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    Clinical Trial Results:
    A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

    Summary
    EudraCT number
    2017-000625-12
    Trial protocol
    NL   ES   DE  
    Global end of trial date
    10 Sep 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Oct 2021
    First version publication date
    17 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CTMX-M-2009-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03149549
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    CytomX Therapeutics, Inc
    Sponsor organisation address
    151 Oyster Point Blvd, South San Francisco, United States, 94080
    Public contact
    Clinical Trial Team, CytomX Therapeutics, Inc, 001 650-763-9501, clinicaltrials@cytomx.com
    Scientific contact
    Clinical Development, CytomX Therapeutics, Inc, 001 650-515-3185, clinicaltrials@cytomx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to determine the safety profile of CX-2009, the maximum tolerated dose (MTD) / Recommended Phase 2 Dose (RP2D), and the dose-limiting toxicities (DLTs) of CX-2009, when administered intravenously (IV) every 21 days as monotherapy to subjects with selected advanced or recurrent solid tumors.
    Protection of trial subjects
    This study was conducted in full accordance with the World Medical Association Declaration of Helsinki concerning written informed consent and the protection of rights of human subjects. The investigators agreed to comply with Food and Drug Administration (FDA) Regulations, IRB/IEC Regulations and International Council of Harmonisation (ICH) Guidelines for Good Clinical Practices (GCP).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 64
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    United Kingdom: 9
    Worldwide total number of subjects
    99
    EEA total number of subjects
    26
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    65
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in 4 parts (Part A, Part A2, Part B, and Part C1). Enrolled patients continued on study through the follow-up period. Each study part consisted of 3 periods: a 30-day screening, a treatment period, and a follow-up period.

    Pre-assignment
    Screening details
    As of 09/April/2020, 99 patients had been enrolled and treated in the study (47 in Part A, 39 in Part A2, 3 in Part B, and 10 in Part C1); enrolled patients continued on study through the follow-up period. The study was terminated early after these subjects were enrolled.

    Period 1
    Period 1 title
    Study Treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dose Group 1 (≤ 4 mg/kg (Q3W))
    Arm description
    less than or equal to 4 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 2 (5 mg/kg (Q3W))
    Arm description
    5 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 3 (6 mg/kg (Q3W))
    Arm description
    6 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 4 (7 mg/kg (Q3W))
    Arm description
    7 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 5 (8 mg/kg (Q3W))
    Arm description
    8 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 6 (9 mg/kg (Q3W))
    Arm description
    9 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 7 (10 mg/kg (Q3W))
    Arm description
    10 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 8 (4 mg/kg (Q2W))
    Arm description
    4 mg/kg (Q2W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 9 (6 mg/kg (Q2W))
    Arm description
    6 mg/kg (Q2W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Number of subjects in period 1
    Dose Group 1 (≤ 4 mg/kg (Q3W)) Dose Group 2 (5 mg/kg (Q3W)) Dose Group 3 (6 mg/kg (Q3W)) Dose Group 4 (7 mg/kg (Q3W)) Dose Group 5 (8 mg/kg (Q3W)) Dose Group 6 (9 mg/kg (Q3W)) Dose Group 7 (10 mg/kg (Q3W)) Dose Group 8 (4 mg/kg (Q2W)) Dose Group 9 (6 mg/kg (Q2W))
    Started
    20
    9
    9
    12
    22
    9
    8
    4
    6
    Completed
    14
    7
    7
    8
    16
    7
    8
    4
    4
    Not completed
    6
    2
    2
    4
    6
    2
    0
    0
    2
         Termination by Sponsor
    -
    -
    -
    1
    -
    -
    -
    -
    1
         Unknown
    -
    -
    -
    1
    -
    1
    -
    -
    -
         Adverse event, serious fatal
    3
    1
    -
    2
    4
    1
    -
    -
    1
         Consent withdrawn by subject
    3
    1
    2
    -
    2
    -
    -
    -
    -
    Period 2
    Period 2 title
    Follow-Up Period
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dose Group 1 (≤ 4 mg/kg (Q3W))
    Arm description
    less than or equal to 4 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 2 (5 mg/kg (Q3W))
    Arm description
    5 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 3 (6 mg/kg (Q3W))
    Arm description
    6 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 4 (7 mg/kg (Q3W))
    Arm description
    7 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 5 (8 mg/kg (Q3W))
    Arm description
    8 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 6 (9 mg/kg (Q3W))
    Arm description
    9 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 7 (10 mg/kg (Q3W))
    Arm description
    10 mg/kg (Q3W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 8 (4 mg/kg (Q2W))
    Arm description
    4 mg/kg (Q2W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Arm title
    Dose Group 9 (6 mg/kg (Q2W))
    Arm description
    6 mg/kg (Q2W)
    Arm type
    Experimental

    Investigational medicinal product name
    CX-2009
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    CX-2009 was supplied as a lyophilized powder (cake) in 25 mg vials to be reconstituted with 5 mL of sterile water for injection to a final concentration of 5.0 mg/mL

    Number of subjects in period 2
    Dose Group 1 (≤ 4 mg/kg (Q3W)) Dose Group 2 (5 mg/kg (Q3W)) Dose Group 3 (6 mg/kg (Q3W)) Dose Group 4 (7 mg/kg (Q3W)) Dose Group 5 (8 mg/kg (Q3W)) Dose Group 6 (9 mg/kg (Q3W)) Dose Group 7 (10 mg/kg (Q3W)) Dose Group 8 (4 mg/kg (Q2W)) Dose Group 9 (6 mg/kg (Q2W))
    Started
    14
    7
    7
    8
    16
    7
    8
    4
    4
    Completed
    12
    3
    6
    3
    9
    5
    5
    1
    1
    Not completed
    2
    4
    1
    5
    7
    2
    3
    3
    3
         Termination by Sponsor
    1
    -
    -
    1
    5
    -
    -
    3
    2
         Unknown
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    1
    -
    -
    4
    1
    1
    3
    -
    1
         Lost to follow-up
    -
    4
    1
    -
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dose Group 1 (≤ 4 mg/kg (Q3W))
    Reporting group description
    less than or equal to 4 mg/kg (Q3W)

    Reporting group title
    Dose Group 2 (5 mg/kg (Q3W))
    Reporting group description
    5 mg/kg (Q3W)

    Reporting group title
    Dose Group 3 (6 mg/kg (Q3W))
    Reporting group description
    6 mg/kg (Q3W)

    Reporting group title
    Dose Group 4 (7 mg/kg (Q3W))
    Reporting group description
    7 mg/kg (Q3W)

    Reporting group title
    Dose Group 5 (8 mg/kg (Q3W))
    Reporting group description
    8 mg/kg (Q3W)

    Reporting group title
    Dose Group 6 (9 mg/kg (Q3W))
    Reporting group description
    9 mg/kg (Q3W)

    Reporting group title
    Dose Group 7 (10 mg/kg (Q3W))
    Reporting group description
    10 mg/kg (Q3W)

    Reporting group title
    Dose Group 8 (4 mg/kg (Q2W))
    Reporting group description
    4 mg/kg (Q2W)

    Reporting group title
    Dose Group 9 (6 mg/kg (Q2W))
    Reporting group description
    6 mg/kg (Q2W)

    Reporting group values
    Dose Group 1 (≤ 4 mg/kg (Q3W)) Dose Group 2 (5 mg/kg (Q3W)) Dose Group 3 (6 mg/kg (Q3W)) Dose Group 4 (7 mg/kg (Q3W)) Dose Group 5 (8 mg/kg (Q3W)) Dose Group 6 (9 mg/kg (Q3W)) Dose Group 7 (10 mg/kg (Q3W)) Dose Group 8 (4 mg/kg (Q2W)) Dose Group 9 (6 mg/kg (Q2W)) Total
    Number of subjects
    20 9 9 12 22 9 8 4 6 99
    Age categorical
    Adult Subjects of at least 18 years of age and older
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    11 7 5 7 15 5 7 3 5 65
        From 65-84 years
    9 2 4 5 7 4 1 1 1 34
        85 years and over
    0 0 0 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    13 7 6 12 18 7 7 4 4 78
        Male
    7 2 3 0 4 2 1 0 2 21
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0 0 0 0
        Asian
    2 0 0 1 2 0 0 0 0 5
        Native Hawaiian or Other Pacific Islander
    0 0 0 1 1 0 0 0 0 2
        Black or African American
    0 0 0 0 0 2 0 0 0 2
        White
    18 8 8 6 17 7 7 4 6 81
        More than one race
    0 1 0 0 1 0 1 0 0 3
        Unknown or Not Reported
    0 0 1 4 1 0 0 0 0 6
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1 2 0 1 1 2 1 0 0 8
        Not Hispanic or Latino
    18 7 8 9 20 7 7 4 6 86
        Unknown or Not Reported
    1 0 1 2 1 0 0 0 0 5

    End points

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    End points reporting groups
    Reporting group title
    Dose Group 1 (≤ 4 mg/kg (Q3W))
    Reporting group description
    less than or equal to 4 mg/kg (Q3W)

    Reporting group title
    Dose Group 2 (5 mg/kg (Q3W))
    Reporting group description
    5 mg/kg (Q3W)

    Reporting group title
    Dose Group 3 (6 mg/kg (Q3W))
    Reporting group description
    6 mg/kg (Q3W)

    Reporting group title
    Dose Group 4 (7 mg/kg (Q3W))
    Reporting group description
    7 mg/kg (Q3W)

    Reporting group title
    Dose Group 5 (8 mg/kg (Q3W))
    Reporting group description
    8 mg/kg (Q3W)

    Reporting group title
    Dose Group 6 (9 mg/kg (Q3W))
    Reporting group description
    9 mg/kg (Q3W)

    Reporting group title
    Dose Group 7 (10 mg/kg (Q3W))
    Reporting group description
    10 mg/kg (Q3W)

    Reporting group title
    Dose Group 8 (4 mg/kg (Q2W))
    Reporting group description
    4 mg/kg (Q2W)

    Reporting group title
    Dose Group 9 (6 mg/kg (Q2W))
    Reporting group description
    6 mg/kg (Q2W)
    Reporting group title
    Dose Group 1 (≤ 4 mg/kg (Q3W))
    Reporting group description
    less than or equal to 4 mg/kg (Q3W)

    Reporting group title
    Dose Group 2 (5 mg/kg (Q3W))
    Reporting group description
    5 mg/kg (Q3W)

    Reporting group title
    Dose Group 3 (6 mg/kg (Q3W))
    Reporting group description
    6 mg/kg (Q3W)

    Reporting group title
    Dose Group 4 (7 mg/kg (Q3W))
    Reporting group description
    7 mg/kg (Q3W)

    Reporting group title
    Dose Group 5 (8 mg/kg (Q3W))
    Reporting group description
    8 mg/kg (Q3W)

    Reporting group title
    Dose Group 6 (9 mg/kg (Q3W))
    Reporting group description
    9 mg/kg (Q3W)

    Reporting group title
    Dose Group 7 (10 mg/kg (Q3W))
    Reporting group description
    10 mg/kg (Q3W)

    Reporting group title
    Dose Group 8 (4 mg/kg (Q2W))
    Reporting group description
    4 mg/kg (Q2W)

    Reporting group title
    Dose Group 9 (6 mg/kg (Q2W))
    Reporting group description
    6 mg/kg (Q2W)

    Primary: The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy

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    End point title
    The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy [1]
    End point description
    Determine the safety profile of CX-2009, the MTD/RP2D, and the DLTs of CX-2009 when administered IV every 14 or 21 days as monotherapy to participants with selected advanced or recurrent solid tumors. Adverse event collection and assessment will be evaluated for all participants receiving study drug to evaluate the safety, tolerability, and determine DLTs at MTD/RP2D.
    End point type
    Primary
    End point timeframe
    Every 14 or 21 days (dose limiting toxicity period)
    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: The study was terminated early, but the RP2D was determined for CX-2009. The study commenced with accelerated dose titration in 1 single-subject cohort (0.25 mg/kg AIBQ), followed by a standard 3+3 design to determine the MTD, and then concluded using a Bayesian interval dose-finding design (mTPI-2) cohort with up to 38 subjects with demonstrated high CD166 expression to determine the RP2D. No other statistical analyses were done.
    End point values
    Dose Group 1 (≤ 4 mg/kg (Q3W)) Dose Group 2 (5 mg/kg (Q3W)) Dose Group 3 (6 mg/kg (Q3W)) Dose Group 4 (7 mg/kg (Q3W)) Dose Group 5 (8 mg/kg (Q3W)) Dose Group 6 (9 mg/kg (Q3W)) Dose Group 7 (10 mg/kg (Q3W)) Dose Group 8 (4 mg/kg (Q2W)) Dose Group 9 (6 mg/kg (Q2W))
    Number of subjects analysed
    20
    9
    9
    12
    22
    9
    8
    4
    6
    Units: Subjects
        Participants experiencing DLTs
    0
    0
    0
    0
    1
    0
    0
    0
    2
        Participants not experiencing DLTs
    20
    9
    9
    12
    21
    9
    8
    4
    4
    No statistical analyses for this end point

    Secondary: The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy

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    End point title
    The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy [2]
    End point description
    Evaluate the efficacy of CX-2009 when administered IV every 21 days as monotherapy at the MTD/RP2D. Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the proportion of patients with complete resonse (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1)
    End point type
    Secondary
    End point timeframe
    2 Years
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary (ORR) and other Outcomes were not analyzed.
    End point values
    Dose Group 4 (7 mg/kg (Q3W))
    Number of subjects analysed
    3
    Units: Not analysed
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Dosing Group 1 (≤ 4 mg/kg (Q3W))
    Reporting group description
    less than or equal to 4 mg/kg (Q3W)

    Reporting group title
    Dosing Group 2 (5 mg/kg (Q3W))
    Reporting group description
    5 mg/kg (Q3W)

    Reporting group title
    Dosing Group 3 (6 mg/kg (Q3W))
    Reporting group description
    6 mg/kg (Q3W)

    Reporting group title
    Dosing Group 4 (7 mg/kg (Q3W))
    Reporting group description
    7 mg/kg (Q3W)

    Reporting group title
    Dosing Group 5 (8 mg/kg (Q3W))
    Reporting group description
    8 mg/kg (Q3W)

    Reporting group title
    Dosing Group 6 (9 mg/kg (Q3W))
    Reporting group description
    9 mg/kg (Q3W)

    Reporting group title
    Dosing Group 7 (10 mg/kg (Q3W))
    Reporting group description
    10 mg/kg (Q3W)

    Reporting group title
    Dosing Group 8 (4 mg/kg (Q2W))
    Reporting group description
    4 mg/kg (Q2W)

    Reporting group title
    Dosing Group 9 (6 mg/kg (Q2W))
    Reporting group description
    6 mg/kg (Q2W)

    Serious adverse events
    Dosing Group 1 (≤ 4 mg/kg (Q3W)) Dosing Group 2 (5 mg/kg (Q3W)) Dosing Group 3 (6 mg/kg (Q3W)) Dosing Group 4 (7 mg/kg (Q3W)) Dosing Group 5 (8 mg/kg (Q3W)) Dosing Group 6 (9 mg/kg (Q3W)) Dosing Group 7 (10 mg/kg (Q3W)) Dosing Group 8 (4 mg/kg (Q2W)) Dosing Group 9 (6 mg/kg (Q2W))
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 9 (22.22%)
    3 / 9 (33.33%)
    5 / 12 (41.67%)
    10 / 22 (45.45%)
    5 / 9 (55.56%)
    4 / 8 (50.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    0
    0
    1
    1
    1
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    1
    1
    1
    0
    0
    Vascular disorders
    Embolism
    Additional description: Embolism
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour ulceration
    Additional description: Tumour ulceration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
    Additional description: Neutrophil count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
    Additional description: Cardiac tamponade
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
    Additional description: Hypoxia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
    Additional description: Respiratory arrest
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhagic stroke
    Additional description: Haemorrhagic stroke
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial haematoma
    Additional description: Intracranial haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurotoxicity
    Additional description: Neurotoxicity
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Keratitis
    Additional description: Keratitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
    Additional description: Small intestinal obstruction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    2 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
    Additional description: Cholangitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haematoma muscle
    Additional description: Haematoma muscle
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion
    Additional description: Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
    Additional description: Hypercalcaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Catheter site infection
    Additional description: Catheter site infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis orbital
    Additional description: Cellulitis orbital
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
    Additional description: Large intestine infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
    Additional description: Septic shock
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    <
    Non-serious adverse events
    Dosing Group 1 (≤ 4 mg/kg (Q3W)) Dosing Group 2 (5 mg/kg (Q3W)) Dosing Group 3 (6 mg/kg (Q3W)) Dosing Group 4 (7 mg/kg (Q3W)) Dosing Group 5 (8 mg/kg (Q3W)) Dosing Group 6 (9 mg/kg (Q3W)) Dosing Group 7 (10 mg/kg (Q3W)) Dosing Group 8 (4 mg/kg (Q2W)) Dosing Group 9 (6 mg/kg (Q2W))
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 20 (95.00%)
    9 / 9 (100.00%)
    9 / 9 (100.00%)
    12 / 12 (100.00%)
    22 / 22 (100.00%)
    9 / 9 (100.00%)
    8 / 8 (100.00%)
    4 / 4 (100.00%)
    6 / 6 (100.00%)
    Vascular disorders
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Flushing
    Additional description: Flushing
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    1
    0
    0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    0
    2
    0
    0
    1
    0
    Surgical and medical procedures
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Malignant neoplasm progression
    Additional description: Malignant neoplasm progression
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Tumour pain
    Additional description: Tumour pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    1
    2
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    3
    5
    1
    0
    0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Chills
    Additional description: Chills
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    7 / 20 (35.00%)
    6 / 9 (66.67%)
    6 / 9 (66.67%)
    7 / 12 (58.33%)
    10 / 22 (45.45%)
    4 / 9 (44.44%)
    2 / 8 (25.00%)
    1 / 4 (25.00%)
    3 / 6 (50.00%)
         occurrences all number
    9
    8
    8
    8
    15
    4
    2
    2
    6
    Feeling cold
    Additional description: Feeling cold
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Infusion site erythema
    Additional description: Infusion site erythema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion site phlebitis
    Additional description: Infusion site phlebitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    0
    0
    2
    0
    0
    0
    1
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    2
    3
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    3 / 22 (13.64%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    2
    4
    1
    0
    0
    0
    Pain
    Additional description: Pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    4 / 12 (33.33%)
    2 / 22 (9.09%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    3 / 4 (75.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    5
    2
    1
    2
    3
    0
    Secretion discharge
    Additional description: Secretion discharge
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    3 / 22 (13.64%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    2
    3
    0
    0
    0
    1
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Depression
    Additional description: Depression
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    0
    0
    0
    0
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 12 (25.00%)
    4 / 22 (18.18%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    1
    1
    3
    5
    1
    2
    1
    4
    Reproductive system and breast disorders
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Pelvic pain
    Additional description: Pelvic pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vaginal discharge
    Additional description: Vaginal discharge
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Vulvovaginal pain
    Additional description: Vulvovaginal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
    Additional description: Concussion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Fall
    Additional description: Fall
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    0
    0
    0
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    4 / 20 (20.00%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    2 / 12 (16.67%)
    5 / 22 (22.73%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    2 / 4 (50.00%)
    2 / 6 (33.33%)
         occurrences all number
    4
    1
    3
    2
    5
    0
    1
    2
    2
    Oral contusion
    Additional description: Oral contusion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Post procedural discomfort
    Additional description: Post procedural discomfort
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
    Additional description: Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    0 / 12 (0.00%)
    7 / 22 (31.82%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    3
    9
    0
    16
    2
    12
    0
    3
    Ammonia increased
    Additional description: Ammonia increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    1 / 12 (8.33%)
    9 / 22 (40.91%)
    2 / 9 (22.22%)
    3 / 8 (37.50%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    3
    8
    1
    32
    2
    14
    0
    6
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    5 / 22 (22.73%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    1
    7
    2
    0
    0
    0
    Blood calcium increased
    Additional description: Blood calcium increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Blood creatine increased
    Additional description: Blood creatine increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    3 / 9 (33.33%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    3
    0
    0
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood iron decreased
    Additional description: Blood iron decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood magnesium increased
    Additional description: Blood magnesium increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    0
    0
    International normalised ratio increased
    Additional description: International normalised ratio increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Lymphocyte count decreased
    Additional description: Lymphocyte count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Neutrophil count decreased
    Additional description: Neutrophil count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    1
    0
    0
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    1
    1
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    4 / 22 (18.18%)
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    1
    0
    5
    2
    2
    0
    0
    White blood cell count decreased
    Additional description: White blood cell count decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis
    Additional description: Allergic bronchitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Aspiration
    Additional description: Aspiration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    0
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    8 / 20 (40.00%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    3 / 12 (25.00%)
    2 / 22 (9.09%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    10
    1
    2
    6
    2
    2
    0
    0
    2
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    0
    0
    0
    Hypoxia
    Additional description: Hypoxia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Laryngeal oedema
    Additional description: Laryngeal oedema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Pharyngeal hypoaesthesia
    Additional description: Pharyngeal hypoaesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Pulmonary pain
    Additional description: Pulmonary pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Respiratory tract congestion
    Additional description: Respiratory tract congestion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus congestion
    Additional description: Sinus congestion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tachypnoea
    Additional description: Tachypnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Upper-airway cough syndrome
    Additional description: Upper-airway cough syndrome
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Wheezing
    Additional description: Wheezing
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    5 / 22 (22.73%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    6
    0
    0
    6
    13
    0
    0
    0
    0
    Lymph node pain
    Additional description: Lymph node pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    1
    0
    2
    0
    1
    0
    0
    Dysaesthesia
    Additional description: Dysaesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1
    0
    0
    Dysarthria
    Additional description: Dysarthria
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    3 / 22 (13.64%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    1
    1
    3
    1
    1
    1
    2
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lethargy
    Additional description: Lethargy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 12 (16.67%)
    6 / 22 (27.27%)
    3 / 9 (33.33%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    0
    1
    2
    3
    8
    4
    0
    0
    9
    Neurotoxicity
    Additional description: Neurotoxicity
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    1
    0
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    1 / 22 (4.55%)
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    2
    1
    1
    3
    1
    0
    1
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Taste disorder
    Additional description: Taste disorder
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Eye disorders
    Asthenopia
    Additional description: Asthenopia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Astigmatism
    Additional description: Astigmatism
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Chalazion
    Additional description: Chalazion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Corneal infiltrates
    Additional description: Corneal infiltrates
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Corneal toxicity
    Additional description: Corneal toxicity
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    2 / 4 (50.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    2
    0
    3
    2
    0
    2
    1
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    0
    0
    Eyelid ptosis
    Additional description: Eyelid ptosis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Glaucoma
    Additional description: Glaucoma
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Keratitis
    Additional description: Keratitis
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    7 / 22 (31.82%)
    2 / 9 (22.22%)
    4 / 8 (50.00%)
    0 / 4 (0.00%)
    4 / 6 (66.67%)
         occurrences all number
    1
    3
    2
    1
    13
    8
    11
    0
    16
    Keratopathy
    Additional description: Keratopathy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    6
    0
    0
    0
    1
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Ocular hyperaemia
    Additional description: Ocular hyperaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Ocular hypertension
    Additional description: Ocular hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Orbital cyst
    Additional description: Orbital cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Photophobia
    Additional description: Photophobia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1
    0
    1
    Presbyopia
    Additional description: Presbyopia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Punctate keratitis
    Additional description: Punctate keratitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    2
    1
    0
    0
    0
    0
    Pupillary reflex impaired
    Additional description: Pupillary reflex impaired
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Retinal degeneration
    Additional description: Retinal degeneration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Retinal detachment
    Additional description: Retinal detachment
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    4 / 22 (18.18%)
    2 / 9 (22.22%)
    5 / 8 (62.50%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    2
    0
    1
    5
    3
    6
    0
    1
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear disorder
    Additional description: Ear disorder
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    3 / 22 (13.64%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    4
    0
    0
    0
    0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 12 (16.67%)
    5 / 22 (22.73%)
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
         occurrences all number
    4
    1
    1
    2
    7
    3
    2
    2
    0
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    0
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ascites
    Additional description: Ascites
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    1
    2
    0
    0
    0
    0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    5 / 20 (25.00%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    4 / 12 (33.33%)
    4 / 22 (18.18%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    3 / 6 (50.00%)
         occurrences all number
    5
    2
    2
    5
    5
    1
    0
    1
    5
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    5 / 20 (25.00%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    2 / 12 (16.67%)
    7 / 22 (31.82%)
    4 / 9 (44.44%)
    3 / 8 (37.50%)
    2 / 4 (50.00%)
    1 / 6 (16.67%)
         occurrences all number
    6
    1
    4
    2
    9
    5
    3
    2
    1
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    3 / 22 (13.64%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    1
    3
    1
    0
    0
    0
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    3
    0
    0
    2
    2
    0
    1
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gingival bleeding
    Additional description: Gingival bleeding
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Large intestinal obstruction
    Additional description: Large intestinal obstruction
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    9 / 20 (45.00%)
    2 / 9 (22.22%)
    4 / 9 (44.44%)
    6 / 12 (50.00%)
    10 / 22 (45.45%)
    6 / 9 (66.67%)
    5 / 8 (62.50%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    14
    2
    8
    7
    12
    7
    6
    0
    2
    Odynophagia
    Additional description: Odynophagia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Proctalgia
    Additional description: Proctalgia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Small intestinal obstruction
    Additional description: Small intestinal obstruction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Upper gastrointestinal haemorrhage
    Additional description: Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0