=63)
    0.27 ± 14.47
        Female: Year 9 follow-up (n=56)
    0.94 ± 8.37
        Female: Year 10 follow-up (n=42)
    -3.38 ± 22.32
        Male: Year 1 follow-up (n=311)
    0.45 ± 10.69
        Male: Year 2 follow-up (n=262)
    0.23 ± 6.66
        Male: Year 3 follow-up (n=193)
    1.27 ± 14.18
        Male: Year 4 follow-up (n=177)
    1.06 ± 10.04
        Male: Year 5 follow-up (n=139)
    0.79 ± 10.53
        Male: Year 6 follow-up (n=120)
    1.56 ± 9.10
        Male: Year 7 follow-up (n=94)
    0.88 ± 10.41
        Male: Year 8 follow-up (n=90)
    0.03 ± 16.37
        Male: Year 9 follow-up (n=66)
    -2.39 ± 23.42
        Male: Year 10 follow-up (n=52)
    -1.14 ± 22.36
    No statistical analyses for this end point

    Secondary: Change from baseline in weight SDS - Paediatric population

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    End point title
    Change from baseline in weight SDS - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: standard deviation scores
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=2452,1114,386,46,117,42,25)
    0.44 ± 0.62
    0.54 ± 0.53
    0.32 ± 0.49
    0.45 ± 0.64
    0.31 ± 0.57
    0.25 ± 0.38
    0.79 ± 0.96
        Year 2 follow-up (n=2008,912,335,29,86,32,18)
    0.82 ± 0.86
    0.87 ± 0.69
    0.64 ± 0.64
    0.72 ± 0.7
    0.69 ± 0.72
    0.6 ± 0.65
    1.3 ± 1.51
        Year 3 follow-up (n=1508,694,270,22,63,24,17)
    1.08 ± 1.02
    1.12 ± 0.8
    0.85 ± 0.76
    1.14 ± 0.83
    0.86 ± 0.87
    0.75 ± 0.78
    1.52 ± 1.76
        Year 4 follow-up (n=1066,510,207,12,37,17,13)
    1.24 ± 1.12
    1.28 ± 0.91
    1.01 ± 0.83
    1 ± 0.9
    0.93 ± 0.88
    0.74 ± 0.73
    2.21 ± 1.79
        Year 5 follow-up (n=733,364,162,6,25,10,7)
    1.46 ± 1.26
    1.42 ± 0.92
    1.1 ± 0.82
    1.04 ± 1.11
    1.07 ± 0.92
    0.97 ± 0.83
    1.68 ± 1.56
        Year 6 follow-up (n=492,256,125,6,15,6,5)
    1.58 ± 1.37
    1.59 ± 0.88
    1.33 ± 0.89
    1.34 ± 1.41
    1.65 ± 1.21
    0.6 ± 0.76
    2.71 ± 1.71
        Year 7 follow-up (n=323,174,88,3,7,3,6)
    1.67 ± 1.49
    1.78 ± 1.06
    1.39 ± 0.91
    1.13 ± 1.45
    1.68 ± 0.91
    0.85 ± 1.19
    1.67 ± 1.7
        Year 8 follow-up (n=234,100,71,3,7,1,7)
    1.79 ± 1.66
    1.99 ± 1.03
    1.47 ± 0.92
    1.59 ± 1.33
    1.66 ± 1.84
    1.6 ± 99999.9999
    1.28 ± 1.73
        Year 9 follow-up (n=160,66,42,2,1,2,4)
    1.86 ± 1.39
    2.07 ± 0.93
    1.54 ± 0.86
    1.43 ± 2.16
    1.68 ± 99999.9999
    1.4 ± 0.34
    1.75 ± 2.38
        Year 10 follow-up (n=95,34,28,1,3,2,3)
    2.07 ± 1.29
    2.05 ± 1.06
    1.44 ± 0.82
    2.75 ± 99999.9999
    1.11 ± 2.03
    1.32 ± 0.34
    2.27 ± 2.89
    No statistical analyses for this end point

    Secondary: Change from baseline in HbA1c - Paediatric population

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    End point title
    Change from baseline in HbA1c - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: percentage of HbA1c
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=734,411,149,18,39,10,5)
    0.04 ± 0.47
    0.05 ± 0.46
    0.1 ± 0.51
    0.36 ± 1.28
    0.02 ± 0.37
    0.15 ± 0.4
    0.1 ± 1.07
        Year 2 follow-up (n=583,309,119,15,29,8,4)
    0.06 ± 0.49
    0.02 ± 0.53
    0.09 ± 0.54
    0.22 ± 0.45
    0.09 ± 0.42
    0.24 ± 0.45
    -0.47 ± 0.84
        Year 3 follow-up (n=444,235,110,9,22,4,2)
    0.04 ± 0.49
    0.05 ± 0.57
    0.05 ± 0.66
    -0.17 ± 0.77
    0.06 ± 0.51
    -0.1 ± 0
    0.6 ± 0.57
        Year 4 follow-up (n=308,169,77,5,10,1,0)
    -0 ± 0.52
    0.05 ± 0.65
    -0.01 ± 0.56
    0.19 ± 0.75
    -0.02 ± 0.41
    -0.1 ± 99999.999
    99999.999 ± 99999.999
        Year 5 follow-up (n=196,126,66,3,6,1,1)
    -0.05 ± 0.57
    0.14 ± 0.45
    0.04 ± 0.6
    0.3 ± 0
    0.05 ± 0.15
    0 ± 99999.999
    0.4 ± 99999.999
        Year 6 follow-up (n=134,91,41,3,2,0,0)
    0.02 ± 0.51
    0.08 ± 0.43
    0.08 ± 0.68
    0.5 ± 0.56
    0.35 ± 0.49
    99999.999 ± 99999.999
    99999.999 ± 99999.999
        Year 7 follow-up (n=77,71,29,1,1,1,0)
    0.01 ± 0.7
    0.07 ± 0.49
    0.06 ± 0.65
    0 ± 99999.999
    0 ± 99999.999
    0.6 ± 99999.999
    99999.999 ± 99999.999
        Year 8 follow-up (n=54,47,18,2,3,1,0)
    0.08 ± 0.43
    0.12 ± 0.42
    0.22 ± 0.54
    0.1 ± 0.28
    -0.6 ± 0.85
    0.5 ± 99999.999
    99999.999 ± 99999.999
        Year 9 follow-up (n=34,33,9,1,0,1,0)
    0.11 ± 0.41
    -0.04 ± 0.34
    1.3 ± 2.87
    -0.3 ± 99999.999
    99999.999 ± 99999.999
    0.3 ± 99999.999
    99999.999 ± 99999.999
        Year 10 follow-up (n=13,15,4,1,0,1,0)
    0.21 ± 0.33
    -0.04 ± 0.33
    -0.05 ± 0.62
    0.1 ± 99999.999
    99999.999 ± 99999.999
    0.3 ± 99999.999
    99999.999 ± 99999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in fasting blood glucose - Paediatric population

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    End point title
    Change from baseline in fasting blood glucose - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: mmol/l
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=466,261,75,13,17,2,3)
    0.33 ± 0.95
    0.21 ± 1.04
    0.26 ± 0.76
    0.44 ± 0.89
    0.22 ± 0.9
    -0.87 ± 1.23
    -0.17 ± 0.47
        Year 2 follow-up (n=325,168,74,7,12,2,0)
    0.3 ± 1.01
    0.34 ± 1.03
    0.41 ± 0.79
    0.44 ± 0.51
    0.6 ± 0.71
    0.62 ± 0.16
    9999.999 ± 9999.999
        Year 3 follow-up (n=209,117,45,7,5,2,4)
    0.35 ± 1.26
    0.47 ± 1.3
    0.75 ± 1.69
    0.31 ± 0.52
    0.21 ± 1.75
    0.71 ± 0.28
    -0.27 ± 0.3
        Year 4 follow-up (n=152,79,40,4,1,0,0)
    0.3 ± 1.23
    0.52 ± 1.37
    0.51 ± 0.63
    0.43 ± 1.49
    0 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 5 follow-up (n=99,59,28,2,1,0,0)
    0.49 ± 1.12
    -0.18 ± 5.38
    0.46 ± 1.13
    0.95 ± 0.93
    0.1 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 6 follow-up (n=90,41,24,3,0,0,0)
    0.32 ± 1.05
    0.06 ± 0.91
    0.38 ± 0.96
    0.96 ± 0.81
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 7 follow-up (n=75,22,23,1,0,0,0)
    0.52 ± 1.03
    0.41 ± 0.76
    0.47 ± 0.96
    1.33 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 8 follow-up (n=60,12,11,2,0,0,0)
    0.7 ± 1.18
    0.31 ± 0.54
    0.48 ± 1.6
    0.8 ± 0.04
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 9 follow-up (n=39,7,6,1,0,0,0)
    0.55 ± 1.15
    0.05 ± 0.83
    0.44 ± 0.89
    1.17 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 10 follow-up (n=21,1,1,1,0,0,0)
    0.5 ± 1.3
    0.44 ± 9999.999
    0.39 ± 9999.999
    1 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in total cholesterol - Paediatric population

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    End point title
    Change from baseline in total cholesterol - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: mmol/l
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=443,193,69,19,18,7,0)
    -0.14 ± 0.73
    -0.06 ± 0.61
    -0.24 ± 0.58
    -0.45 ± 0.86
    -0.04 ± 0.62
    -0.46 ± 0.69
    9999.999 ± 9999.999
        Year 2 follow-up (n=314,124,48,12,14,3,0)
    -0.27 ± 0.82
    -0.23 ± 0.65
    -0.15 ± 0.72
    -0.87 ± 0.75
    -0.09 ± 1.08
    -0.89 ± 0.75
    9999.999 ± 9999.999
        Year 3 follow-up (n=202,67,31,7,6,3,3)
    -0.39 ± 0.9
    -0.12 ± 0.63
    -0.13 ± 0.9
    -0.84 ± 0.84
    0.47 ± 0.97
    -1.5 ± 1.42
    -0.16 ± 0.73
        Year 4 follow-up (n=143,60,24,6,2,2,0)
    -0.39 ± 0.94
    -0.24 ± 0.64
    0.01 ± 0.88
    -0.28 ± 0.51
    0.3 ± 0.57
    -1.35 ± 0.49
    9999.999 ± 9999.999
        Year 5 follow-up (n=87,49,12,3,1,1,0)
    -0.35 ± 0.75
    -0.23 ± 0.75
    -0.1 ± 0.71
    -0.63 ± 0.24
    -0.2 ± 9999.999
    -1.13 ± 9999.999
    9999.999 ± 9999.999
        Year 6 follow-up (n=79,38,10,2,0,1,0)
    -0.16 ± 0.75
    -0.27 ± 0.79
    0.25 ± 0.69
    -1 ± 0.68
    9999.999 ± 9999.999
    -0.77 ± 9999.999
    9999.999 ± 9999.999
        Year 7 follow-up (n=63,20,7,2,0,0,0)
    -0.3 ± 1.13
    -0.34 ± 0.63
    0.7 ± 0.93
    -3.74 ± 3.79
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 8 follow-up (n=48,18,5,2,0,0,0)
    -0.19 ± 0.67
    -0.33 ± 0.71
    -0.23 ± 1.25
    -4.13 ± 3.35
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 9 follow-up (n=26,20,2,1,0,0,0)
    -0.39 ± 0.88
    -0.27 ± 0.68
    0.11 ± 1.29
    -1.14 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 10 follow-up (n=12,8,1,1,0,1,0)
    -0.19 ± 0.8
    -0.15 ± 0.46
    0.88 ± 9999.999
    -2.14 ± 9999.999
    9999.999 ± 9999.999
    -1.38 ± 9999.999
    9999.999 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in HDL cholesterol - Paediatric population

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    End point title
    Change from baseline in HDL cholesterol - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: mmol/l
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=233,110,30,6,5,3,0)
    -0.06 ± 0.44
    0.04 ± 0.34
    0 ± 0.35
    -0.04 ± 0.12
    -0.01 ± 0.16
    -0.03 ± 0.27
    9999.999 ± 9999.999
        Year 2 follow-up (n=168,64,19,4,6,2,0)
    -0.06 ± 0.34
    -0.04 ± 0.51
    0.07 ± 0.41
    -0.04 ± 0.42
    -0.01 ± 0.38
    -0.09 ± 0.13
    9999.999 ± 9999.999
        Year 3 follow-up (n=106,34,13,3,3,0,3)
    -0.12 ± 0.36
    0.02 ± 0.35
    0.02 ± 0.21
    0.08 ± 0.55
    0.05 ± 0.13
    9999.999 ± 9999.999
    0.06 ± 0.22
        Year 4 follow-up (n=65,37,9,3,2,0,0)
    -0.13 ± 0.41
    -0.06 ± 0.66
    0.21 ± 0.37
    0 ± 0.49
    0.03 ± 0.1
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 5 follow-up (n=31,25,4,1,1,0,0)
    -0.04 ± 0.31
    0.04 ± 0.37
    0.2 ± 0.57
    -0.34 ± 9999.999
    -0.42 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 6 follow-up (n=29,20,2,1,0,0,0)
    0.01 ± 0.34
    0.05 ± 0.46
    0.43 ± 0.05
    -0.28 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 7 follow-up (n=24,13,3,1,0,0,0)
    -0.09 ± 0.98
    -0.04 ± 0.32
    0.04 ± 0.12
    -0.08 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 8 follow-up (n=18,13,1,1,0,0,0)
    -0.31 ± 0.8
    0.29 ± 0.89
    0.13 ± 9999.999
    -0.05 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 9 follow-up (n=8,13,1,0,0,0,0)
    -0.43 ± 1.16
    -0.05 ± 0.21
    0.18 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 10 follow-up (n=2,6,0,0,0,0,0)
    0.26 ± 0.99
    0.67 ± 0.68
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in LDL cholesterol - Paediatric population

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    End point title
    Change from baseline in LDL cholesterol - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: mmol/l
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=218,105,30,5,5,3,0)
    -0.22 ± 0.73
    -0.08 ± 0.65
    -0.27 ± 0.52
    -0.4 ± 0.37
    -0.58 ± 1.86
    -0.03 ± 0.23
    9999.999 ± 9999.999
        Year 2 follow-up (n=151,60,18,3,6,2,0)
    -0.26 ± 0.64
    -0.17 ± 0.58
    -0.06 ± 0.65
    -1.86 ± 1.55
    0.02 ± 2.14
    -0.9 ± 0.57
    9999.999 ± 9999.999
        Year 3 follow-up (n=95,30,13,3,3,0,3)
    -0.41 ± 0.79
    -0.28 ± 0.44
    -0.41 ± 0.88
    -0.28 ± 1.14
    1.18 ± 1.03
    9999.999 ± 9999.999
    -0.15 ± 0.44
        Year 4 follow-up (n=59,34,9,3,2,0,0)
    -0.46 ± 0.8
    -0.26 ± 0.71
    0.15 ± 0.79
    -0.48 ± 0.48
    0.7 ± 1.13
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 5 follow-up (n=30,25,4,1,1,0,0)
    -0.4 ± 0.62
    -0.4 ± 0.6
    -0.69 ± 0.72
    -0.96 ± 9999.999
    0 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 6 follow-up (n=30,19,3,1,0,0,0)
    -0.35 ± 0.76
    -0.26 ± 0.49
    -0.53 ± 0.82
    -1.5 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 7 follow-up (n=24,12,4,1,0,0,0)
    -0.36 ± 0.95
    -0.32 ± 0.57
    -0.32 ± 1.13
    -5.98 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 8 follow-up (n=17,11,2,1,0,0,0)
    -0.51 ± 0.57
    -0.2 ± 0.59
    -0.94 ± 1.12
    -6.03 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 9 follow-up (n=8,13,1,0,0,0,0)
    -0.18 ± 1.04
    -0.29 ± 0.65
    -1.71 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 10 follow-up (n=1,5,0,0,0,0,0)
    0.1 ± 9999.999
    -0.93 ± 1.06
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in triglycerides - Paediatric population

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    End point title
    Change from baseline in triglycerides - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: mmol/l
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=267,114,44,8,17,6,0)
    0.18 ± 0.62
    0.09 ± 0.72
    0.12 ± 0.38
    0.64 ± 1.01
    -0.01 ± 0.55
    0.2 ± 0.24
    9999.999 ± 9999.999
        Year 2 follow-up (n=176,65,27,4,11,2,0)
    0.15 ± 0.65
    -0.07 ± 0.52
    0.06 ± 0.62
    -0.82 ± 1.36
    0.02 ± 0.56
    0.05 ± 0.64
    9999.999 ± 9999.999
        Year 3 follow-up (n=107,29,18,2,6,3,3)
    0.12 ± 0.77
    0.21 ± 0.65
    0.33 ± 0.62
    -0.03 ± 0.81
    -0.46 ± 0.52
    0.28 ± 0.28
    -0.15 ± 0.33
        Year 4 follow-up (n=67,35,14,1,1,1,0)
    0.29 ± 0.74
    0.11 ± 0.49
    0.17 ± 0.95
    1.31 ± 9999.999
    -0.04 ± 9999.999
    0 ± 9999.999
    9999.999 ± 9999.999
        Year 5 follow-up (n=37,24,6,1,1,0,0)
    0.29 ± 0.56
    0.18 ± 0.55
    0.13 ± 0.27
    1.22 ± 9999.999
    0.39 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 6 follow-up (n=30,18,4,1,0,0,0)
    0.31 ± 0.86
    0.01 ± 0.61
    0.1 ± 1.19
    0.5 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 7 follow-up (n=20,12,4,1,0,0,0)
    0.35 ± 0.62
    0.13 ± 0.58
    0.72 ± 1.32
    -3.73 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 8 follow-up (n=15,9,2,1,0,0,0)
    0.28 ± 0.56
    -0.04 ± 0.6
    0.93 ± 0.19
    -3.91 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 9 follow-up (n=8,4,1,0,0,0,0)
    0.21 ± 0.38
    -0.41 ± 0.48
    1.57 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
        Year 10 follow-up (n=1,0,0,0,0,0,0)
    0.38 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in HbA1c - Adult population

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    End point title
    Change from baseline in HbA1c - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: percentage of HbA1c
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=141)
    -0.03 ± 0.48
        Female: Year 2 follow-up (n=104)
    0.03 ± 0.5
        Female: Year 3 follow-up (n=73)
    -0.05 ± 0.71
        Female: Year 4 follow-up (n=64)
    0.13 ± 0.86
        Female: Year 5 follow-up (n=55)
    0.18 ± 0.76
        Female: Year 6 follow-up (n=46)
    0.09 ± 0.7
        Female: Year 7 follow-up (n=33)
    0.12 ± 0.68
        Female: Year 8 follow-up (n=26)
    0.1 ± 0.76
        Female: Year 9 follow-up (n=18)
    0.03 ± 0.42
        Female: Year 10 follow-up (n=19)
    0.02 ± 1
        Male: Year 1 follow-up (n=155)
    0.01 ± 0.43
        Male: Year 2 follow-up (n=140)
    -0.04 ± 0.55
        Male: Year 3 follow-up (n=100)
    0.08 ± 0.37
        Male: Year 4 follow-up (n=83)
    0.1 ± 0.7
        Male: Year 5 follow-up (n=63)
    0.05 ± 0.53
        Male: Year 6 follow-up (n=56)
    0.12 ± 0.4
        Male: Year 7 follow-up (n=48)
    -0.03 ± 0.5
        Male: Year 8 follow-up (n=40)
    0.13 ± 0.74
        Male: Year 9 follow-up (n=22)
    0.23 ± 0.64
        Male: Year 10 follow-up (n=13)
    -0.01 ± 0.65
    No statistical analyses for this end point

    Secondary: Change from baseline in fasting blood glucose - Adult population

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    End point title
    Change from baseline in fasting blood glucose - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: mmol/l
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=102)
    0.16 ± 1.19
        Female: Year 2 follow-up (n=71)
    0.28 ± 1.76
        Female: Year 3 follow-up (n=58)
    0.4 ± 0.83
        Female: Year 4 follow-up (n=49)
    1.22 ± 4.99
        Female: Year 5 follow-up (n=38)
    0.24 ± 0.82
        Female: Year 6 follow-up (n=28)
    0.42 ± 1.02
        Female: Year 7 follow-up (n=23)
    0.15 ± 1.86
        Female: Year 8 follow-up (n=16)
    0.52 ± 0.96
        Female: Year 9 follow-up (n=15)
    0.27 ± 0.82
        Female: Year 10 follow-up (n=11)
    -0.34 ± 2.91
        Male: Year 1 follow-up (n=121)
    0.23 ± 1.15
        Male: Year 2 follow-up (n=90)
    0.21 ± 0.86
        Male: Year 3 follow-up (n=71)
    0.18 ± 0.76
        Male: Year 4 follow-up (n=61)
    0.21 ± 1.06
        Male: Year 5 follow-up (n=43)
    0.47 ± 0.86
        Male: Year 6 follow-up (n=38)
    0.6 ± 1.21
        Male: Year 7 follow-up (n=31)
    0.55 ± 0.85
        Male: Year 8 follow-up (n=29)
    0.84 ± 2.48
        Male: Year 9 follow-up (n=17)
    0.26 ± 1.4
        Male: Year 10 follow-up (n=18)
    1.22 ± 2.9
    No statistical analyses for this end point

    Secondary: Change from baseline in total cholesterol - Adult population

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    End point title
    Change from baseline in total cholesterol - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: mmol/l
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=132)
    0.03 ± 0.88
        Female: Year 2 follow-up (n=103)
    -0.06 ± 1.09
        Female: Year 3 follow-up (n=79)
    -0.07 ± 1.24
        Female: Year 4 follow-up (n=64)
    -0.16 ± 1.07
        Female: Year 5 follow-up (n=58)
    -0.19 ± 1.15
        Female: Year 6 follow-up (n=48)
    -0.2 ± 0.93
        Female: Year 7 follow-up (n=36)
    -0.53 ± 1.46
        Female: Year 8 follow-up (n=27)
    -0.46 ± 1.29
        Female: Year 9 follow-up (n=30)
    -0.43 ± 1.58
        Female: Year 10 follow-up (n=18)
    -0.52 ± 1.63
        Male: Year 1 follow-up (n=160)
    -0.25 ± 0.94
        Male: Year 2 follow-up (n=144)
    -0.44 ± 1.01
        Male: Year 3 follow-up (n=106)
    -0.37 ± 1.24
        Male: Year 4 follow-up (n=87)
    -0.39 ± 1.15
        Male: Year 5 follow-up (n=72)
    -0.24 ± 1.02
        Male: Year 6 follow-up (n=62)
    -0.51 ± 1.05
        Male: Year 7 follow-up (n=51)
    -0.72 ± 1.27
        Male: Year 8 follow-up (n=40)
    -0.74 ± 1.3
        Male: Year 9 follow-up (n=33)
    -1.02 ± 1.08
        Male: Year 10 follow-up (n=25)
    -0.87 ± 1.39
    No statistical analyses for this end point

    Secondary: Change from baseline in HDL cholesterol - Adult population

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    End point title
    Change from baseline in HDL cholesterol - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: mmol/l
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=127)
    0.03 ± 0.41
        Female: Year 2 follow-up (n=98)
    -0.01 ± 0.33
        Female: Year 3 follow-up (n=79)
    0.03 ± 0.46
        Female: Year 4 follow-up (n=65)
    0.03 ± 0.4
        Female: Year 5 follow-up (n=57)
    0.05 ± 0.4
        Female: Year 6 follow-up (n=46)
    -0.06 ± 0.44
        Female: Year 7 follow-up (n=33)
    -0.04 ± 0.5
        Female: Year 8 follow-up (n=24)
    0.04 ± 0.41
        Female: Year 9 follow-up (n=27)
    0.03 ± 0.33
        Female: Year 10 follow-up (n=18)
    0.06 ± 0.27
        Male: Year 1 follow-up (n=160)
    -0.02 ± 0.23
        Male: Year 2 follow-up (n=139)
    -0 ± 0.28
        Male: Year 3 follow-up (n=101)
    0 ± 0.21
        Male: Year 4 follow-up (n=81)
    0.04 ± 0.28
        Male: Year 5 follow-up (n=67)
    0.07 ± 0.21
        Male: Year 6 follow-up (n=54)
    0.08 ± 0.46
        Male: Year 7 follow-up (n=50)
    0.18 ± 0.52
        Male: Year 8 follow-up (n=34)
    0.12 ± 0.43
        Male: Year 9 follow-up (n=31)
    0.14 ± 0.35
        Male: Year 10 follow-up (n=23)
    0.1 ± 0.2
    No statistical analyses for this end point

    Secondary: Change from baseline in LDL cholesterol - Adult population

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    End point title
    Change from baseline in LDL cholesterol - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: mmol/l
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=104)
    -0.04 ± 0.9
        Female: Year 2 follow-up (n=74)
    -0.08 ± 1.06
        Female: Year 3 follow-up (n=54)
    -0.01 ± 1.34
        Female: Year 4 follow-up (n=46)
    -0.08 ± 0.86
        Female: Year 5 follow-up (n=43)
    0.05 ± 1.06
        Female: Year 6 follow-up (n=36)
    -0.11 ± 1.19
        Female: Year 7 follow-up (n=24)
    -0.33 ± 1.4
        Female: Year 8 follow-up (n=15)
    0 ± 1.59
        Female: Year 9 follow-up (n=17)
    -0.31 ± 1.48
        Female: Year 10 follow-up (n=9)
    -0.05 ± 1.68
        Male: Year 1 follow-up (n=120)
    -0.28 ± 0.85
        Male: Year 2 follow-up (n=106)
    -0.42 ± 0.85
        Male: Year 3 follow-up (n=70)
    -0.42 ± 0.9
        Male: Year 4 follow-up (n=51)
    -0.37 ± 0.9
        Male: Year 5 follow-up (n=47)
    -0.19 ± 0.82
        Male: Year 6 follow-up (n=37)
    -0.45 ± 0.98
        Male: Year 7 follow-up (n=31)
    -0.34 ± 0.97
        Male: Year 8 follow-up (n=21)
    -0.53 ± 0.74
        Male: Year 9 follow-up (n=18)
    -0.61 ± 0.84
        Male: Year 10 follow-up (n=9)
    -0.63 ± 0.73
    No statistical analyses for this end point

    Secondary: Change from baseline in triglycerides - Adult population

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    End point title
    Change from baseline in triglycerides - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm.
    End point type
    Secondary
    End point timeframe
    Up to 9 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: mmol/l
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=35)
    0.17 ± 1
        Female: Year 2 follow-up (n=18)
    0.04 ± 0.7
        Female: Year 3 follow-up (n=10)
    -0.02 ± 0.66
        Female: Year 4 follow-up (n=10)
    0.2 ± 1.05
        Female: Year 5 follow-up (n=10)
    -0.06 ± 0.93
        Female: Year 6 follow-up (n=9)
    0.09 ± 0.7
        Female: Year 7 follow-up (n=3)
    0.48 ± 2.63
        Female: Year 8 follow-up (n=1)
    1.06 ± 9999.999
        Male: Year 1 follow-up (n=50)
    0.2 ± 0.78
        Male: Year 2 follow-up (n=40)
    0.19 ± 0.74
        Male: Year 3 follow-up (n=16)
    0.02 ± 0.38
        Male: Year 4 follow-up (n=11)
    -0.05 ± 0.6
        Male: Year 5 follow-up (n=9)
    -0.17 ± 0.67
        Male: Year 6 follow-up (n=6)
    -0.41 ± 0.99
        Male: Year 7 follow-up (n=5)
    -0.17 ± 0.74
        Male: Year 9 follow-up (n=1)
    1.7 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in Bone age/Chronological age - Paediatric population

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    End point title
    Change from baseline in Bone age/Chronological age - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: ratio
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=1250,602,199,31,39,11,3)
    0.04 ± 0.12
    0.05 ± 0.13
    0.02 ± 0.14
    0.04 ± 0.09
    0.02 ± 0.1
    0.01 ± 0.09
    0.1 ± 0.15
        Year 2 follow-up (n=975,475,164,16,32,12,4)
    0.09 ± 0.14
    0.09 ± 0.15
    0.07 ± 0.15
    0.12 ± 0.17
    0.05 ± 0.12
    0.09 ± 0.13
    0.11 ± 0.32
        Year 3 follow-up (n=774,364,146,14,19,7,3)
    0.13 ± 0.15
    0.15 ± 0.17
    0.07 ± 0.15
    0.1 ± 0.12
    0.07 ± 0.14
    0.13 ± 0.15
    0.08 ± 0.28
        Year 4 follow-up (n=518,265,116,8,14,3,5)
    0.17 ± 0.17
    0.18 ± 0.17
    0.1 ± 0.17
    0.18 ± 0.2
    0.03 ± 0.16
    0.16 ± 0.14
    0.21 ± 0.33
        Year 5 follow-up (n=406,194,87,6,11,5,5)
    0.21 ± 0.18
    0.21 ± 0.18
    0.13 ± 0.18
    0.1 ± 0.26
    0.14 ± 0.13
    0.23 ± 0.17
    0.28 ± 0.39
        Year 6 follow-up (n=244,138,55,4,2,2,1)
    0.25 ± 0.33
    0.24 ± 0.18
    0.15 ± 0.19
    0.17 ± 0.45
    0.25 ± 0.11
    0.13 ± 0.05
    0.25 ± 9999.999
        Year 7 follow-up (n=172,109,48,3,3,0,1)
    0.27 ± 0.37
    0.25 ± 0.23
    0.16 ± 0.19
    0.34 ± 0.18
    0.22 ± 0.09
    9999.999 ± 9999.999
    0.15 ± 9999.999
        Year 8 follow-up (n=123,66,31,0,3,1,2)
    0.28 ± 0.42
    0.32 ± 0.18
    0.2 ± 0.17
    9999.999 ± 9999.999
    0.04 ± 0.08
    0.03 ± 9999.999
    0.29 ± 0.05
        Year 9 follow-up (n=82,45,15,1,3,2,2)
    0.25 ± 0.5
    0.3 ± 0.26
    0.17 ± 0.19
    0.23 ± 9999.999
    0.24 ± 0.13
    0.09 ± 0.12
    0.26 ± 0
        Year 10 follow-up (n=29,14,10,1,1,0,1)
    0.21 ± 0.8
    0.35 ± 0.22
    0.13 ± 0.34
    0.38 ± 9999.999
    0.18 ± 9999.999
    9999.999 ± 9999.999
    0.27 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in insulin-like growth factor 1 (IGF-I) SDS (Brabant) - Paediatric population

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    End point title
    Change from baseline in insulin-like growth factor 1 (IGF-I) SDS (Brabant) - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: Standard deviation scores
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=2562,1044,314,30,93,20,16)
    2.17 ± 1.62
    1.73 ± 1.41
    2.26 ± 1.45
    2.03 ± 1.69
    1.8 ± 1.57
    1.53 ± 1.3
    1.71 ± 1.85
        Year 2 follow-up (n=2092,826,252,17,67,20,14)
    2.42 ± 1.81
    1.78 ± 1.54
    2.28 ± 1.69
    2.32 ± 2.27
    2.18 ± 1.72
    1.79 ± 1.52
    2.1 ± 1.52
        Year 3 follow-up (n=1673,652,235,19,47,11,11)
    2.45 ± 1.88
    1.83 ± 1.59
    2.37 ± 1.76
    2.47 ± 2.03
    2.41 ± 1.95
    1.58 ± 2.23
    1.91 ± 1.78
        Year 4 follow-up (n=1248,502,176,9,31,10,11)
    2.25 ± 1.9
    1.68 ± 1.7
    2.1 ± 1.81
    2.84 ± 1.82
    2.04 ± 2.09
    1.6 ± 1.91
    2.1 ± 1.69
        Year 5 follow-up (n=881,361,139,7,19,5,7)
    2.18 ± 1.92
    1.36 ± 1.9
    1.86 ± 2.1
    1.42 ± 2.12
    2.09 ± 1.75
    0.65 ± 2.15
    1.65 ± 1.94
        Year 6 follow-up (n=634,267,96,5,10,4,3)
    1.95 ± 1.93
    1.39 ± 1.76
    1.71 ± 1.69
    2.36 ± 0.99
    1.12 ± 2.18
    0.99 ± 2.84
    0.52 ± 2.69
        Year 7 follow-up (n=428,188,73,4,9,3,2)
    1.91 ± 1.8
    1.54 ± 1.68
    1.71 ± 1.83
    1.31 ± 1.22
    1.81 ± 1.45
    -2.07 ± 1.31
    -0.32 ± 2.59
        Year 8 follow-up (n=285,117,44,2,5,3,1)
    1.68 ± 2.01
    1.37 ± 1.69
    1.5 ± 1.83
    1.04 ± 1.73
    2.68 ± 2.11
    -0.81 ± 1.03
    -0.45 ± 9999.999
        Year 9 follow-up (n=204,83,29,3,1,3,2)
    1.67 ± 1.78
    1.44 ± 1.76
    1.75 ± 1.4
    2.38 ± 2.27
    3.13 ± 9999.999
    -1.35 ± 1.82
    -0.98 ± 3.47
        Year 10 follow-up (n=108,39,16,3,1,1,2)
    1.72 ± 1.8
    1.23 ± 1.53
    1.83 ± 1.47
    2.03 ± 0.54
    4.16 ± 9999.999
    -1.27 ± 9999.999
    -0.81 ± 4.01
    No statistical analyses for this end point

    Secondary: Change from baseline in insulin-like growth factor binding protein 3 (IGFBP-3) SDS (Juul) - Paediatric population

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    End point title
    Change from baseline in insulin-like growth factor binding protein 3 (IGFBP-3) SDS (Juul) - Paediatric population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints. The number "9999.999" represents data not applicable for a particular arm
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Growth Hormone Deficiency (GHD) - Paediatric Population Small for Gestational Age (SGA) - Paediatric Population Turner Syndrome (TS) - Paediatric Population Chronic Renal Disease (CRD) - Paediatric Population Idiopathic Short Stature (ISS) - Paediatric Population Noonan Syndrome (NS) - Paediatric Population Prader-Willi Syndrome (PWS) - Paediatric Population
    Number of subjects analysed
    7141
    3200
    936
    200
    317
    106
    67
    Units: Standard deviation scores
    arithmetic mean (standard deviation)
        Year 1 follow-up (n=1386,589,145,18,45,11,9)
    1.4 ± 1.7
    1.33 ± 1.5
    1.43 ± 1.74
    2.04 ± 1.77
    1.3 ± 2.19
    1.01 ± 1.42
    2.16 ± 1.24
        Year 2 follow-up (n=1126,453,119,8,30,7,8)
    1.63 ± 1.79
    1.47 ± 1.65
    1.79 ± 1.82
    2.23 ± 1.63
    1.94 ± 1.21
    1.28 ± 1.14
    1.69 ± 1.4
        Year 3 follow-up (n=893,359,117,9,18,5,7)
    1.82 ± 1.92
    1.65 ± 1.73
    2.02 ± 1.89
    2.87 ± 3.34
    1.88 ± 1.53
    2.39 ± 2.78
    2.37 ± 2.29
        Year 4 follow-up (n=670,283,80,3,15,2,5)
    1.92 ± 1.98
    1.75 ± 1.9
    1.85 ± 2.34
    2.31 ± 2.16
    1.45 ± 1.3
    1.22 ± 0.91
    2.83 ± 1.4
        Year 5 follow-up (n=488,204,66,2,9,2,4)
    2.01 ± 1.95
    1.85 ± 2.06
    1.51 ± 2.31
    2.41 ± 0.12
    1.91 ± 1.51
    1.34 ± 0.81
    3 ± 2.83
        Year 6 follow-up (n=339,160,44,2,5,1,1)
    2.05 ± 2.11
    2.21 ± 1.97
    2 ± 2.01
    2.32 ± 1.53
    1.16 ± 1.8
    0.32 ± 9999.999
    3.08 ± 9999.999
        Year 7 follow-up (n=210,113,32,3,6,1,0)
    2.3 ± 2.16
    2.26 ± 2.18
    1.98 ± 2.09
    2.43 ± 1.67
    2.27 ± 3.01
    0.29 ± 9999.999
    9999.999 ± 9999.999
        Year 8 follow-up (n=140,75,19,2,2,1,0)
    1.79 ± 2.22
    2.1 ± 1.96
    1.86 ± 2.62
    1.98 ± 1.63
    1.08 ± 1.94
    0.59 ± 9999.999
    9999.999 ± 9999.999
        Year 9 follow-up (n=91,57,12,1,0,1,0)
    2.2 ± 2.19
    2.08 ± 2.03
    1.8 ± 1.96
    3.15 ± 9999.999
    9999.999 ± 9999.999
    0.28 ± 9999.999
    9999.999 ± 9999.999
        Year 10 follow-up (n=44,28,5,2,0,0,0)
    2.43 ± 2.15
    2.1 ± 1.64
    2.69 ± 1.28
    3.14 ± 1.16
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    9999.999 ± 9999.999
    No statistical analyses for this end point

    Secondary: Change from baseline in BMI - Adult population

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    End point title
    Change from baseline in BMI - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: kg/sqm
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=268)
    -0.04 ± 3.02
        Female: Year 2 follow-up (n=206)
    0.57 ± 4.89
        Female: Year 3 follow-up (n=166)
    0.6 ± 4.29
        Female: Year 4 follow-up (n=134)
    0.46 ± 2.92
        Female: Year 5 follow-up (n=112)
    0.23 ± 2.72
        Female: Year 6 follow-up (n=95)
    0.18 ± 2.66
        Female: Year 7 follow-up (n=82)
    0.27 ± 3.17
        Female: Year 8 follow-up (n=62)
    0.8 ± 2.9
        Female: Year 9 follow-up (n=56)
    0.4 ± 3.1
        Female: Year 10 follow-up (n=39)
    0.82 ± 3.11
        Male: Year 1 follow-up (n=310)
    0.18 ± 3.21
        Male: Year 2 follow-up (n=262)
    0 ± 2.52
        Male: Year 3 follow-up (n=193)
    0.41 ± 4.53
        Male: Year 4 follow-up (n=177)
    0.31 ± 3.64
        Male: Year 5 follow-up (n=139)
    0.31 ± 3.38
        Male: Year 6 follow-up (n=120)
    0.52 ± 2.95
        Male: Year 7 follow-up (n=94)
    0.32 ± 3.48
        Male: Year 8 follow-up (n=88)
    0.68 ± 3.51
        Male: Year 9 follow-up (n=63)
    0.66 ± 3.53
        Male: Year 10 follow-up (n=50)
    1.07 ± 3.04
    No statistical analyses for this end point

    Secondary: Change from baseline in IGF-I SDS (Brabant) - Adult population

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    End point title
    Change from baseline in IGF-I SDS (Brabant) - Adult population
    End point description
    Analysis was based on the effectiveness analysis set. Here, "n" represents the number of subjects with data available at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to 10 years of follow up
    End point values
    Adult Growth Hormone Deficiency (AGHD) - Adult Population
    Number of subjects analysed
    971
    Units: Standard deviation scores
    arithmetic mean (standard deviation)
        Female: Year 1 follow-up (n=219)
    1.2 ± 1.51
        Female: Year 2 follow-up (n=168)
    1.32 ± 1.47
        Female: Year 3 follow-up (n=133)
    1.29 ± 1.4
        Female: Year 4 follow-up (n=112)
    1.52 ± 1.45
        Female: Year 5 follow-up (n=90)
    1.27 ± 1.43
        Female: Year 6 follow-up (n=69)
    1.47 ± 1.56
        Female: Year 7 follow-up (n=62)
    1.8 ± 1.17
        Female: Year 8 follow-up (n=47)
    1.54 ± 1.46
        Female: Year 9 follow-up (n=41)
    1.93 ± 1.44
        Female: Year 10 follow-up (n=27)
    1.46 ± 1.49
        Male: Year 1 follow-up (n=258)
    1.52 ± 1.47
        Male: Year 2 follow-up (n=218)
    1.64 ± 1.46
        Male: Year 3 follow-up (n=167)
    1.51 ± 1.52
        Male: Year 4 follow-up (n=149)
    1.42 ± 1.47
        Male: Year 5 follow-up (n=107)
    1.41 ± 1.55
        Male: Year 6 follow-up (n=97)
    1.54 ± 1.53
        Male: Year 7 follow-up (n=82)
    1.34 ± 1.43
        Male: Year 8 follow-up (n=71)
    1.03 ± 1.49
        Male: Year 9 follow-up (n=54)
    1.48 ± 1.45
        Male: Year 10 follow-up (n=46)
    1.72 ± 1.29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Full study duration (01 Apr 2006 to 31 Dec 2016)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Paediatric GHD
    Reporting group description
    Paediatric patients with Growth Hormone Deficiency who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric SGA
    Reporting group description
    Paediatric patients with Small for Gestational Age (SGA) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric TS
    Reporting group description
    Paediatric patients with Turner Syndrome (TA) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric CRD
    Reporting group description
    Paediatric patients with chronic renal disease (CRD) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric ISS
    Reporting group description
    Paediatric patients with idiopathic short stature (ISS) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric NS
    Reporting group description
    Paediatric patients with Noonan syndrome (NS) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric PWS
    Reporting group description
    Paediatric patients with Prader-Willi Syndrome (PWS) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Paediatric Other
    Reporting group description
    The paediatric population with other growth disorder. The population represents full analysis set.

    Reporting group title
    Adult GHD
    Reporting group description
    Adult patients with adult growth hormone disease (GHD) who were being treated with Norditropin®. The population represents full analysis set.

    Reporting group title
    Adult Other
    Reporting group description
    -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events with frequency of more than 5% in any sub-group.
    Serious adverse events
    Paediatric GHD Paediatric SGA Paediatric TS Paediatric CRD Paediatric ISS Paediatric NS Paediatric PWS Paediatric Other Adult GHD Adult Other
    Total subjects affected by serious adverse events
         subjects affected / exposed
    174 / 9996 (1.74%)
    51 / 4274 (1.19%)
    30 / 1374 (2.18%)
    7 / 290 (2.41%)
    9 / 485 (1.86%)
    3 / 154 (1.95%)
    11 / 132 (8.33%)
    18 / 1035 (1.74%)
    133 / 2321 (5.73%)
    10 / 163 (6.13%)
         number of deaths (all causes)
    4
    1
    0
    2
    0
    0
    1
    3
    14
    0
         number of deaths resulting from adverse events
    1
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accident at work
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    1 / 485 (0.21%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    1 / 485 (0.21%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 9996 (0.00%)
    2 / 4274 (0.05%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    2 / 2321 (0.09%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Greenstick fracture
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open fracture
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shunt malfunction
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood glucose decreased
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Body temperature fluctuation
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cortisol abnormal
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cortisol decreased
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    3 / 2321 (0.13%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    1 / 485 (0.21%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paracentesis
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    6 / 2321 (0.26%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 9996 (0.02%)
    1 / 4274 (0.02%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    5 / 2321 (0.22%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arnold-Chiari malformation
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bicuspid aortic valve
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choanal atresia
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital foot malformation
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Developmental glaucoma
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gonadal dysgenesis
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hamartoma
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interruption of aortic arch
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pectus excavatum
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibial torsion
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type V hyperlipidaemia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic haematoma
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    3 / 2321 (0.13%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral cyst
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral disorder
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    4 / 2321 (0.17%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    5 / 9996 (0.05%)
    2 / 4274 (0.05%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    1 / 154 (0.65%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    2 / 9996 (0.02%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    2 / 9996 (0.02%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    8 / 9996 (0.08%)
    2 / 4274 (0.05%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    7 / 8
    2 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    2 / 9996 (0.02%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic intracranial hypertension
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    4 / 9996 (0.04%)
    2 / 4274 (0.05%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    2 / 9996 (0.02%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    12 / 9996 (0.12%)
    3 / 4274 (0.07%)
    2 / 1374 (0.15%)
    1 / 290 (0.34%)
    1 / 485 (0.21%)
    0 / 154 (0.00%)
    2 / 132 (1.52%)
    1 / 1035 (0.10%)
    5 / 2321 (0.22%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 3
    1 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    2 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 9996 (0.01%)
    2 / 4274 (0.05%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    5 / 2321 (0.22%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Temporal lobe epilepsy
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transverse sinus thrombosis
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Macular degeneration
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Maculopathy
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strabismus
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 9996 (0.01%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Middle ear disorder
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otorrhoea
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal prolapse
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    2 / 163 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0