Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase I/II, multicenter, open-label study of oral FGF401 in adult patients with hepatocellular carcinoma or solid malignancies characterized by positive FGFR4 and KLB expression Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

    Summary
    EudraCT number
    2014-002929-35
    Trial protocol
    ES   DE   FR  
    Global end of trial date
    30 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Jun 2020
    First version publication date
    14 Jun 2020
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CFGF401X2101
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02325739
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111, novartis.email@novartis.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
    30 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I part: To estimate the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of FGF401 single agent and in combination with PDR001. Phase II part: To investigate the anti-tumor activity of FGF401 single agent and in combination with PDR001.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Taiwan: 19
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    China: 1
    Country: Number of subjects enrolled
    France: 46
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Hong Kong: 22
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 11
    Country: Number of subjects enrolled
    Korea, Republic of: 19
    Country: Number of subjects enrolled
    Singapore: 9
    Worldwide total number of subjects
    172
    EEA total number of subjects
    84
    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)
    96
    From 65 to 84 years
    75
    85 years and over
    1

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    160 subjects were enrolled & treated with FGF401 single agent. In the Phase I part 74 subjects & 86 subjects in the Phase II part. 12 subjects were treated in the Phase I of the combination of FGF401 and PDR001. All subjects completed the study as per protocol & reasons for discontinuation of treatment are provided in the 'Not Completed' section.

    Pre-assignment
    Screening details
    At least 21 evaluable subjects were to be treated in Phase I for the model to have reasonable operating characteristics relating to its MTD &/or RP2D. Each group in the Phase II dose expansion targeted a different number of subjects. Group 1 & Group 2 planned to enroll around 40 subjects each & Group 3 planned to enroll approximately 20 subjects.

    Period 1
    Period 1 title
    Phase I and Phase II (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Phase I: 50 mg Fasted
    Arm description
    Participants received 50 mg of FGF401 while fasted
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: 80 mg Fasted
    Arm description
    Participants received 80 mg of FGF401 while fasted
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: 80 mg Fed
    Arm description
    Participants received 80 mg of FGF401 while fed.
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: 120 mg Fasted
    Arm description
    Participants received 120 mg of FGF401 while fasted
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: 120 mg Fed
    Arm description
    Participants received 120 mg of FGF401 while fed.
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: 150 mg Fasted
    Arm description
    Participants received 150 mg of FGF401 while fasted.
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: FGF401 80 mg + PDR001 300 mg
    Arm description
    Participants received 80 mg of FGF401 and 300 mg of PDR001 while fasted.
    Arm type
    Experimental

    Investigational medicinal product name
    PDR001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    PDR001 was taken every three weeks (3QW)

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase I: FGF401 120 mg + PDR001 300 mg
    Arm description
    Participants received 120 mg of FGF401 and 300mg of PDR001 while fasted
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Investigational medicinal product name
    PDR001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    PDR001 was taken every three weeks (3QW)

    Arm title
    Phase II: Group 1
    Arm description
    Group 1 comprised of HCC participants from Asian countries
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase II: Group 2
    Arm description
    HCC subjects from non-Asian countries
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Arm title
    Phase II: Group 3
    Arm description
    Subjects with other solid malignancies regardless of geography
    Arm type
    Experimental

    Investigational medicinal product name
    FGF401
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    FGF401 was taken on a flat scale of mg/day once daily (QD) on a continuous dosing regimen or the combination of FGF401 on a continuous once daily dosing regimen.

    Number of subjects in period 1
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg Phase II: Group 1 Phase II: Group 2 Phase II: Group 3
    Started
    11
    6
    5
    26
    19
    7
    6
    6
    30
    36
    20
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    11
    6
    5
    26
    19
    7
    6
    6
    30
    36
    20
         Progressive disease
    9
    6
    3
    23
    14
    6
    6
    3
    22
    29
    18
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
         Adverse event, serious fatal
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    1
    -
    1
    2
    3
    1
    -
    2
    4
    5
    1
         Subject/guardian decision
    1
    -
    1
    1
    -
    -
    -
    1
    4
    1
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Phase I: 50 mg Fasted
    Reporting group description
    Participants received 50 mg of FGF401 while fasted

    Reporting group title
    Phase I: 80 mg Fasted
    Reporting group description
    Participants received 80 mg of FGF401 while fasted

    Reporting group title
    Phase I: 80 mg Fed
    Reporting group description
    Participants received 80 mg of FGF401 while fed.

    Reporting group title
    Phase I: 120 mg Fasted
    Reporting group description
    Participants received 120 mg of FGF401 while fasted

    Reporting group title
    Phase I: 120 mg Fed
    Reporting group description
    Participants received 120 mg of FGF401 while fed.

    Reporting group title
    Phase I: 150 mg Fasted
    Reporting group description
    Participants received 150 mg of FGF401 while fasted.

    Reporting group title
    Phase I: FGF401 80 mg + PDR001 300 mg
    Reporting group description
    Participants received 80 mg of FGF401 and 300 mg of PDR001 while fasted.

    Reporting group title
    Phase I: FGF401 120 mg + PDR001 300 mg
    Reporting group description
    Participants received 120 mg of FGF401 and 300mg of PDR001 while fasted

    Reporting group title
    Phase II: Group 1
    Reporting group description
    Group 1 comprised of HCC participants from Asian countries

    Reporting group title
    Phase II: Group 2
    Reporting group description
    HCC subjects from non-Asian countries

    Reporting group title
    Phase II: Group 3
    Reporting group description
    Subjects with other solid malignancies regardless of geography

    Reporting group values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg Phase II: Group 1 Phase II: Group 2 Phase II: Group 3 Total
    Number of subjects
    11 6 5 26 19 7 6 6 30 36 20 172
    Age Categorical
    Units: participants
        18 y - <65 y
    6 4 3 14 12 4 3 3 22 15 10 96
        65 y - <85 y
    5 2 2 12 6 3 3 3 8 21 10 75
        >=85 y
    0 0 0 0 1 0 0 0 0 0 0 1
    Sex: Female, Male
    Units: participants
        Female
    4 1 1 3 6 0 1 4 8 7 12 47
        Male
    7 5 4 23 13 7 5 2 22 29 8 125
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    9 2 2 14 10 4 3 5 30 0 2 81
        Black
    0 0 0 0 1 1 0 0 0 0 0 2
        Caucasian
    2 4 3 12 8 1 3 1 0 21 11 66
        Not applicable
    0 0 0 0 0 0 0 0 0 1 0 1
        Other
    0 0 0 0 0 0 0 0 0 1 0 1
        Pacific Islander
    0 0 0 0 0 0 0 0 0 1 0 1
        Unknown
    0 0 0 0 0 1 0 0 0 12 7 20

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Phase I: 50 mg Fasted
    Reporting group description
    Participants received 50 mg of FGF401 while fasted

    Reporting group title
    Phase I: 80 mg Fasted
    Reporting group description
    Participants received 80 mg of FGF401 while fasted

    Reporting group title
    Phase I: 80 mg Fed
    Reporting group description
    Participants received 80 mg of FGF401 while fed.

    Reporting group title
    Phase I: 120 mg Fasted
    Reporting group description
    Participants received 120 mg of FGF401 while fasted

    Reporting group title
    Phase I: 120 mg Fed
    Reporting group description
    Participants received 120 mg of FGF401 while fed.

    Reporting group title
    Phase I: 150 mg Fasted
    Reporting group description
    Participants received 150 mg of FGF401 while fasted.

    Reporting group title
    Phase I: FGF401 80 mg + PDR001 300 mg
    Reporting group description
    Participants received 80 mg of FGF401 and 300 mg of PDR001 while fasted.

    Reporting group title
    Phase I: FGF401 120 mg + PDR001 300 mg
    Reporting group description
    Participants received 120 mg of FGF401 and 300mg of PDR001 while fasted

    Reporting group title
    Phase II: Group 1
    Reporting group description
    Group 1 comprised of HCC participants from Asian countries

    Reporting group title
    Phase II: Group 2
    Reporting group description
    HCC subjects from non-Asian countries

    Reporting group title
    Phase II: Group 3
    Reporting group description
    Subjects with other solid malignancies regardless of geography

    Primary: Incidence rate of Dose-limiting Toxicity (DLT): Phase I only

    Close Top of page
    End point title
    Incidence rate of Dose-limiting Toxicity (DLT): Phase I only [1] [2]
    End point description
    A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining set (DDS). A subject with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. A subject with multiple DLTs within a primary system organ class is counted only once in the total row.
    End point type
    Primary
    End point timeframe
    Cycle 1 (C1) (21 days) for FGF401 single agent, Cycle 1 and Cycle 2 (C2) (42 days) for FGF401 and PDR001 combination
    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: No statistical analysis was planned for this endpoint
    [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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    10
    6
    5
    23
    18
    7
    6
    6
    Units: Percentage of DLTs
    number (not applicable)
        Any Primary system organ class (SOC)
    10.0
    0
    0
    4.3
    5.6
    42.9
    0
    0
        Invest.: Aspartate Aminotrans. increased
    0
    0
    0
    4.3
    0
    42.9
    0
    0
        Invest.: Alanine aminotrans. increased
    10.0
    0
    0
    0
    0
    14.3
    0
    0
        Invest.: Blood bilirubin increased
    0
    0
    0
    0
    5.6
    0
    0
    0
    No statistical analyses for this end point

    Primary: Time to progression (TTP): Group 1 & Group 2 (Phase II only)

    Close Top of page
    End point title
    Time to progression (TTP): Group 1 & Group 2 (Phase II only) [3] [4]
    End point description
    TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis. Group 1: HCC subjects form Asian countries Group 2: HCC subjects form non-Asian countries
    End point type
    Primary
    End point timeframe
    5 years
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    [4] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase II: Group 1 Phase II: Group 2
    Number of subjects analysed
    30
    36
    Units: months
        median (confidence interval 90%)
    2.6 (1.3 to 999)
    3.9 (2.9 to 999)
    No statistical analyses for this end point

    Primary: Overall response rate (ORR) based on local assessment: Group 3 (Phase II only)

    Close Top of page
    End point title
    Overall response rate (ORR) based on local assessment: Group 3 (Phase II only) [5] [6]
    End point description
    ORR is defined as the percentage of patients with a best overall response of CR or PR (RECIST v1.1). FGF401 single agent-Phase II part - Group 3 (non-HCC, other solid tumors).
    End point type
    Primary
    End point timeframe
    5 years
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    [6] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase II: Group 3
    Number of subjects analysed
    20
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 16.8)
    No statistical analyses for this end point

    Secondary: Best Overall Response (BOR) by Investigator assessment: Phase I and Phase II

    Close Top of page
    End point title
    Best Overall Response (BOR) by Investigator assessment: Phase I and Phase II
    End point description
    BOR is the best response recorded from the start of the treatment until disease progression/recurrence. BOR is determined according to: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and unknown.
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg Phase II: Group 1 Phase II: Group 2 Phase II: Group 3
    Number of subjects analysed
    11
    6
    5
    26
    19
    7
    6
    6
    30
    36
    20
    Units: participants
        Complete Response
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Partial Response
    0
    1
    1
    0
    0
    1
    1
    1
    2
    2
    0
        Stable Disease
    2
    1
    2
    12
    9
    4
    2
    2
    11
    20
    6
        Progressive Disease
    7
    4
    1
    11
    8
    2
    3
    1
    16
    6
    12
        Unknown
    2
    0
    1
    2
    2
    0
    0
    2
    1
    8
    2
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) by Investigator assessment Phase I and FGF401 single agent Phase II Groups 1 & 2

    Close Top of page
    End point title
    Overall Response Rate (ORR) by Investigator assessment Phase I and FGF401 single agent Phase II Groups 1 & 2
    End point description
    ORR is defined as the proportion of patients with a best overall response of CR or PR (RECIST v1.1). Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians)
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg Phase II: Group 1 Phase II: Group 2 Phase II: Group 3
    Number of subjects analysed
    11
    6
    5
    26
    19
    7
    6
    6
    30
    36
    0 [7]
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 28.5)
    16.7 (0.4 to 64.1)
    20.0 (0.5 to 71.6)
    3.8 (0.1 to 19.6)
    0 (0.0 to 17.6)
    14.3 (0.4 to 57.9)
    16.7 (0.4 to 64.1)
    16.7 (0.4 to 64.1)
    6.7 (0.8 to 22.1)
    5.6 (0.7 to 18.7)
    ( to )
    Notes
    [7] - This arm was not analyzed for this endpoint.
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) by local Investigator assessment Phase I and FGF401 single agent Phase II Groups 1, 2 & 3

    Close Top of page
    End point title
    Disease Control Rate (DCR) by local Investigator assessment Phase I and FGF401 single agent Phase II Groups 1, 2 & 3
    End point description
    DCR is the percentage of participants with a best overall response of CR or PR or SD per local assessment according to RECIST v1.1. Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians) and Group 3 (non-HCC, other solid tumors).
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg Phase II: Group 1 Phase II: Group 2 Phase II: Group 3
    Number of subjects analysed
    11
    6
    5
    26
    19
    7
    6
    6
    30
    36
    20
    Units: percentage of participants
        number (confidence interval 95%)
    18.2 (2.3 to 51.8)
    33.3 (4.3 to 77.7)
    60.0 (14.7 to 94.7)
    50.0 (29.9 to 70.1)
    47.4 (24.4 to 71.1)
    71.4 (29.0 to 96.3)
    50.0 (11.8 to 88.2)
    50.0 (11.8 to 88.2)
    43.3 (25.5 to 62.6)
    61.1 (43.5 to 76.9)
    30.0 (11.9 to 54.3)
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP) - Phase I (single agent FGF401 & in combination with PDR001) dosed at RP2D

    Close Top of page
    End point title
    Time to Progression (TTP) - Phase I (single agent FGF401 & in combination with PDR001) dosed at RP2D [8]
    End point description
    TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis.
    End point type
    Secondary
    End point timeframe
    5 years
    Notes
    [8] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    26
    19
    6
    Units: months
        median (confidence interval 90%)
    4.1 (1.6 to 999)
    2.0 (1.4 to 999)
    5.3 (3.0 to 999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) - Phase I (single agent & combination) dosed at RP2D and Phase II FGF401 single agent

    Close Top of page
    End point title
    Overall Survival (OS) - Phase I (single agent & combination) dosed at RP2D and Phase II FGF401 single agent [9]
    End point description
    Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. Method used was Kaplan-Meier analysis.
    End point type
    Secondary
    End point timeframe
    start of treatment to death, up to about 53 months
    Notes
    [9] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: FGF401 120 mg + PDR001 300 mg Phase II: Group 1 Phase II: Group 2 Phase II: Group 3
    Number of subjects analysed
    26
    19
    6
    30
    36
    20
    Units: months
        median (confidence interval 90%)
    7.0 (5.1 to 999)
    4.9 (2.6 to 999)
    999 (999 to 999)
    5.9 (5.1 to 999)
    10.9 (7.9 to 999)
    6.2 (4.2 to 999)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) - FGF401 single agent Phase II: Group 3

    Close Top of page
    End point title
    Progression-free Survival (PFS) - FGF401 single agent Phase II: Group 3 [10]
    End point description
    Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Group 3 - non-HCC, other solid tumors. Method used was Kaplan-Meier analysis.
    End point type
    Secondary
    End point timeframe
    5 years
    Notes
    [10] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase II: Group 3
    Number of subjects analysed
    20
    Units: months
        median (confidence interval 95%)
    1.4 (1.4 to 2.8)
    No statistical analyses for this end point

    Secondary: Presence and/or concentration of anti-PDR001 antibodies

    Close Top of page
    End point title
    Presence and/or concentration of anti-PDR001 antibodies [11]
    End point description
    Serum PDR001 concentrations as well as immunogenicity analysis were performed for all subjects receiving PDR001. Treatment-induced ADA-positive percentage was based on percentage subjects ADA-negative at baseline. Treatment-boosted ADA-positive percentage was based on subjects ADA-positive at baseline.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1 to 6, approx. 10 months after C1D1 and 150-day safety ollow up (FU)
    Notes
    [11] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    6
    6
    Units: percentage of participants
    number (not applicable)
        ADA-negative
    100.0
    83.3
        ADA-positive (i.e. ADA incidence)
    0
    16.7
        Treatment-induced ADA-positive
    0
    20.0
        Treatment-boosted ADA-positive
    0
    0
    No statistical analyses for this end point

    Secondary: Cmax of PDR001 in combination with FGF401: Phase I

    Close Top of page
    End point title
    Cmax of PDR001 in combination with FGF401: Phase I [12]
    End point description
    Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
    End point type
    Secondary
    End point timeframe
    After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
    Notes
    [12] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    6
    6
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    74.7 ± 43.0
    87.7 ± 5.4
    No statistical analyses for this end point

    Secondary: AUClast and AUCtau of PDR001 in combination with FGF401: Phase I

    Close Top of page
    End point title
    AUClast and AUCtau of PDR001 in combination with FGF401: Phase I [13]
    End point description
    AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
    End point type
    Secondary
    End point timeframe
    After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
    Notes
    [13] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    6
    6
    Units: day*μg/mL
    geometric mean (geometric coefficient of variation)
        AUClast
    795 ± 34.5
    978 ± 15.8
        AUC0-504h (n = 3, 6)
    760 ± 1.9
    967 ± 13.9
    No statistical analyses for this end point

    Secondary: T1/2 of PDR001: Phase I

    Close Top of page
    End point title
    T1/2 of PDR001: Phase I [14]
    End point description
    Due to the sparse PK sampling designed from PDR001, the PDR001 concentration data was insufficient for accurate estimation of secondary PK parameters including T1/2 which were considered not reportable
    End point type
    Secondary
    End point timeframe
    After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
    Notes
    [14] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: hour (hr)
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [15] - This endpoint was not analyzed
    [16] - This endpoint was not analyzed
    No statistical analyses for this end point

    Secondary: Cmax of FGF401: Phase I

    Close Top of page
    End point title
    Cmax of FGF401: Phase I [17]
    End point description
    Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 & Day 8, Cycle 2 Day 1 (each cycle is 21 days)
    Notes
    [17] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted
    Number of subjects analysed
    10
    6
    5
    26
    19
    7
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1 (n=6, 5, 5, 26, 19,7)
    698 ± 36.1
    967 ± 25.0
    659 ± 15.2
    1090 ± 37.9
    1050 ± 32.3
    1400 ± 32.1
        Cycle 1 Day 8 (7, 6, 4, 24, 18, 6)
    663 ± 46.8
    838 ± 16.5
    704 ± 22.1
    1120 ± 36.5
    1060 ± 22.1
    1070 ± 46.0
        Cycle 2 Day 1 (n = 9, 6, 5, 22, 17, 4)
    696 ± 44.2
    786 ± 25.5
    703 ± 41.7
    1070 ± 32.2
    1000 ± 23.9
    1350 ± 28.1
    No statistical analyses for this end point

    Secondary: Cmax of FGF401 in combination with PDR001: Phase I

    Close Top of page
    End point title
    Cmax of FGF401 in combination with PDR001: Phase I [18]
    End point description
    Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1
    Notes
    [18] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    6
    6
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    732 ± 26.8
    1450 ± 31.4
    No statistical analyses for this end point

    Secondary: AUCinf, AUClast & AUCtau of FGF401: Phase I

    Close Top of page
    End point title
    AUCinf, AUClast & AUCtau of FGF401: Phase I [19]
    End point description
    AUCinf: The AUC from time zero to infinity (mass x time x volume-1) AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 & Day 8, Cycle 2 Day 1 (each cycle is 21 days)
    Notes
    [19] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted
    Number of subjects analysed
    10
    6
    5
    26
    19
    7
    Units: hr*ng/mL
    geometric mean (geometric coefficient of variation)
        AUCinf C1D1 (n = 6, 5, 4, 24, 17,7)
    4920 ± 51.9
    5090 ± 32.9
    5560 ± 23.1
    7210 ± 35.4
    8520 ± 35.2
    8190 ± 42.7
        AUClast C1D1 (n =6, 5, 5, 26, 19, 7)
    4610 ± 50.4
    4710 ± 38.0
    4600 ± 39.2
    6710 ± 35.6
    7850 ± 34.1
    7920 ± 42.0
        AUCtau C1D1 (n = 6, 5, 5, 26, 18, 7)
    4610 ± 50.4
    4910 ± 30.3
    4860 ± 29.4
    6840 ± 33.6
    8020 ± 33.5
    7930 ± 41.8
        AUCinf C1D8 (n = 6, 6, 4, 18, 15, 6)
    3650 ± 71.9
    5130 ± 28.9
    5550 ± 23.2
    7590 ± 43.0
    7980 ± 25.1
    7850 ± 29.4
        AUClast C1D8 (n = 6, 6, 4, 24, 18, 6)
    3460 ± 62.5
    4840 ± 27.0
    5280 ± 23.9
    6480 ± 47.5
    7640 ± 33.1
    7550 ± 28.6
        AUCtau C1D8 (n = 7, 6, 4, 24, 16, 6)
    3650 ± 65.6
    4850 ± 27.0
    5290 ± 24.0
    6970 ± 38.7
    7330 ± 26.7
    7510 ± 29.8
        AUCinf C2D1 (n = 9, 6, 5, 22, 13, 4)
    4390 ± 54.0
    4580 ± 30.6
    5110 ± 44.3
    7770 ± 33.2
    8760 ± 23.5
    7850 ± 25.7
        AUClast C2D1 (n = 9, 6, 5, 22, 17, 4)
    4100 ± 52.9
    4210 ± 32.5
    4880 ± 43.1
    7260 ± 33.6
    7520 ± 38.7
    7610 ± 25.8
        AUCtau C2D1 (n = 9, 6, 5, 22, 15, 4)
    4100 ± 52.7
    4360 ± 28.5
    4870 ± 43.7
    7330 ± 31.7
    7830 ± 23.4
    7620 ± 25.7
    No statistical analyses for this end point

    Secondary: AUCinf, AUClast & AUCtau of FGF401 in combination with PDR001: Phase I

    Close Top of page
    End point title
    AUCinf, AUClast & AUCtau of FGF401 in combination with PDR001: Phase I [20]
    End point description
    AUCinf: The AUC from time zero to infinity (mass x time x volume-1) AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1
    Notes
    [20] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: FGF401 80 mg + PDR001 300 mg Phase I: FGF401 120 mg + PDR001 300 mg
    Number of subjects analysed
    6
    6
    Units: hr*ng/mL
    geometric mean (geometric coefficient of variation)
        AUCinf
    5030 ± 25.5
    7540 ± 37.0
        AUClast
    4760 ± 25.0
    7280 ± 36.7
        AUCtau
    4770 ± 24.4
    7280 ± 36.7
    No statistical analyses for this end point

    Secondary: T1/2 of FGF401: Phase I

    Close Top of page
    End point title
    T1/2 of FGF401: Phase I [21]
    End point description
    The elimination half-life associated with the terminal slope ( z) of a semi logarithmic concentration-time curve (time).
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 & Day 8, Cycle 2 Day 1 (each cycle is 21 days)
    Notes
    [21] - 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: No statistical analysis was planned for this endpoint
    End point values
    Phase I: 50 mg Fasted Phase I: 80 mg Fasted Phase I: 80 mg Fed Phase I: 120 mg Fasted Phase I: 120 mg Fed Phase I: 150 mg Fasted
    Number of subjects analysed
    10
    6
    5
    26
    19
    7
    Units: hour (hr)
    geometric mean (geometric coefficient of variation)
        C1D1 (n = 6, 5, 4, 24, 17, 7)
    6.27 ± 16.2
    4.91 ± 31.6
    5.2 ± 8.8
    5.47 ± 14.4
    5.16 ± 16.3
    5 ± 11.3
        C1D8 (n = 6, 6, 4, 18, 15, 6)
    6.57 ± 16.6
    6.08 ± 13.8
    5.58 ± 12.0
    5.43 ± 30.0
    5.58 ± 17.1
    5.24 ± 12.4
        C2D1 (n = 9, 6, 5, 22, 13, 4)
    6.46 ± 18.9
    5.44 ± 34.9
    5.43 ± 17.2
    5.8 ± 22.1
    5.81 ± 20.2
    4.92 ± 14.4
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    .Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Phase I Part 50 mg Fasted
    Reporting group description
    Participants received 50 mg of FGF401 while fasted

    Reporting group title
    Phase I Part 80 mg Fasted
    Reporting group description
    Participants received 80 mg of FGF401 while fasted

    Reporting group title
    Phase I Part 80 mg Fed
    Reporting group description
    Participants received 80 mg of FGF401 while fed

    Reporting group title
    Phase I Part 120 mg Fasted
    Reporting group description
    Participants received 120 mg of FGF401 while fasted

    Reporting group title
    Phase I Part 120 mg Fed
    Reporting group description
    Participants received 120 mg of FGF401 while fed

    Reporting group title
    Phase I Part 150 mg Fasted
    Reporting group description
    Participants received 150 mg of FGF401 while fasted

    Reporting group title
    Phase II Part Group 1
    Reporting group description
    This group is comprised of HCC participants from Asian countries who received the RP2D of FGF401 while fasted

    Reporting group title
    Phase II Part Group 2
    Reporting group description
    This group is comprised of HCC participants from non- Asian countries who received the RP2D of FGF401 while fasted

    Reporting group title
    Phase II Part Group 3
    Reporting group description
    This group comprised of participants with other solid malignancies regardless of geography who received the RP2D of FGF401 while fasted

    Reporting group title
    All Patients Single agent
    Reporting group description
    This group comprised of all participants who took single agent FGF401

    Reporting group title
    Phase I Part FGF401 80 mg + PDR001 300 mg
    Reporting group description
    Participants received 80 mg of FGF401 and 300 mg of PDR001 while fasted.

    Reporting group title
    Phase I Part FGF401 120 mg + PDR001 300 mg
    Reporting group description
    Participants received 120 mg of FGF402 and 300 mg of PDR001 while fasted

    Reporting group title
    All Patients Combination
    Reporting group description
    This group comprised of all participants who took combination treatment of FGF401 and PDR001

    Reporting group title
    All Patients
    Reporting group description
    These are all the participants in the study

    Serious adverse events
    Phase I Part 50 mg Fasted Phase I Part 80 mg Fasted Phase I Part 80 mg Fed Phase I Part 120 mg Fasted Phase I Part 120 mg Fed Phase I Part 150 mg Fasted Phase II Part Group 1 Phase II Part Group 2 Phase II Part Group 3 All Patients Single agent Phase I Part FGF401 80 mg + PDR001 300 mg Phase I Part FGF401 120 mg + PDR001 300 mg All Patients Combination All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    5 / 6 (83.33%)
    3 / 5 (60.00%)
    15 / 26 (57.69%)
    9 / 19 (47.37%)
    3 / 7 (42.86%)
    15 / 30 (50.00%)
    9 / 36 (25.00%)
    8 / 20 (40.00%)
    70 / 160 (43.75%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
    72 / 172 (41.86%)
         number of deaths (all causes)
    2
    1
    0
    4
    6
    1
    2
    2
    2
    20
    0
    0
    0
    20
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bleeding varicose vein
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inferior vena caval occlusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Liver carcinoma ruptured
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Oedema peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    2 / 20 (10.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
    5 / 172 (2.91%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 2
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Bone contusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    2 / 7 (28.57%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    3 / 172 (1.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    1 / 1
    0 / 0
    0 / 0
    3 / 3
    0 / 0
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchostenosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    4 / 160 (2.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    4 / 172 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    3 / 19 (15.79%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    3 / 20 (15.00%)
    9 / 160 (5.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    9 / 172 (5.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 9
    0 / 0
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    3 / 172 (1.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    2 / 26 (7.69%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    5 / 160 (3.13%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    5 / 172 (2.91%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
    3 / 172 (1.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 2
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric varices
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Gastritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    3 / 172 (1.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
    3 / 172 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    3 / 172 (1.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biloma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    0 / 160 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Phase I Part 50 mg Fasted Phase I Part 80 mg Fasted Phase I Part 80 mg Fed Phase I Part 120 mg Fasted Phase I Part 120 mg Fed Phase I Part 150 mg Fasted Phase II Part Group 1 Phase II Part Group 2 Phase II Part Group 3 All Patients Single agent Phase I Part FGF401 80 mg + PDR001 300 mg Phase I Part FGF401 120 mg + PDR001 300 mg All Patients Combination All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    6 / 6 (100.00%)
    5 / 5 (100.00%)
    26 / 26 (100.00%)
    19 / 19 (100.00%)
    7 / 7 (100.00%)
    30 / 30 (100.00%)
    36 / 36 (100.00%)
    20 / 20 (100.00%)
    160 / 160 (100.00%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    12 / 12 (100.00%)
    172 / 172 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    2
    Hot flush
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    0 / 160 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    2 / 12 (16.67%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    2
    2
    Hypertension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    2 / 7 (28.57%)
    0 / 30 (0.00%)
    3 / 36 (8.33%)
    2 / 20 (10.00%)
    9 / 160 (5.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    9 / 172 (5.23%)
         occurrences all number
    0
    1
    0
    1
    0
    4
    0
    5
    2
    13
    0
    0
    0
    13
    Hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Inferior vena cava syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Vascular compression
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Vena cava thrombosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Venous thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Cancer pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Pyogenic granuloma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Tumour associated fever
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    4 / 26 (15.38%)
    3 / 19 (15.79%)
    2 / 7 (28.57%)
    3 / 30 (10.00%)
    6 / 36 (16.67%)
    4 / 20 (20.00%)
    26 / 160 (16.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    26 / 172 (15.12%)
         occurrences all number
    3
    3
    0
    5
    4
    2
    4
    14
    8
    43
    0
    0
    0
    43
    Chest discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    2 / 30 (6.67%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    0
    2
    Chest pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    3 / 30 (10.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    5 / 160 (3.13%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    5 / 172 (2.91%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    3
    0
    3
    7
    0
    0
    0
    7
    Face oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    6 / 26 (23.08%)
    4 / 19 (21.05%)
    0 / 7 (0.00%)
    2 / 30 (6.67%)
    8 / 36 (22.22%)
    7 / 20 (35.00%)
    30 / 160 (18.75%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    3 / 12 (25.00%)
    33 / 172 (19.19%)
         occurrences all number
    2
    1
    0
    6
    5
    0
    2
    10
    9
    35
    1
    2
    3
    38
    Gait disturbance
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    General physical health deterioration
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    2
    Hernia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    Injection site pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Localised oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    2
    0
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 26 (7.69%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    3 / 172 (1.74%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    1
    0
    3
    0
    0
    0
    3
    Mucosal inflammation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    3 / 172 (1.74%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    2
    1
    0
    1
    3
    Oedema peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    9 / 26 (34.62%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    8 / 30 (26.67%)
    9 / 36 (25.00%)
    3 / 20 (15.00%)
    30 / 160 (18.75%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
    32 / 172 (18.60%)
         occurrences all number
    0
    2
    0
    10
    0
    0
    8
    10
    3
    33
    0
    3
    3
    36
    Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    1 / 20 (5.00%)
    4 / 160 (2.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    4 / 172 (2.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    2
    1
    4
    0
    0
    0
    4
    Peripheral swelling
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    3 / 160 (1.88%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    3 / 172 (1.74%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    3
    0
    0
    0
    3
    Pyrexia
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    6 / 26 (23.08%)
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    9 / 30 (30.00%)
    4 / 36 (11.11%)
    5 / 20 (25.00%)
    31 / 160 (19.38%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    4 / 12 (33.33%)
    35 / 172 (20.35%)
         occurrences all number
    6
    0
    2
    8
    1
    1
    13
    5
    12
    48
    1
    3
    4
    52
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    2 / 36 (5.56%)
    1 / 20 (5.00%)
    5 / 160 (3.13%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    5 / 172 (2.91%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1
    2
    2
    7
    0
    0
    0
    7
    Bulimia nervosa
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    0
    2
    Emotional disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 26 (3.85%)
    1 / 19 (5.26%)
    2 / 7 (28.57%)
    4 / 30 (13.33%)
    2 / 36 (5.56%)
    5 / 20 (25.00%)
    16 / 160 (10.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
    17 / 172 (9.88%)
         occurrences all number
    0
    0
    1
    1
    1
    2
    4
    2
    5
    16
    0
    1
    1
    17
    Nightmare
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    2 / 36 (5.56%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    2
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Female genital tract fistula
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Oedema genital
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Pelvic pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    2
    0
    0
    0
    2
    Scrotal oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    0
    0
    0
    2
    Varicocele
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Bone contusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Clavicle fracture
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Face injury
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Fracture
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Humerus fracture
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    Periorbital haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    1 / 36 (2.78%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Post procedural discharge
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    5 / 30 (16.67%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    7 / 160 (4.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    7 / 172 (4.07%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    5
    0
    1
    7
    0
    0
    0
    7
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    1 / 20 (5.00%)
    2 / 160 (1.25%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 172 (1.16%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 11 (27.27%)
    3 / 6 (50.00%)
    2 / 5 (40.00%)
    14 / 26 (53.85%)
    11 / 19 (57.89%)
    7 / 7 (100.00%)
    13 / 30 (43.33%)
    11 / 36 (30.56%)
    6 / 20 (30.00%)
    70 / 160 (43.75%)
    0 / 6 (0.00%)
    4 / 6 (66.67%)
    4 / 12 (33.33%)
    74 / 172 (43.02%)
         occurrences all number
    3
    6
    5
    19
    13
    11
    16
    12
    8
    93
    0
    4
    4
    97
    Alpha 1 foetoprotein increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    0 / 30 (0.00%)
    0 / 36 (0.00%)
    0 / 20 (0.00%)
    1 / 160 (0.63%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Amylase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 30 (3.33%)
    2 / 36 (5.56%)
    0 / 20 (0.00%)
    4 / 160 (2.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    4 / 172 (2.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    2
    0
    4
    0
    0
    0
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 11 (36.36%)
    3 / 6 (50.00%)
    2 / 5 (40.00%)
    16 / 26 (61.54%)
    14 / 19 (73.68%)
    7 / 7 (100.00%)
    14 / 30 (46.67%)