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    Clinical Trial Results:
    An Open-label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970/M6620 in Combination with Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors

    Summary
    EudraCT number
    2012-003126-25
    Trial protocol
    GB  
    Global end of trial date
    11 Mar 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Mar 2021
    First version publication date
    21 Mar 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    MS201923-0001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02157792
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck KGaA, Darmstadt, Germany
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre, Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center, Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.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
    11 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of multiple ascending doses of intravenously administered M6620 in combination with gemcitabine, and in combination with cisplatin and gemcitabine, in subjects with advanced solid tumors.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Dec 2012
    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
    United Kingdom: 118
    Country: Number of subjects enrolled
    United States: 79
    Worldwide total number of subjects
    197
    EEA total number of subjects
    0
    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)
    134
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    First subject signed informed consent: 10 Dec 2012, Last subject last visit: 11 Mar 2020.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at a initial dose of 18 milligrams per square meter (mg/m^2) approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at a initial dose of 18 milligrams per square meter (mg/m^2) approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 36 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 36 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 60 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 60 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 72 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 72 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabineat at a dose of 875 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 in combination with M6620.

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Arm title
    Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at dose of 500 mg/m^2 on Days 1 and 8 in combination with M6620.

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Arm title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 750 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 750 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 in combination with M6620.

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Arm title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 41 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine and Cisplatin.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 in combination with M6620 and Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose 60 mg/m^2 on Day 1 in combination with M6620 and Gemcitabine.

    Arm title
    Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 120 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 41 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 120 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine and Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose of 60 mg/m^2 on Day 1 in combination with M6620 and Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 n combination with M6620 and Cisplatin.

    Arm title
    Part B1: M6620 140 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9.

    Arm title
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose of 40 mg/m^2 of on Day 1 in combination with M6620.

    Arm title
    Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 140mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 140mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of 40 mg/m^2 of Cisplatin on Day 1 in combination with M6620.

    Arm title
    Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose of 40 mg/m^2 of on Day 1 in combination with M6620.

    Arm title
    Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 60 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose of 60 mg/m^2 of on Day 1 in combination with M6620.

    Arm title
    Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose of 75 mg/m^2 on Day 1 in combination with M6620.

    Arm title
    Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of Cisplatin at a dose of 75 mg/m^2 of on Day 1 in combination with M6620.

    Arm title
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at a dose of 60 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at a dose of 60 mg/m^2, in combination with irinotecan.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 in combination with M6620.

    Arm title
    Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Arm description
    Subjects received intravenous infusion of M6620 at a dose of 90 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of M6620 at a dose of 90 mg/m^2, in combination with irinotecan.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use, Intravenous use
    Dosage and administration details
    Subjects received intravenous infusion of irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 in combination with M6620.

    Arm title
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Arm description
    Subjects with advanced non-small cell lung cancer (NSCLC) received intravenous infusion of M6620 at a dose of 210 mg/m^2 on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 63 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with advanced non-small cell lung cancer (NSCLC) received intravenous infusion of M6620 at a dose of 210 mg/m^2 on Days 2 and 9 in combination with Gemcitabine.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with advanced non-small cell lung cancer (NSCLC) received intravenous infusion of Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 in combination with M6620.

    Arm title
    Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Arm description
    Subjects with advanced triple negative breast cancer (TNBC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 137 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with advanced triple negative breast cancer (TNBC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with advanced triple negative breast cancer (TNBC) received intravenous infusion of Cisplatin at a dose of 75 mg/m^2 on Day 1 in combination with M6620.

    Arm title
    Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Arm description
    Subjects with platinum-resistant advanced small cell lung cancer (SCLC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 27 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with platinum-resistant advanced small cell lung cancer (SCLC) received intravenous infusion of Cisplatin at a dose of 75 mg/m^2 on Day 1 in combination with M6620.

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with platinum-resistant advanced small cell lung cancer (SCLC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin.

    Arm title
    Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Arm description
    Subjects with platinum-resistant advanced SCLC received intravenous infusion of M6620 at a dose of 90 mg/m^2 on Days 2 and 9 in combination with carboplatin area under concentration-time curve (AUC) at a dose of 5 milligrams.minute per milliliter on Day 1 of a 21-day cycle up to 27 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with platinum-resistant advanced SCLC received intravenous infusion of Carboplatin are under concentration-time curve (AUC) at a dose of 5 mg.min/mL on Day 1 in combination with M6620.

    Investigational medicinal product name
    M6620
    Investigational medicinal product code
    M6620
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects with platinum-resistant advanced SCLC received intravenous infusion of M6620 at a dose of 90 mg/m^2 on Days 2 and 9 in combination with Carboplatin.

    Number of subjects in period 1
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2 Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2 Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Started
    3
    3
    4
    7
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    4
    10
    7
    3
    5
    3
    38
    47
    2
    13
    Completed
    3
    3
    4
    7
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    4
    10
    7
    3
    5
    3
    38
    47
    2
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a initial dose of 18 milligrams per square meter (mg/m^2) approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 36 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 60 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 72 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 750 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 41 weeks.

    Reporting group title
    Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 120 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 41 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 60 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a dose of 60 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Reporting group title
    Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a dose of 90 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Reporting group title
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Reporting group description
    Subjects with advanced non-small cell lung cancer (NSCLC) received intravenous infusion of M6620 at a dose of 210 mg/m^2 on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 63 weeks.

    Reporting group title
    Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects with advanced triple negative breast cancer (TNBC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 137 weeks.

    Reporting group title
    Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects with platinum-resistant advanced small cell lung cancer (SCLC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 27 weeks.

    Reporting group title
    Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Reporting group description
    Subjects with platinum-resistant advanced SCLC received intravenous infusion of M6620 at a dose of 90 mg/m^2 on Days 2 and 9 in combination with carboplatin area under concentration-time curve (AUC) at a dose of 5 milligrams.minute per milliliter on Day 1 of a 21-day cycle up to 27 weeks.

    Reporting group values
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2 Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2 Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL Total
    Number of subjects
    3 3 4 7 6 8 3 3 7 6 6 2 1 3 3 4 10 7 3 5 3 38 47 2 13 197
    Age Categorical
    Units: subjects
        <=18 years
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    3 2 3 5 3 6 3 2 3 3 4 2 1 2 0 3 4 5 1 4 2 22 43 2 6 134
        >=65 years
    0 1 1 2 3 2 0 1 4 3 2 0 0 1 3 1 6 2 2 1 1 16 4 0 7 63
    Sex: Female, Male
    Units: subjects
        Female
    2 0 1 4 3 2 2 2 3 3 3 1 1 2 1 1 5 6 1 3 1 18 47 2 8 122
        Male
    1 3 3 3 3 6 1 1 4 3 3 1 0 1 2 3 5 1 2 2 2 20 0 0 5 75
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 1 1 0 0 5
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Black or African American
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 2 0 2 6
        White
    3 2 4 7 6 8 3 3 7 6 6 2 1 3 2 3 8 7 3 3 3 34 41 2 11 178
        More than one race
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 2
        Unknown or Not Reported
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 3 0 0 6
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 3 3 4 0 0 15
        Not Hispanic or Latino
    3 3 4 7 5 8 3 3 7 6 6 2 1 3 3 4 10 7 3 0 0 32 41 1 13 175
        Unknown or Not Reported
    0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 2 1 0 7

    End points

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    End points reporting groups
    Reporting group title
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a initial dose of 18 milligrams per square meter (mg/m^2) approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 36 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 60 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 72 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 750 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 41 weeks.

    Reporting group title
    Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 120 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 41 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1, of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 40 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 60 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a dose of 60 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Reporting group title
    Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a dose of 90 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Reporting group title
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Reporting group description
    Subjects with advanced non-small cell lung cancer (NSCLC) received intravenous infusion of M6620 at a dose of 210 mg/m^2 on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 63 weeks.

    Reporting group title
    Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects with advanced triple negative breast cancer (TNBC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 137 weeks.

    Reporting group title
    Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects with platinum-resistant advanced small cell lung cancer (SCLC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 27 weeks.

    Reporting group title
    Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Reporting group description
    Subjects with platinum-resistant advanced SCLC received intravenous infusion of M6620 at a dose of 90 mg/m^2 on Days 2 and 9 in combination with carboplatin area under concentration-time curve (AUC) at a dose of 5 milligrams.minute per milliliter on Day 1 of a 21-day cycle up to 27 weeks.

    Subject analysis set title
    Part A1: All Subjects
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received M6620 at a dose of 18, 36, 60, 72, 90, 140 or 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemicitabine at a dose of 875, 500, 750 or 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Subject analysis set title
    Part A2: All Subjects
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received M6620 at a dose of 90 or120 mg/m^2 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and 60 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 41 weeks.

    Subject analysis set title
    Parts B1: All Subjects
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received intravenous infusion of M6620 at dose of 140, 90 or 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin at a dose 40, 60 or 75 mg/m^2 on Day 1 of a 21-day cycle up to 74 weeks.

    Subject analysis set title
    Part B2: All Subjects
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received intravenous infusion of M6620 at a dose of 60 or 90 mg/m^2 in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Subject analysis set title
    Part A1: M6620 120 mg/m^2 and Gemcitabine
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received intravenous infusion of M6620 at escalated dose of 120 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500, 750, 875 or 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Subject analysis set title
    Part A1: M6620 210 mg/m^2 and Gemcitabine
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 750, 875 or 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Subject analysis set title
    Part B1: M6620 140 mg/m^2 and Cisplatin
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received intravenous infusion of M6620 at dose of 140mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin at a dose of 40 or 75 mg/m^2 on Day 1 of a 21-day cycle up to 74 weeks.

    Subject analysis set title
    Part B1: M6620 210 mg/m^2 and Cisplatin
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin at a dose of 40, 60 or 75 mg/m^2 on Day 1 of a 21-day cycle up to 74 weeks.

    Primary: Parts A1, A2, B1: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Parts A1, A2, B1: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) [1] [2]
    End point description
    Adverse event (AE) was defined as any untoward medical occurrence in a subject, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period. TEAEs included both serious TEAEs and non-serious TEAEs. Safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.6 years
    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: Only descriptive summary statistics 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: In this endpoint, we have reported data for Part A1, Part A2 and Part B1 arms only. For Part B2, Part C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    3
    3
    4
    7
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    4
    10
    7
    3
    Units: subjects
    3
    3
    4
    6
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    3
    10
    7
    3
    No statistical analyses for this end point

    Primary: Parts A1, A2, B1: Number of Subjects with Clinically Significant Changes From Baseline in Laboratory Parameters

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    End point title
    Parts A1, A2, B1: Number of Subjects with Clinically Significant Changes From Baseline in Laboratory Parameters [3] [4]
    End point description
    Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in laboratory parameters were reported. Safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.6 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: Only descriptive summary statistics 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: In this endpoint, we have reported data for Part A1, Part A2 and Part B1 arms only. For Part B2, Part C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    3
    3
    4
    7
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    4
    10
    7
    3
    Units: subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Parts A1, A2, B1: Number of Subjects with Clinically Significant Changes From Baseline in Vital Signs

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    End point title
    Parts A1, A2, B1: Number of Subjects with Clinically Significant Changes From Baseline in Vital Signs [5] [6]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate and respiratory rate. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes fom baseline in vital signs were reported. Safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.6 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: Only descriptive summary statistics 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: In this endpoint, we have reported data for Part A1, Part A2 and Part B1 arms only. For Part B2, Part C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    3
    3
    4
    7
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    4
    10
    7
    3
    Units: subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Parts A1, A2, B1: Number of Subjects with Clinically Significant Changes From Baseline in 12-Lead Electrocardiograms (ECGs) Findings

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    End point title
    Parts A1, A2, B1: Number of Subjects with Clinically Significant Changes From Baseline in 12-Lead Electrocardiograms (ECGs) Findings [7] [8]
    End point description
    12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the subjects have rested for at least 5 minutes in supine position. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in 12-lead ECG findings were reported. Safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.6 years
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics was planned for this endpoint.
    [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: In this endpoint, we have reported data for Part A1, Part A2 and Part B1 arms only. For Part B2, Part C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    3
    3
    4
    7
    6
    8
    3
    3
    7
    6
    6
    2
    1
    3
    3
    4
    10
    7
    3
    Units: subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B2: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Part B2: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) [9] [10]
    End point description
    Adverse event (AE) was defined as any untoward medical occurrence in a subject, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period. TEAEs included both serious TEAEs and non-serious TEAEs. Safety Analysis Set (SAF) included all screening analysis set subjects who received at least 1 administration of study drug (irinotecan or M6620).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 1.6 years
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics was planned for this endpoint.
    [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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    5
    3
    Units: subjects
    5
    3
    No statistical analyses for this end point

    Primary: Part B2: Number of Subjects with Clinically Significant Changes from Baseline in Laboratory Parameters

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    End point title
    Part B2: Number of Subjects with Clinically Significant Changes from Baseline in Laboratory Parameters [11] [12]
    End point description
    Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in laboratory parameters were reported. SAF included all screening analysis set subjects who received at least 1 administration of study drug (irinotecan or M6620).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 1.6 years
    Notes
    [11] - 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: Only descriptive summary statistics was planned for this endpoint.
    [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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    5
    3
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Primary: Part B2: Number of Subjects with Clinically Significant Changes from Baseline in Vital Signs

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    End point title
    Part B2: Number of Subjects with Clinically Significant Changes from Baseline in Vital Signs [13] [14]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate and respiratory rate. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in vital signs were reported. SAF included all screening analysis set subjects who received at least 1 administration of study drug (irinotecan or M6620).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 1.6 years
    Notes
    [13] - 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: Only descriptive summary statistics was planned for this endpoint.
    [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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    5
    3
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Primary: Part B2: Number of Subjects with Clinically Significant Changes from Baseline in 12-Lead Electrocardiograms (ECGs) Findings

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    End point title
    Part B2: Number of Subjects with Clinically Significant Changes from Baseline in 12-Lead Electrocardiograms (ECGs) Findings [15] [16]
    End point description
    12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the subjects have rested for at least 5 minutes in supine position. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in 12-lead ECG findings were reported. SAF included all screening analysis set subjects who received at least 1 administration of study drug (irinotecan or M6620).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 1.6 years
    Notes
    [15] - 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: Only descriptive summary statistics was planned for this endpoint.
    [16] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    5
    3
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Primary: Parts C1, C2, C3: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Parts C1, C2, C3: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) [17] [18]
    End point description
    Adverse event (AE) was defined as any untoward medical occurrence in a subject, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period. TEAEs included both serious TEAEs and non-serious TEAEs. SAF: all enrolled subjects (irrespective of biomarker status) who received at least 1 dose of study drug (M6620, gemcitabine, cisplatin, or carboplatin; actual amount > 0 mg and/or the duration of infusion > 0 minutes).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [17] - 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: Only descriptive summary statistics was planned for this endpoint.
    [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: In this endpoint, we have reported data for Part C1, C2 and C3 arms only. For Parts A1, A2, B1 and B2 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: subjects
    38
    47
    2
    13
    No statistical analyses for this end point

    Primary: Parts C1, C2, C3: Number of Subjects with Clinically Significant Changes from Baseline in Laboratory Parameters

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    End point title
    Parts C1, C2, C3: Number of Subjects with Clinically Significant Changes from Baseline in Laboratory Parameters [19] [20]
    End point description
    Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in laboratory parameters were reported. SAF: all enrolled subjects (irrespective of biomarker status) who received at least 1 dose of study drug (M6620, gemcitabine, cisplatin, or carboplatin; actual amount > 0 mg and/or the duration of infusion > 0 minutes).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [19] - 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: Only descriptive summary statistics was planned for this endpoint.
    [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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Parts C1, C2, C3: Number of Subjects with Clinically Significant Changes from Baseline in Vital Signs

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    End point title
    Parts C1, C2, C3: Number of Subjects with Clinically Significant Changes from Baseline in Vital Signs [21] [22]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate and respiratory rate. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in vital signs were reported. SAF: all enrolled subjects (irrespective of biomarker status) who received at least 1 dose of study drug (M6620, gemcitabine, cisplatin, or carboplatin; actual amount > 0 mg and/or the duration of infusion > 0 minutes).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [21] - 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: Only descriptive summary statistics was planned for this endpoint.
    [22] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Parts C1, C2 and C3: Number of Subjects with Clinically Significant Changes from Baseline in 12-Lead Electrocardiograms (ECGs) Findings

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    End point title
    Parts C1, C2 and C3: Number of Subjects with Clinically Significant Changes from Baseline in 12-Lead Electrocardiograms (ECGs) Findings [23] [24]
    End point description
    12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the subjects have rested for at least 5 minutes in supine position. Clinical significance was determined by the investigator. The number of subjects with clinically significant changes from baseline in 12-lead ECG findings were reported. SAF: all enrolled subjects (irrespective of biomarker status) who received at least 1 dose of study drug (M6620, gemcitabine, cisplatin, or carboplatin; actual amount > 0 mg and/or the duration of infusion > 0 minutes).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [23] - 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: Only descriptive summary statistics was planned for this endpoint.
    [24] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Parts C1 and C3: Percentage of Subjects with Objective Response (OR)

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    End point title
    Parts C1 and C3: Percentage of Subjects with Objective Response (OR) [25] [26]
    End point description
    OR was defined as the percentage of subjects who had achieved partial response (PR) or complete response (CR) as the best overall response according to according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Modified Full Analysis Set (mFAS): all enrolled subjects who satisfy both of following conditions:1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [25] - 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: Only descriptive summary statistics was planned for this endpoint.
    [26] - 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: In this endpoint, we have reported data for Parts C1 and C3 arms only. For Part A1, A2, B1, B2 and C2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    2
    13
    Units: percentage of subjects
        number (confidence interval 90%)
    10.5 (3.7 to 22.5)
    0.0 (0.0 to 77.6)
    0.0 (0.0 to 20.6)
    No statistical analyses for this end point

    Primary: Part C2: Percentage of Subjects with Objective Response (OR) in Part C2 (TNBC) Who are Basaloid Subtype and BRCA1/BRCA2 Germline wild-type

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    End point title
    Part C2: Percentage of Subjects with Objective Response (OR) in Part C2 (TNBC) Who are Basaloid Subtype and BRCA1/BRCA2 Germline wild-type [27] [28]
    End point description
    OR was defined as the percentage of subjects who had achieved partial response (PR) or complete response (CR) as the best overall response according to according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Modified Full Analysis Set (mFAS): all enrolled subjects who satisfy both of following conditions:1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]).
    End point type
    Primary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [27] - 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: Only descriptive summary statistics was planned for this endpoint.
    [28] - 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: In this endpoint, the data was planned to be reported for subjects with Basaloid subtype (BRCA1/BRCA2) in Part B2 only.
    End point values
    Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    47
    Units: percentage of subjects
        number (confidence interval 90%)
    22.6 (11.1 to 38.3)
    No statistical analyses for this end point

    Secondary: Parts A1 and A2: Maximum Tolerated Dose (MTD) of M6620

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    End point title
    Parts A1 and A2: Maximum Tolerated Dose (MTD) of M6620
    End point description
    Part A1: MTD of M6620 with gemcitabine was defined as the highest dose of M6620 tolerated in combination with a gemcitabine. Part A2: MTD of M6620 was defined as the highest dose of M6620 tolerated in combination with a cisplatin and gemcitabine. Dose limiting toxicity (DLT) evaluable set was defined as all subjects enrolled in Part A or Part B1 who either had a DLT before Day 21 in Cycle 1; or received all doses of gemcitabine and/or cisplatin, as applicable, and all doses of M6620 during Cycle.
    End point type
    Secondary
    End point timeframe
    Up to Cycle 1 Day 21 (each cycle is 21 days)
    End point values
    Part A1: All Subjects Part A2: All Subjects
    Number of subjects analysed
    50
    8
    Units: mg/m^2
        number (not applicable)
    210
    90
    No statistical analyses for this end point

    Secondary: Part A1: Maximum Observed Plasma Concentration (Cmax) of M6620

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    End point title
    Part A1: Maximum Observed Plasma Concentration (Cmax) of M6620 [29]
    End point description
    Cmax was obtained directly from the concentration versus time curve. Full Analysis Set (FAS) included all subjects who had baseline scan and received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to progression disease [PD] or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [29] - 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: In this endpoint, we have reported data for Part A1 arms only. For Parts A2, B1, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 120 mg/m^2 and Gemcitabine Part A1: M6620 210 mg/m^2 and Gemcitabine
    Number of subjects analysed
    6
    2
    16
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    571 ( 34 )
    486 ( 28 )
    899 ( 41 )
    No statistical analyses for this end point

    Secondary: Part A1: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of M6620

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    End point title
    Part A1: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of M6620 [30]
    End point description
    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. FAS included all subjecst who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to progression disease [PD] or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [30] - 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: In this endpoint, we have reported data for Part A1 arms only. For Parts A2, B1, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 120 mg/m^2 and Gemcitabine Part A1: M6620 210 mg/m^2 and Gemcitabine
    Number of subjects analysed
    6
    2
    16
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    3100 ( 39 )
    4160 ( 3.5 )
    6690 ( 31 )
    No statistical analyses for this end point

    Secondary: Part A1: Apparent Volume of Distribution at Steady-state (Vss) of M6620

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    End point title
    Part A1: Apparent Volume of Distribution at Steady-state (Vss) of M6620 [31]
    End point description
    Vss was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to progression disease [PD] or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [31] - 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: In this endpoint, we have reported data for Part A1 arms only. For Parts A2, B1, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 120 mg/m^2 and Gemcitabine Part A1: M6620 210 mg/m^2 and Gemcitabine
    Number of subjects analysed
    6
    2
    16
    Units: liters
        geometric mean (geometric coefficient of variation)
    983 ( 35 )
    1240 ( 14 )
    1250 ( 22 )
    No statistical analyses for this end point

    Secondary: Part A1: Apparent Total Body Clearance (CL) of M6620

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    End point title
    Part A1: Apparent Total Body Clearance (CL) of M6620 [32]
    End point description
    CL was a measure of the rate at which M6620 was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [32] - 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: In this endpoint, we have reported data for Part A1 arms only. For Parts A2, B1, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 120 mg/m^2 and Gemcitabine Part A1: M6620 210 mg/m^2 and Gemcitabine
    Number of subjects analysed
    6
    2
    16
    Units: liter per hour
        geometric mean (geometric coefficient of variation)
    64.2 ( 45 )
    55.5 ( 1 )
    62.3 ( 31 )
    No statistical analyses for this end point

    Secondary: Part A1: Apparent Terminal Half-Life (t1/2) of M6620

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    End point title
    Part A1: Apparent Terminal Half-Life (t1/2) of M6620 [33]
    End point description
    Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [33] - 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: In this endpoint, we have reported data for Part A1 arms only. For Parts A2, B1, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 120 mg/m^2 and Gemcitabine Part A1: M6620 210 mg/m^2 and Gemcitabine
    Number of subjects analysed
    6
    2
    16
    Units: hours
        geometric mean (geometric coefficient of variation)
    14.2 ( 27 )
    17.6 ( 14 )
    17.3 ( 24 )
    No statistical analyses for this end point

    Secondary: Parts A1, A2 and B1: Percentage of Subjects with Objective Tumor Response (OR) as Evaluated by Response Criteria Evaluation in Solid Tumors (RECIST) 1.1

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    End point title
    Parts A1, A2 and B1: Percentage of Subjects with Objective Tumor Response (OR) as Evaluated by Response Criteria Evaluation in Solid Tumors (RECIST) 1.1 [34]
    End point description
    Objective tumor response was defined as having a complete response (CR) or a partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. FAS included all subjecst who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death). Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint. Here, '99999' signifies that data is not available as none of the subjects showed CR or PR at specified time point.
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment up to 4.6 years
    Notes
    [34] - 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: In this endpoint, we have reported data for Part A1, Part A2 and Part B1 arms only. For Part B2, Part C1, C2 and C3 arms we have created separate endpoints due to change in the time frame.
    End point values
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    3
    3
    4
    7
    6
    7
    3
    3
    6
    6
    6
    1
    3
    3
    3
    9
    4
    3
    Units: percentage of subjects
        number (confidence interval 90%)
    99999 (99999 to 99999)
    33.3 (1.7 to 86.5)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    28.6 (5.3 to 65.9)
    99999 (99999 to 99999)
    33.3 (1.7 to 86.5)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    16.7 (0.9 to 58.2)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    25.0 (1.3 to 75.1)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    75.0 (24.9 to 98.7)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Part B1: Maximum Tolerated Dose (MTD) of M6620

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    End point title
    Part B1: Maximum Tolerated Dose (MTD) of M6620
    End point description
    M6620 MTD was defined as the highest dose of M6620 tolerated in combination with a cisplatin. DLT evaluable set was defined as all subjects enrolled in Part A or Part B1 who either had a DLT before Day 21 in Cycle 1; or received all doses of gemcitabine and/or cisplatin, as applicable, and all doses of M6620 during Cycle.
    End point type
    Secondary
    End point timeframe
    Up to Cycle 1 Day 21 (each cycle is 21 days)
    End point values
    Parts B1: All Subjects
    Number of subjects analysed
    31
    Units: mg/m^2
        number (not applicable)
    140
    No statistical analyses for this end point

    Secondary: Part B2: Maximum Tolerated Dose (MTD) of M6620

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    End point title
    Part B2: Maximum Tolerated Dose (MTD) of M6620
    End point description
    The MTD for M6620 in combination with irinotecan was defined as the highest dose for a given schedule at which there were no more than 1 of 6 subjects with DLT. DLT Evaluable Set: all SAF subjects who either experienced a DLT before the end of Cycle 1 and received any amount of M6620 or received at least 80% of the cumulative planned dose of irinotecan and at least 80% of the cumulative planned dose of M6620 during Cycle 1 and completed Cycle 1, i.e., had a study visit on Day 28 or later
    End point type
    Secondary
    End point timeframe
    Up to Cycle 1 Day 28 (each cycle is of 28 days)
    End point values
    Part B2: All Subjects
    Number of subjects analysed
    0 [35]
    Units: mg/m^2
        number (not applicable)
    Notes
    [35] - MTD was not determined as Part B2 was discontinued after observing toxicities at first dose level.
    No statistical analyses for this end point

    Secondary: Part B1: Maximum Observed Plasma Concentration (Cmax) of M6620

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    End point title
    Part B1: Maximum Observed Plasma Concentration (Cmax) of M6620 [36]
    End point description
    Cmax was obtained directly from the concentration versus time curve. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after EOI on Cycle 1 Day 2 (each cycle is 21 days)
    Notes
    [36] - 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: In this endpoint, we have reported data for Part B1 arms only. For Parts A1, A2, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 and Cisplatin Part B1: M6620 210 mg/m^2 and Cisplatin
    Number of subjects analysed
    2
    8
    17
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    458 ( 13 )
    854 ( 63 )
    1230 ( 43 )
    No statistical analyses for this end point

    Secondary: Part B1: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of M6620

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    End point title
    Part B1: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of M6620 [37]
    End point description
    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after EOI on Cycle 1 Day 2 (each cycle is 21 days)
    Notes
    [37] - 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: In this endpoint, we have reported data for Part B1 arms only. For Parts A1, A2, B2, C1, C2 and C3 arms we have created separate endpoint.
    End point values
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 and Cisplatin Part B1: M6620 210 mg/m^2 and Cisplatin
    Number of subjects analysed
    2
    8
    17
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    2820 ( 15 )
    4870 ( 28 )
    6740 ( 32 )
    No statistical analyses for this end point

    Secondary: Part B1: Apparent Volume of Distribution at Steady-state (Vss) of M6620

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    End point title
    Part B1: Apparent Volume of Distribution at Steady-state (Vss) of M6620 [38]
    End point description
    Vss was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after EOI on Cycle 1 Day 2 (each cycle is 21 days)
    Notes
    [38] - 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: In this endpoint, we have reported data for Part B1 arms only. For Parts A1, A2, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 and Cisplatin Part B1: M6620 210 mg/m^2 and Cisplatin
    Number of subjects analysed
    2
    8
    17
    Units: liters
        geometric mean (geometric coefficient of variation)
    1260 ( 38 )
    1060 ( 36 )
    1270 ( 28 )
    No statistical analyses for this end point

    Secondary: Part B1: Apparent Total Body Clearance (CL) of M6620

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    End point title
    Part B1: Apparent Total Body Clearance (CL) of M6620 [39]
    End point description
    CL was a measure of the rate at which M6620 was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after EOI on Cycle 1 Day 2 (each cycle is 21 days)
    Notes
    [39] - 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: In this endpoint, we have reported data for Part B1 arms only. For Parts A1, A2, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 and Cisplatin Part B1: M6620 210 mg/m^2 and Cisplatin
    Number of subjects analysed
    2
    8
    17
    Units: liters
        geometric mean (geometric coefficient of variation)
    61.1 ( 20 )
    54.7 ( 31 )
    62.6 ( 32 )
    No statistical analyses for this end point

    Secondary: Part B1: Apparent Terminal Half-Life (t1/2) of M6620

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    End point title
    Part B1: Apparent Terminal Half-Life (t1/2) of M6620 [40]
    End point description
    Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. FAS included all subjects who had baseline scan, received at least 1 dose of study drug and had at least once post-baseline disease assessment (including staging CT scan or nonstaging CT scan indicating disease progression, end of treatment due to PD or death).
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after EOI on Cycle 1 Day 2 (each cycle is 21 days)
    Notes
    [40] - 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: In this endpoint, we have reported data for Part B1 arms only. For Parts A1, A2, B2, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 and Cisplatin Part B1: M6620 210 mg/m^2 and Cisplatin
    Number of subjects analysed
    2
    8
    17
    Units: hours
        geometric mean (geometric coefficient of variation)
    17.0 ( 26 )
    17.5 ( 34 )
    17.3 ( 17 )
    No statistical analyses for this end point

    Secondary: Part B2: Maximum Observed Plasma Concentration (Cmax) of M6620

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    End point title
    Part B2: Maximum Observed Plasma Concentration (Cmax) of M6620 [41]
    End point description
    Cmax was obtained directly from the concentration versus time curve. Pharmacokinetic Analysis Set (PAS) included all SAF subjects who received at least 1 administration of study drug (irinotecan or M6620) and provided at least 1 measurable postdose concentration of M6620 or irinotecan or its metabolites.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1 through 3: pre-infusion, and 1, 2, 3, 7, 23 and 47 hours after EOI; Cycle 1 Day 15 and Cycle 2 Day 1 at pre-infusion, and EOI to 2 hours after EOI (each cycle is of 28 days)
    Notes
    [41] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    0 [42]
    0 [43]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [42] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    [43] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    No statistical analyses for this end point

    Secondary: Part B2: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of M6620

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    End point title
    Part B2: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of M6620 [44]
    End point description
    AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. PAS included all SAF subjects who received at least 1 administration of study drug (irinotecan or M6620) and provided at least 1 measurable postdose concentration of M6620 or irinotecan or its metabolites.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1 through 3: pre-infusion, and 1, 2, 3, 7, 23 and 47 hours after EOI; Cycle 1 Day 15 and Cycle 2 Day 1 at pre-infusion, and EOI to 2 hours after EOI (each cycle is of 28 days)
    Notes
    [44] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    0 [45]
    0 [46]
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [45] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    [46] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    No statistical analyses for this end point

    Secondary: Part B2: Volume of Distribution at Steady-state (Vss) of M6620

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    End point title
    Part B2: Volume of Distribution at Steady-state (Vss) of M6620 [47]
    End point description
    Vss was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state. PAS included all SAF subjects who received at least 1 administration of study drug (irinotecan or M6620) and provided at least 1 measurable postdose concentration of M6620 or irinotecan or its metabolites
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1 through 3: pre-infusion, and 1, 2, 3, 7, 23 and 47 hours after EOI; Cycle 1 Day 15 and Cycle 2 Day 1 at pre-infusion, and EOI to 2 hours after EOI (each cycle is of 28 days)
    Notes
    [47] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    0 [48]
    0 [49]
    Units: liters
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [48] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    [49] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    No statistical analyses for this end point

    Secondary: Part B2: Apparent Total Body Clearance (CL) of M6620

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    End point title
    Part B2: Apparent Total Body Clearance (CL) of M6620 [50]
    End point description
    CL was a measure of the rate at which M6620 was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. PAS included all SAF subjects who received at least 1 administration of study drug (irinotecan or M6620) and provided at least 1 measurable postdose concentration of M6620 or irinotecan or its metabolites.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1 through 3: pre-infusion, and 1, 2, 3, 7, 23 and 47 hours after EOI; Cycle 1 Day 15 and Cycle 2 Day 1 at pre-infusion, and EOI to 2 hours after EOI (each cycle is of 28 days)
    Notes
    [50] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    0 [51]
    0 [52]
    Units: liter per hour
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [51] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    [52] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    No statistical analyses for this end point

    Secondary: Part B2: Apparent Terminal Half-Life (t1/2) of M6620

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    End point title
    Part B2: Apparent Terminal Half-Life (t1/2) of M6620 [53]
    End point description
    Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. PAS included all SAF subjects who received at least 1 administration of study drug (irinotecan or M6620) and provided at least 1 measurable postdose concentration of M6620 or irinotecan or its metabolites.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1 through 3: pre-infusion, and 1, 2, 3, 7, 23 and 47 hours after EOI; Cycle 1 Day 15 and Cycle 2 Day 1 at pre-infusion, and EOI to 2 hours after EOI (each cycle is of 28 days)
    Notes
    [53] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    0 [54]
    0 [55]
    Units: hours
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [54] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    [55] - As per revised planned analysis, pharmacokinetic parameters for Part B2 was not assessed.
    No statistical analyses for this end point

    Secondary: Part B2: Percentage of Subjects with Objective Tumor Response (OR) as Evaluated by Response Criteria Evaluation in Solid Tumors (RECIST) 1.1

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    End point title
    Part B2: Percentage of Subjects with Objective Tumor Response (OR) as Evaluated by Response Criteria Evaluation in Solid Tumors (RECIST) 1.1 [56]
    End point description
    OR was defined as the percentage of subjects who had achieved partial response (PR) or complete response (CR) as the best overall response according to according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. FAS included all SAF subjects who had a baseline scan and at least 1 disease assessment on treatment.
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment up to 1.6 years
    Notes
    [56] - 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: In this endpoint, we have reported data for Part B2 arms only. For Parts A1, A2, B1, C1, C2 and C3 arms we have created separate endpoints.
    End point values
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Number of subjects analysed
    0 [57]
    0 [58]
    Units: percentage of subjects
        number (confidence interval 90%)
    ( to )
    ( to )
    Notes
    [57] - OR was not calculated as Part B2 was discontinued after observing toxicities at first dose level.
    [58] - OR was not calculated as Part B2 was discontinued after observing toxicities at first dose level.
    No statistical analyses for this end point

    Secondary: Part C2: Percentage of Subjects with Objective Response (OR)

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    End point title
    Part C2: Percentage of Subjects with Objective Response (OR) [59]
    End point description
    OR was defined as the percentage of subjects who had achieved partial response (PR) or complete response (CR) as the best overall response according to according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. mFAS: all enrolled subjects who satisfy both of following conditions:1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]).
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment up to 4.3 years
    Notes
    [59] - 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: In this endpoint, the data was planned to be reported for Part C2 arm only.
    End point values
    Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Number of subjects analysed
    47
    Units: percentage of subjects
        number (confidence interval 90%)
    23.4 (13.7 to 35.8)
    No statistical analyses for this end point

    Secondary: Parts C1, C2, C3: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

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    End point title
    Parts C1, C2, C3: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [60]
    End point description
    PFS according to RECIST v1.1 was defined as the time from the date of the first dose of a study drug to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. PD was defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. mFAS: all enrolled subjects who satisfy both of following conditions:1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]).
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment to 4.3 years
    Notes
    [60] - 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: In this endpoint, the data was planned to be reported for Parts C1, C2 and C3 arms only .
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: months
        median (confidence interval 90%)
    4.0 (3.2 to 5.0)
    4.0 (2.8 to 6.0)
    3.3 (1.2 to 5.3)
    1.9 (1.4 to 2.1)
    No statistical analyses for this end point

    Secondary: Parts C1, C2, C3: Duration of Response (DoR)

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    End point title
    Parts C1, C2, C3: Duration of Response (DoR) [61]
    End point description
    DoR was calculated only for those subjects who achieved a CR or PR and was measured from the time the response criteria were first met for CR/PR (whichever was recorded first) until the first date that recurrent or PD was objectively documented. FAS: all enrolled subjects who satisfy both of following conditions: 1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]). As there were no responders (CR or PR) in Part C3 (mFAS), the analysis of DoR is presented for Parts C1 and C2 only. Here, "number of subjects snalyzed" signifies those subjects who were evaluable for this endpoint .
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment to 4.3 years
    Notes
    [61] - 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: In this endpoint, the data was planned to be reported for Parts C1, C2 and C3 arms only .
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    4
    11
    0 [62]
    0 [63]
    Units: months
        median (full range (min-max))
    6.0 (3.6 to 13.2)
    6.0 (3.0 to 28.6)
    ( to )
    ( to )
    Notes
    [62] - None of subjects showed complete response or partial response.
    [63] - None of subjects showed complete response or partial response.
    No statistical analyses for this end point

    Secondary: Parts C1, C2, C3: Overall Survival (OS)

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    End point title
    Parts C1, C2, C3: Overall Survival (OS) [64]
    End point description
    OS time was defined as the time from the date of the first dose of a study drug to death due to any cause. mFAS: all enrolled subjects who satisfy both of following conditions:1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]).
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment to 4.3 years
    Notes
    [64] - 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: In this endpoint, the data was planned to be reported for Parts C1, C2 and C3 arms only .
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: months
        median (full range (min-max))
    7.4 (0.8 to 28.2)
    12.4 (1.4 to 31.6)
    7.0 (6.3 to 7.0)
    5.5 (0.8 to 16.4)
    No statistical analyses for this end point

    Secondary: Parts C1, C2, C3: Percentage of Subjects with Clinical benefit (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) of 6 months or greater)

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    End point title
    Parts C1, C2, C3: Percentage of Subjects with Clinical benefit (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) of 6 months or greater) [65]
    End point description
    Clinical benefit rate was defined as the proportion of subjects who achieved a BOR of CR, PR or SD greater than or equal to [>=] 6 months. mFAS: all enrolled subjects who satisfy both of following conditions:1) Received at least 1 dose of study drug (M6620, gemcitabine, cisplatin/carboplatin with the actual amount greater than [>] 0 mg and/the duration of infusion > 0 minutes; 2) Had a Baseline scan of disease assessment (Computed tomography [CT]/Magnetic resonance imaging [MRI]) with a measurable target lesion (sum of diameters of all target lesions > 0 millimeter [mm]).
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment to 4.3 years
    Notes
    [65] - 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: In this endpoint, the data was planned to be reported for Parts C1, C2 and C3 arms only .
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    38
    47
    2
    13
    Units: percentage of subjects
        number (confidence interval 90%)
    15.8 (7.1 to 28.8)
    27.7 (17.2 to 40.3)
    0 (0.0 to 77.6)
    0 (0.0 to 20.6)
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Maximum Observed Plasma Concentration (Cmax) of M6620

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    End point title
    Parts C1, C2 and C3: Maximum Observed Plasma Concentration (Cmax) of M6620 [66]
    End point description
    Cmax was obtained directly from the concentration versus time curve. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [66] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    882 ( 55.2 )
    555 ( 42.9 )
    683 ( 99999 )
    528 ( 46.9 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve from Time Zero to the Last Sampling Time (tlast) of M6620

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    End point title
    Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve from Time Zero to the Last Sampling Time (tlast) of M6620 [67]
    End point description
    Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "3.3333" signifies that median was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [67] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: hours
        median (full range (min-max))
    4.00 (3.00 to 8.00)
    4.00 (3.67 to 8.07)
    3.3333 (2.00 to 4.00)
    4.03 (3.68 to 8.00)
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Time to Reach Maximum Plasma Concentration (Tmax) of M6620

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    End point title
    Parts C1, C2 and C3: Time to Reach Maximum Plasma Concentration (Tmax) of M6620 [68]
    End point description
    Tmax is time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [68] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: hours
        median (full range (min-max))
    0.917 (0.483 to 2.28)
    0.917 (0.500 to 2.00)
    0.742 (0.533 to 0.950)
    0.967 (0.467 to 1.23)
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve From Time Zero to 4 hours [hr] (AUC0-4hr) of of M6620

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    End point title
    Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve From Time Zero to 4 hours [hr] (AUC0-4hr) of of M6620 [69]
    End point description
    Area under the plasma concentration-time curve from time 0 to 4 hours post-dose (AUC0-4) was calculated using the linear trapezoidal rule. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 4 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [69] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    34
    2
    12
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    1600 ( 35.8 )
    1110 ( 26.4 )
    1030 ( 99999 )
    693 ( 32.9 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve From Time Zero to 8 hours [hr] (AUC0-8 hr) of of M6620

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    End point title
    Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve From Time Zero to 8 hours [hr] (AUC0-8 hr) of of M6620 [70]
    End point description
    Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [70] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    3
    2
    0 [71]
    2
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    2000 ( 10.9 )
    1800 ( 99999 )
    ( )
    970 ( 99999 )
    Notes
    [71] - None of subjects were evaluable at the given timepoints.
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time (AUC0-t) of of M6620

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    End point title
    Parts C1, C2 and C3: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time (AUC0-t) of of M6620 [72]
    End point description
    Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3, and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [72] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    1660 ( 35.8 )
    1110 ( 28.8 )
    910 ( 99999 )
    730 ( 36.0 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Maximum Concentration (Cmax/Dose_mg ) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Maximum Concentration (Cmax/Dose_mg ) of M6620 [73]
    End point description
    Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3, and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [73] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: ng/mL/mg
        geometric mean (geometric coefficient of variation)
    2.37 ( 52.4 )
    2.18 ( 44.6 )
    2.72 ( 99999 )
    3.24 ( 54.4 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Maximum Concentration (Cmax/Dose_mg/m^2) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Maximum Concentration (Cmax/Dose_mg/m^2) of M6620 [74]
    End point description
    Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3, and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [74] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: ng/mL/(mg/m^2)
        geometric mean (geometric coefficient of variation)
    4.28 ( 54.6 )
    3.97 ( 42.9 )
    4.89 ( 99999 )
    5.88 ( 47.1 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Area Under The Concentration-Time Curve (AUC) from Start of Infusion to The 4 hour Sampling Time After Start of Infusion (AUC0-4h/Dose_mg) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Area Under The Concentration-Time Curve (AUC) from Start of Infusion to The 4 hour Sampling Time After Start of Infusion (AUC0-4h/Dose_mg) of M6620 [75]
    End point description
    Dose normalized was calculated as area under the plasma concentration-time curve from time zero to 4 hour postdose divided by dose. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 4 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [75] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    34
    2
    12
    Units: ng*h/mL/mg
        geometric mean (geometric coefficient of variation)
    4.29 ( 37.0 )
    4.41 ( 26.1 )
    4.11 ( 99999 )
    4.24 ( 39.8 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Area Under the Concentration-Time Curve (AUC) from Start of Infusion to the 4 hour Sampling Time After Start of Infusion (AUC0-4h/Dose_mg/m^2) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Area Under the Concentration-Time Curve (AUC) from Start of Infusion to the 4 hour Sampling Time After Start of Infusion (AUC0-4h/Dose_mg/m^2) of M6620 [76]
    End point description
    Dose normalized was calculated as area under the plasma concentration-time curve from rom start of infusion to the 4 hour postdose divided by dose. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 4 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [76] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    34
    2
    12
    Units: ng*h/mL/(mg/m^2)
        geometric mean (geometric coefficient of variation)
    7.76 ( 36.7 )
    7.95 ( 26.4 )
    7.40 ( 99999 )
    7.71 ( 33.0 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Area Under the Concentration-Time Curve (AUC) from Start of Infusion to the 8 hour Sampling Time After Start of Infusion (AUC0-8h/Dose_mg) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Area Under the Concentration-Time Curve (AUC) from Start of Infusion to the 8 hour Sampling Time After Start of Infusion (AUC0-8h/Dose_mg) of M6620 [77]
    End point description
    Dose normalized was calculated as area under the plasma concentration-time curve from time zero to 8 hour postdose divided by dose. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [77] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    3
    2
    0 [78]
    2
    Units: ng*h/mL/mg
        geometric mean (geometric coefficient of variation)
    5.43 ( 10.1 )
    7.53 ( 99999 )
    ( )
    5.63 ( 99999 )
    Notes
    [78] - None of the subjects were evaluable at given time points.
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Area Under the Concentration-Time Curve (AUC) from Start of Infusion to the 8 hour Sampling Time After Start of Infusion (AUC0-8h/Dose_mg/m^2) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Area Under the Concentration-Time Curve (AUC) from Start of Infusion to the 8 hour Sampling Time After Start of Infusion (AUC0-8h/Dose_mg/m^2) of M6620 [79]
    End point description
    Dose normalized was calculated as area under the plasma concentration-time curve from time zero to 8 hours postdose divided by dose. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3 and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [79] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    3
    2
    0 [80]
    2
    Units: ng*h/mL/(mg/m^2)
        geometric mean (geometric coefficient of variation)
    9.54 ( 10.9 )
    12.9 ( 99999 )
    ( )
    10.8 ( 99999 )
    Notes
    [80] - None of the subjects were evaluable at given time points.
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Area Under Concentarion-Time Curve (AUC) from Time Zero to the Last Sampling Time (tlast) (AUC0-t/Dose_mg) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Area Under Concentarion-Time Curve (AUC) from Time Zero to the Last Sampling Time (tlast) (AUC0-t/Dose_mg) of M6620 [81]
    End point description
    Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3, and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [81] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: ng*h/mL/mg
        geometric mean (geometric coefficient of variation)
    4.47 ( 36.3 )
    4.36 ( 30.6 )
    3.62 ( 99999 )
    4.47 ( 41.7 )
    No statistical analyses for this end point

    Secondary: Parts C1, C2 and C3: Dose Normalized Area Under Concentarion-Time Curve (AUC) from Time Zero to the Last Sampling Time (tlast) (AUC0-t/Dose_mg/m^2) of M6620

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    End point title
    Parts C1, C2 and C3: Dose Normalized Area Under Concentarion-Time Curve (AUC) from Time Zero to the Last Sampling Time (tlast) (AUC0-t/Dose_mg/m^2) of M6620 [82]
    End point description
    Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. PAS included all subjects who received at least 1 dose of M6620 (with the actual amount > 0 mg and/or the duration of infusion > 0 minutes), and provided at least 1 measurable post-dose concentration. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint at given time points. Here, "99999" signifies that geometric coefficient of variation was not calculated.
    End point type
    Secondary
    End point timeframe
    Pre-infusion, 0.5, 1, 2, 3, and 7 hours after end of infusion (EOI) on Cycle 1 Day 2 (each cycle is of 21 days)
    Notes
    [82] - 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: In this endpoint, we have reported data for Parts C1, C2 and C3 arms only. For Part A1, A2, B1 and B2 arms we have created separate endpoints.
    End point values
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Number of subjects analysed
    35
    37
    2
    12
    Units: ng*h/mL/(mg/m^2)
        geometric mean (geometric coefficient of variation)
    8.08 ( 36.7 )
    7.92 ( 28.8 )
    6.51 ( 99999 )
    8.12 ( 36.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Parts A1, A2 and B1: Time from first dose of study treatment up to 4.6 years; Part B2: Time from first dose of study treatment up to 1.6 years; Parts C1, C2 and C3: Time from first dose of study treatment up to 4.3 years.
    Adverse event reporting additional description
    Non-serious Adverse Event Section: Treatment-Emergent Adverse Events were reported for Parts A1, A2 and B1 and Non-serious Adverse event for Parts B2, C1, C2 and C3 with same threshold frequency (0%).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18,22.1&21
    Reporting groups
    Reporting group title
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a initial dose of 18 milligrams per square meter (mg/m^2) approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 36 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 60 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 72 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 500 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 750 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at escalated dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 61 weeks.

    Reporting group title
    Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and Cisplatin at a dose of 60 mg/m^2 on Day 1, of a 21-day cycle up to 41 weeks.

    Reporting group title
    Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 120 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Gemcitabine at a dose of 875 mg/m^2 on Days 1 and 8 and Cisplatin at a dose of 60 mg/m^2 on Day 1, of a 21-day cycle up to 41 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 90 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin at a dose of 40 mg/m^2 on Day 1, of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin ata dose of 40 mg/m^2 on Day 1 of a 21-day cycle for up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin at a dose of 40 mg/m^2 on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 60 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 140 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with 75 mg/m^2 of Cisplatin on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at dose of 210 mg/m^2 approximately for 24 hours later on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 74 weeks.

    Reporting group title
    Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a dose of 60 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Reporting group title
    Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2
    Reporting group description
    Subjects received intravenous infusion of M6620 at a dose of 90 mg/m^2, in combination with irinotecan at a dose of 180 mg/m^2 (over 90 minutes) on Days 1 and 15 of a 28-day cycle up to 72 weeks.

    Reporting group title
    Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2
    Reporting group description
    Subjects with advanced non-small cell lung cancer (NSCLC) received intravenous infusion of M6620 at a dose of 210 mg/m^2 on Days 2 and 9 in combination with Gemcitabine at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21-day cycle up to 63 weeks.

    Reporting group title
    Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects with advanced triple negative breast cancer (TNBC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 137 weeks.

    Reporting group title
    Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2
    Reporting group description
    Subjects with platinum-resistant advanced small cell lung cancer (SCLC) received intravenous infusion of M6620 at a dose of 140 mg/m^2 on Days 2 and 9 in combination with Cisplatin at a dose of 75 mg/m^2 on Day 1 of a 21-day cycle up to 27 weeks.

    Reporting group title
    Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Reporting group description
    Subjects with platinum-resistant advanced SCLC received intravenous infusion of M6620 at a dose of 90 mg/m^2 on Days 2 and 9 in combination with Carboplatin area under concentration-time curve (AUC) at a dose of 5 milligrams.minute per milliliter on Day 1 of a 21-day cycle up to 27 weeks.

    Serious adverse events
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2 Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2 Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    4 / 7 (57.14%)
    3 / 6 (50.00%)
    5 / 8 (62.50%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    3 / 7 (42.86%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    2 / 2 (100.00%)
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    4 / 10 (40.00%)
    3 / 7 (42.86%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    2 / 3 (66.67%)
    24 / 38 (63.16%)
    15 / 47 (31.91%)
    0 / 2 (0.00%)
    3 / 13 (23.08%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    3 / 8 (37.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    3 / 3
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast haematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    4 / 38 (10.53%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 0
    0 / 0
    0 / 0
         deaths causally 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
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 0
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Body temperature increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Infusion related reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Allergic transfusion reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Atrial flutter
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 arrest
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Serotonin syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
         deaths causally 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
    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
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    3 / 3
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Portal vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash erythematous
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Flank pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 0
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cellulitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    4 / 38 (10.53%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 4
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Part A1: M6620 18 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 36 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 60 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 72 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 90 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 140 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 500 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 750 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 875 mg/m^2 Part A1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part A2: M6620 90 mg/m^2 + Gemcitabine + Cisplatin Part A2: M6620 120 mg/m^2 + Gemcitabine + Cisplatin Part B1: M6620 140 mg/m^2 Part B1: M6620 90 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 40 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 60 mg/m^2 Part B1: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part B1: M6620 210 mg/m^2 + Cisplatin 75 mg/m^2 Part B2: M6620 60 mg/m^2 + Irinotecan 180 mg/m^2 Part B2: M6620 90 mg/m^2 + Irinotecan 180 mg/m^2 Part C1: M6620 210 mg/m^2 + Gemcitabine 1000 mg/m^2 Part C2: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 140 mg/m^2 + Cisplatin 75 mg/m^2 Part C3: M6620 90 mg/m^2 + Carboplatin AUC 5 mg∙min/mL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    6 / 7 (85.71%)
    6 / 6 (100.00%)
    8 / 8 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    7 / 7 (100.00%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    2 / 2 (100.00%)
    3 / 4 (75.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    3 / 4 (75.00%)
    10 / 10 (100.00%)
    7 / 7 (100.00%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    3 / 3 (100.00%)
    37 / 38 (97.37%)
    47 / 47 (100.00%)
    2 / 2 (100.00%)
    13 / 13 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tumour pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Brain neoplasm
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Metastases to peritoneum
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    0
    0
    Flushing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    5 / 47 (10.64%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    2
    0
    1
    0
    0
    0
    5
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    1
    2
    0
    0
    0
    3
    4
    0
    2
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Vascular compression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 10 (10.00%)
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    1
    1
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    1
    2
    1
    0
    1
    1
    1
    0
    0
    White coat hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lymphoedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Phlebitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    Embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Superior vena cava occlusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Vein disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    3 / 38 (7.89%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    3
    1
    0
    0
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    4 / 38 (10.53%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    2
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    6 / 8 (75.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    6 / 7 (85.71%)
    4 / 6 (66.67%)
    6 / 6 (100.00%)
    2 / 2 (100.00%)
    0 / 4 (0.00%)
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    4 / 10 (40.00%)
    4 / 7 (57.14%)
    3 / 3 (100.00%)
    2 / 5 (40.00%)
    2 / 3 (66.67%)
    21 / 38 (55.26%)
    32 / 47 (68.09%)
    2 / 2 (100.00%)
    5 / 13 (38.46%)
         occurrences all number
    2
    2
    1
    2
    3
    6
    3
    3
    6
    4
    6
    2
    0
    3
    1
    2
    4
    4
    3
    2
    2
    21
    32
    2
    5
    Influenza like illness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 7 (28.57%)
    4 / 6 (66.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    2
    1
    2
    2
    4
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    4 / 38 (10.53%)
    6 / 47 (12.77%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    6
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    6 / 38 (15.79%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    0
    1
    0
    1
    1
    1
    0
    0
    0
    0
    1
    2
    1
    1
    0
    6
    4
    0
    0
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    3 / 6 (50.00%)
    4 / 8 (50.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    12 / 38 (31.58%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    2
    1
    3
    4
    0
    2
    2
    3
    2
    1
    0
    1
    0
    0
    0
    1
    1
    0
    0
    12
    7
    0
    1
    Face oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Infusion site reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infusion site erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    Axillary pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Catheter site rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site related reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Device occlusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypothermia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion site discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion site rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site phlebitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion site pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Catheter site bruise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Catheter site induration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Catheter site inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Extravasation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Injection site mass
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Thirst
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Prostatism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Testicular pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Testicular swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Breast pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metrorrhagia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    1 / 7 (14.29%)
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    3 / 5 (60.00%)
    0 / 3 (0.00%)
    5 / 38 (13.16%)
    8 / 47 (17.02%)
    1 / 2 (50.00%)
    2 / 13 (15.38%)
         occurrences all number
    1
    0
    0
    2
    2
    3
    1
    2
    1
    3
    1
    0
    0
    1
    1
    0
    0
    2
    0
    3
    0
    5
    8
    1
    2
    Epistaxis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    2
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    1
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    2
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    3 / 6 (50.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    14 / 38 (36.84%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    0
    2
    3
    0
    1
    0
    0
    3
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    1
    14
    7
    0
    2
    Hypoxia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pleuritic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Asthma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    14 / 38 (36.84%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    14
    7
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    1
    0
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sputum increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Pneumonitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Rales
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory failure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    6 / 47 (12.77%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    2
    6
    0
    0
    Depression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    2
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    2
    3
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dissociation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    4 / 6 (66.67%)
    5 / 8 (62.50%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    4 / 7 (57.14%)
    4 / 6 (66.67%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    10 / 38 (26.32%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    1
    4
    5
    2
    2
    4
    4
    2
    1
    1
    1
    1
    0
    1
    1
    1
    0
    1
    10
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    4 / 6 (66.67%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    3 / 7 (42.86%)
    3 / 6 (50.00%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    3 / 10 (30.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    3 / 3 (100.00%)
    11 / 38 (28.95%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    2
    1
    4
    3
    1
    2
    3
    3
    2
    1
    1
    0
    1
    0
    3
    0
    1
    0
    3
    11
    0
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    3 / 8 (37.50%)
    3 / 3 (100.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    2
    1
    3
    3
    0
    0
    2
    1
    1
    1
    1
    1
    0
    0
    0
    0
    1
    1
    2
    1
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    3 / 38 (7.89%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    3
    1
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    2 / 47 (4.26%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    2
    1
    1
    4
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    3
    2
    0
    3
    Weight decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    1
    1
    4
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    3 / 7 (42.86%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    8 / 38 (21.05%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    3
    1
    2
    1
    8
    4
    0
    3
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    1
    0
    2
    0
    0
    2
    0
    0
    Platelet count increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bacterial test positive
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood calcium increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood urea increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eastern Cooperative Oncology Group performance status worsened
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory rate increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Blood Chloride Decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Blood albumin decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Amylase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Glomerular filtration rate increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Troponin increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0
    1
    Infusion related reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    1
    1
    1
    0
    2
    7
    0
    1
    Contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Allergic transfusion reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Animal bite
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Procedural headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Spinal fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tooth fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    3 / 38 (7.89%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    3
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    3
    1
    0
    1
    Extrasystoles
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Balance disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 4 (75.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    11 / 47 (23.40%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    0
    0
    2
    0
    2
    1
    0
    0
    0
    3
    1
    1
    0
    0
    0
    3
    11
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    9 / 47 (19.15%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    9
    0
    0
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    4 / 8 (50.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    8 / 38 (21.05%)
    18 / 47 (38.30%)
    0 / 2 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    0
    0
    2
    1
    1
    4
    2
    2
    0
    1
    0
    1
    0
    2
    1
    2
    0
    1
    0
    0
    1
    8
    18
    0
    4
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    8 / 47 (17.02%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    8
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    4
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    8 / 47 (17.02%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    8
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    2 / 6 (33.33%)
    4 / 8 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    1
    1
    2
    4
    0
    0
    1
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neurotoxicity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Serotonin syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Parosmia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Vocal cord paralysis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hemiparesis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aphasia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Brain oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hemiparaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Migraine
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    4 / 7 (57.14%)
    2 / 6 (33.33%)
    4 / 8 (50.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    4 / 7 (57.14%)
    5 / 6 (83.33%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    5 / 10 (50.00%)
    6 / 7 (85.71%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    2 / 3 (66.67%)
    19 / 38 (50.00%)
    19 / 47 (40.43%)
    1 / 2 (50.00%)
    6 / 13 (46.15%)
         occurrences all number
    0
    1
    1
    4
    2
    4
    2
    3
    4
    5
    2
    1
    0
    1
    1
    1
    5
    6
    1
    2
    2
    19
    19
    1
    6
    Leukopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    5 / 47 (10.64%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    1
    3
    1
    1
    0
    0
    0
    1
    1
    1
    0
    0
    0
    3
    5
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    4 / 6 (66.67%)
    4 / 6 (66.67%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    6 / 10 (60.00%)
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    11 / 38 (28.95%)
    29 / 47 (61.70%)
    1 / 2 (50.00%)
    3 / 13 (23.08%)
         occurrences all number
    1
    1
    1
    0
    1
    2
    1
    1
    2
    4
    4
    1
    0
    0
    0
    1
    6
    1
    2
    1
    1
    11
    29
    1
    3
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    3 / 6 (50.00%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    12 / 38 (31.58%)
    9 / 47 (19.15%)
    1 / 2 (50.00%)
    6 / 13 (46.15%)
         occurrences all number
    0
    0
    2
    1
    0
    2
    2
    1
    1
    3
    2
    1
    0
    0
    0
    0
    2
    1
    0
    0
    0
    12
    9
    1
    6
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Iron deficiency anameia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pancytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    Ear discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Hyperacusis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    3 / 7 (42.86%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    21 / 47 (44.68%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    3
    1
    0
    0
    1
    21
    1
    0
    External ear inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    Middle ear inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hearing impaired
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Hypoacusis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neurosensory hypoacusis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    3
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Photopsia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eyelid odema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Diplopia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    2 / 4 (50.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    2 / 3 (66.67%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    5 / 47 (10.64%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    1
    0
    1
    1
    0
    0
    0
    0
    2
    2
    1
    0
    2
    2
    0
    3
    5
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    3 / 47 (6.38%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    1
    2
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    Constipation
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    5 / 10 (50.00%)
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    4 / 5 (80.00%)
    1 / 3 (33.33%)
    6 / 38 (15.79%)
    14 / 47 (29.79%)
    2 / 2 (100.00%)
    4 / 13 (30.77%)
         occurrences all number
    1
    1
    2
    2
    2
    2
    1
    1
    3
    1
    2
    1
    0
    1
    1
    1
    5
    2
    1
    4
    1
    6
    14
    2
    4
    Diarrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    5 / 38 (13.16%)
    16 / 47 (34.04%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    1
    0
    2
    2
    3
    2
    1
    1
    2
    1
    3
    0
    0
    1
    0
    2
    1
    1
    2
    2
    1
    5
    16
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    5 / 47 (10.64%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    1
    1
    2
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    3
    5
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    3 / 4 (75.00%)
    3 / 7 (42.86%)
    3 / 6 (50.00%)
    5 / 8 (62.50%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    4 / 7 (57.14%)
    4 / 6 (66.67%)
    5 / 6 (83.33%)
    2 / 2 (100.00%)
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    2 / 4 (50.00%)
    4 / 10 (40.00%)
    4 / 7 (57.14%)
    1 / 3 (33.33%)
    3 / 5 (60.00%)
    2 / 3 (66.67%)
    15 / 38 (39.47%)
    39 / 47 (82.98%)
    1 / 2 (50.00%)
    4 / 13 (30.77%)
         occurrences all number
    2
    2
    3
    3
    3
    5
    2
    3
    4
    4
    5
    2
    1
    2
    2
    4
    4
    1
    1
    3
    2
    15
    39
    1
    4
    Stomatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    6 / 47 (12.77%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    0
    0
    0
    2
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    6
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    3 / 4 (75.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    2 / 10 (20.00%)
    3 / 7 (42.86%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    11 / 38 (28.95%)
    28 / 47 (59.57%)
    1 / 2 (50.00%)
    4 / 13 (30.77%)
         occurrences all number
    2
    3
    3
    2
    3
    2
    1
    2
    2
    2
    3
    0
    0
    1
    1
    1
    2
    3
    1
    2
    1
    11
    28
    1
    4
    Abdominal distension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    2
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Retching
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    2
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    1
    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
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Small intestine obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eructation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Gingival swelling
    alternative dictionary used: MedDRA 18,22.1&21
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Oesophageal obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oral dysaesthesia
    alternative dictionary used: MedDRA 18,22.1&21
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hepatomegaly
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    7
    0
    0
    Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    3
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    2
    2
    0
    0
    Rash
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    7 / 38 (18.42%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    1
    1
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    7
    2
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nail ridging
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Cold sweat
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Petechiae
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    1
    Nocturia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal impairment
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urine flow decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary hesitation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    5 / 38 (13.16%)
    5 / 47 (10.64%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    5
    5
    0
    1
    Back pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    3 / 3 (100.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    4 / 38 (10.53%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    1
    0
    1
    3
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    4
    7
    0
    2
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    9
    1
    4
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    2
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    1
    0
    0
    2
    0
    0
    1
    0
    1
    0
    0
    0
    2
    1
    2
    2
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    4
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    3 / 38 (7.89%)
    4 / 47 (8.51%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    3
    4
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Myopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pathological fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    0
    0
    Limb discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Soft tissue swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    2 / 6 (33.33%)
    3 / 8 (37.50%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    7 / 38 (18.42%)
    1 / 47 (2.13%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    1
    1
    2
    3
    0
    1
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    7
    1
    1
    0
    Lung infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    2
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    3 / 6 (50.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    5 / 47 (10.64%)
    1 / 2 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    5
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    4 / 38 (10.53%)
    9 / 47 (19.15%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    0
    2
    1
    2
    1
    0
    1
    0
    0
    2
    0
    0
    0
    1
    4
    9
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Tooth infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Breast abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site cellulitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    Chest wall abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Escherichia sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Genital candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infected skin ulcer infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pelvic infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Perichondritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bacterial infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Catheter site infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Device related infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Enteritis infectious
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Mastitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Mastoiditis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    3 / 7 (42.86%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    11 / 38 (28.95%)
    10 / 47 (21.28%)
    0 / 2 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    0
    2
    0
    3
    1
    3
    1
    1
    3
    2
    1
    1
    0
    3
    1
    0
    0
    0
    2
    1
    1
    11
    10
    0
    4
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    2
    3
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    2 / 38 (5.26%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    3
    0
    0
    2
    2
    3
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    3 / 38 (7.89%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    3
    2
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    2 / 38 (5.26%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    2
    1
    0
    2
    1
    2
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 38 (5.26%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    2
    2
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    3 / 38 (7.89%)
    7 / 47 (14.89%)
    0 / 2 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    1
    0
    1
    1
    2
    0
    1
    0
    1
    1
    1
    3
    7
    0
    3
    Hypomagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    4 / 38 (10.53%)
    9 / 47 (19.15%)
    0 / 2 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    1
    0
    0
    2
    0
    0
    1
    0
    1
    0
    2
    4
    9
    0
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    3 / 10 (30.00%)
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    3 / 38 (7.89%)
    3 / 47 (6.38%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    3
    1
    2
    0
    1
    3
    3
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Hypovolaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    0
    0
    1
    0
    1
    0
    0
    Fluid retention
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    2 / 47 (4.26%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    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
    Hyperalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 38 (2.63%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 38 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2013
    • To change cycle length from 28 to 21 days to align with standard chemotherapy cycle duration • To revise the definition of DLT • To add survival follow-up assessment for all subjects • Part A: To add cisplatin to the gemcitabine dose escalation after the initial gemcitabine escalation in order to determine the appropriate doses of M6620, cisplatin, and gemcitabine for Part C1 • Part B: To add a cisplatin-only escalation in order to determine the appropriate doses of M6620 and cisplatin for Part C2 • Part C: To expand Part C to 3 parts (Part C1 in NSCLC, Part C2 in TNBC, and Part C3 in SCLC)
    26 Nov 2013
    To revise the definition of DLT • Part C: To delete urinalysis on Days 3 and 9 • Parts C1, C2, and C3: To reduce the number of PK samples • Part C2: To exclude any prior platinum therapy for breast cancer in any setting (EC2)
    16 May 2014
    • To clarify the definition of refractory disease (Part C3) • To clarify stopping rules for subjects with progression disease (PD) • Part C3: To revise EC2 to exclude subjects who have not received at least 1 cycle instead of 2 cycles of prior platinum-based chemotherapy for SCLC • To allow preparation of gemcitabine and cisplatin per institutional practice • To update all timed assessments including PK and biomarkers to coincide with the actual end of infusion and allow for sample collections relative to the end of infusion • To update acceptable PK sampling windows • To update SAE reporting information
    12 Jun 2014
    • To remove the restriction on subjects receiving treatment with medications that are mainly metabolized by CYP3A4 as M6620 is not a potent inhibitor or inducer of Cytochrome P450(CYP) 3A and the probability of M6620 impacting such concomitant medications is low (EC14) • Part C3: To exclude subjects who had not received at least 1 cycle (rather than 2 cycles) of prior platinum-based chemotherapy for SCLC
    13 Aug 2014
    • To remove the restriction on treatment duration for subjects who appear to tolerate and respond to treatment for future subjects who may have potential clinical benefit from extended therapy • To expand the pretreatment window for safety laboratory assessments to 3 days before dosing • To allow Cycle 1 Day 21 assessments to be performed on Cycle 2 Day 1
    08 Dec 2014
    • To modify language to allow escalation of chemotherapy doses prior to escalation of M6620 to 200 mg/m^2 if exposures to M6620 exceed the predicted efficacious exposures at lower doses • To prevent pruritus by adding a rationale for management of potential infusion reactions, providing additional guidance for prevention, extending duration of M6620 infusion beyond 60 minutes, and updating the dilution volume for total doses of M6620 over 400 mg • Part C: To clarify that subjects who had received any prior platinum for squamous NSCLC except in the adjuvant or neoadjuvant settings are excluded
    07 Apr 2015
    • To revise the definition of DLT to exclude transient Grade 3 elevations in liver function tests (LFTs)
    10 Jun 2015
    • To revise the definition of DLT to exclude any grade of acute hypersensitivity reaction or the need to interrupt or discontinue treatment in the event of acute hypersensitivity • Part C: To exclude subjects receiving treatment with ototoxic or nephrotoxic medications that could not be discontinued >= 7 days before the first dose of study drug and for the duration of the study • Parts C1 and C2: To allow subjects who discontinue for reasons other than PD, who are nonevaluable for efficacy, or who discontinue due to PD before completing Cycle 1 to be replaced • Part C1: To redesign Part C1 to evaluate safety and efficacy of M6620 in combination with gemcitabine in approximately 30 subjects with advanced NSCLC who have received previous chemotherapy • Part C2: To redesign Part C2 to evaluate safety and efficacy of M6620 in combination with cisplatin in approximately 50 subjects with advanced TNBC • Part C3: To delete Part C3, which aimed to evaluate safety and tolerability of M6620 in combination with cisplatin and etoposide in subjects with relapsed or refractory SCLC
    14 Dec 2015
    • Part C1: To remove Prescreening • Part C2: To remove the requirement for >= 30 subjects to be androgen receptor (AR) negative
    16 Feb 2016
    • To clarify that MRI or bone scans may be used as an alternative to computed tomography (CT) scans for disease assessment but that the same technique should be used for assessment of response in an individual subject throughout the study • To exclude subjects diagnosed with Li-Fraumeni Syndrome or ataxia telangiectasia (EC 12) • Parts C1 and C2: To add starting doses for M6620/gemcitabine and M6620/cisplatin in Parts C1 and C2, respectively • Part C1: To allow enrollment of subject who had received an additional line of nonplatinum-based chemotherapy and those who had received prior gemcitabine for the treatment of non-small cell lung cancer (NSCLC) within 6 rather than 12 months (EC2) • Part C1: To enroll 10 subject without TP53 mutation or without ATM loss of expression and to remove the requirement for eligible subject to have documented radiologic progression • Part C2: To exclude the following subjects (EC2): Those who had received any prior platinum therapy for breast cancer within 6 months (rather than 2 years) of Screening; Those who had relapsed within 3 (rather than 12) months after completion of prior adjuvant or neoadjuvant chemotherapy; Those who had received any prior chemotherapy in the metastatic setting except for either a taxane or an anthracycline and 1 other nonplatinum-based chemotherapy • Part C2: To allow escalation of the dose of M6620 from 140 mg/m^2 to 210 mg/m^2 with 75 mg/m^2 cisplatin if initial doses of M6620 and cisplatin were tolerated in the first 5 of 6 subjects for 2 cycles • Part C3: To add a new Part C3, to evaluate the safety and efficacy of M6620 in combination with carboplatin in approximately 25 subjects with platinum-resistant advanced SCLC • Parts C1 and C2: Cycle 1 Day 9 PK sample removed
    21 Aug 2017
    • To remove the 5 mg/mL formulation of M6620
    25 Jan 2018
    • To add Part B2

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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