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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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenoma benign
         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
    Anaplastic astrocytoma
         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
    1 / 1
    0 / 0
    Angiosarcoma metastatic
         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
    Astrocytoma malignant
         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
    Benign neoplasm
         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
    Bladder neoplasm
         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 neoplasm
         subjects affected / exposed
    3 / 9996 (0.03%)
    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 / 3
    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
    Bronchial carcinoma
         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
    Burkitt's lymphoma
         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
    Choroid plexus carcinoma
         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
    Colon cancer metastatic
         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
    1 / 1
    0 / 0
    Craniopharyngioma
         subjects affected / exposed
    3 / 9996 (0.03%)
    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 / 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
    Craniopharyngioma benign
         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
    Enchondromatosis
         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
    Follicle centre lymphoma, follicular grade I, II, III
         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
    Gastric cancer stage 0
         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
    Glioma
         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
    Glioneuronal tumour
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    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 / 0
    0 / 0
    0 / 0
    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
    Haemangioma
         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
    Hodgkin's disease
         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
    Intraductal papillary mucinous neoplasm
         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
    Lipoma
         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
    Lung adenocarcinoma
         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
    Lymphocytic leukaemia
         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
    Malignant melanoma
         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%)
    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 / 1
    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 / 1
    0 / 0
    Mantle cell lymphoma
         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
    Medulloblastoma recurrent
         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
    Metastases to meninges
         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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to spine
         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
    Multiple myeloma
         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
    Myelofibrosis
         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
    Nasal sinus cancer
         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
    Neoplasm
         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
    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
    Neoplasm malignant
         subjects affected / exposed
    3 / 9996 (0.03%)
    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%)
    9 / 2321 (0.39%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    4 / 11
    0 / 2
         deaths 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
    Neoplasm progression
         subjects affected / exposed
    3 / 9996 (0.03%)
    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%)
    3 / 2321 (0.13%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 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
    Neoplasm recurrence
         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%)
    2 / 1035 (0.19%)
    1 / 2321 (0.04%)
    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 / 2
    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 / 1
    0 / 0
    Nephroblastoma
         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
    Non-secretory adenoma of pituitary
         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
    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
    Oral neoplasm benign
         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
    Papillary renal cell carcinoma
         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
    Papillary thyroid cancer
         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
    Pituitary tumour
         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
    Pituitary tumour benign
         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
    2 / 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
    Primitive neuroectodermal tumour
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    1 / 485 (0.21%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    2 / 1035 (0.19%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Prostate cancer
         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
    Recurrent cancer
         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
    1 / 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
    Renal cancer
         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
    Renal cell carcinoma
         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
    Schwannoma
         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
    T-cell lymphoma
         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
    Vascular disorders
    Deep vein thrombosis
         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
    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%)
    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
    Hypertension
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    1 / 1374 (0.07%)
    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
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    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
    Hypotension
         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
    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
    Venous thrombosis
         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
    Venous thrombosis limb
         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
    Surgical and medical procedures
    Adenoidectomy
         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
    Adenotonsillectomy
         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%)
    1 / 1035 (0.10%)
    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 / 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
    Bone lesion excision
         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
    Cholecystectomy
         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
    Cholecystostomy
         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
    Ear operation
         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
    Gastrostomy closure
         subjects affected / exposed
    1 / 9996 (0.01%)
    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 / 1
    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
    Hip surgery
         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
    Hospitalisation
         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
    Limb operation
         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
    Myringotomy
         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
    Orchidopexy
         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
    Peritoneal dialysis
         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
    Pituitary tumour removal
         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
    Plastic surgery to the face
         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
    Renal transplant
         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%)
    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 / 1
    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
    Rotator cuff repair
         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
    Spinal fusion surgery
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    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 / 0
    0 / 0
    0 / 0
    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
    Strabismus correction
         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
    Ventricular septal defect repair
         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
    Wisdom teeth removal
         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
    Pregnancy, puerperium and perinatal conditions
    Pre-eclampsia
         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
    General disorders and administration site conditions
    Asthenia
         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
    Chest pain
         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
    Condition aggravated
         subjects affected / exposed
    2 / 9996 (0.02%)
    2 / 4274 (0.05%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    1 / 154 (0.65%)
    2 / 132 (1.52%)
    1 / 1035 (0.10%)
    3 / 2321 (0.13%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    1 / 3
    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
    Death
         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 / 4
    0 / 0
    Discomfort
         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
    Disease recurrence
         subjects affected / exposed
    3 / 9996 (0.03%)
    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 / 3
    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
    Face oedema
         subjects affected / exposed
    1 / 9996 (0.01%)
    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
    1 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         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
    1 / 2
    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
    General physical health deterioration
         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
    Hyperthermia
         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 / 3
    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
    Injection site atrophy
         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
    Malaise
         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
    1 / 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
    Oedema
         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
    1 / 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
    Peripheral swelling
         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
    Pyrexia
         subjects affected / exposed
    3 / 9996 (0.03%)
    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
    Sudden death
         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%)
    1 / 132 (0.76%)
    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 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         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
    Ovarian disorder
         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
    Varicocele
         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
    Respiratory, thoracic and mediastinal disorders
    Adenoidal disorder
         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
    Asthma
         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%)
    1 / 132 (0.76%)
    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 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphonia
         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
    Dyspnoea
         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%)
    1 / 2321 (0.04%)
    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 / 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
    Hyperventilation
         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
    Lung disorder
         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
    Oropharyngeal pain
         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
    Pleural effusion
         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
    Pneumothorax
         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
    Pulmonary artery wall hypertrophy
         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
    Pulmonary embolism
         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 / 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
    Pulmonary 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
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         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
    Rhinorrhoea
         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
    Sleep apnoea syndrome
         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%)
    1 / 132 (0.76%)
    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
    1 / 1
    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
    Stridor
         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
    Tonsillar hypertrophy
         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
    Psychiatric disorders
    Anxiety
         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
    Completed suicide
         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 / 1
    0 / 0
    Depression
         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%)
    3 / 2321 (0.13%)
    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 / 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
    Mental disorder
         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%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    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 / 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
    Restlessness
         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
    2 / 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
    Screaming
         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
    2 / 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
    Sleep disorder
         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
    2 / 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
    Stress
         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
    Suicide attempt
         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 / 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
    Tic
         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
    Product issues
    Device malfunction
    alternative dictionary used: MedDRA 3
         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
    Hepatobiliary disorders
    Biliary colic
         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
    Cholelithiasis
         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%)
    1 / 163 (0.61%)
         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 / 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
    Hepatitis
         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%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Hepatorenal 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%)
    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
    Hyperbilirubinaemia
         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
    Liver 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%)
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         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
    Duodenal ulcer perforation
         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
    Gastric ulcer 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
    Gastritis
         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
    Giant cell epulis
         subjects affected / exposed
    0 / 9996 (0.00%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    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 / 0
    0 / 0
    0 / 0
    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
    Ileus
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammatory bowel disease
         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
    Inguinal hernia
         subjects affected / exposed
    2 / 9996 (0.02%)
    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 / 2
    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
    Large intestine perforation
         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
    Nausea
         subjects affected / exposed
    0 / 9996 (0.00%)
    1 / 4274 (0.02%)
    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
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    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
    Pancreatitis
         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
    Pancreatitis acute
         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%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Stomatitis
         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
    Vomiting
         subjects affected / exposed
    5 / 9996 (0.05%)
    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%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 1
    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
    Skin and subcutaneous tissue disorders
    Erythema
         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
    Night sweats
         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
    Pruritus
         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
    Rash generalised
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin striae
         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
    Swelling face
         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
    Renal and urinary disorders
    Glycosuria
         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
    Nephropathy
         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
    Prerenal failure
         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
    Renal failure
         subjects affected / exposed
    1 / 9996 (0.01%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    1 / 290 (0.34%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    0 / 132 (0.00%)
    1 / 1035 (0.10%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Renal impairment
         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
    Urethral stenosis
         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
    Endocrine disorders
    Adrenocortical insufficiency acute
         subjects affected / exposed
    1 / 9996 (0.01%)
    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%)
    3 / 2321 (0.13%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    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
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 9996 (0.01%)
    2 / 4274 (0.05%)
    2 / 1374 (0.15%)
    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 / 2
    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
    Glucocorticoid deficiency
         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
    Hypothyroidism
         subjects affected / exposed
    4 / 9996 (0.04%)
    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
    4 / 4
    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
    Pituitary 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
    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
    Thyroid mass
         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%)
    2 / 1035 (0.19%)
    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 / 2
    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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 9996 (0.03%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    1 / 132 (0.76%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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
    Arthritis
         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
    Arthritis reactive
         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
    Bone 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
    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
    Chondromalacia
         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
    Collagen disorder
         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
    Epiphysiolysis
         subjects affected / exposed
    3 / 9996 (0.03%)
    3 / 4274 (0.07%)
    2 / 1374 (0.15%)
    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
    2 / 3
    3 / 3
    2 / 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
    Exostosis
         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
    Fibromyalgia
         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
    Intervertebral disc protrusion
         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 / 0
    0 / 0
    Joint instability
         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
    Kyphoscoliosis
         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
    Lumbar spinal stenosis
         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
    Muscle tightness
         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
    Musculoskeletal stiffness
         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
    Myalgia
         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
    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
    Osteoarthritis
         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
    Osteochondrosis
         subjects affected / exposed
    4 / 9996 (0.04%)
    0 / 4274 (0.00%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    2 / 485 (0.41%)
    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
    3 / 4
    0 / 0
    0 / 0
    0 / 0
    2 / 4
    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
    Osteonecrosis
         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
    Pain in extremity
         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
    Psoriatic arthropathy
         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
    Scoliosis
         subjects affected / exposed
    4 / 9996 (0.04%)
    1 / 4274 (0.02%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    1 / 154 (0.65%)
    5 / 132 (3.79%)
    1 / 1035 (0.10%)
    2 / 2321 (0.09%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    1 / 5
    0 / 1
    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
    Spinal column stenosis
         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
    Infections and infestations
    Appendicitis
         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%)
    1 / 2321 (0.04%)
    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 / 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
    Cellulitis
         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
    Cellulitis orbital
         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
    Chronic sinusitis
         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
    Chronic tonsillitis
         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
    Dermo-hypodermitis
         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
    Diverticulitis
         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
    Encephalitis
         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
    Endocarditis
         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
    Erysipelas
         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
    Gastroenteritis
         subjects affected / exposed
    4 / 9996 (0.04%)
    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%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    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
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 9996 (0.01%)
    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%)
    1 / 2321 (0.04%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    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
    Gastroenteritis rotavirus
         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
    Gastroenteritis viral
         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
    Gastrointestinal infection
         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
    Haemorrhagic fever with renal 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%)
    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
    Hepatitis C
         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
    Herpes zoster infection neurological
         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
    Herpes zoster meningitis
         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
    Infection
         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
    Influenza
         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
    Mastoiditis
         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
    Meningitis pneumococcal
         subjects affected / exposed
    1 / 9996 (0.01%)
    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 / 1
    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
    Orchitis
         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
    Osteomyelitis chronic
         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
    Otitis media
         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
    Peritonitis
         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%)
    0 / 1035 (0.00%)
    1 / 2321 (0.04%)
    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 / 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
    Pilonidal cyst
         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
    Pneumonia
         subjects affected / exposed
    7 / 9996 (0.07%)
    1 / 4274 (0.02%)
    2 / 1374 (0.15%)
    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 / 8
    0 / 1
    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
    Pneumonia influenzal
         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
    Pyelonephritis
         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
    Respiratory syncytial virus bronchitis
         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
    Respiratory tract infection
         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
    Rhinitis
         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
    Sepsis
         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
    Sinusitis
         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
    Tonsillitis
         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
    Tracheobronchitis
         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
    Urinary tract infection
         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
    Viral upper respiratory tract infection
         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
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 9996 (0.02%)
    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
    1 / 2
    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
    Dehydration
         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
    Diabetes mellitus
         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
    Diabetic ketoacidosis
         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%)
    2 / 1035 (0.19%)
    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 / 2
    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
    Hyperglycaemia
         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
    2 / 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
    Hyperlipidaemia
         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
    Hypernatraemia
         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
    Hypoglycaemia
         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
    Hypokalaemia
         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
    Hyponatraemia
         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
    Lack of satiety
         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
    Metabolic alkalosis
         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
    Type 1 diabetes mellitus
         subjects affected / exposed
    4 / 9996 (0.04%)
    1 / 4274 (0.02%)
    1 / 1374 (0.07%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    1 / 132 (0.76%)
    0 / 1035 (0.00%)
    0 / 2321 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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 2 diabetes mellitus
         subjects affected / exposed
    2 / 9996 (0.02%)
    3 / 4274 (0.07%)
    0 / 1374 (0.00%)
    0 / 290 (0.00%)
    0 / 485 (0.00%)
    0 / 154 (0.00%)
    1 / 132 (0.76%)
    0 / 1035 (0.00%)
    3 / 2321 (0.13%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    2 / 3
    1 / 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
    Vitamin B12 deficiency
         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
    Vitamin D deficiency
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-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 non serious adverse events
         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%)
    0 / 163 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2008
    1. The International Outcome Study becomes a part of the Novo Nordisk IMPACT system with the number: GHLiquid-3676. 2. Changes in the content of methodology section to clarify the information on parameters based on specificities of different patient populations and different diagnosis. 3. A new subsections "Visit Procedures/Core parameters" and "Bone age assessment" were added. 4. The section "Adverse events and pregnancies reporting" was updated.
    15 Jun 2009
    1. Addition of quality of life assessment in adult population. 2. Addition of medical events of special interest for safety assessment. 3. In the “Baseline” and Follow-up” part, the QoL was added and Resistance, Lean tissue and Fat tissue measurements are deleted. In addition, the “End of GH treatment/De-registration/Change of clinic” part was deleted. 4. Changes to Ethical considerations section for more clarification.
    12 May 2011
    1. Study timelines was updated to reflect a 5-year extension of recruitment period. 2. Study objective section was updated to provide more clarity about Norditropin® efficacy according to different patient groups. 3. The study sample size was updated in line with a 5-year extension of recruitment period. 4. The former subsection Visit procedure/Core parameters was replaced with the sub-section Visit procedures. 5. Bone age assessment: the section was updated to reflect reporting of Bone Health Index value in the Nordinet section related to the BoneXpert®. 6. Data management: The content was updated to include requirement for written consent for off-treatment data collection. 7. Sub-section "validation of data": The content was updated in accordance with Nordinet® system advancement. 8. The section "Adverse events" was renamed as Safety reporting. 9. A new section was added: severity assessment definitions. 10. Specified that the reporting of pregnancy in female partner was done if accepted by IEC. 11. Ethical consideration: This section was updated in relation to informed consent for off-treatment data collection in GHD transition phase, pregnancy in female partners and in patients after achieving 18 years.
    30 Sep 2013
    1. The subsection "timelines" was updated to implement a Quality Assurance Report. 2. Information on the sample size was updated to reflect the current status of the study. 3. Serious adverse events section was updated to integrate important medical events in the definition of a serious adverse event. 4. The definition of adverse drug reactions(ADRs)/serious adverse drug reactions was clarified. 5. Changes in the section- Identification of AE/ADR: The section was updated to reflect the Novo Nordisk SOP “Handling of Adverse Events and Other Safety Information” (edition 17) and the new EMA Legislation. 6. Changes in the section - Supervision Activities: The section was added to implement supervision activities as described in the Novo Nordisk SOP “Planning, Conduct and Reporting of Non-interventional Studies” (edition 5).

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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