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    Clinical Trial Results:
    A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

    Summary
    EudraCT number
    		 2010-020199-45
    Trial protocol
    		 GB   DE   IT   PT   DK   ES  
    Global end of trial date
    16 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2018
    First version publication date
    06 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MOR-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01415427
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BioMarin Pharmaceutical Inc.
    Sponsor organisation address
    105 Digital Drive, Novato, United States, CA 94949
    Public contact
    Clinical Trials Information, BioMarin Pharmaceutical Inc., clinicaltrials@bmrn.com
    Scientific contact
    Clinical Trials Information, BioMarin Pharmaceutical Inc., clinicaltrials@bmrn.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000973-PIP01-10
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and efficacy of BMN 110 administration at 2.0 mg/kg/qw and 2.0 mg/kg/qow in patients with MPS IVA.
    Protection of trial subjects
    This study was designed and monitored in accordance with sponsor procedures, which comply with the ethical principles of Good Clinical Practice, as required by the major regulatory authorities and in accordance with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jul 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 55 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 2
    Country: Number of subjects enrolled
    Brazil: 20
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Colombia: 6
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Japan: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Qatar: 2
    Country: Number of subjects enrolled
    Saudi Arabia: 7
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    175
    EEA total number of subjects
    73
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    93
    Adolescents (12-17 years)
    43
    Adults (18-64 years)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No screening was carried out in this study

    Period 1
    Period 1 title
    MOR-005 Part 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PBO-QOW
    Arm description
    		 Placebo-BMN 110 2.0 mg/kg/qow
    Arm type
    		 Placebo-BMN 110 2.0 mg/kg/qow

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients randomized to the 2.0 mg/kg/qow arm will receive infusions of placebo on alternating weeks, to mask active drug weeks.

    Arm title
    		 PBO-QW
    Arm description
    		 Placebo-BMN 110 2.0 mg/kg/qw
    Arm type
    		 Placebo-BMN 110 2.0 mg/kg/qw

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients randomized to the 2.0 mg/kg/qw arm will receive infusions of placebo on alternating weeks, to mask active drug weeks.

    Arm title
    		 QOW-QOW
    Arm description
    		 BMN 110-BMN 110 2.0 mg/kg/qow
    Arm type
    		 BMN 110-BMN 110 2.0 mg/kg/qow

    Investigational medicinal product name
    Elosulfase alfa
    Investigational medicinal product code
    BMN110
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the double-blind phase of the study, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw or 2.0 mg/kg/qow.

    Arm title
    		 QW-QW
    Arm description
    		 BMN 110-BMN 110 2.0 mg/kg/qw
    Arm type
    		 BMN 110-BMN 110 2.0 mg/kg/qw

    Investigational medicinal product name
    elosulfase alfa
    Investigational medicinal product code
    BMN110
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the double-blind phase of the study, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw or 2.0 mg/kg/qow.

    Number of subjects in period 1
    		PBO-QOW PBO-QW QOW-QOW QW-QW
    Started
    29
    29
    59
    58
    Completed
    29
    28
    58
    55
    Not completed
    0
    1
    1
    3
         Consent withdrawn by subject
    -
    -
    -
    1
         Subjects in Mor004 but not enrolled in Mor005
    -
    -
    -
    2
         Lost to follow-up
    -
    1
    1
    -
    Period 2
    Period 2 title
    MOR-005 Part 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PBO-QOW
    Arm description
    		 Placebo-BMN 110 2.0 mg/kg/qow
    Arm type
    		 Placebo-BMN 110 2.0 mg/kg/qow

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients randomized to the 2.0 mg/kg/qow arm will receive infusions of placebo on alternating weeks, to mask active drug weeks.

    Arm title
    		 PBO-QW
    Arm description
    		 Placebo-BMN 110 2.0 mg/kg/qw
    Arm type
    		 Placebo-BMN 110 2.0 mg/kg/qw

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients randomized to the 2.0 mg/kg/qw arm will receive infusions of placebo on alternating weeks, to mask active drug weeks.

    Arm title
    		 QOW-QOW
    Arm description
    		 BMN 110-BMN 110 2.0 mg/kg/qow
    Arm type
    		 BMN 110-BMN 110 2.0 mg/kg/qow

    Investigational medicinal product name
    elosulfase alfa
    Investigational medicinal product code
    BMN110
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the double-blind phase of the study, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw or 2.0 mg/kg/qow.

    Arm title
    		 QW-QW
    Arm description
    		 BMN 110-BMN 110 2.0 mg/kg/qw
    Arm type
    		 BMN 110-BMN 110 2.0 mg/kg/qw

    Investigational medicinal product name
    elosulfase alfa
    Investigational medicinal product code
    BMN110
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the double-blind phase of the study, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw or 2.0 mg/kg/qow.

    Number of subjects in period 2
    		PBO-QOW PBO-QW QOW-QOW QW-QW
    Started
    29
    28
    58
    55
    Completed
    0
    0
    1
    0
    Not completed
    29
    28
    57
    55
         Adverse event, serious fatal
    -
    -
    1
    -
         Consent withdrawn by subject
    1
    -
    4
    1
         Adverse event, non-fatal
    -
    -
    2
    1
         Other
    -
    -
    1
    -
         Study Termination by Sponsor
    28
    28
    49
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PBO-QOW
    Reporting group description
    		 Placebo-BMN 110 2.0 mg/kg/qow

    Reporting group title
    PBO-QW
    Reporting group description
    		 Placebo-BMN 110 2.0 mg/kg/qw

    Reporting group title
    QOW-QOW
    Reporting group description
    		 BMN 110-BMN 110 2.0 mg/kg/qow

    Reporting group title
    QW-QW
    Reporting group description
    		 BMN 110-BMN 110 2.0 mg/kg/qw

    Reporting group values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Total
    Number of subjects
    		 29 29 59 58 175
    Age categorical
    Units: Subjects
        5 - 11
    		 15 15 31 32 93
        12 - 18
    		 7 7 16 16 46
        >=19
    		 7 7 12 10 36
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 16.7 ( 13.66 ) 13.5 ( 8.5 ) 15.3 ( 10.79 ) 13.1 ( 8.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 18 25 32 89
        Male
    		 15 11 34 26 86

    End points

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    End points reporting groups
    Reporting group title
    PBO-QOW
    Reporting group description
    		 Placebo-BMN 110 2.0 mg/kg/qow

    Reporting group title
    PBO-QW
    Reporting group description
    		 Placebo-BMN 110 2.0 mg/kg/qw

    Reporting group title
    QOW-QOW
    Reporting group description
    		 BMN 110-BMN 110 2.0 mg/kg/qow

    Reporting group title
    QW-QW
    Reporting group description
    		 BMN 110-BMN 110 2.0 mg/kg/qw
    Reporting group title
    PBO-QOW
    Reporting group description
    		 Placebo-BMN 110 2.0 mg/kg/qow

    Reporting group title
    PBO-QW
    Reporting group description
    		 Placebo-BMN 110 2.0 mg/kg/qw

    Reporting group title
    QOW-QOW
    Reporting group description
    		 BMN 110-BMN 110 2.0 mg/kg/qow

    Reporting group title
    QW-QW
    Reporting group description
    		 BMN 110-BMN 110 2.0 mg/kg/qw

    Subject analysis set title
    Intent-to-Treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who were randomized into the parent MOR-004 study and received at least one dose of study drug.

    Subject analysis set title
    Modified Per-Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who were randomized into the parent MOR-004 study and received at least one dose of study drug with the exception of: 1. Subjects who underwent orthopaedic surgery in the first 120 weeks of MOR-004/005, based on medical monitor review. 2. Subjects who were administered less than 80% of dosing within the first 120 weeks of MOR-004/005.

    Primary: Baseline Distance Walked in Six Minutes - ITT Population

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    End point title
    		 Baseline Distance Walked in Six Minutes - ITT Population [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline
    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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    29
    29
    59
    58
    176
    Units: Metres
        arithmetic mean (standard deviation)
    219.7 ( 74.22 )
    207.2 ( 64.87 )
    205.7 ( 81.19 )
    203.9 ( 76.32 )
    207.2 ( 75.58 )
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 24 in Distance Walked in Six Minutes - ITT Population

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    End point title
    		 Change from Baseline to Week 24 in Distance Walked in Six Minutes - ITT Population [2]
    End point description
    End point type
    Primary
    End point timeframe
    Week 24 (MOR-005 Week 0)
    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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    29
    29
    59
    57
    175
    Units: Metres
        arithmetic mean (standard deviation)
    23.8 ( 56.21 )
    5 ( 43.27 )
    11.1 ( 49.95 )
    36.5 ( 58.49 )
    20.2 ( 54.02 )
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 72 in Distance Walked in Six Minutes - ITT Population

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    End point title
    		 Change from Baseline to Week 72 in Distance Walked in Six Minutes - ITT Population [3]
    End point description
    End point type
    Primary
    End point timeframe
    Week 72 (MOR-005 Week 48)
    Notes
    [3] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    28
    27
    57
    55
    167
    Units: Metres
        arithmetic mean (standard deviation)
    41.5 ( 89.24 )
    -1.5 ( 112.07 )
    27.2 ( 56.66 )
    30.6 ( 73.66 )
    26.1 ( 79.26 )
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 120 in Distance Walked in Six Minutes - ITT Population

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    End point title
    		 Change from Baseline to Week 120 in Distance Walked in Six Minutes - ITT Population [4]
    End point description
    End point type
    Primary
    End point timeframe
    Week 120 (MOR-005 Week 96)
    Notes
    [4] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    28
    27
    54
    54
    163
    Units: Metres
        arithmetic mean (standard deviation)
    32.3 ( 92.13 )
    -2.9 ( 95.69 )
    6 ( 86.28 )
    29.7 ( 81.37 )
    16.9 ( 87.67 )
    No statistical analyses for this end point

    Primary: Baseline Distance Walked in Six Minutes - MPP Population

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    End point title
    		 Baseline Distance Walked in Six Minutes - MPP Population [5]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [5] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    19
    42
    43
    124
    Units: Metres
        arithmetic mean (standard deviation)
    208.7 ( 78.12 )
    190.2 ( 65.54 )
    195.9 ( 80.4 )
    208.8 ( 73.24 )
    201.6 ( 74.94 )
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 24 in Distance Walked in Six Minutes - MPP Population

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    End point title
    		 Change from Baseline to Week 24 in Distance Walked in Six Minutes - MPP Population [6]
    End point description
    End point type
    Primary
    End point timeframe
    Week 24 (MOR-005 Week 0)
    Notes
    [6] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    19
    42
    43
    124
    Units: Metres
        arithmetic mean (standard deviation)
    30.3 ( 56.53 )
    9.6 ( 46.87 )
    13.6 ( 52.65 )
    41.5 ( 59.89 )
    25.4 ( 56.08 )
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 72 in Distance Walked in Six Minutes - MPP Population

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    End point title
    		 Change from Baseline to Week 72 in Distance Walked in Six Minutes - MPP Population [7]
    End point description
    End point type
    Primary
    End point timeframe
    Week 72 (MOR-005 Week 48)
    Notes
    [7] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    18
    42
    43
    123
    Units: Metres
        arithmetic mean (standard deviation)
    54.5 ( 85.19 )
    37.7 ( 69.35 )
    35.3 ( 58.19 )
    37.5 ( 72.17 )
    39.6 ( 69.11 )
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 120 in Distance Walked in Six Minutes - MPP Population

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    End point title
    		 Change from Baseline to Week 120 in Distance Walked in Six Minutes - MPP Population [8]
    End point description
    End point type
    Primary
    End point timeframe
    Week 120 (MOR-005 Week 96)
    Notes
    [8] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    19
    41
    43
    123
    Units: Metres
        arithmetic mean (standard deviation)
    60.8 ( 64.45 )
    19.8 ( 86.69 )
    19.7 ( 77.29 )
    38.6 ( 66.65 )
    33 ( 73.94 )
    No statistical analyses for this end point

    Primary: Baseline Average Three Minute Stair Climb Rate - ITT Population

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    End point title
    		 Baseline Average Three Minute Stair Climb Rate - ITT Population [9]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [9] - 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: Justification: No statistical analysis performed for this endpoint as it is descriptive analysis
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    29
    29
    59
    58
    176
    Units: stairs/min
        arithmetic mean (standard deviation)
    33.1 ( 15.6 )
    26.9 ( 12.08 )
    27.1 ( 15.8 )
    29.6 ( 16.44 )
    28.9 ( 15.42 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 in Average Three Minute Stair Climb Rate - ITT Population

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    End point title
    		 Change from Baseline to Week 24 in Average Three Minute Stair Climb Rate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24 (MOR-005 Week 0)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    29
    29
    59
    57
    173
    Units: stairs/min
        arithmetic mean (standard deviation)
    4.7 ( 9.65 )
    2.9 ( 7.3 )
    2.9 ( 10.94 )
    4.8 ( 8.06 )
    3.8 ( 9.25 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 72 in Average Three Minute Stair Climb Rate - ITT Population

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    End point title
    		 Change from Baseline to Week 72 in Average Three Minute Stair Climb Rate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 72 (MOR-005 Week 48)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    28
    26
    56
    54
    164
    Units: stairs/min
        arithmetic mean (standard deviation)
    8.9 ( 15.44 )
    1.2 ( 14.95 )
    5.5 ( 11.96 )
    5.3 ( 9.88 )
    5.3 ( 12.6 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 120 in Average Three Minute Stair Climb Rate - ITT Population

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    End point title
    		 Change from Baseline to Week 120 in Average Three Minute Stair Climb Rate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 120 (MOR-005 Week 96)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    28
    27
    54
    53
    162
    Units: stairs/min
        arithmetic mean (standard deviation)
    6 ( 17.05 )
    1.7 ( 14.8 )
    4.7 ( 14.6 )
    5.8 ( 13.42 )
    4.8 ( 14.65 )
    No statistical analyses for this end point

    Secondary: Baseline Average Three Minute Stair Climb Rate - MPP Population

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    End point title
    		 Baseline Average Three Minute Stair Climb Rate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    20
    19
    42
    43
    124
    Units: stairs/min
        arithmetic mean (standard deviation)
    33.1 ( 14.12 )
    24.8 ( 13.92 )
    25.6 ( 13.73 )
    31.3 ( 16.22 )
    28.7 ( 14.93 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 in Average Three Minute Stair Climb Rate - MPP Population

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    End point title
    		 Change from Baseline to Week 24 in Average Three Minute Stair Climb Rate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24 (MOR-005 Week 0)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    19
    42
    43
    124
    Units: stairs/min
        arithmetic mean (standard deviation)
    3.4 ( 8.09 )
    3.6 ( 8.63 )
    5 ( 11.46 )
    3.9 ( 7.67 )
    4.1 ( 9.23 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 72 in Average Three Minute Stair Climb Rate - MPP Population

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    End point title
    		 Change from Baseline to Week 72 in Average Three Minute Stair Climb Rate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 72 (MOR-005 Week 48)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    18
    42
    43
    123
    Units: stairs/min
        arithmetic mean (standard deviation)
    10.4 ( 13.77 )
    6.1 ( 10.56 )
    7.4 ( 12.53 )
    5.7 ( 9.98 )
    7.1 ( 11.61 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 120 in Average Three Minute Stair Climb Rate - MPP Population

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    End point title
    		 Change from Baseline to Week 120 in Average Three Minute Stair Climb Rate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 120 (MOR-005 Week 96)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    20
    19
    41
    42
    122
    Units: stairs/min
        arithmetic mean (standard deviation)
    9.1 ( 13.38 )
    4.2 ( 12.49 )
    8.1 ( 13.83 )
    7.2 ( 12.58 )
    7.4 ( 13.05 )
    No statistical analyses for this end point

    Secondary: Baseline Normalized Urine Keratan Sulfate - ITT Population

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    End point title
    		 Baseline Normalized Urine Keratan Sulfate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    28
    29
    59
    58
    175
    Units: ug/mg
        arithmetic mean (standard deviation)
    22.7 ( 15.27 )
    28.5 ( 14.89 )
    28.6 ( 21.17 )
    26.9 ( 14.11 )
    27.1 ( 17.05 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline to Week 24 in Normalized Urine Keratan Sulfate - ITT Population

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    End point title
    		 Percent Change from Baseline to Week 24 in Normalized Urine Keratan Sulfate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24 (MOR-005 Week 0)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    26
    28
    57
    54
    166
    Units: ug/mg
        arithmetic mean (standard deviation)
    3.4 ( 29.15 )
    -11.3 ( 23.68 )
    -35.2 ( 20.7 )
    -45.1 ( 19.89 )
    -28.2 ( 28.46 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline to Week 72 in Normalized Urine Keratan Sulfate - ITT Population

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    End point title
    		 Percent Change from Baseline to Week 72 in Normalized Urine Keratan Sulfate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 72 (MOR-005 Week 48)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    26
    28
    57
    51
    162
    Units: ug/mg
        arithmetic mean (standard deviation)
    -54.1 ( 17.21 )
    -56.8 ( 13.69 )
    -55.6 ( 14.23 )
    -53.7 ( 17.45 )
    -55 ( 15.61 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline to Week 120 in Normalized Urine Keratan Sulfate - ITT Population

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    End point title
    		 Percent Change from Baseline to Week 120 in Normalized Urine Keratan Sulfate - ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 120 (MOR-005 Week 96)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    26
    24
    53
    53
    156
    Units: ug/mg
        arithmetic mean (standard deviation)
    -55.5 ( 18.6 )
    -62.2 ( 15.39 )
    -55.8 ( 26.56 )
    -61.5 ( 20.59 )
    -58.7 ( 21.88 )
    No statistical analyses for this end point

    Secondary: Baseline Normalized Urine Keratan Sulfate - MPP Population

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    End point title
    		 Baseline Normalized Urine Keratan Sulfate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Intent-to-Treat
    Number of subjects analysed
    19
    19
    42
    43
    123
    Units: ug/mg
        arithmetic mean (standard deviation)
    21.2 ( 15.55 )
    27.5 ( 15.24 )
    27.2 ( 22.9 )
    24.9 ( 13.13 )
    25.5 ( 17.61 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline to Week 24 in Normalized Urine Keratan Sulfate - MPP Population

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    End point title
    		 Percent Change from Baseline to Week 24 in Normalized Urine Keratan Sulfate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24 (MOR-005 Week 0)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    17
    19
    41
    40
    117
    Units: ug/mg
        arithmetic mean (standard deviation)
    1.2 ( 24.34 )
    -12.9 ( 24.29 )
    -35.5 ( 22.62 )
    -44.9 ( 19.6 )
    -29.7 ( 27.52 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline to Week 72 in Normalized Urine Keratan Sulfate - MPP Population

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    End point title
    		 Percent Change from Baseline to Week 72 in Normalized Urine Keratan Sulfate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 72 (MOR-005 Week 48)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    18
    19
    41
    41
    119
    Units: ug/mg
        arithmetic mean (standard deviation)
    -51.7 ( 19.34 )
    -58.8 ( 14.6 )
    -56.9 ( 13.55 )
    -53.7 ( 17.87 )
    -55.3 ( 16.21 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline to Week 120 in Normalized Urine Keratan Sulfate - MPP Population

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    End point title
    		 Percent Change from Baseline to Week 120 in Normalized Urine Keratan Sulfate - MPP Population
    End point description
    End point type
    Secondary
    End point timeframe
    Week 120 (MOR-005 Week 96)
    End point values
    		 PBO-QOW PBO-QW QOW-QOW QW-QW Modified Per-Protocol
    Number of subjects analysed
    18
    17
    40
    42
    117
    Units: ug/mg
        arithmetic mean (standard deviation)
    -58.3 ( 15.87 )
    -64.2 ( 16.58 )
    -62.1 ( 15.97 )
    -61.8 ( 21.28 )
    -61.7 ( 17.98 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study Period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    PBO-QOW
    Reporting group description
    		 -

    Reporting group title
    PBO-QW
    Reporting group description
    		 -

    Reporting group title
    QOW-QOW
    Reporting group description
    		 -

    Reporting group title
    QW-QW
    Reporting group description
    		 -

    Serious adverse events
    		 PBO-QOW PBO-QW QOW-QOW QW-QW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 29 (58.62%)
    15 / 29 (51.72%)
    26 / 59 (44.07%)
    31 / 56 (55.36%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Poor venous access
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    5 / 59 (8.47%)
    5 / 56 (8.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Central venous catheterisation
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiphyseal stapling
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee operation
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device implantation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device removal
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    4 / 56 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal decompression
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Blighted ovum
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device dislocation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Child abuse
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Somatoform disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomeningocele
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital osteodystrophy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Developmental hip dysplasia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cervical cord compression
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Quadriplegia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord ischaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Middle ear effusion
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Strabismus
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee deformity
         subjects affected / exposed
    6 / 29 (20.69%)
    8 / 29 (27.59%)
    7 / 59 (11.86%)
    8 / 56 (14.29%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb deformity
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mononucleosis syndrome
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PBO-QOW PBO-QW QOW-QOW QW-QW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 29 (100.00%)
    29 / 29 (100.00%)
    59 / 59 (100.00%)
    56 / 56 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    0 / 56 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    2 / 59 (3.39%)
    5 / 56 (8.93%)
         occurrences all number
    3
    2
    2
    8
    Hot flush
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    0
    6
    5
    2
    Hypertension
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 29 (13.79%)
    6 / 59 (10.17%)
    6 / 56 (10.71%)
         occurrences all number
    1
    13
    28
    16
    Hypotension
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    6 / 56 (10.71%)
         occurrences all number
    2
    1
    6
    7
    Pallor
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    2 / 59 (3.39%)
    7 / 56 (12.50%)
         occurrences all number
    3
    2
    4
    21
    Poor venous access
         subjects affected / exposed
    6 / 29 (20.69%)
    5 / 29 (17.24%)
    6 / 59 (10.17%)
    8 / 56 (14.29%)
         occurrences all number
    21
    10
    7
    16
    Surgical and medical procedures
    Central venous catheterisation
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    1
    1
    3
    1
    Tooth extraction
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    4 / 59 (6.78%)
    0 / 56 (0.00%)
         occurrences all number
    1
    2
    6
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    1 / 59 (1.69%)
    4 / 56 (7.14%)
         occurrences all number
    1
    2
    2
    5
    Catheter site pain
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    6 / 59 (10.17%)
    5 / 56 (8.93%)
         occurrences all number
    6
    0
    6
    12
    Chest discomfort
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    4
    3
    2
    3
    Chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    4 / 56 (7.14%)
         occurrences all number
    1
    2
    5
    4
    Chills
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 29 (3.45%)
    8 / 59 (13.56%)
    9 / 56 (16.07%)
         occurrences all number
    4
    1
    10
    14
    Device dislocation
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    4
    1
    Device occlusion
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    4 / 56 (7.14%)
         occurrences all number
    1
    3
    2
    6
    Effusion
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    1
    2
    Extravasation
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
    3 / 59 (5.08%)
    5 / 56 (8.93%)
         occurrences all number
    0
    3
    6
    5
    Fatigue
         subjects affected / exposed
    10 / 29 (34.48%)
    13 / 29 (44.83%)
    16 / 59 (27.12%)
    19 / 56 (33.93%)
         occurrences all number
    17
    45
    32
    50
    Feeling hot
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    0
    1
    4
    3
    Gait disturbance
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    5 / 56 (8.93%)
         occurrences all number
    0
    1
    4
    5
    Hyperthermia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    0
    1
    Influenza like illness
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences all number
    3
    1
    1
    4
    Infusion site extravasation
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    9 / 59 (15.25%)
    4 / 56 (7.14%)
         occurrences all number
    4
    2
    12
    4
    Infusion site pain
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    6 / 59 (10.17%)
    4 / 56 (7.14%)
         occurrences all number
    2
    1
    8
    6
    Infusion site rash
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    2
    1
    Infusion site swelling
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    1
    0
    3
    2
    Irritability
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    0
    5
    Local swelling
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    5 / 59 (8.47%)
    4 / 56 (7.14%)
         occurrences all number
    7
    0
    5
    9
    Malaise
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    6 / 59 (10.17%)
    3 / 56 (5.36%)
         occurrences all number
    2
    5
    7
    5
    Medical device complication
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    5 / 59 (8.47%)
    5 / 56 (8.93%)
         occurrences all number
    2
    3
    6
    8
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    1
    1
    4
    2
    Oedema
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    3 / 56 (5.36%)
         occurrences all number
    4
    0
    4
    4
    Pain
         subjects affected / exposed
    5 / 29 (17.24%)
    1 / 29 (3.45%)
    6 / 59 (10.17%)
    5 / 56 (8.93%)
         occurrences all number
    6
    3
    8
    7
    Puncture site pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    1 / 56 (1.79%)
         occurrences all number
    1
    0
    4
    1
    Pyrexia
         subjects affected / exposed
    22 / 29 (75.86%)
    19 / 29 (65.52%)
    38 / 59 (64.41%)
    39 / 56 (69.64%)
         occurrences all number
    91
    62
    113
    231
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    5 / 59 (8.47%)
    3 / 56 (5.36%)
         occurrences all number
    1
    0
    8
    3
    Seasonal allergy
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    2
    4
    6
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    5 / 59 (8.47%)
    3 / 56 (5.36%)
         occurrences all number
    11
    4
    24
    9
    Respiratory, thoracic and mediastinal disorders
    Allergic cough
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    3
    1
    Asthma
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    5 / 59 (8.47%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    12
    11
    Bronchospasm
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    5 / 59 (8.47%)
    2 / 56 (3.57%)
         occurrences all number
    0
    1
    6
    2
    Cough
         subjects affected / exposed
    21 / 29 (72.41%)
    14 / 29 (48.28%)
    37 / 59 (62.71%)
    28 / 56 (50.00%)
         occurrences all number
    62
    49
    85
    70
    Dyspnoea
         subjects affected / exposed
    6 / 29 (20.69%)
    5 / 29 (17.24%)
    12 / 59 (20.34%)
    11 / 56 (19.64%)
         occurrences all number
    8
    7
    33
    23
    Epistaxis
         subjects affected / exposed
    3 / 29 (10.34%)
    4 / 29 (13.79%)
    5 / 59 (8.47%)
    8 / 56 (14.29%)
         occurrences all number
    9
    8
    6
    19
    Nasal congestion
         subjects affected / exposed
    10 / 29 (34.48%)
    4 / 29 (13.79%)
    15 / 59 (25.42%)
    16 / 56 (28.57%)
         occurrences all number
    21
    6
    24
    38
    Nasal obstruction
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
    6 / 59 (10.17%)
    3 / 56 (5.36%)
         occurrences all number
    10
    3
    7
    3
    Neonatal hypoxia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    2
    4
    Obstructive airways disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences all number
    0
    1
    1
    4
    Oropharyngeal pain
         subjects affected / exposed
    13 / 29 (44.83%)
    11 / 29 (37.93%)
    23 / 59 (38.98%)
    27 / 56 (48.21%)
         occurrences all number
    24
    16
    48
    63
    Pharyngeal disorder
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    0
    5
    Productive cough
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
    2 / 59 (3.39%)
    0 / 56 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    5
    1
    Restrictive pulmonary disease
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    1
    2
    Rhinitis allergic
         subjects affected / exposed
    3 / 29 (10.34%)
    5 / 29 (17.24%)
    9 / 59 (15.25%)
    2 / 56 (3.57%)
         occurrences all number
    3
    7
    14
    2
    Rhinorrhoea
         subjects affected / exposed
    5 / 29 (17.24%)
    5 / 29 (17.24%)
    7 / 59 (11.86%)
    14 / 56 (25.00%)
         occurrences all number
    6
    10
    16
    24
    Sinus congestion
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    2
    1
    0
    4
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    1
    2
    4
    2
    Sneezing
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    2 / 56 (3.57%)
         occurrences all number
    2
    1
    1
    2
    Tachypnoea
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    3
    1
    6
    4
    Throat irritation
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    4 / 56 (7.14%)
         occurrences all number
    3
    1
    0
    5
    Tonsillar hypertrophy
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    2 / 59 (3.39%)
    1 / 56 (1.79%)
         occurrences all number
    3
    2
    3
    1
    Wheezing
         subjects affected / exposed
    5 / 29 (17.24%)
    5 / 29 (17.24%)
    6 / 59 (10.17%)
    4 / 56 (7.14%)
         occurrences all number
    10
    6
    8
    6
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    4 / 56 (7.14%)
         occurrences all number
    1
    0
    2
    6
    Anxiety
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
    5 / 59 (8.47%)
    1 / 56 (1.79%)
         occurrences all number
    4
    4
    7
    1
    Insomnia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    0 / 56 (0.00%)
         occurrences all number
    2
    1
    3
    0
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    2
    0
    0
    2
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    0
    4
    9
    4
    Blood pressure increased
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    6
    0
    3
    1
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    0
    7
    28
    2
    Blood urine present
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences all number
    5
    0
    1
    0
    Heart rate decreased
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    7 / 56 (12.50%)
         occurrences all number
    3
    1
    4
    13
    Oxygen saturation decreased
         subjects affected / exposed
    6 / 29 (20.69%)
    3 / 29 (10.34%)
    9 / 59 (15.25%)
    10 / 56 (17.86%)
         occurrences all number
    17
    15
    16
    26
    Respiratory rate increased
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    5
    1
    2
    3
    Vital capacity decreased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    6 / 56 (10.71%)
         occurrences all number
    0
    1
    2
    7
    Contusion
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    2 / 56 (3.57%)
         occurrences all number
    3
    0
    3
    3
    Excoriation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    0
    0
    5
    2
    Fall
         subjects affected / exposed
    4 / 29 (13.79%)
    3 / 29 (10.34%)
    12 / 59 (20.34%)
    5 / 56 (8.93%)
         occurrences all number
    5
    4
    20
    7
    Head injury
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    1
    0
    8
    2
    Infusion related reaction
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    2 / 56 (3.57%)
         occurrences all number
    5
    0
    4
    3
    Joint dislocation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Joint injury
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    2 / 56 (3.57%)
         occurrences all number
    0
    0
    4
    2
    Ligament sprain
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    2
    1
    1
    1
    Limb injury
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    3
    1
    Procedural pain
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
    6 / 59 (10.17%)
    7 / 56 (12.50%)
         occurrences all number
    9
    2
    7
    9
    Tooth fracture
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Cardiac disorders
    Aortic valve disease
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    5 / 59 (8.47%)
    2 / 56 (3.57%)
         occurrences all number
    1
    1
    5
    2
    Aortic valve incompetence
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
    8 / 59 (13.56%)
    4 / 56 (7.14%)
         occurrences all number
    1
    3
    8
    4
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    4 / 56 (7.14%)
         occurrences all number
    0
    0
    1
    4
    Mitral valve disease
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    6 / 59 (10.17%)
    3 / 56 (5.36%)
         occurrences all number
    1
    1
    6
    4
    Mitral valve incompetence
         subjects affected / exposed
    4 / 29 (13.79%)
    6 / 29 (20.69%)
    12 / 59 (20.34%)
    4 / 56 (7.14%)
         occurrences all number
    4
    6
    12
    5
    Palpitations
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    1 / 59 (1.69%)
    2 / 56 (3.57%)
         occurrences all number
    1
    4
    1
    2
    Pulmonary valve incompetence
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    2 / 59 (3.39%)
    5 / 56 (8.93%)
         occurrences all number
    2
    3
    2
    5
    Sinus arrhythmia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    3
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    1
    4
    1
    11
    Tachycardia
         subjects affected / exposed
    8 / 29 (27.59%)
    4 / 29 (13.79%)
    8 / 59 (13.56%)
    11 / 56 (19.64%)
         occurrences all number
    14
    15
    31
    29
    Tricuspid valve incompetence
         subjects affected / exposed
    6 / 29 (20.69%)
    1 / 29 (3.45%)
    11 / 59 (18.64%)
    7 / 56 (12.50%)
         occurrences all number
    6
    1
    12
    8
    Nervous system disorders
    Cervical cord compression
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dizziness
         subjects affected / exposed
    5 / 29 (17.24%)
    6 / 29 (20.69%)
    8 / 59 (13.56%)
    12 / 56 (21.43%)
         occurrences all number
    6
    6
    20
    30
    Headache
         subjects affected / exposed
    23 / 29 (79.31%)
    16 / 29 (55.17%)
    39 / 59 (66.10%)
    36 / 56 (64.29%)
         occurrences all number
    102
    67
    232
    271
    Hyperreflexia
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences all number
    3
    4
    2
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    1 / 56 (1.79%)
         occurrences all number
    1
    1
    5
    1
    Lethargy
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    1
    1
    3
    4
    Paraesthesia
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    7 / 56 (12.50%)
         occurrences all number
    1
    1
    2
    18
    Somnolence
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    1 / 59 (1.69%)
    4 / 56 (7.14%)
         occurrences all number
    28
    3
    1
    4
    Syncope
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    9
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    2 / 56 (3.57%)
         occurrences all number
    3
    0
    1
    6
    Ear pain
         subjects affected / exposed
    10 / 29 (34.48%)
    7 / 29 (24.14%)
    19 / 59 (32.20%)
    19 / 56 (33.93%)
         occurrences all number
    16
    8
    42
    26
    Hypoacusis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    3
    0
    3
    4
    Middle ear effusion
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    2 / 56 (3.57%)
         occurrences all number
    2
    0
    1
    2
    Motion sickness
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    1
    1
    0
    3
    Tinnitus
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    0
    6
    Vertigo
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    4
    2
    7
    4
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    3
    0
    1
    Conjunctivitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    6 / 59 (10.17%)
    8 / 56 (14.29%)
         occurrences all number
    2
    2
    9
    9
    Corneal opacity
         subjects affected / exposed
    3 / 29 (10.34%)
    5 / 29 (17.24%)
    5 / 59 (8.47%)
    12 / 56 (21.43%)
         occurrences all number
    3
    5
    5
    13
    Glaucoma
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Myopia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    0
    2
    4
    3
    Visual impairment
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    0
    5
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    5 / 59 (8.47%)
    7 / 56 (12.50%)
         occurrences all number
    6
    1
    8
    18
    Abdominal distension
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    19
    0
    0
    5
    Abdominal pain
         subjects affected / exposed
    12 / 29 (41.38%)
    6 / 29 (20.69%)
    22 / 59 (37.29%)
    24 / 56 (42.86%)
         occurrences all number
    19
    8
    59
    60
    Abdominal pain lower
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    0 / 56 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    8 / 29 (27.59%)
    9 / 29 (31.03%)
    9 / 59 (15.25%)
    18 / 56 (32.14%)
         occurrences all number
    15
    11
    16
    72
    Anal pruritus
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Breath odour
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Constipation
         subjects affected / exposed
    4 / 29 (13.79%)
    4 / 29 (13.79%)
    7 / 59 (11.86%)
    8 / 56 (14.29%)
         occurrences all number
    5
    4
    7
    9
    Dental caries
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
    4 / 59 (6.78%)
    3 / 56 (5.36%)
         occurrences all number
    0
    3
    4
    4
    Diarrhoea
         subjects affected / exposed
    11 / 29 (37.93%)
    11 / 29 (37.93%)
    25 / 59 (42.37%)
    23 / 56 (41.07%)
         occurrences all number
    26
    27
    71
    43
    Dyspepsia
         subjects affected / exposed
    3 / 29 (10.34%)
    5 / 29 (17.24%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    26
    5
    5
    2
    Enterocolitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    3
    1
    Flatulence
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    1 / 56 (1.79%)
         occurrences all number
    6
    1
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    1
    1
    3
    4
    Haemorrhoids
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    1 / 56 (1.79%)
         occurrences all number
    3
    0
    3
    1
    Nausea
         subjects affected / exposed
    15 / 29 (51.72%)
    10 / 29 (34.48%)
    26 / 59 (44.07%)
    28 / 56 (50.00%)
         occurrences all number
    34
    18
    65
    91
    Proctalgia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    0
    1
    3
    1
    Toothache
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
    8 / 59 (13.56%)
    4 / 56 (7.14%)
         occurrences all number
    4
    5
    14
    4
    Vomiting
         subjects affected / exposed
    20 / 29 (68.97%)
    17 / 29 (58.62%)
    39 / 59 (66.10%)
    38 / 56 (67.86%)
         occurrences all number
    105
    62
    134
    160
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    2
    4
    Blister
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    0
    0
    6
    4
    Dermatitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences all number
    1
    0
    1
    4
    Dermatitis allergic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    5 / 59 (8.47%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    5
    0
    Dry skin
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    2 / 56 (3.57%)
         occurrences all number
    3
    0
    1
    3
    Eczema
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 29 (13.79%)
    8 / 59 (13.56%)
    1 / 56 (1.79%)
         occurrences all number
    2
    7
    10
    2
    Erythema
         subjects affected / exposed
    6 / 29 (20.69%)
    3 / 29 (10.34%)
    7 / 59 (11.86%)
    10 / 56 (17.86%)
         occurrences all number
    12
    4
    7
    29
    Hyperhidrosis
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 29 (13.79%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences all number
    1
    6
    1
    3
    Petechiae
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Pruritus
         subjects affected / exposed
    7 / 29 (24.14%)
    3 / 29 (10.34%)
    8 / 59 (13.56%)
    19 / 56 (33.93%)
         occurrences all number
    18
    6
    28
    32
    Rash
         subjects affected / exposed
    8 / 29 (27.59%)
    8 / 29 (27.59%)
    15 / 59 (25.42%)
    19 / 56 (33.93%)
         occurrences all number
    13
    30
    61
    103
    Rash erythematous
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    3
    0
    3
    1
    Rash macular
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences all number
    5
    1
    1
    3
    Rash maculo-papular
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    0
    0
    59
    28
    Rash pruritic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Skin disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    0
    7
    Skin lesion
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    2
    1
    3
    3
    Urticaria
         subjects affected / exposed
    6 / 29 (20.69%)
    1 / 29 (3.45%)
    11 / 59 (18.64%)
    12 / 56 (21.43%)
         occurrences all number
    38
    37
    53
    33
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    2
    0
    3
    2
    Haematuria
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    4 / 56 (7.14%)
         occurrences all number
    0
    0
    2
    4
    Pollakiuria
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    4 / 59 (6.78%)
    3 / 56 (5.36%)
         occurrences all number
    0
    0
    4
    3
    Proteinuria
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    2
    0
    4
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    20 / 29 (68.97%)
    16 / 29 (55.17%)
    40 / 59 (67.80%)
    29 / 56 (51.79%)
         occurrences all number
    90
    57
    93
    94
    Back pain
         subjects affected / exposed
    10 / 29 (34.48%)
    4 / 29 (13.79%)
    19 / 59 (32.20%)
    18 / 56 (32.14%)
         occurrences all number
    17
    6
    45
    46
    Joint swelling
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    2
    1
    Knee deformity
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 29 (17.24%)
    1 / 59 (1.69%)
    6 / 56 (10.71%)
         occurrences all number
    2
    6
    1
    6
    Muscle spasms
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
    1 / 59 (1.69%)
    3 / 56 (5.36%)
         occurrences all number
    2
    4
    1
    4
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    5 / 59 (8.47%)
    2 / 56 (3.57%)
         occurrences all number
    3
    2
    5
    2
    Musculoskeletal pain
         subjects affected / exposed
    7 / 29 (24.14%)
    4 / 29 (13.79%)
    10 / 59 (16.95%)
    9 / 56 (16.07%)
         occurrences all number
    14
    9
    14
    20
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    1 / 56 (1.79%)
         occurrences all number
    2
    2
    4
    1
    Myalgia
         subjects affected / exposed
    7 / 29 (24.14%)
    1 / 29 (3.45%)
    3 / 59 (5.08%)
    5 / 56 (8.93%)
         occurrences all number
    11
    1
    3
    9
    Neck pain
         subjects affected / exposed
    9 / 29 (31.03%)
    3 / 29 (10.34%)
    9 / 59 (15.25%)
    10 / 56 (17.86%)
         occurrences all number
    9
    3
    14
    24
    Osteopenia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    0 / 56 (0.00%)
         occurrences all number
    2
    1
    4
    0
    Pain in extremity
         subjects affected / exposed
    16 / 29 (55.17%)
    12 / 29 (41.38%)
    27 / 59 (45.76%)
    31 / 56 (55.36%)
         occurrences all number
    54
    25
    80
    102
    Spinal pain
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    5 / 56 (8.93%)
         occurrences all number
    3
    0
    0
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 29 (17.24%)
    3 / 29 (10.34%)
    7 / 59 (11.86%)
    6 / 56 (10.71%)
         occurrences all number
    7
    4
    8
    8
    Cellulitis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Ear infection
         subjects affected / exposed
    7 / 29 (24.14%)
    3 / 29 (10.34%)
    5 / 59 (8.47%)
    16 / 56 (28.57%)
         occurrences all number
    9
    3
    13
    42
    Fungal infection
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    2
    0
    2
    3
    Furuncle
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    4
    0
    0
    3
    Gastroenteritis
         subjects affected / exposed
    5 / 29 (17.24%)
    9 / 29 (31.03%)
    24 / 59 (40.68%)
    17 / 56 (30.36%)
         occurrences all number
    9
    13
    36
    20
    Gastroenteritis viral
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    2 / 56 (3.57%)
         occurrences all number
    2
    1
    2
    2
    Gingivitis
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    0
    3
    3
    2
    Hordeolum
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    6 / 59 (10.17%)
    0 / 56 (0.00%)
         occurrences all number
    2
    1
    14
    0
    Influenza
         subjects affected / exposed
    3 / 29 (10.34%)
    5 / 29 (17.24%)
    11 / 59 (18.64%)
    5 / 56 (8.93%)
         occurrences all number
    7
    6
    24
    6
    Laryngitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Lice infestation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 59 (1.69%)
    5 / 56 (8.93%)
         occurrences all number
    0
    0
    2
    6
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    2 / 59 (3.39%)
    3 / 56 (5.36%)
         occurrences all number
    2
    1
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    13 / 29 (44.83%)
    13 / 29 (44.83%)
    29 / 59 (49.15%)
    28 / 56 (50.00%)
         occurrences all number
    34
    28
    62
    67
    Oral candidiasis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    1 / 56 (1.79%)
         occurrences all number
    0
    1
    7
    1
    Oral herpes
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    0 / 56 (0.00%)
         occurrences all number
    2
    1
    7
    0
    Otitis externa
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
    8 / 59 (13.56%)
    6 / 56 (10.71%)
         occurrences all number
    4
    1
    15
    8
    Otitis media
         subjects affected / exposed
    8 / 29 (27.59%)
    5 / 29 (17.24%)
    11 / 59 (18.64%)
    10 / 56 (17.86%)
         occurrences all number
    10
    5
    29
    18
    Otitis media acute
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    5 / 59 (8.47%)
    4 / 56 (7.14%)
         occurrences all number
    2
    2
    11
    6
    Pharyngitis
         subjects affected / exposed
    9 / 29 (31.03%)
    6 / 29 (20.69%)
    8 / 59 (13.56%)
    11 / 56 (19.64%)
         occurrences all number
    12
    7
    10
    18
    Rash pustular
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    3 / 59 (5.08%)
    3 / 56 (5.36%)
         occurrences all number
    1
    2
    6
    4
    Rhinitis
         subjects affected / exposed
    9 / 29 (31.03%)
    6 / 29 (20.69%)
    11 / 59 (18.64%)
    9 / 56 (16.07%)
         occurrences all number
    21
    17
    30
    19
    Sinusitis
         subjects affected / exposed
    5 / 29 (17.24%)
    1 / 29 (3.45%)
    4 / 59 (6.78%)
    4 / 56 (7.14%)
         occurrences all number
    7
    1
    4
    6
    Tinea pedis
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
    0 / 59 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    2
    1
    0
    2
    Tonsillitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    5 / 59 (8.47%)
    6 / 56 (10.71%)
         occurrences all number
    3
    2
    8
    7
    Tooth infection
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
    1 / 59 (1.69%)
    1 / 56 (1.79%)
         occurrences all number
    0
    2
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 29 (44.83%)
    8 / 29 (27.59%)
    24 / 59 (40.68%)
    24 / 56 (42.86%)
         occurrences all number
    53
    25
    82
    81
    Varicella
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    3 / 59 (5.08%)
    2 / 56 (3.57%)
         occurrences all number
    1
    0
    3
    2
    Viral infection
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
    9 / 59 (15.25%)
    5 / 56 (8.93%)
         occurrences all number
    3
    5
    12
    6
    Viral pharyngitis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
    0 / 59 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    6 / 29 (20.69%)
    0 / 29 (0.00%)
    5 / 59 (8.47%)
    5 / 56 (8.93%)
         occurrences all number
    12
    0
    9
    10
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    1 / 59 (1.69%)
    5 / 56 (8.93%)
         occurrences all number
    1
    3
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Notes: Efficacy analysis based on all patients randomized (pbo-QOW, pbo-QW, QOW-QOW, QW-QW(N=175)), meanwhile it is available for the first 24 weeks in MOR-004 (N=176).The safety evaluation is based on patients who entered MOR-005(N=173)
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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